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Best podcasts about levine cancer institute

Latest podcast episodes about levine cancer institute

Oncology Peer Review On-The-Go
S1 Ep115: Ensuring Quality Outcomes in Hematologic Cancer Subgroups at EHA 2024

Oncology Peer Review On-The-Go

Play Episode Listen Later Jun 24, 2024 8:13


At the 2024 European Hematology Association (EHA) Congress, CancerNetwork® spoke with a variety of experts in the hematologic oncology space about optimizing outcomes across different patient populations and subgroups based on updated research they presented at the meeting.  Manali Kamdar, MD, an associate professor of medicine-hematology and clinical director of Lymphoma Services at the University of Colorado Anschutz Medical Campus, in Colorado, spoke about data from the phase 1 TRANSCEND NHL 001 trial (NCT02631044) supporting the use of lisocabtagene maraleucel (liso-cel; Breyanzi) in earlier lines of therapy for patients with relapsed/refractory mantle cell lymphoma (MCL).1  Specifically, Kamdar highlighted how research should continue to focus on the potential utility of liso-cel in MCL subgroups such as those with TP53 mutations or blastoid morphology. Additionally, she stated that liso-cel may need to be further tested in earlier lines of therapy for patients with diffuse large B-cell lymphoma, including those with double-hit lymphoma. Michael R. Grunwald, MD, chief of the Leukemia Division and director of the Transplantation and Cellular Therapy Program at Atrium Health's Levine Cancer Institute, in North Carolina, discussed findings from the Prospective Observational Study of Patients With Polycythemia Vera (PV) in US Clinical Practices Trial (REVEAL) exploring risk factors for disease progression in patients with polycythemia vera (PV).2 According to Grunwald, a history of thromboembolic events, elevated white blood cell counts, and higher variant allele frequencies may contribute to a patient's likelihood of experiencing progression to myelofibrosis or acute myeloid leukemia (AML). Additionally, he highlighted ongoing research into the potential molecular factors that may prognosticate disease transformation in PV among a small cohort of patients enrolled on the REVEAL trial.3 Harry P. Erba, MD, PhD, a professor of medicine in the Division of Hematologic Malignancies and Cellular Therapy and the director of the Leukemia Program and Phase I Development in Hematologic Malignancies at Duke Cancer Institute, in North Carolina, discussed the clinical implications of data from the phase 3 QuANTUM-First study (NCT02668653).4  Specifically, findings demonstrated that continuation therapy with quizartinib (Vanflyta) elicited a more pronounced survival benefit vs placebo in patients with newly diagnosed FLT3-ITD–positive AML who did not undergo allogeneic hematopoietic stem cell transplant (allo-HSCT). However, Erba noted that survival outcomes were not significantly different in the quizartinib and placebo arms among patients who received allo-HSCT. References 1.        Palomba ML, Siddiqi T, Gordon LI, et al. Subgroup analyses in patients with R/R MCL treated with lisocabtagene maraleucel by prior lines of therapy and response to Bruton tyrosine kinase inhibitor from the TRANSCEND NHL 001 MCL cohort. Presented at the European Hematology Association (EHA) 2024 Congress; Madrid, Spain; June 13-16, 2024. P1126. 2.        Grunwald M, Zwicker J, Gerds A, et al. A real-world evaluation of risk factors for disease progression in patients with polycythemia vera (PV) enrolled in REVEAL. Presented at the 2024 European Hematology Association (EHA) Congress; June 13-16, 2024; Madrid, Spain. Abstract P1047. 3.        Crowgey E, Timmers C, Xue Z, et al. Analysis of molecular mechanisms and predictive biomarkers of disease transformation in polycythemia vera. Presented at the 2024 European Hematology Association (EHA) Congress; June 13-16, 2024; Madrid, Spain. Abstract S217. 4.        Sekeres MA, Erba H, Montesinos P, et al. QuANTUM-First: efficacy in newly diagnosed patients with FMS-like tyrosine kinase 3-internal tandem duplication–positive (FLT3-ITD+) acute myeloid leukemia (AML) who received continuation therapy. Presented at the 2024 European Hematology Association (EHA) Congress; June 13-16, 2024; Madrid, Spain. Abstract S142.

Project Oncology®
The Impact of Advocacy on Healthcare

Project Oncology®

Play Episode Listen Later Jun 14, 2024


Guest: Ashley L. Sumrall, MD If we want to ensure that we and our patients have healthcare when we're older and it continues to be available, it's important to take a stand and be a part of advocacy work. There are multiple ways to get involved, and it's not as intimidating as someone might think, so to share some of these strategies and the impact it could have on the future of healthcare, join Dr. Ashely Sumrall, Medical Oncologist, Hematologist, and Associate Professor at Atrium Health in Charlotte, North Carolina at the Levine Cancer Institute.

Project Oncology®
The Power of Patient Advocacy in Daily Clinical Practice

Project Oncology®

Play Episode Listen Later Jun 14, 2024


Guest: Ashley L. Sumrall, MD Advocacy is rooted in patients telling their stories, and every patient can be an advocate to help and allow others to hear about their experience. This has also helped clinicians get the medicine they need for their patients. Dive in to hear how you can incorporate advocacy strategies into your practice with Dr. Ashley Sumrall, Neuro- and Medical Oncologist, Hematologist, and Associate Professor at Atrium Health in Charlotte, North Carolina at the Levine Cancer Institute.

ASCO Daily News
Exploring CAR T Cells in GI Cancers at ASCO24

ASCO Daily News

Play Episode Listen Later May 25, 2024 17:58


Dr. Shaalan Beg and Dr.Mohamed Salem discuss key abstracts that will be presented at the 2024 ASCO Annual Meeting, including hypoxia-response CAR T- cell therapy for solid tumors, GPC3-specific CAR T- cell therapy in hepatocellular carcinoma, and the promising efficacy of targeted therapies in GI cancers.  TRANSCRIPT Dr. Shaalan Beg: Hello and welcome to the ASCO Daily News Podcast. I am Dr. Shaalan Beg, your guest host of the podcast today. I'm an adjunct associate professor at UT Southwestern's Simmons Comprehensive Cancer Center. In today's episode, we'll be discussing some key abstracts in GI cancers that will be presented at the 2024 ASCO Annual Meeting. I'm delighted to welcome Dr. Mohammed Salem, a GI medical oncologist at the Levine Cancer Institute at Atrium Health, for this discussion. Our full disclosures are available in the transcript of this episode. Mohammed, it's great to have you back on the podcast. Dr. Mohamed Salem: Thank you, Dr. Beg. It's always a pleasure to be here. Thanks for having me.  Dr. Shaalan Beg: So we're seeing more and more exciting data emerge on the role of ctDNA in GI cancers. And that's a topic that we've covered fairly extensively on the podcast. This year, in Abstract 3513, investigators used a novel, highly sensitive HPV ctDNA assay to evaluate the clinical outcomes of HPV ctDNA status in people with localized anal cancer treated with chemoradiation. And we know that prior HPV infection is associated with 90% of anal cancers. Can you give us a summary of the study and why it's so important to the clinical care we're giving our patients today?  Dr. Mohamed Salem: Sure. So, as you already alluded to, in the current era of precision oncology or precision medicine in general, there is an effort to try to maximize treatment efficacy and minimize the side effects. We're trying to understand how to do that by developing more biomarkers. I think this was a very interesting study that was led by Dr. Morris of MD Anderson. As you mentioned, he tried to determine the correlation between that circulating tumor DNA at different timelines and also associated that with the relapse. Obviously, as we all know, HPV infection is linked to about over 90% of anal cancers, and anal cancer is increasingly common in the U.S.  The study design includes patients from stage 1, 2, and 3 anal cancer treated with curative intent concurrent chemo radiation and the plot sample to collect circulating DNA was taken at five weeks of treatment and then at various intervals, including 3months, 6  months, 9 months and 12 months, to detect the HPV circulating DNA. And the analysis was done to correlate detection of circulating DNA with a relapse.  So what they observed is after collecting the samples at the end of the treatment, which is 5 weeks, followed by 3 months, 6 months, 9 months, and 12 months following treatment using the correlation between the detection of circulating tumor DNA as well as the recurrence rate, they were able to identify that about 22% was seen at 5 weeks, 13% was seen at three months, then 10% was seen at 6 months, and 0% actually was seen at 12 months. In the final analysis, they concluded that detection of circulating DNA at 3 months was significantly associated with a relapse rate of those patients. And also, they looked at the baseline stage, T stage, end stage, age and other perhaps prognostic factors. But the clinical implication of that trial is this finding supports the potential of integrating now the circulating DNA analysis and routine post-treatment surveillance, which hopefully will help us identify those patients with high risk of relapse and whether they can be treated with adjuvant therapy  in context-free drug trial or even like more close surveillance. Obviously, this is a very novel study, so it needs validation. Also, we need to understand more about the platform used because with the immersion technology and how fast this field is moving, I think it's important to look at this platform or other platforms. I think as a concept it's very interesting and hopefully will help us to identify patients with higher risk. So, I'm looking forward to hearing the full presentation. Dr. Shaalan Beg: Moving on to colorectal cancer, Abstract 3514 is a trial of hypoxia-responsive CEA CAR T-cell therapy for people with heavily pretreated solid tumors where this was administered intraperitoneally or intravenously. And you know, as a solid tumor oncologist or GI oncologist, we've been watching the hematologic space evolve so dramatically in the last five years with cellular therapies that it's exciting to see these CAR T-cell approaches being applied in solid tumors with some results. So can you talk about this study and whether you think it will influence clinical practice?  Dr. Mohamed Salem: Of course, I'm actually very excited to see this study because as you mentioned, CAR T-cell therapy has been utilized in hematological malignancies for the last several years and in fact it's becoming a center of care. As you know, it's very effective in certain tumors. Unfortunately, we did not see a similar result in solid tumors thus far. I know we are trying to make progress, but we are definitely not seeing the same efficacy in solid tumors. And also, of course, in CRC and many other tumors, we need more target options, so I was very excited to see this abstract. And I want to give a little bit of background why this abstract is important. Many solid tumors have a low oxygen level environment, hypoxia obviously, which can impact the effectiveness of CAR T therapy. So hypoxia can suppress the immune response, leading to poor performance of the immune cells like the T cell within the tumor. The investigators, to overcome that challenge, meaning hypoxia impacting the efficacy of the T cell, they were actually able to engineer a CAR T cell to be hypoxia responsive. And what does that mean? That the cells are designed to become more active in low oxygen conditions, which is more difficult in many of the solid tumors. The reason that's very interesting is because, one, it reduces exhaustion of the T cell, meaning like when you have the T cell active all the time, they get exhausted. So when you have the T cell in the resting state, until they reach the tumor environment and they get activated by the hypoxia status, now you reduce the expulsion of the T cell. But also that one overcomes the resistance. So once activated in the tumor hypoxic environment, this CAR T cell shows increased efficacy in targeting and killing the cancer cell.  Based on that concept, the investigators conducted a phase 1 dose escalation study in solid tumors. So this was a phase 1 open label group escalation study involving patients with tumor suppressed CEA and also had relapsed refractory second line treatment. The trial actually included 2 routes of administration, which I think was very interesting – IV versus intraperitoneal, IP, way of administration. And they enrolled about 40 patients between June of 2022 and January 2023. And 35 patients had colorectal cancer, 3 patients had gastric cancer, and 2 patients had non-small cell lung cancer. Overall, there was no surprising safety data. In terms of side effects, it was largely macrocystis, colitis. Unfortunately, they had 1 treatment that did not finish. But the interesting feature was the efficacy of that concept was demonstrated and in fact they were able to see more disease response and control at this rate with IP infusion, which I think is a very novel approach. I would look forward to trying and looking into this kind of delivery, especially in CRC and other tumors. Dr. Shaalan Beg: Because we've known that historically managing disease intraperitoneally has been challenging with cytotoxic chemotherapies and even surgical approaches that have been deployed can be fairly morbid as well. So looking at novel delivery mechanisms can help us understand, maybe be able to manage side effects of treatments in different ways and open doors for treatment in diseases that otherwise we couldn't manage. So definitely a very novel and exciting approach on this study.  Dr. Mohamed Salem: I agree. I think the idea of administering an IP route is a very interesting idea.   Well, Shaalan, there is another study in CRC, Abstract 3515. This is the first human study of ABBV-400, cMET–targeting antibody-drug conjugate in advanced solid tumors. Can you tell us about this promising data? Dr. Shaalan Beg: Yeah, so we've known that cMET is a very relevant biomarker across many cancers, particularly colorectal cancer, and it is overexpressed in a fairly large proportion of multiple diseases. But there hasn't been an effective regimen that has been found to be tolerable to target this specific biomarker. In this study, the investigators are evaluating an antibody drug conjugate, which takes the cMET targeting antibody telisotuzumab and conjugates it to a novel topoisomerase one inhibitor payload. And there's a phase one study that enrolled people across multiple different tumor types. This was presented at ASCO 2023. And this year, the investigators are coming in and giving the results of a colorectal cancer cohort within that study. Patients were enrolled in the dose escalation phase, and in the dose expansion phase, there were 122 colorectal cancer cases; so a fairly healthy size colorectal cancer population. And the median number of prior lines of therapy was 4, which is fairly consistent with what we would expect in our clinical population for people with colorectal cancer. So what they found in terms of efficacy is that the response rates, the confirmed overall response rates, were between 15 and 20%, depending on what dose of the medication the patients had received. They enrolled people regardless of cMET expression and then evaluated the response based on a higher or lower cMET expression. And those with higher cMET expression had an overall response rate of >30%, while those with lower cMET expression had a response rate of 10 to 15%. So they still had a response rate, which for fifth-line colorectal cancer is something to be aware of and it could be a marker of more significant clinical activity than other treatments that are out there.  And with the antibody drug conjugates, it's also important for us to keep an eye on the side effect profiles because a lot of these agents can have distinct side effect profiles that otherwise we wouldn't be familiar with. And in this study, 64% of participants had a grade 3 or above treatment emergent adverse events, and 41% had serious adverse events. So definitely something to think about. And most of these were hematologic toxicities, 30% had grade 3 or worse anemia. Neutropenia was seen, in grade three and above, was seen in 25%, leukopenia or grade three and above was seen in 12%, and thrombocytopenia again around 12%. And the non-hematologic toxicities were nausea, fatigue, vomiting and diarrhea. There was some interstitial lung disease, pneumonitis, which was seen in 7% of the total population, of which 2% had grade three or above. So definitely something to think about. From my perspective, I really am excited about this presentation because we're seeing evidence of clinical activity focused on cMET for refractory colorectal cancer compared to other agents that are out in the market. If this pans out in future studies, it could definitely change the way we deliver our treatments. Dr. Mohamed Salem: I totally agree that we actually need more therapy for those patients. And I'm not surprised that the myelosuppression, as you mentioned, was in fifth-line treatment. So this patient had large exposure to cytotoxic agents before.   So, looking at CAR T once more, there is a very interesting Abstract 4019, which is a study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR T, in patients with advanced hepatocellular carcinoma (HCC). What are your key takeaways from this study, Shaalan? Dr. Shaalan Beg: This is a first-in-human study. It enrolled people with advanced HCC who failed on one or more lines of prior therapy and they were given one single infusion of C-CAR031 after standard lymphodepletion and they enrolled 24 patients across 4 dose levels. If we look at the overall response rate, 50% of the 22 people who were eligible for response assessments had a partial response. This response rate varies based on the dose level itself and the investigators claim a 90% disease control rate. So definitely when we think about standard treatments for hepatocellular cancer after first line therapy, this is something which will catch a lot of people's attention. Again, with CAR T-cell therapy, we need to be aware of the risk of potential toxicities. There were no dose limiting toxicities and CRS or cytokine release syndrome was observed in 91% of patients, while a very small proportion, about less than 5%, had grade three CRS. Most of the side effects here were, again, lymphocytopenia, neutropenia, thrombocytopenia, and some transaminitis in 16% of patients. They did see tumor reduction in 90%, not only in the intrahepatic disease, but also in the extrahepatic disease. And again, these are people who had BCLC stage C disease. So this included people with hepatic and extrahepatic metastases. And in terms of prior lines of therapy, 96% of patients had either received immune checkpoint inhibitors and TKIs.  If we think about how some other immune therapy regimens are being developed in the GI cancer space, there is some indication that liver lesions may respond differently compared to extra hepatic disease. So in this case, they saw responses in both scenarios, which makes it very exciting, because even though we've seen many approvals of TKIs and immunotherapy, anti-androgenic therapy in hepatocellular cancer, the treatment of these patients is still extremely difficult because of their underlying hepatic dysfunction. And it'll be very interesting to see how this treatment unfolds.  Dr. Mohamed Salem: You summarized it very well, Shaalan. I echo your thoughts. What is also interesting about that study, it's actually targeted at the GPC strain, which is prevalent in HCC but not normal tissue, which goes back to your comment about the toxicity, and hopefully we can also manage treatment in the context of underlying liver disease.  Dr. Shaalan Beg: I guess it's fair to say that we're both very excited to see what's ahead in GI cancers at the Annual Meeting.   Mohamed, thanks as always for sharing your great insights with us on the ASCO Daily News Podcast.  Dr. Mohamed Salem: Thank you all for having me, and I'm looking forward to meeting you and all our colleagues in Chicago in a couple of weeks. Dr. Shaalan Beg: And thank you to our listeners for your time today. You'll find links to the abstracts discussed today in the transcripts of this episode. I'll be back to cover late breaking abstracts and other key advances in GI oncology after the annual meeting, so please join me for more key insights from ASCO24 and on the ASCO Daily News Podcast. Finally, if you value the insights that you hear on the podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Find out more about today's speakers:  Dr. Shaalan Beg  @ShaalanBeg  Dr. Mohamed Salem  @SalemGIOncDoc    Follow ASCO on social media:  @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn   Disclosures: Dr. Shaalan Beg:  Consulting or Advisory Role: Ispen, Cancer Commons, Foundation Medicine, Genmab/Seagen  Speakers' Bureau: Sirtex  Research Funding (An Immediate Family Member): ImmuneSensor Therapeutics  Research Funding (Institution): Bristol-Myers Squibb, Tolero Pharmaceuticals, Delfi Diagnostics, Merck, Merck Serono, AstraZeneca/MedImmune    Dr. Mohamed Salem: Consulting or Advisory Role: Taiho Pharmaceutical, Exelixis, Bristol-Myers Squibb, Exelixis, QED Therapeutics, Novartis, Pfizer, Daiichi Sankyo/Astra Zeneca  Speakers' Bureau: Genentech/Roche, Taiho Pharmaceutical, Daiichi Sankyo/Astra Zeneca, BMS, Merck 

Oncology Overdrive
Patient and Physician Advocacy with Ashley Sumrall, MD

Oncology Overdrive

Play Episode Listen Later Feb 22, 2024 33:16


In this episode, host Shikha Jain, MD, speaks with Ashley Sumrall, MD, about advocacy outside of their oncology practices and organizations, what lies ahead for the field of neuro-oncology and more. •    Welcome to another exciting episode of Oncology Overdrive :58 •    About Sumrall 1:16 •    The interview 2:54 •    How did you end up in the neuro-oncology space? 3:21 •    As a neuro-oncologist, how do you stay up-to-date with neurology, oncology and medicine? 7:28 •    Is there a difference in the way you interact with a neuro-oncologist versus a medical oncologist?  8:58 •    What drove you to get into the advocacy space? 10:09 •    Do you predominantly do advocacy work through ASCO, or do you do it through other avenues as well?  12:20 •    If someone is interested in getting involved in becoming an advocate with ASCO, on the local level or on the national level, what is the best way for them to start that process? 15:24 •    How do you talk to people in and outside of organizations about current situations facing health care? 19:40 •    If people are interested in learning more about the AMA or getting involved with an organization like the AMA, how can they do so? 22:31 •    What do you see coming down the pipeline that you think is going to transform the neuro-oncology space? 27:16 •    If someone could only listen to the last minute of this episode, what would you want them to take away? 30:04 •    How to contact Sumrall 32:13 •    Thanks for listening 32:56 Ashley L. Sumrall, MD, is a neuro-oncologist practicing at Levine Cancer Institute in Charlotte, NC.  We'd love to hear from you! Send your comments/questions to Dr. Jain at oncologyoverdrive@healio.com. Follow Healio on X, formerly known as Twitter, and LinkedIn: @HemOncToday and https://www.linkedin.com/company/hemonctoday/. Follow Dr. Jain on X, formerly known as Twitter: @ShikhaJainMD. Sumrall can be reached on X, formerly known as Twitter: @AshleySumrallMD.  Disclosures: Jain reports no relevant financial disclosures. Sumrall reports receiving funding from Bristol-Myers Squibb, Exelixis, Kura Oncology, Novocure and Oncoceutics, and being a consultant for Abbvie, Athenex, Bayer, Exelixis and Novocure. 

ASCO Daily News
Managing the Complexities of Oncology Practice in 2024

ASCO Daily News

Play Episode Listen Later Dec 7, 2023 26:19


Drs. John Sweetenham and Lawrence Shulman discuss the challenges that oncologists will be confronting in 2024 and share insights on how to build clinician resilience and optimize the oncology workforce to provide better, safer care for patients with cancer. TRANSCRIPT Dr. John Sweetenham: Hello, I'm Dr. John Sweetenham from the UT Southwestern Harold C. Simmons Comprehensive Cancer Center and host of the ASCO Daily News Podcast. I'm thrilled to welcome my friend and colleague, Dr. Larry Shulman, to the podcast today. Dr. Shulman is a professor of medicine, associate director of special projects, and the director of the Center for Global Medicine at the University of Pennsylvania Abramson Cancer Center. Dr. Shulman is also the immediate past chair of the Commission on Cancer, and also serves on the National Cancer Policy Forum of the National Academies of Science, Engineering, and Medicine. His acclaimed research has led to the development of models of clinical care to improve the patient experience and quality of care in the United States and internationally. His activities have also included innovations in health information technology, cancer survivorship care, and some other related areas. Today, Dr. Shulman will be sharing his valuable insights on some of the growing complexities and challenges that we'll be grappling with in oncology in 2024 and beyond, and potential solutions to address these issues. You'll find our four disclosures in the transcript of this episode, and disclosures of all guests on the podcasts are available at asco.org/DNpod. Larry, it's great to have you on the podcast today. Dr. Lawrence Shulman: Thank you so much, John. Dr. John Sweetenham: To start with Larry, as you know, the growth in the number of patients with cancer and cancer survivors in the U.S. is greatly outpacing the number of clinicians available to care for them. The American Association for Cancer Research, for example, estimates that there will be nearly 2 million new cancer cases in the U.S. alone this year and that the number will increase significantly in the years to come. The number of cancer survivors in total in the U.S. is predicted to grow to around 20.3 million by 2026. So, the question our community has been grappling with for some time now is: “How do we confront these realities and provide optimal care for patients, while at the same time building the resilience of the clinicians who need to care for them?” This is an area I know that you've focused on for a long time and you've published several papers in recent years as well as the great work that you've done as co-chair of the National Cancer Policy Forum workshop on the oncology workforce. Can you share your insights into some of these challenges? Dr. Lawrence Shulman: Sure, John. Thank you very much. As you mentioned, the number of oncologists in this country is pretty stable. There's consistent but relatively low number entering the workforce and those of us who were really in the first wave of oncologists in the 1970s are beginning to retire. A number of years ago we thought, well, we need to figure out ways to recruit more medical students and trainees into the field of oncology, but that's clearly not going to happen. And as you also mentioned, the number of cancer patients is rapidly increasing in this country, partly because of the aging population and partly because frankly we're better at treating them. The cure rates are better, and the number of survivors is going up. So, the math is pretty straightforward. We have a relatively stable number of oncology providers trying to care for a rapidly increasing number of patients and that's just not going to change. So, we need to have plan B; we need to figure out how we can better meet the needs in this country. And I think all of us who practice are feeling the strain of trying to take care of these increasing number of patients. I think there are a few things that are contributing to this as well. One—the good news is we have lots of new therapies, we have lots of genomics, which are leading us to better tailor therapies for our patients. But this is all complicated and it's a lot for us all to learn and keep abreast of and to manage on a day-to-day basis in the middle of a busy clinic. But the other thing is that I believe our care has become progressively more inefficient, making it harder every day that we go to clinic to care for the number of patients we need to. And that really has to change. For those of us who've been doing this for a long time, and I know you have as well, this has been a trend really over decades. It's gone in the wrong direction. It was a lot easier to practice a number of decades ago. Now, the requirements for documentation and pre-authorization and many other administrative tasks has just grown progressively over these years. And we need to figure out how to change that. And in addition, our electronic health records, which is where we live in clinic, have been remarkable and wonderful in many ways, but are also inefficient to use and we need to do a better job in optimizing their functionality. Dr. John Sweetenham: Great, thanks Larry. I do agree with you there and I think that in addition to the challenges of running the electronic health record and using that at the point of care, of course the other thing that many of our clinicians face now is an increasingly complex treatment landscape and a greater need for clinical decision support tools, which of course are not always at the moment quite as facile as we would like them to be. And I think partly because of that, many oncologists are feeling overburdened partly with these various administrative tasks they have, partly with frankly keeping up with their own specialty areas or if they're community-based general oncologists, just keeping up in general with the new information that's coming at them. And then add on top of all of that the emotional toll of caring for patients with cancer. And not surprisingly, perhaps I think we have started to see, certainly we have experienced an exodus of some oncologists in recent years who've decided to pursue careers outside of direct patient care and oncology. And those included some moving into other areas of academia, some going into industry, some going into various tech companies and so on. Are you concerned that we all struggle in the effort of building and support a resilient oncology workforce to meet the needs of this growing population that you mentioned? Dr. Lawrence Shulman: Yeah, I'm very concerned about that, John. And I think one way to think about this is that as you say, the practice of oncology inherently is a stressful and difficult, though quite rewarding way to spend your professional career. But we layer on top of that a lot of frustration and difficulties that really don't need to exist. And when I think about this, I think about really two buckets. There's a bucket of factors that are within our control in an individual institution or an individual practice, and I'll come back to that in a minute. The other bucket are external forces, things that are required by the government regulators, by the payers that need to be done in routine practice. We have less direct influence over those, though I think it's a profession, we need to think hard about how to influence the external factors as well. At the practice level, there are a lot of things that we can do. One has to do with optimizing our electronic health record, which does have, in most cases, the ability to have it customized by institution in a way that would make it optimal. And some of that again, is external because we're dealing with a vendor product that has some limited ability to be customized, but we need to do a better job of the technology that underlies our practice every day when we go to clinic. The other major factor in support, whether it's advanced practice providers, nurses, medical assistants, navigators, and other personnel who can in fact help to support the patients, help to support their families, and help to support the clinicians who are on the front line trying to care for these patients. And we all use the term, practicing at the top of your license and aspire to that. But I think frankly we don't do a great job in that regard, and we need to really think harder about how we do have the appropriate team around us. In addition, I would say that there are a lot of other things at the practice level that we need to think about, including the facility of ordering radiologic studies and consultations and so on, all of which are often more cumbersome than they should be. We really need to not put these obstacles in the way of our clinicians. Externally, I think we need to get the payers and to get the government CMS to understand that the current state, it's just not going to be viable going forward and they need to make some big changes. And I think one of the ways to think about this is that rather than doing something differently, you want to do a different thing. I mean, they really need to make some paradigm changes and what's required day in and day out from our clinicians. Dr. John Sweetenham: Absolutely. So, I want to pick up on something that you mentioned there, which is the role of navigators and the benefits that navigation, patient navigation, can have in several domains, but certainly it can help to reduce the burden on oncologists and strain in the system in general. But to take that a little bit further, I wonder if we could talk a little bit about how navigation can help in reducing care disparities. You were saying before we came on the podcast today, the concept of using patient navigators to reduce disparities in care is not new. It's been around for many, many years, but it seems like we almost have to keep relearning that they really help in terms of reducing various disparities which may be rural disparities, racial and ethnic and so on. There are plenty of data out there, as you've mentioned, just to quote a couple of studies, there was the ACCURE trial published a couple of years ago now, which was really a multi-pronged intervention to help Black patients overcome obstacles to completion of treatment. And it included navigation along with a number of other interventions, electronic health record flags to alert caregivers to missed appointments, providers to missed appointments, I should say. It also included physician champions to help engage the health care teams and some educational interventions as well with a significant impact on the access to care from Black patients. The Levine Cancer Institute in the Carolinas conducted a study in my own world, in aggressive large B-cell lymphoma a number of years ago, where they showed that they were able to navigate all of their patients into guideline-concordant care, which essentially eliminated the disparity in outcome between Black and White patients in their population. And then more recently, a study from the University of Maryland looked at Black men with prostate cancer and demonstrated that with the intervention from a navigator, the number of those patients who had their appropriate genetic testing was increased enormously to levels which were comparable with the White patients in their community. No clear evidence yet that that's impacted outcome, although intuitively, I think it would, but nevertheless, as you've already pointed out, there is a ton of evidence that navigation can help us to eliminate disparities. Could you talk a little bit about your own insights into that area and the work that you've done? Dr. Lawrence Shulman: Sure. A few years ago, the National Cancer Policy Forum held a workshop on navigation in cancer and we spent a couple of days in Washington going over many of the studies you've mentioned. And one of our speakers was Harold Freeman, who was a surgeon in Harlem. About 60 years ago, he showed that patient navigation could reduce disparities in cancer care in his setting. And I think the surprising and somewhat disappointing aspect of this is, well, we have a new therapy, whether it's immunotherapy or whatever that is shown to improve overall survival and outcomes. We adopt that, and we start using it. And yet here something that's relatively straightforward, patient navigation, which has been shown as you say, to improve access to care, to improve guideline-concordant diagnostics, guideline-concordant treatment, patient satisfaction, and ultimately improve outcomes and reduce disparities, but has not been embraced in the same way that new therapies have been embraced. And from my point of view, these factors are equally important. They translate in the patient outcomes ultimately just like the therapies that we choose to. And we need to really buy into that. We need to understand that this really affects our patient outcomes as much as our therapies do. So, a couple of things. One is that you've already mentioned the different ways that navigation might improve outcomes, and that's clearly the case. But there are other aspects which are really critical to a lot of conversations we've been having, and that is that navigators fill vital roles that when they're not present are often filled by the treating physician, trying to make sure that the diagnostic tests, the genomics are all done, trying to make sure that the patient is getting their radiologic studies on time, trying to make sure that the appropriate appointments are being set up. Navigators are very, very good at doing this. They're very good at bonding to the patients and helping the patients feel secure through this cancer journey. But if they're not there, either those things don't get done or the clinician, the treating physician or the advanced practice provider is doing that. And so, it has the dual effect of both burdening clinicians who really have another role in the care of the patients doing these other scheduling and navigation functions as well as improving the overall care. I will say that in my own experience, it's important to have navigators who are skilled in their areas, that understand the diseases that we're treating, that understand the patient's needs in relation to those diseases and the treatments and diagnostics that we have to offer. So, there is a real skill to navigation, but a skilled navigator really makes a huge difference to the patient. And again, not only in the very tangible ways that you mentioned, but also frankly in the psychological security of the patient. And patients will tell you this and there are surveys out there that show this, that patients who are undergoing a new diagnosis of cancer are terrified, do much better psychologically when they have a navigator at their side through this journey. But it has tremendous benefit to the clinicians as well. And why haven't we embraced navigators? I can only speculate, but one of the comments that I get from health system administrators is, “Well, they cost a lot of money, and their work is not reimbursed as part of health care reimbursement.” But there is, again, overwhelming evidence to show that the return on investment for navigators is substantial. And it's substantial because it keeps patients in your practice, it provides more efficient care at all levels. And we published out of the National Cancer Policy Forum work, an article that basically shows from a variety of different centers, including mine at Penn, that there is a tremendous ROI for having navigators. So yeah, it's a little bit of money upfront to hire them, but ultimately, it's a good thing financially as well as clinically. Dr. John Sweetenham: Yeah. So often with these kind of wraparound services that are so important to our patients showing and being able to clearly demonstrate the kind of downstream revenue from those services is difficult, but is I think probably evident to those of us who are in the clinic and see what happens. So, maybe we need some more sophisticated financial models to be able to highlight that to our leaders in the health systems, I think that the evidence is really quite clear. So, Larry, one of the disparities that you've mentioned, and perhaps we haven't focused on quite so much in this discussion, has been the issue of cancer care for rural versus urban communities. And I think it's important that we highlight the challenges that oncologists are facing in rural communities across the country in caring for patients who live many miles away from a hospital or clinical practice and where the oncologists do not have the kind of support system that you'd find in an academic center in a major city. Can you comment a little on that? Lawrence Shulman: Sure, John. This is a real problem. I and others have published on cancer survival statistics in rural settings and in small community hospitals and they are in fact inferior to larger academic cancer centers, probably for a multitude of reasons. And one of our colleagues, Dr. Otis Brawley, made the comment a number of years ago and still repeats it, that your likelihood of surviving cancer in the U.S. is more tightly linked to your ZIP code than your genetic code. And there is some truth to that. Now, there are tremendous challenges for providing cancer care in a small, rural hospital. We practice in academic medical centers; I'm a breast cancer doctor and I spend all of my time trying to stay current in breast cancer. And it's a field that's changing rapidly. It's hard for me to imagine how my colleagues who are generalists in the community are keeping up with the advances in so many different diseases. And I think frankly, it's really, really hard to do that. In addition, all of us at academic centers have weekly tumor boards. We get to ask our colleagues what their thoughts are about our difficult cases. We get a lot of input from pathologists, radiologists, and other colleagues. And frequently clinicians, physicians, oncologists, practicing in rural hospitals don't have that constituency around them for them to bounce difficult patients off of to try to figure out what the best approach might be for a patient. So, the differences are terrific, and the support is just not there. This is something that our country has not really confronted. We have a very big country geographically. Some of the areas of the country are quite rural. A patient can't be expected to travel four hours in each direction to an academic cancer center. We need to figure out how to better partner between our academic cancer centers and our community colleagues to support their care in ways that we've not done routinely up to this point. I know that the National Cancer Institute is very interested in this and trying to figure it out. But again, I think we have to feel a collective responsibility to support our colleagues in the community. They try really hard, they're working really hard, they're doing the best they can, but they just don't have the support that we have in academic cancer centers. Dr. John Sweetenham: Yeah, sure. Before we wrap up the podcast today, I'd like to circle back a little to something that you said earlier and a topic that I know that you've published about quite extensively in the past and that's the issue of health care technology. And I think we probably all agree that health care's been a little bit slow to capitalize on technology to improve our care processes and outcomes. And your research has highlighted that technology can facilitate patient-clinician interactions in a number of ways through augmented intelligence, texting, chatbots, among other things. Can you tell us a little bit about this, how you think that AI might be able to help us in the future to streamline the management of some of these medical and administrative issues that we've been talking about today? Dr. Lawrence Shulman: Sure, John. It's hard to turn the TV on or read a newspaper without an article on artificial intelligence. But the word you used is the word that I use, which is augmented intelligence. I don't think we're looking to replace clinicians with technology, but we're looking to in fact make their jobs easier, to remove some of the tasks that they don't need to do themselves as really an assistant, if you will, another assistant. We have used technology extremely poorly in the medical profession overall. I'm not quite sure why that is. But if you look at the banking industry or other industries, they've used technology tremendously well with great benefit, benefit not only for the people who are using the services, in our case, the patients, but also those who are providing the services, in our case, the clinicians. So, I think we need to do a better job. We need to have electronic health records that are in fact helping rather than sometimes hindering or making frustrating the care of the patients. We need to use artificial intelligence or augmented intelligence to interact with patients and help to manage them. We're using augmented intelligence chatbots to manage patients who are on oral chemotherapy able to do a lot of the tasks that normally the clinicians would be doing without in any way jeopardizing the safety or the well-being of the patients. The patients actually tell us that they like this, that it's just another way to feel connected to their practice in a way that's efficient and easy for them through texting rather than sometimes trying to call the practice, which can be frustrating. But there are lots of other things as well in analyzing data, bringing data forward that will help us to make the appropriate decisions. And one of the things that I often use as an example is the airline industry. And they have a remarkable safety record as we all know, thank goodness. But if you sit in the cockpit of an airplane and you look at the instruments, all the critical data is right in front of them, unencumbered and very clearly presented because they need those data to fly the plane, and they need those data to be rapidly and easily accessible. They can get all the data they need; you look at the cockpit ceiling, it's got a thousand switches on, everything they need is there, but the critical data is never hidden and always presented. I don't think that that in fact is the way our electronic health records are set up. In fact, quite the contrary. And all of us spend a fair amount of time looking for data and so on because the records are complicated, and they're used by a lot of different specialists. But we can use augmented intelligence to bring all the critical data up, just like the cockpit in an airplane, to make sure that we have what we need rapidly accessible, and we don't miss anything. We don't go looking for the genomic test and can't find them and then assume they weren't done and make a decision without critical data when in fact they were done, but the data is hidden. So, I think we have a lot of options to use technology to improve our daily lives. I think it will take away some of the frustrations that lead to burnout, and we'll also make practice not only more efficient, but frankly also much safer. I think we have to work hard on this. We could partner with that technology colleagues. We at Penn are trying to do that. I know others are trying to do it as well. And I think the patients will benefit, will all benefit. Practice will be better, safer, less frustrating, and the outcomes of the patients will be better. Dr. John Sweetenham: Yeah, thanks Larry. I think your analogy with an aircraft cockpit is so perceptive and I think that that's something if we could unclutter our electronic health records and what we're seeing in front of us in at the points of care in the clinic, I agree 100% that will be such a step forward. So, thanks for sharing that. Thanks also, Larry, for discussing some of these challenges that we're going to be confronting in the next year and beyond, as well as the potential solutions. I think one thing that is really important to remember despite these challenges is something that I mentioned in the introduction to the podcast today. So, when we are all feeling a little bit disheartened because of the challenges ahead of us, it's important to remember that in 2026 there will be an estimated 20.3 million cancer survivors in the United States, which really does underline how far we've come, certainly in the time that you and I have been practicing oncology, and really important not to lose sight of that. We had a lot of challenges, but really the achievements of the last 50 years or so are pretty remarkable. It's been a real pleasure to have you on the podcast today, so thank you again for joining us and for sharing your thoughts with us. Dr. Lawrence Shulman: Thanks so much for having me, John. Dr. John Sweetenham: And thank you to our listeners for your time today. If you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. For more information on Dr. Shulman's research discussed in this episode, please see the articles below: The Future of Cancer Care in the United States—Overcoming Workforce Capacity Limitations | Health Care Workforce | JAMA Oncology | JAMA Network Developing and Sustaining an Effective and Resilient Oncology Careforce: Opportunities for Action - PubMed (nih.gov) Re-envisioning the Paradigm for Oncology Electronic Health Record Documentation by Paying for What Matters for Patients, Quality, and Research | Health Care Reform | JAMA Oncology | JAMA Network Survival As a Quality Metric of Cancer Care: Use of the National Cancer Data Base to Assess Hospital Performance - PubMed (nih.gov) Establishing effective patient navigation programs in oncology - PubMed (nih.gov) Patient Navigation in Cancer: The Business Case to Support Clinical Needs Cancer Care and Cancer Survivorship Care in the United States: Will We Be Able to Care for These Patients in the Future? - PMC (nih.gov) Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:      Dr. John Sweetenham  Dr. Lawrence Shulman     Follow ASCO on social media:       @ASCO on Twitter    ASCO on Facebook    ASCO on LinkedIn       Disclosures:      Dr. John Sweetenham:   Consulting or Advisory Role: EMA Wellness     Dr. Lawrence Shulman: Consulting or Advisory Role: Genetech Research Funding (Inst.): Celgene, Independence Blue Cross

The Oncology Nursing Podcast
Episode 274: Music Therapy for Patients With Cancer

The Oncology Nursing Podcast

Play Episode Listen Later Aug 25, 2023 34:15


“You don't have to have any musical background to benefit from musical therapy,” ONS member Susan Yaguda, MSN, RN, manager of integrative oncology and survivorship in the Department of Supportive Oncology at the Levine Cancer Institute in Charlotte, North Carolina, told Jaime Weimer, MSN, RN, AGCNS-BS, AOCNS®, manager of oncology nursing practice at ONS, during a discussion about how music therapists and oncology nurses collaborate to offer music therapy's benefits to patients with cancer.   You can earn free NCPD contact hours after listening to this episode and completing the evaluation linked below.   Music Credit: “Fireflies and Stardust” by Kevin MacLeod  Licensed under Creative Commons by Attribution 3.0  Earn 0.5 contact hours of nursing continuing professional development (NCPD), which may be applied to the Symptom Management, Palliative Care, and Supportive Care ILNA categories, by listening to the full recording and completing an evaluation at myoutcomes.ons.org http://myoutcomes.ons.org/by August 25, 2025. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of NCPD by the American Nurses Credentialing Center's Commission on Accreditation.  Learning outcome: The learner will report an increase in knowledge related to the use of music therapy.  Episode Notes  Complete this evaluation for free NCPD.  ONS Voice articles:  What the Evidence Says About Music Therapy for Cancer-Related Fatigue  Music Therapy May Bridge Race-Related Gaps in Cancer Pain Management  Clinical Journal of Oncology Nursing article: Mindful Awareness of Music: A Modality for Symptom Management  Academy of Neurologic Music Therapy  American Music Therapy Association  Association for Music and Imagery  Certification Board of Music Therapists  To discuss the information in this episode with other oncology nurses, visit the ONS Communities.   To find resources for creating an ONS Podcast Club in your chapter or nursing community, visit the ONS Podcast Library.  To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org.  Highlights From Today's Episode  “A lot of people have their workout playlist or something that kind of pumps them up before they're going to go play a tennis match or something like that. But in using music in this way, there isn't really a specific therapeutic goal and the relationship in these situations. And while any of us can provide recorded music or live music to patients, certainly our care partners, if we're not trained as music therapists, it just should not be considered or referred to as music therapy.” TS 3:56  “It might be using music to help regulate breath work, to reduce stress and anxiety associated with whatever they're having done in the suite. It can also be used as a distraction.” TS 6:19  “Oftentimes after that point, our patients may be starting to experience some other troubling side effects or symptoms from their treatment or their cancer. The music therapist can help them with better manage those in a supportive way. And this can be done in things like techniques to help them manage pain, techniques to help them maybe destress and get more restful, sleep even.” TS 7:00  “Sometimes using music as that tool helps create the space that does feel even more safe. It's not necessarily having to talk to someone directly, but music is the vehicle for doing that processing work.” TS 15:01  “There is receptive music therapy. So that is basically where the person receiving music therapy is not co-creating music, or writing lyrics, or anything like that, they're just listening. There might just be some paced breathing exercises that are incorporated into this. It tends to be a more repetitive type of cadence to the music that can help create just being in a better zone if they're trying to and bring the anxiety level down.” TS 16:16 

Cancer Buzz
Treating Small Cell Lung Cancer Through Multidisciplinary Enhanced Supportive Care

Cancer Buzz

Play Episode Listen Later Jun 29, 2023 11:13


Significant declines in the screening, diagnosis, and treatment of patients with small cell lung cancer have increased challenges that impact patient care. Many patients with small cell lung cancer have a high symptom burden, poor prognosis, adherence challenges due to treatment-related adverse events, stigmatization, and emotional distress. The team at Atrium Health's Levine Cancer Institute is testing supportive care options with the goal of meeting the needs of all their patients.   CANCER BUZZ spoke to Michele Szafranski, MS, RD, CSO, LDN, Registered Dietitian, Susan Yaguda, RN, Manager, Integrative Oncology, and Kathryn F. Mileham, MD, FACP, Chief, Thoracic Medical Oncology at Levine Cancer Institute, Atrium Health in Charlotte, NC. Listen as we discuss supportive care initiatives such as music therapy through a multidisciplinary care team lens when caring for patients with small cell lung cancer (SCLC). “Started an initiative to identify what some of those missing components may be, what do people most want. We tried to ensure we were aligning our goals with their (patient) goals. And we learned there were many needs, through patients and care providers that may not have been addressed previously.” Kathryn F. Mileham, MD, FACP “In this initiative we really looked for community partners that were well-vetted. Patients had already had strong relationships with some of the lung cancer programs here in town, and so we tried to really partner with them. We got their input about what they think patients needed, (and) what was missing from our offerings that patients could benefit from.” Michele Szafranski, MS, RD, CSO, LDN Kathryn F. Mileham, MD, FACP Chief, Thoracic Medical Oncology Levine Cancer Institute, Atrium Health Charlotte, NC Michele Szafranski, MS, RD, CSO, LDN Registered Dietitian Levine Cancer Institute, Atrium Health Charlotte, NC Susan Yaguda, RN Manager, Integrative Oncology Levine Cancer Institute, Atrium Health Charlotte, NC  Resources: Cancer Support Community Go2 for Lung Cancer LUNGEVITY Lung Cancer Research Foundation

ASCO Daily News
SONIA, NATALEE, and Other Advances in Breast Cancer at ASCO23

ASCO Daily News

Play Episode Listen Later Jun 21, 2023 25:11


Drs. Allison Zibelli and Arielle Heeke discuss the NATALEE trial's novel approach to high-risk HR+ breast cancer, the potential of delaying CDK4/6 inhibitors in HR+, HER2-negative mBC to decrease toxicities and costs in the SONIA trial, and de-escalation strategies in HER2+ early-stage breast cancer. TRANSCRIPT Dr. Allison Zibelli: Hello. I'm Dr. Allison Zibelli, your guest host for the ASCO Daily News Podcast today. I'm an associate professor of medicine and a breast medical oncologist at the Sidney Kimmel Cancer Center at Jefferson Health in Philadelphia. My guest today is Dr. Arielle Heeke, a breast medical oncologist at the Levine Cancer Institute at Atrium Health in North Carolina.  Today, we'll be discussing practice-changing studies and other key advances in breast cancer that were featured at the 2023 ASCO Annual Meeting.   Our full disclosures are available in the show notes and disclosures of all guests on the podcast can be found on our transcripts at asco.org/DNpod.   Arielle, it's great to speak with you today.   Dr. Arielle Heeke: Thank you so much for having me.  Dr. Allison Zibelli: Let's start with LBA500. This was the NATALEE trial of ribociclib and endocrine therapy as adjuvant treatment in patients with hormone receptor-positive HER2-negative early breast cancer. What are your key takeaways from the study, and how do you think this changes our approach to high-risk ER-positive breast cancer?  Dr. Arielle Heeke: Yeah, this was definitely the study for which many of us were waiting to see the results. It was exciting to see the results come through so quickly. As you mentioned, the NATALEE trial was a phase 3 study that evaluated three years of adjuvant ribociclib at a dose of 400 milligrams, which is a little different than what we're used to in the metastatic space at 600 milligrams. But essentially, it randomized patients to receive this 400-milligram dose with their adjuvant aromatase inhibitor therapy versus just the standard of care adjuvant endocrine therapy in patients that are high risk with early-stage breast cancer.   What made NATALEE somewhat unique is they defined high risk a little bit more broadly than we've seen in previous studies, such as monarchE. So, what I mean by that is NATALEE enrolled patients with stage 2 and 3 early-stage breast cancer. And notably, they allowed for patients that were lymph node-negative but had some other high-risk features, such as a grade 3 tumor or a grade 2 tumor with high-risk genomics, such as oncotype or a high Ki-67. So, by broadening who was eligible, NATALEE captured more patients at risk for recurrence. Of course, we know that recurrence is not specific for patients with lymph node-positive disease. We can see recurrence even with stage 1, but certainly, we start to see more recurrence risk as patients drift into stage 2 and stage 3.   In the NATALEE study, the majority of these patients did receive prior chemotherapy, which I also think is interesting. We've kind of seen in the metastatic space that sometimes chemotherapy can augment patients' responsiveness to CDK4/6 inhibitors. But specifically in NATALEE, 88% of patients had received prior chemotherapy, and ultimately, about a third of the patients were lymph node-negative.   So, diving into some of the results with this first analysis that we saw at ASCO, with the median follow-up for invasive disease-free survival of just 27.7 months, they were able to show that the risk for invasive disease was reduced by 25.2% with the addition of ribociclib plus endocrine therapy compared to endocrine therapy alone. And this three-year invasive disease-free survival rate was 90.4% for the combination therapy compared to 87.1% for endocrine therapy alone, which is an absolute difference of 3.3%. Additionally, patients treated with ribociclib and endocrine therapy had a 26.1% reduced risk for distant disease-free survival compared with endocrine therapy alone, and this was a rate of 90.8% for ribociclib with endocrine therapy compared to 88.6% with endocrine therapy alone, which correlates to an absolute benefit of 2.2%.    They did show results for overall survival as well, but again, follow-up was just a median of 27.7 months. So, data was essentially immature to show any true overall survival benefit from this approach. And in fact, only 20% of patients had completed three years of ribociclib at this data cutoff. And as a reminder, again, NATALEE involved ribociclib for three years compared to two years, which we've seen with other studies in this space.   Also, what was encouraging from NATALEE were the readouts for toxicities. Neutropenia is definitely a concern with this class of medication, and they were able to show that rates of neutropenia were overall lower than what we've seen in the pooled data in the metastatic space. And also that problematic QTc prolongation for which we have to get EKGs baseline two weeks and four weeks. They also showed that the likelihood of having QTc prolongation on this therapy was significantly less at that 400-milligram dose compared to 600.   I think the key takeaway is yes, this drug is effective as adjuvant therapy, which is perhaps not surprising since we've seen such promising results in the metastatic space, but numerically not as striking as what we have at this point with adjuvant abemaciclib, but of course, this is a newer study. We hope to see that continued separation of the curves as we were fortunate enough to see with the abemaciclib data, but obviously we'll be looking for additional analyses from NATALEE.    And then how this will change practice, of course, we'll have to wait to see if the therapy is approved for use in the adjuvant setting for early-stage hormone receptor-positive breast cancer, but it certainly will be a nice option for patients that struggle with GI toxicity kind of at baseline. But also, if they were previously on abemaciclib and were not able to tolerate due to the GI toxicity, this would be an option for them. Also, as mentioned, it's a broader patient population, so we can consider this perhaps for a patient with lymph node-negative disease.   Although we will have to ask ourselves that just because someone meets eligibility for the NATALEE  study, and if the therapy is ultimately approved, is it appropriate to give it to all those patients? Or do we need to still kind of think of this in the setting of the highest-risk patient, not just any patient with stage 2 plus disease? There was a lot of talk at the meeting, certainly about biomarkers and potentially using ctDNA to try to find these predictors of benefit from CDK4/6 inhibitor therapy, but obviously, still a long way to go before we can use that type of technology in this space.  Dr. Allison Zibelli: Thank you. Staying on the topic of CDK4/6 inhibitors, everybody was excited about the SONIA trial, which was LBA1000, and this trial was asking if we can delay using CDK4/6 inhibitors for newly diagnosed ER-positive HER2-negative metastatic breast cancer as a way to decrease both toxicity and cost. Tell us about this study.  Dr. Arielle Heeke: The SONIA trial was such a cool study to see, and the presenter reported findings in such a thought-provoking way. Really great to see this sort of work being done because I think we all wonder deep down in our gut, if more is more, or if we do need to kind of be a little bit more thoughtful about how we introduce these therapies certainly from a patient perspective. Patients that participate at ASCO [meetings] have been saying for years how important it is to consider the toxicities in terms of side effects, but also, of course, financial toxicities. So, it was great to see the SONIA trial at center stage.   Essentially, as you mentioned, it was a study that randomized patients in the first-line setting with metastatic hormone receptor-positive breast cancer to receive either first-line CDK4/6 inhibitor therapy or second-line CDK4/6 inhibitor therapy. So basically, there was a mandated crossover, so patients that received the CDK4/6 inhibitor first-line did not receive a second line and vice versa. Patients that were randomized to receive their endocrine therapy as monotherapy first line went on to receive CDK4/6 inhibitor at second-line. And the second-line endocrine therapy was fulvestrant in both of those situations.    We kind of run into this problem with patients now where we have so many therapies available to us that we don't typically run out of treatment options, but rather we run up against treatment toxicity or ultimate failure of the human body to keep up with the demands of ongoing therapy. So, again, while it's maybe somewhat attractive to start treatments earlier using things first-line rather than second-line or longer, just kind of post-CDK4/6 inhibitor progression, you know using this CDK4/6 inhibitor again with a different endocrine therapy backbone is probably not offering a meaningful benefit to that many patients. So this type of study is so necessary to really try to help us frame who needs those therapies sooner and longer or perhaps is there a substantial portion of patients that we don't need to put them through that sort of toxicity.   So that's the SONIA trial. Some things to note about the patient population, these patients were a bit older than what we've seen in some of our metastatic CDK4/6 inhibitor trials. There was a median age of 64 and 87% were postmenopausal. Additionally, just 40% had received prior chemotherapy. And as is true for most of our studies, 91% have received palbociclib on study with just 8% receiving ribociclib. And the choice of the CDK4/6 inhibitor was per the treating provider, and at the time of the of study globally, palbociclib was the more commonly prescribed CDK4/6 inhibitor. But over the last year or so, data has certainly emerged favoring ribociclib in the metastatic setting.   On the SONIA trial, patients were monitored for a median of 37.3 months. And looking at the primary endpoint of the second progression-free survival, which is defined as the time for random assignment to the second objective disease progression or death, for those patients who received first-line CDK4/6 inhibition, had a PFS2 of 31 months compared to 26.8 months with second-line CDK4/6 inhibitor use. And this slight difference was non-statistically significant. So the conclusion was that time to second progression was not impacted by whether or not a patient received first-line CDK4/6  inhibition or second-line CDK4/6 inhibition. Additionally, there were no differences in overall survival between the 2 arms with a median overall survival of 45.9 months with first-line CDK4/6 inhibitor use versus 53.7 months in second-line CDK4/6 inhibitor use.  And that actually equates to significant differences in time on drug. The median duration of CDK4/6 inhibitor use with first-line therapy was 24.6 months compared to 8.1 months with second-line use. And by being on therapy for an additional 16.5 months if you use CDK4/6 inhibitor first-line, this, of course, leads to increased toxicity and certainly increased financial burden. And it was estimated that for each patient that receives this therapy first-line, there is an additional $200,000 spent on getting them the CDK4/6 inhibitor first-line, whereas the results from SONIA suggested that whether you use it first-line or second-line, the outcomes are essentially exactly the same.   And then specific for the SONIA trial, by conducting the study, they saved approximately €25 million on drug expenditure during the conduct of the trial. It's just amazing when you take it to that scale. And then lastly just to mention, they looked at quality of life assessments as well and there were no differences in the two arms whether they got first-line or second-line CDK4/6 inhibition.  Dr. Allison Zibelli: I thought this study was remarkable, and it got a long ovation when it was presented at the meeting. I'm certainly going to use this strategy and prioritize who needs upfront CDK4/6 inhibitor therapy.  I think that we have to think of not just drug toxicity for our patients, but financial toxicity. A lot of these drugs have very high copays and the number one cause of bankruptcy in the United States is medical costs. So that's something we really have to keep in mind. I also thought it was very interesting that the study was designed in cooperation with the patient advocacy group and patients themselves were very enthusiastic about this study and helped design it and helped recruit to it. So all in all, I thought this was a remarkable study.    So moving on, LBA1013 was the TORCHLIGHT study of toripalimab versus placebo in combination with nab-paclitaxel for patients with metastatic or recurrent triple-negative breast cancer. Many of us are not familiar with toripalimab. Can you tell us about the drug and how it was used in this study?  Dr. Arielle Heeke: Yes, toripalimab is essentially an immunotherapy agent. It's an IgG4K monoclonal antibody that targets PD-1. In this study, TORCHLIGHT, patients were randomized to receive toripalimab versus placebo in combination with nab-paclitaxel in newly metastatic triple-negative breast cancer. The patients on study were randomized two to one to receive drug or placebo. The drug is given on day 1 of a 3-week cycle at 240 milligrams and then patients of course also receive nab-paclitaxel on a day 1 and day 8 schedule of a 21-day cycle. They did look at outcomes on the study based on PD-L1 positivity status and they assessed for PD-L1 with an IHC assay JS311 antibody that ultimately generated a combined positive score. And PD-L1 positivity was defined as a CPS of greater than or equal to one based off of this assay. In the study population, about a third of patients were- patients' tumors were CPS negative, a third had a CPS of 1 to 10 and about a quarter had a CPS of greater than or equal to 10. And then approximately 7% of the tumors had an unknown status.   And then getting right into the results, we were provided results in the PD-L1 positive subgroup as well as the whole patient population. Looking at the primary endpoint of PFS, there were significant improvements seen in median PFS with the addition of toripalimab to nab-paclitaxel, again in the first line setting with a median PFS of 8.4 months with the addition of the immunotherapy agent versus 5.6 months with placebo. And this was statistically significant.  And then in the intent to treat population, there were some numeric improvements, in median, progression-free survival at 8.4 months with the addition of toripalimab versus 6.9 months with placebo.   We also got some results with overall survival that were quite intriguing, although this initial analysis was not designed to necessarily prove statistically significant differences in overall survival. But again, there were some promising trends. Looking first at the PD-L1 positive subgroup, the median overall survival was 32.8 months with the addition of toripalimab versus 19.5 months with placebo. Breaking it down a little bit further based on CPS values, for a CPS of 1 to 10, median overall survival was 32.8 months versus 19.5 months. And then for those very high CPS or greater than or equal to ten, median overall survival was not reached in this group versus 18.3 months with placebo. Also, looking in the intent-to-treat population, there were also improvements in overall survival with the addition of toripalimab with a median overall survival of 33.1 months with the addition of immunotherapy versus 23.5 months with nab-paclitaxel alone. So potentially, depending on next steps of this study, we would potentially have an option to add immunotherapy that is not biomarker specific, meaning we can potentially provide toripalimab to all patients regardless of their PD-L1 status.  Dr. Allison Zibelli: Very interesting new drug to look forward to. So, one of the major themes of this year's meeting was de-escalation strategies. For example, LBA506 reported the three-year invasive disease-free survival of the PHERGain trial, which looked at eliminating chemotherapy for HER2-positive patients getting neoadjuvant therapy. Tell us about the design of this study and how will it impact the care of these patients?   Dr. Arielle Heeke: The design was very complicated. I had to look at it a few times to really make sure I got my head around it. But I think once you do figure it out, you can see how there might be a path forward in clinical practice. Although I think for all of this work, it's maybe not ready yet for primetime, but certainly thought-provoking. But the PHERGain clinical trial, I feel like we've heard about this study for a little while and this concept of de-escalation really kind of started in the HER2-positive space. But this study was a randomized study of chemotherapy de-escalation and early HER2-positive breast cancer using PET/CT as a marker of response to therapies that don't involve chemotherapy.   Patients were eligible for the study if they had stage 1 to 3a HER2-positive breast cancer with no prior therapy for breast cancer, and ultimately 356 patients were enrolled in a 1 to 4 randomization scheme with the majority of patients ultimately enrolled into the experimental group, which is called Group B. So, to break down Group A and Group B, Group A essentially were patients that receive typical standard of care, which at this point is TCHP for six cycles, neoadjuvantly or prior to surgery. Once they complete those cycles they move into surgery and then Herceptin-PERJETA adjuvantly for additional twelve cycles.  I should also note that this study was conducted prior to results of the KATHERINE trial that showed benefit of switching to adjuvant T-DM1 if there's residual disease. So, patients in Group A as well as Group B did not receive T-DM1 at any point. So, again, Group A is kind of your standard of care. Group B was the “experimental arm.” And so, what they did in this arm to assess potential de-escalation strategies, patients first received Herceptin-PERJETA alone for two cycles with or without endocrine therapy, if they were also hormone receptor-positive. But after those two cycles, they underwent a PET/CT, and then if a response was garnered, they would continue with Herceptin-PERJETA and again plus or minus endocrine therapy to complete six cycles total before proceeding on with surgery. Then if they were fortunate enough to achieve complete response at the time of surgery, then they just continued with Herceptin-PERJETA maintenance, whereas if they did not achieve a complete response at the time of surgery, then they actually received TCHP 6 times adjuvantly. So, the chemotherapy was introduced after surgery.   And then going back to that PET/CT time point, if patients did not achieve a response at that check-in point, after 2 cycles of Herceptin-PERJETA, at that point they were transitioned to chemotherapy with TCHP, again, for six cycles. So, either they could kind of ride all the way through if they got that complete response at the time of surgery with Herceptin-PERJETA only, or if at surgery there was residual disease, they went on to receive TCHP after surgery, or if they did not have a response on that interim PET/CT after 2 cycles of HP then they would go on to receive TCHP neoadjuvantly.    So, looking at the results, they actually had 2 primary endpoints. The first primary endpoint was rates of a complete response at the time of surgery in patients that had a PET response. So, PET responses were actually seen in nearly 80% of all the patients treated with Herceptin-PERJETA without chemotherapy. And in those PET responders, a complete response rate at the time of surgery was seen in approximately 38% of patients. So, 37.9% of PET responders actually achieved a complete response when they went to surgery after receiving Herceptin-PERJETA alone, which is pretty amazing. I mean, we're used to seeing higher complete response rates with neoadjuvant therapy for HER2-positive disease, but again, this is a chemo-free regimen so that is encouraging for that 38% of patients that really didn't need chemotherapy.   And then the second primary endpoint, and this was what we saw basically for the first time with the 2023 ASCO Meeting, was results for the 3-year invasive disease-free survival in Group B or this experimental de-escalation group. And ultimately it was shown that the three-year invasive disease-free survival and the intent to treat group B population was 95.4%, which met its statistical endpoint, or, basically the null hypothesis was rejected. They just needed some sort of outcome that was not worse in terms of the 3-year invasive disease-free survival of 89%.   And then looking actually at the patients that kind of did the best. So, the patients that were PET responders and achieved a complete response at the time of surgery and therefore really only ever received Herceptin-PERJETA, their three-year invasive disease-free survival was 98.8%. So, really very good. Additional endpoints they looked at in Group A and Group B were favorable in terms of three-year invasive disease-free survival in Group A, and then three-year distant disease-free survival and three-year overall survival in both groups, all approximately 98%. So, very favorable.   So, ultimately, these findings reflect a potential role for a chemotherapy-free treatment approach for some patients with early-stage HER2-positive breast cancer. And this particular study, they used PET/CT to influence chemotherapy decision-making, which potentially identified 1 in 3 patients who can omit chemotherapy. With that, 80% of patients receiving the response with a PET/CT, and then of that, 80%, again, 38% actually having that complete response. And ongoing work is also being done to look at other mechanisms to assess for an opportunity to de-escalate with MRI imaging or HER2DX testing to again try to identify patients who can potentially defer chemotherapy in this setting. I did not see from the results what proportion of patients were hormone receptor-positive, which I think is also interesting when thinking about chemotherapy de-escalation, can you lean a little bit more heavily on endocrine therapy? Perhaps we'll get that data in the future.   Dr. Allison Zibelli: That's a very important point.  I would like to thank you, Dr. Heeke, for coming on the podcast today and sharing your valuable insights with us. We really appreciate it.  Dr. Arielle Heeke: Absolutely. It was a great meeting to dive into. It's always exciting to see what comes out of ASCO in the breast space. We're usually well represented there, and I hope that these studies will lead to further exploration.   Dr. Allison Zibelli: And thank you to our listeners for joining us today. You'll find links to all abstracts discussed today in the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts.  Disclaimer:   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Follow today's speakers:   Dr. Allison Zibelli   Dr. Arielle Heeke  @HeekeMD     Follow ASCO on social media:    @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn      Disclosures:    Dr. Allison Zibelli:    None Disclosed   Dr. Arielle Heeke:   Honoraria: Merck  Consulting or Advisory Role: Jazz Pharmaceuticals, Caris Life Sciences, Amgen, Daiichi Sankyo/Astra Zeneca, Pfizer, AstraZeneca, Menarini, Genome Insight  Speakers' Bureau: Daiichi Sankyo/Astra Zeneca      

ACCRU Transformative Research
Dr. Shebli Atrash on the Challenges in High-Risk Myeloma Research

ACCRU Transformative Research

Play Episode Listen Later Jun 13, 2023 21:44


High-risk myeloma is a moving target. Myeloma plasma cells always learn to fight back. The key to treating myeloma is to fight multiple targets, understand the biology, and find out why myeloma is becoming more aggressive.  In this episode, ACCRU podcast host Dr. Kristen Ciombor interviews Dr. Shebli Atrash, who specializes in hematology and oncology at the Levine Cancer Institute in Charlotte, N.C. He is also a Community Member of the ACCRU Board of Directors. Dr. Atrash discusses what drew him to hematology oncology and shares what needs to be improved in high-risk myeloma research. His current myeloma study with ACCRU will enroll approximately 42 patients across 7 centers.  Dr. Atrash also shares his advice for junior investigators getting started in their field of research.  

ASCO Daily News
ASCO23: CodeBreak-101, NAPOLI-3, and Other Advances in GI Cancers

ASCO Daily News

Play Episode Listen Later May 25, 2023 21:45


Dr. Shaalan Beg and Dr. Mohamed Salem discuss novel therapies in gastrointestinal cancers, including CAR T therapy and the CodeBreak-101 trial in mCRC, new advances in uHCC in the HIMALAYA trial, and an exciting update from the NAPOLI-3 trial in pancreatic cancer, ahead of the 2023 ASCO Annual Meeting.  TRANSCRIPT Dr. Shaalan Beg: Hello, and welcome to the ASCO Daily News Podcast. I'm Dr. Shaalan Beg, your guest host of the podcast today. I'm the vice president of oncology at Science 37 and an adjunct associate professor at UT Southwestern Simmons Comprehensive Cancer Center. My guest today is Dr. Mohamed Salem, a GI oncologist at the Levine Cancer Institute at Atrium Health. We'll be discussing key posters and oral abstracts in GI oncology that will be featured at the 2023 ASCO Annual Meeting.  Our full disclosures are available in the transcript of this episode, and disclosures of all guests on the podcast can be found in our transcripts at asco.org/DNpod. Mohamed, thanks for coming on the podcast today.  Dr. Mohamed Salem: Thanks, Shaalan.  Dr. Shaalan Beg: There's some interesting studies in colorectal cancer that I'd like to get us started with today. Abstract 3547 is titled “A Phase I Dose-escalation Study of GCC19 CAR T: A Novel Coupled CAR Therapy for Patients with Metastatic Colorectal Cancer.” What are your thoughts on the study? Dr. Mohamed Salem: Actually, this was a very exciting study to see coming out in GI cancer, especially colorectal cancer. As you know, CAR T made its way to the treatment of lymphoma and other heme malignancies. In fact, we saw a fascinating response and outcome using that technique and that niche in the immunotherapy module. The challenge we had was that we could not replicate this in solid tumors until very recently. I'm sure you had the same thing in your clinic, too. A lot of patients with GI cancer or colorectal cancer come to you and say, "Okay, why can't I have CAR T?" And the response was, "We don't know if it's effective or if it's going to work yet." Here at our center, we had a phase 1 study, I think that was looking also at CAR T and solid tumors, particularly prostate cancer. So that I think was very exciting to see that technology is making its way to the solid tumor. I was very pleased to see this CAR T study coming out from the work of our Chinese colleagues looking into this in the CRC space.  Obviously, as you know, in colorectal cancer, we made a significant advancement, but I don't think we made enough advancement yet, and especially for refractory patients, patients with refractory disease who have underwent multiple lines of therapy. And this study actually addressed the need for those patients. So in this study, that was a phase I escalation dose, very much is we looked at about 13 patients who had metastatic CRC, they had at least two lines of therapy. So in what we say is a "refractory setting," unfortunately for those patients, we don't have large treatment options. And they used two doses, the first dose and the second dose that was a little bit higher. And the interesting part is that they were able to see very nice responses on this patient population. In the lower dose, I think the response was the PFS was about 1.9 months. But when they went up on the dose, actually the PFS was 6.3 months, which I think in the refractory setting is very meaningful.   And also the median overall survival for the first group was 13 months, which in the refractory setting is something we don't see often, and the higher dose was 18 months, which was even better. So there was a trend that higher doses are perhaps more effective or have better efficacies than lower doses, but also in terms of side effects, actually patients were relatively able to tolerate it well, and there were no surprising adverse events. So again, yes, that's 13 patients in total. So it's a very small study, but like everything else, the proof of concept sometimes is the first step and it's very important to see that data to suggest that this technology now can be utilized in solid tumors and CRC, especially now there is an unmet need for those patient populations. I'm sure you and I will see a lot of patients at the clinic with good progress status, and just looking for the next option, and I'm glad to see that. Hopefully, we can continue to build on that work.  Dr. Shaalan Beg: Another key abstract in colorectal cancer is Abstract 3513, the CodeBreak 101 study. This is a phase 1b safety efficacy trial of sotorasib plus panitumumab and chemotherapy with FOLFIRI for previously treated KRAS-G12C mutated colorectal cancer. And this is a really important study because even though KRAS-G12C represents a minority of KRAS mutated colorectal cancer, we know that this treatment can cause meaningful improvement in disease for other cancers like non-small cell lung cancer. And when sotorasib was tested as monotherapy in colorectal cancer, it saw an objective response rate of 9.7% that increased to 30% when added to panitumumab.   So in this trial, they took sotorasib plus panitumumab and added it to chemotherapy to see how it's tolerated and what its effectiveness is going to look like. And they enrolled people who had more than one or more lines of prior therapy for metastatic disease. They treated 33 patients. The most common side effect was dermatologic, which is probably related to EGFR-based therapy, and they saw a confirmed overall response rate of 58%. Side effects are those that we look to expect with this specific regimen. I don't see any additional safety concerns here, but this can be a big step forward for KRAS-G12C-altered colorectal cancer. What do you think? Dr. Mohamed Salem: I totally agree. And again, it was very exciting to see that abstract and that result. I totally believe now, and I'm sure you would agree with me too, Shaalan, that we're moving from an era of one size fits all to a precision oncology and tailored treatment. And the fact now we have a treatment option for patients with a KRAS mutation is very exciting because before, we didn't have much that we can do about that mutation. So now it's not just a proof of concept. Now you're hitting that target with the chemotherapy and you're getting a 50% response rate. That's something interesting also to see for this patient population and as you highlighted as safety also, and the adverse event was not high and patients were able to tolerate it, which makes it more doable for us to use it. Dr. Shaalan Beg: Yeah. And one of the challenges in the precision oncology space, which I'm sure you're experiencing in clinic as well, are the real-world applications of precision oncology and the drop-offs that happen that are preventing us from universal precision oncology - meaning the drop-offs that we see on eligible patients receiving the appropriate genomic testing, those who have genomic testing receiving the appropriate treatment. And we've seen a couple of fairly high-profile studies that are describing this in non-small cell lung cancer where the rates are not as encouraging as we would want it to be, which to me, as a physician, makes me worried that there are people out there who we don't know are carrying these mutations or have these mutations, and it hasn't been acted upon.   And related to that, there is an abstract at ASCO23, which is Abstract 3602, that looked at the real-world rates of FDA-approved targeted therapy and immunotherapy for people with metastatic colorectal cancer. They used the VA's National Precision Oncology Program data to study the prevalence of these mutations and how many of the folks ended up receiving the treatment that would be appropriate for those mutations. And this is a very exciting study. They looked at 908 metastatic colorectal cancer patients who underwent genomic profiling, 81% were colon and the rest were rectal. They found that 34% of patients harbored NRAS, KRAS, BRAF mutations, 9.6% were TMB-high, 7.7% had BRAF V600E, and 5.6% were MSI-high, which kind of puts the overall actionable variant prevalence in colon cancer at 47% and for rectal cancer at 44%.  And then they went down to see amongst those 424 eligible patients, how many ended up on appropriate therapy. And these were their numbers: for MSI-high 70%, TMB-high 47%, NRAS, KRAS, BRAF, wild-type 38%, BRAF V600E 17%. So nearly 30% of patients with MSI-high colorectal cancer did not receive immune checkpoint inhibitor therapy, and again, other aspects in terms of EGFR use, and I know that there are other challenges that may affect the use of EGFR inhibitors in colorectal cancer, but it really begs the point on aspects related to implementation science, on getting the testing and acting on those results. And I'm curious to what you're seeing that's being done on these initiatives nationally.  Dr. Mohamed Salem: I totally agree with you, Shaalan. This is a big problem we're facing day in and day out because we struggle to find treatment options for our patients. And I think if we're missing patient with targetable or actionable mutations and we're not utilizing that, I don't think that's a good situation to be in. And I think that's just a group effort. You have to work with the pathologist, you have to work with your team at the clinic. And as an oncologist treating this patient, we have to pay close attention to those markers. And frankly, just look for them. At least  the ones that you know are going to have therapeutic implications.  I do also think patient advocacy has a huge role here and huge opportunities that they can contribute. I am sure you are familiar with the pancreatic study that was published by our colleague Mike Pishvaian in Lancet a year or two ago. I think he named it the Know Your Tumor Type. I think that should be the way forward now, not just for pancreatic but for any cancer. Patients should ask their oncologists what my tumor is. Is it MSI-high, is it KRAS-G12C, is it BRAF? Because it will affect the treatment. I think it's multi-layer and all of us should work in a cohesive manner to be able to not ever miss those markers which carry therapeutic potential.   Dr. Shaalan Beg: So moving on to hepatocellular carcinoma, Dr. George Lau and colleagues, they'll be sharing data from the phase 3 HIMALAYA study with hepatocellular carcinoma in the Annual Meeting that's Abstract 4004. And he looked at outcomes by occurrence of immune-related events for people who received tremelimumab and durvalumab. What are your thoughts on this study?  Dr. Mohamed Salem: This was a very interesting abstract to see. For a long time, we didn't have many treatment options in hepatocellular carcinoma. So, over the last two or three years now, I think we've made nice advancements in the therapeutic landscape. So, we have multiple options including immunotherapy which is very exciting for all of us to be able to utilize those powerful drugs in that disease. The question that comes out is who actually responds? Obviously, in HCC you don't have a lot of biomarkers like the immune therapy biomarkers like MSI-high and PDL-1, and TMB. It isn't really playing a huge role in HCC. So, as you know, the HIMALAYA study is a phase 3 study and examined the STRIDE regimen which is treme plus durva in the first line of patients with metastatic or unresectable HCC against sorafenib. And the outcome was in favor of the STRIDE regimen with improvement in OS response rate and duration of response and because of that, it became one of the standards of care for that disease. But Abstract 4004 is actually asking a very interesting question - whether immune-related adverse events can predict outcomes. Meaning like those patients who experience immune-related adverse events will likely do better compared to those patients who didn't experience immune-related adverse events or not. The idea of adverse events as a biomarker if you will, for efficacy is not new. I mean we saw that back in the renal carcinoma TKI, hypertension. People who had hypertension were more likely to have a better response. In the GI also there was some data suggesting that rash might be a biomarker in predicting response to EGFR. So the same question we're applying here - immune-related adverse events can function as a biomarker for efficacy for the immune system.  And there are some data out there in other tumors that may be the case, but I think at least to my knowledge in the HCC or GI, this was the first study to address that question. So just to remind our audience that the HIMALAYA was a phase 3 study using the STRIDE regimen as a frontline for patients with hepatocellular carcinoma, either unresectable or metastatic disease. And they compared the STRIDE which is durva-treme compared to the standard of care at that time was sorafenib. The primary endpoint was overall survival and they had secondary endpoint duration of response, response rate, and obviously adverse event.  The study was positive, it met its primary endpoint and OS was in favor of the STRIDE regimen compared to sorafenib. But that part of the abstract now is focusing mainly on those patients who had immune therapy and whether that was a STRIDE regimen or the third arm that durva alone treatment. And they're looking at those patients who had immune-related adverse events, and those who didn't have immune-related adverse events. So basically four groups of patients, the patient who had a STRIDE regimen, about 139 patients had immune-related adverse events, and about 249 didn't have immune-related adverse events. For the cohort who had durva alone, about 64 patients had immune-related adverse events, almost 300 patients had no immune-related adverse events.  And it was very interesting that at least in the STRIDE arm, those patients who experienced immune-related adverse events, their outcome was better than those patients who did not have immune-related adverse events. It's the same trend seen on the durva alone arm, but I think the number was very small to make a statistical value out of it. But I think at least in the STRIDE arm there was a suggestive trend toward the outcome of those patients who experienced immune-related adverse events. So I think this is in a way very interesting because we're always wondering if we give the same dose at least in immunotherapy like for everyone.   What I was wondering is if it's too much, too little, or just right. It's hard to know for sure. But perhaps in my opinion and just me trying to understand why, in my theory, maybe that's just an indication of patients receiving enough drugs and effective drugs that will translate into efficacy. But at the same time, I also wanted to just put a word of caution here because we don't want to see side effects as a good thing. I think we want to make sure that us as oncologists treating these patients and patients also don't see like it's good to have a side effect. Side effects associated with especially those grade 3 or 4 can be associated with significant problems and decreased quality of life. So, definitely should be looking at those side effects and be careful interpreting those data. But I think that is very interesting and I will look for more work on that.   Dr. Shaalan Beg: Let's move on to pancreatic cancer. We heard the results of the NAPOLI-3 clinical trial at GI ASCO and this year in ASCO 2023 we will hear the results of Abstract 4006 by Dr. O'Reilly that are presenting results of the 12 and 18-month survival rates from the study that compared NALIRIFOX or nano-liposomal irinotecan, 5-fluoro/leucovorin, and oxaliplatin versus nab-paclitaxel/gemcitabine for newly diagnosed pancreatic cancer patients. I'm interested to hear what you think about that study. Dr. Mohamed Salem: Thank you, Shaalan. So this also is a very exciting abstract to see, and anyone who treats pancreatic cancer patients realizes that, unfortunately, even in 2023, we don't have a lot of treatment options. And yes, I think over the last decade we're now talking about second-line and third-line, but yet we still don't have a lot of treatment options. So, having more options is always good. But the question now is how do you sequence those chemotherapy options? Most of us obviously use FOLFIRINOX in the first line or gemcitabine and paclitaxel in the first line. Until very recently– because we didn't have a head-to-head comparison– we couldn't tell patients for sure if one is better than the other. I think we had some assumptions, but it wasn't really proven. It was just a cross-trial comparison.  So, the fact is that now we have that phase 3 trial looking at liposomal irinotecan, 5-fluoro/leucovorin and the oxaliplatin comparing to nab-paclitaxel/gemcitabine. To me, that was actually very exciting because now, at least, I can see a triplet chemotherapy drug compared to a doublet chemotherapy drug. And as you mentioned, Shaalan, the first initial read was positive in favor of the triplet regimen compared to the doublet, which I think was an important message to give to our colleagues and all of us that if you can, obviously, the triplet comes with side effects, but if you can deliver the triplet, that's perhaps a better starting point for the treatment. But the study here, we're trying to get more read after more mature or more time-lapsing. So the initial study was initial read was positive. And I think this is good to see, too because it translates that even with a longer follow-up, we're still seeing the same benefit. So the OS rate in 12 months for the triplet was about 45% compared to 39.5% for the doublet, and the 18 months, a year and a half, was 26% compared to 19%. So, definitely, you can see an improvement in every single endpoint. OS in general was 11.1 months compared to 9.2 months, and PFS was also in favor of the triplet. So I think it's a message here to reinforce what we saw a few months ago in the initial presentation that, in fact, the triplet is associated with better outcomes if you can safely manage the toxicity and guide the patient through the process. Dr. Shaalan Beg: Well, thank you very much, Mohamed. This was a lot of fun. Thanks for sharing your valuable insights with us on the ASCO Daily News Podcast. Dr. Mohamed Salem: Thank you for having me and looking forward to the full presentation at the meeting. And please, if you haven't registered for the meeting yet, make sure you attend. It's a wonderful opportunity to learn from an expert in the field and also meet your colleagues and make new friends. I also want to take this opportunity to thank the ASCO Daily News Podcast team for taking the time, and also for our colleagues who reviewed these abstracts. This takes a lot of time and effort, and I think they're doing a wonderful job. So, thank you to all of them, and I'll see you all at ASCO.  Dr. Shaalan Beg: And thank you to our listeners for your time today. You'll find links to the abstracts discussed today in the transcript of this episode. I'll be back to cover late-breaking abstracts and other key advances in GI oncology after the annual meeting, so please join us for more key insights from ASCO 23 on the ASCO Daily News Podcast.  Finally, if you value the insights that you hear on the podcast, please take a moment to rate, review, and subscribe wherever you get your podcast.  Disclaimer:The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experiences, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Find out more about today's speakers: Dr. Shaalan Beg @ShaalanBeg Dr. Mohamed Salem @SalemGIOncDoc   Follow ASCO on social media: @ASCO on Twitter  ASCO on Facebook  ASCO on LinkedIn   Disclosures:  Dr. Shaalan Beg: Consulting or Advisory Role:  Ispen, Cancer Commons, Foundation Medicine, Genmab/Seagen Speakers' Bureau: Sirtex Research Funding (An Immediate Family Member): ImmuneSensor Therapeutics Research Funding (Institution): Bristol-Myers Squibb, Tolero Pharmaceuticals, Delfi Diagnostics, Merck, Merck Serono, AstraZeneca/MedImmune  Dr. Mohamed Salem: Consulting or Advisory Role: Taiho Pharmaceutical, Exelixis, Bristol-Myers Squibb, Exelixis, QED Therapeutics, Novartis, Pfizer, Daiichi Sankyo/Astra Zeneca Speakers' Bureau: Genentech/Roche, Taiho Pharmaceutical, Daiichi Sankyo/Astra Zeneca, BMS, Merck

The Research Evangelist
Meet Mellisa Wheeler. Award winning community outreach leader. Dedicated to helping eradicate the burden of cancer in underserved communities.

The Research Evangelist

Play Episode Listen Later May 19, 2023 50:28


Mellisa Wheeler has over 20 years of experience in health care with a specialized focus in oncology. Mellisa is the Director of the Disparities & Outreach program at Levine Cancer Institute, a department dedicated to eradicating the burden of cancer in underserved communities through prevention education, screening and early detection. She has designed and launched several community outreach initiatives, including authoring a grant proposal that resulted in $1.6 million funding for the nation's first mobile lung cancer screening bus as part of the Lung B.A.S.E.S. 4 Life program. Mellisa received her undergrad degree from University of South Florida and her Masters in Health Administration from Ohio University.

Cancer Buzz
Utilizing Subcutaneous and IV Treatment for Improved Outcomes with Multiple Myeloma Patients

Cancer Buzz

Play Episode Listen Later Apr 20, 2023 4:10


While significant advances have been made overall in the treatment of multiple myeloma, the management of transplant-ineligible patients remains challenging. Patients with multiple myeloma are not cured with conventional therapy. Treatment does, however, alleviate symptoms, improve quality of life, and prolong survival. The current standard of care for multiple myeloma patients includes an anti-CD38 monoclonal antibody in either first- or second-line treatment of myeloma. CANCER BUZZ spoke to Cindy Varga, MD, Hematologist at Atrium Health's Levine Cancer Institute in Charlotte, NC. Listen as Dr. Varga discusses the positives and negatives with subcutaneous versus intravenous drugs in treating patients with multiple myeloma. “There are benefits to the patient (for subcutaneous administration), it is very fast, as quick as 5-minutes. So. there is convenience there and less side effects.” “Having patients be able to access these amazing drugs (both IV and subcutaneous) in their local infusion center, definitely helps with their up-front treatment plan. These patients are going into remissions, feeling better, and their quality of life is better on these drugs because they are so effective…” -        Cindy Varga, MD, Hematologist at Atrium Health's Levine Cancer Institute Cindy Varga, MD Hematologist Levine Cancer Institute at Atrium Health Charlotte, NC Resources: -        Leukemia & Lymphoma Society -        American Cancer Society -        Multiple Myeloma Research Foundation  This project is sponsored by Johnson & Johnson   ACCC is collaborating with The Leukemia & Lymphoma Society on this project.

ASCO Daily News
Advances in Neoadjuvant IO in MSI-H/dMMR Colorectal Cancer

ASCO Daily News

Play Episode Listen Later Mar 16, 2023 27:45


Dr. Mohamed Salem, Dr. Myriam Chalabi, and Dr. Andrea Cercek discuss pivotal neoadjuvant immunotherapy clinical trials for patients with MSI-H/dMMR colorectal cancer, focusing on the development of active therapies in the neoadjuvant setting—where patients are treated without surgery, radiation, or chemotherapy—and the importance of patient selection in finding the right target and treatment to improve outcomes. TRANSCRIPT Dr. Mohamed Salem: Hello, and welcome to the ASCO Daily News Podcast. I'm your guest host today, Dr. Mohamed Salem. I'm a GI oncologist at the Levine Cancer Institute at Atrium Health. Today, we will be discussing very promising advancements in the neoadjuvant immunotherapy for patients with MSI-H/dMMR colorectal cancer. And I'm very delighted to welcome two world-renowned oncologists whose research has tremendously helped shape the treatment landscape of colorectal cancer. Dr. Myriam Chalabi is a GI medical oncologist at the Netherlands Cancer Institute, and Dr. Andrea Cercek is a medical oncologist at Memorial Sloan Kettering in the United States.  Our full disclosures are available in the transcript of this episode, and disclosures relating to all episodes of the podcast are available on our transcripts at asco.org/DNpod.  Dr. Chalabi and Dr. Cercek, welcome to the ASCO Daily News Podcast. Dr. Myriam Chalabi: Thank you for having me. Dr. Andrea Cercek: Thank you very much for having me. Dr. Mohamed Salem: It's a pleasure to have two world-renowned stars like you. Thank you for taking the time.  So, before we start going deep into the topic, obviously, now we are seeing emerging data in CRC using immunotherapy as the neoadjuvant approach, which actually can reduce or even eliminate some of the other treatment modalities and potentially save patients from toxicities. Both of you led what I think are landmark studies in this field. I wanted to give you the chance to tell our audience about your studies and why you think they're important. Dr. Cercek? Dr. Andrea Cercek: Sure. Thank you so much. So, our study was a neoadjuvant study in early-stage, locally advanced rectal cancer with tumors that were mismatch repair-deficient or MSI-H. And rectal cancer normally is treated with chemotherapy, chemoradiation, and surgery. And the goal of the trial was to utilize PD-1 blockade alone in this subpopulation and evaluate the response.  Patients received six months of dostarlimab, which is a PD-1 blocking agent, and then were evaluated for response. If there was no residual disease, they were able to avoid radiation and surgery. And what we've seen thus far in the presentation at GI ASCO in 2022 was that all patients who received six months of dostarlimab had a clinical complete response, so no residual tumor, and were able to avoid chemotherapy, radiation, and surgery and are on observation. And the study is ongoing and actively accruing patients. Dr. Mohamed Salem: All of us were very excited seeing that presentation at ASCO. And when we came back to the clinic everyone was talking about it, including patients, obviously. Thank you for this, Dr. Cercek. Dr. Chalabi, you also led a similar study that was actually presented in ESMO in 2022. Can you please give us, like, a brief description of that trial? Dr. Myriam Chalabi: Yeah, sure. So, this is the NICHE trial, and actually the NICHE trial has been ongoing for quite some time now. We recently presented a larger NICHE-2 study, but basically– so what we started out by doing in NICHE is giving patients what we considered back then a window of opportunity study. We treated patients with MMR-deficient tumors, which I'll be focusing on for now, with two cycles of nivolumab and one single cycle of low-dose ipilimumab. And patients all undergo surgery within six weeks of registration within the study. And back in 2020, we published the first data of NICHE-1 showing 100% pathologic responses with 60% pathologic complete responses and decided that this should definitely be a treatment that we need to explore in a larger group of patients. And that's where NICHE-2 was born, which we presented at ESMO last year, where we treated over 100 patients with this neoadjuvant approach of two cycles nivolumab, one single cycle ipilimumab, showing 99% pathologic responses, including 95% major pathologic responses and 67% pathologic complete responses. And this was all within five and a half weeks of the first treatment with immunotherapy, so a very short treatment duration with dual checkpoint blockade. Dr. Mohamed Salem: Amazing results, too. And I know you had a standing ovation when you presented the outcome of the study. And again, congratulations to you, your investigator, and also all the patients participated. Dr. Myriam Chalabi: Thank you so much.  Dr. Mohamed Salem: I guess the first question that comes to my mind - we have two trials, obviously, now we're moving from one size fits all to precision therapy, like getting actually the right treatment for the right patient. But in the NICHE study, it was a checkpoint inhibitor, and the rectal study was a single agent. I want to start with you, Dr. Chalabi. In your opinion, when should we use single agent or double blockade immunotherapy? Dr. Myriam Chalabi: That is a great question. I'm going to start off by saying that I don't know the exact answer. I don't think we know that answer. And Dr. Cercek is going to share also her thoughts on this because we're seeing, of course, fantastic responses with monotherapy as well in Dr. Cercek's study. And we've also seen that in a study by Dr. Overman with monotherapy. So that may suffice in some patients, although what we're seeing is that you need to treat patients longer, probably to achieve that response, at least clinically. And I think that is the difference with dual checkpoint blockade, that we're giving in NICHE where we're seeing these very deep responses in just under six weeks' time.  So, I think it may be more of a question of how long we want to treat patients for to achieve the endpoint that we're aiming for. And, of course, there may be, at some point, patients that need dual checkpoint blockade, but so far, we're seeing great responses in both of our studies. So I think we need more patients, more data to see whether we're going to see non-responders. And hopefully, the studies that are ongoing in the metastatic disease setting will give us at least a little bit of insight into what the differences are in response to mono and dual checkpoint blockade and whether we can tell which patients might benefit more from the combination. But I think there's still a lot of work to be done in that field. Dr. Mohamed Salem: I totally agree. Dr. Cercek, same question to you. What do you think?  Dr. Andrea Cercek: Dr. Chalabi answered beautifully and very comprehensively. I agree completely with what she said. It's hard to argue with the responses that we're seeing with PD-1 blockade alone. But then again, dual checkpoint inhibitors in the NICHE study with just one month of therapy had phenomenal responses as well. So I think it's a question of duration of therapy and, really importantly, what we're trying to achieve. If our goal is organ preservation, then perhaps longer duration is better. The question then becomes, can we do, should we do longer duration with dual checkpoint inhibitors versus single agent? So I think, as she concluded, I couldn't agree more that we just need more information, we need more work to do, basically to answer this question for our patients. Dr. Mohamed Salem: More to come and more studies, which is fascinating.  So, Dr. Chalabi, you created actually a new term on Twitter called ‘Chalabi Plot'. It was amazing to see such a response. But we're curious, among those patients who achieved complete response so far, did you see any relapse? Dr. Myriam Chalabi: Short answer, no.  we're waiting, of course on the disease-free survival data, the three-year DFS data for NICHE-2, and we hope to have that by the end of this year, beginning of next year. But as of now, we showed that data, and so far, we haven't seen any recurrences in, actually, any of the patients treated in NICHE-2. Dr. Mohamed Salem: Fantastic. Dr. Cercek. So I think your slide -- I remember clearly from the ASCO presentation -- was all complete response, every single patient.  Same question, did you see any relapse so far? Dr. Andrea Cercek: So far, no, we have not. Dr. Mohamed Salem: Amazing. So, Dr. Cercek, as you know, and obviously, this is metastatic disease, but in KEYNOTE-177, as you know, about 30% of patients with MSI-high tumors did not respond to checkpoint inhibitors. So that makes some of us feel nervous about using checkpoint inhibitors alone in colorectal cancer, even with MSI-high status. I was curious if you can comment on this and if there is a way we can perhaps sort out who actually is likely to respond and who is likely not going to respond. Dr. Andrea Cercek: I think that's a really important question and an excellent point. And we believe that the difference lies in the fact that in KEYNOTE-177, the patients had metastatic disease, whereas in our neoadjuvant studies that we're discussing, they have early-stage disease. And whether that has to do with the tumor differences, young tumors versus older tumors once they become metastatic, or the microenvironment, remains to be determined. But certainly, there is this pattern of incredible responses with checkpoint inhibitors in early-stage dMMR tumors. And in KEYNOTE-177, as you mentioned, about 30% of patients progressed. And I think we don't know why that is. We are seeing this, about a third of progressors repeatedly in the metastatic setting with checkpoint inhibitors. And so perhaps there is a population. But whether this is driven by genomics or something else, we don't know. Dr. Mohamed Salem: Great. So, along the same lines, especially rectal cancer, obviously, because surgical resection is a key component in the treatment paradigm, do you feel patients who achieve pathological complete response should still go under surgical resection or should go under the ‘watch and wait' approach? Dr. Andrea Cercek: In general, I'm a fan of organ preservation. I think in rectal cancer, the reasons are obvious. It's a challenging surgery. It's very toxic to the patients. It changes their lives forever. In survivorship, 30% of them require a permanent colostomy because of the location of the tumor. So there, the field of rectal cancer, in general, is moving towards non-operative management, even in the MSI-proficient patients, by trying to optimize therapy to increase clinical complete responses and therefore omit surgery. So that's the difference with rectal cancer. In colon cancer, it's a different discussion. I think for many patients, surgery is very straightforward. It's a hemicolectomy. It doesn't alter lifestyle in survivorship, so it's not as morbid as it is in rectal cancer. Of course, I think if a patient is older with MSI-deficient tumor perhaps can undergo surgery, then clinical complete responses become critical because then we can monitor them after just checkpoint blockade, and they don't need surgery.  The challenge there, and I would love to hear Dr. Chalabi's comments on this, too, is just that imaging is challenging. We have a hard time in colon cancer determining whether someone has a clinical complete response or not. It seems to be very different than in rectal cancer, where with endoscopy and with the rectal MRI, we really can't tell whether the tumor is still present or not. This remains a challenge in colon cancer. Dr. Mohamed Salem: Dr. Chalabi, I would like to hear your thoughts and also how you practice in Europe. I don't know if it's the same like here in US or different. Dr. Myriam Chalabi: I completely agree with Dr. Cercek. Well, if we look at the rectal cancer patients, I think this is fantastic. That even though this is a small population achieving this high clinical complete response rate, not having to operate or even give any chemotherapy or radiation therapy to these patients, it is extremely important both in the short term but also in terms of long-term complications and morbidity. When it comes to the colon cancer responses that we're seeing in NICHE, those are all pathologic responses, of course. And we have been evaluating also preoperatively using scans to see whether we can assess these complete responses based on imaging. That doesn't seem to be the case. We do see responses in all patients, so we see these are all very large bulky tumors that we're treating in NICHE-2. And we do see responses in almost all of these patients, but it's not close to complete responses, definitely not in all of the complete responders that we're seeing. So that makes it difficult.  And the question is, what if we would be waiting or treating longer because these bulky tumors need more time to disappear or to be cleared before you're going to see it on the imaging? So that is a question that I don't have an answer to just yet. We may be getting some more data on that with the currently ongoing trials. And as Dr. Cercek pointed out, the endoscopies when you have a right-sided colon tumor are different than doing just a sigmoidoscopy for a rectal tumor. So, we actually do have one patient who hasn't undergone surgery, and that is actually a patient with an MMR-proficient tumor within the NICHE trial who had a complete response. And that patient has a sigmoidal tumor, and he actually had toxicities which prevented him from undergoing timely surgery and now has a complete response after two years, both endoscopically and on imaging. So, he hasn't undergone surgery, and that is a great example of how we may be doing this in the future. It's an interesting case within the trial to follow and see how we can do it in the future. Dr. Mohamed Salem: That's fascinating news. So, was it MMR-proficient? Dr. Myriam Chalabi: Yes, this is an MMR-proficient tumor.  Dr. Mohamed Salem Wow. Any particular biomarkers that you think he or she had to predict that? Dr. Myriam Chalabi: We have treated more patients with MMR-proficient tumors. We have 31 patients, and we have seen actually responses in 9 out of 31 patients in the MMR-proficient tumors with the same combination of two doses of nivolumab and one of ipilimumab. We previously published on half of the cohort approximately on what the possible predictive biomarkers of response could be, and that was a costimulation for CD8 and PD-1. So PD-1 positive CD8 T cells. And we're currently doing the same work for the rest of the cohort. So hopefully, we'll be able to show that soon and see whether this still stands for the completed MMR-proficient cohort. But definitely also very exciting data for the MMR-proficient. Dr. Mohamed Salem: So, this is actually a very good segue to my next question because I know all of us are looking for this. Like, obviously, we're seeing a fascinating response in those patients with MSI-high tumors, but majority of colorectal cancer, as you know, they actually have MSS-proficient tumors. Any thoughts about how we can overcome the primary resistance for this tumor to checkpoint inhibitors? So let me start with you, Dr. Cercek.  Dr. Andrea Cercek: I'm very much looking forward to Dr. Chalabi's data on this because, honestly, we have not seen such amazing responses to immunotherapy in MSS tumors. The initial studies were complete flatline, no responses at all. And here, she just described a patient that had a complete response to just a month of checkpoint inhibitors. So that's phenomenal, and hopefully, we'll learn from the responders.  We believe that there is a subpopulation of MSS colorectal cancer that is more immune sensitive, immune hot, whichever term you like to use. And it's just a matter of appropriately identifying those patients. And personally, I think the answer lies in the neoadjuvant setting in early tumors where they're treatment-naive, not exposed to chemo, not exposed to radiation, younger, have their innate microenvironment. And so, I think it's likely a combination of the above. But obviously, the ultimate goal is to find out who those patients are and then potentially treat them just like this with immunotherapy. And that would be another nice chunk of the pie where we could utilize immunotherapy for our patients. Dr. Mohamed Salem: Very true. Dr. Chalabi, especially with your experience and just showing there is a chance for those people to respond, what are your thoughts about how we can overcome this primary resistance? Dr. Myriam Chalabi: It's great to be here with Dr. Cercek because, obviously, we have very similar interests but it's also good to see that we think the same way because I completely agree with what she just said in terms of neoadjuvant. I think that was one of the most important things that we did here, giving this neoadjuvant treatment in non-metastatic tumors. It's probably a very important driver in the responses that we're seeing. So, we've been seeing data now a bit more in the metastatic disease setting where MSS tumors seem to be responding to new generations of checkpoint blockade. And the question is how those would do in the neoadjuvant setting that would be even different than what we're seeing now. But there's definitely some proof of MSS tumors that can respond to immunotherapy. The question on how to overcome the primary resistance, I think that question is for us: Who are the patients with primary resistant tumors and why are they primarily resistant? And then we can think about how to change that and how to change them into the tumors that are responding. I think these types of data will be key to understand more and know; hopefully, even you said, in the metastatic disease setting, to make these tumors more pliable in response to immunotherapy. Dr. Mohamed Salem: I agree. So, both of you are leading us toward how to choose the right patient with the right target for the right treatment. That's an amazing journey you're taking all of us on.  So, Dr. Cercek, I have to admit that with your data, it created some problems for us in the clinic because all patients the following day came in asking for immunotherapy. We had a hard time trying to explain that maybe this is not the right treatment for them or, like, not the right platform. But I wanted to ask you, if we'll have a patient tomorrow in the clinic with localized rectal cancer and happen to have an MSI-high tumor, what would be your recommendation in terms of how to approach that patient? Dr. Andrea Cercek: I think, ideally, you would discuss clinical trials with the patient. We have opened the study now to not just rectal cancer but colon cancer and, in fact, all solid tumors that are mismatch repair-deficient. So I think at this time, the patients really should be treated on a clinical trial. As we learn more, in particular, until we are more comfortable assessing for a clinical complete response and follow-up. I think the surveillance piece will be critically important. In rectal cancer, it's well established, but it's not in the other tumor types. So my recommendation would be to enroll the patient on a trial. Dr. Mohamed Salem: Just to add to that too, obviously, as you know, there is now the cooperative group trial that's looking at that option and we obviously encourage all centers to participate and open that study to have this option for our patients. Dr. Chalabi, so what do you guys do in Europe for these patients? Dr. Myriam Chalabi: In Europe, it's a very different situation. I would have answered this question differently by saying, well, we don't have that option of treating patients outside of clinical trials. So basically, we have to make sure that we have clinical trials for these patients. And that's something that we've had for colon cancer patients. That is still the case. And we're getting rectal cancer trials also for patients with MMR deficient tumors and have those also for MMR proficient tumors. For us and I agree completely that we should be treating patients within clinical trials, we don't have another option. But still, even if we did, I think it's important to create data within clinical trials to be able to ultimately also show why this should be standard of care and how we can make it standard of care. Because if you're not accumulating that data, then it's going to become very difficult if accrual is lacking. Now, we treat patients either with standard-of-care treatments, but usually, we try to find something within clinical trials.  Dr. Mohamed Salem: I totally agree. And as we always say, the standard of care should be a clinical trial participation. So, I must say, both of you, Dr. Cercek and Dr. Chalabi, you made 2022 a very exciting year for us in GI cancers. You really changed the way we look at how to treat these patients and give them a huge chance of, I would say, actually cure and obviously organ preservation. So, I'm very curious to know what you are both are working on now and what we should expect in 2023 and 2024.  Dr. Andrea Cercek: So, for me, the study is ongoing, as I mentioned, and we've expanded to all mismatch repair-deficient solid tumors with the same approach of six months of dostarlimab and then the option of nonoperative management. And I think that it'll be important for us to learn in terms of responses on the luminal versus some of the other tumor types, like, for example, pancreas cancer, where we don't see these robust responses in the metastatic setting, that will be important to do. We're doing some correlative analysis, as Dr. Chalabi described as well in our patients.  And then, I'm interested in optimizing neoadjuvant approaches to minimize therapy in rectal cancer specifically. So, we have a study now for HER-2 amplified RAS wild-type patients with locally advanced rectal cancer with a similar approach of utilizing HER-2 targeted therapy first and then in combination with chemotherapy. In our case, it's a combination of trastuzumab and tucatinib and then chemotherapy with CAPOX and assessing for response and potential omission of radiation and surgery depending on responders. So, I'm very excited that study is open and actively accruing, and hopefully, we can get similar responses that we did in the MSI population with PD-1 blockade. Dr. Mohamed Salem: Is that only available at MSK? Dr. Andrea Cercek: It is at this time. However, we will likely be expanding, so if there's any interest, let me know. Dr. Mohamed Salem: Great. I'm sure many centers will be. Great. What about you, Dr. Chalabi? Any sneak peek in the future? Dr. Myriam Chalabi: So many sneak peeks, where to begin? I think it's very exciting to be working in this space at this time, and we're very lucky to be in it. So, for NICHE, we're actually accruing now in new cohorts for both MMR-deficient and MMR-proficient tumors. For the patients with MMR-deficient tumors, we're actually testing a new combination of nivolumab plus relatlimab, so anti-LAG-3 plus anti-PD1. And we're testing the same co-formulation in patients with pMMR tumors. In addition to another cohort for the pMMR tumors with nivolumab, all within this window of opportunity, as we did previously in NICHE, and to see if we're going to see more responses if these are going to be different tumors than the ones responding to nivolumab and ipilimumab. And for the MMR deficient tumors, we're treating longer with this combination now. So, we're operating after eight weeks instead of six weeks. We're giving two cycles, four weekly cycles, to see whether we can even improve the PCR rates, even though this is, of course, a different combination treatment. So, very exciting times for NICHE, and we'll have the readout for the DFS at the end of this year, so that's also very exciting. And then, well, it's similar to Dr. Cercek. So again, we're on the same page when it comes to these neoadjuvant treatments. We have actually an ongoing trial for neoadjuvant treatment of patients with MMR proficient rectal cancers, and that is using a combination of radiation therapy followed by a combination of atezolizumab or anti-PDL1 with Bevacizumab with the aim of organ sparing approach in these patients. And we actually presented stage 1 of this trial as a poster at ASCO GI, showing that we achieved 56% complete or near complete responses clinically at 12 weeks. And after at least a year of follow-up for all patients, we have 50% organ preservation. So those are very exciting data as well. Also, in the MMR proficient tumors, I'm very excited to hear about the HER-2-positive tumors and Dr. Cercek's study. So there's definitely a lot going on that we hope to share as soon as the data are available. Dr. Mohamed Salem: We'll be looking forward to your next presentation and seeing that. So again, most of your work showed us that we really have to choose the right patient with the right target for the right treatment to achieve the best possible outcome. So we're getting short on time here. But before we conclude, ASCO Daily News Podcast has a huge audience of oncologists, I wanted to give you the chance to share anything you'd like to share with our audience today before we finish. Dr. Cercek? Dr. Andrea Cercek: I believe this is an incredibly exciting time in colorectal cancer. I think it's finally our turn, which feels really nice, and obviously, we have a lot more work that needs to be done. But my personal belief is to keep trying to chip away at the pie and identify responders and keep working to have better-targeted drugs and better treatment options that will improve responses and improve outcomes for our patients. But I certainly believe that we are well on our way there, and it's very exciting. Dr. Mohamed Salem: I totally agree. Dr. Chalabi, any thoughts? Dr. Myriam Chalabi: I think after 2022 and the data that we've been showing, I think it's important to– and I think by now, maybe it's not even necessary anymore to say it– but I think it's important to really look at the tumors and look at these MMR proteins or MSI, and to make sure that you're treating the patient in the right way, and to consider that. Before, it wasn't as important in the neoadjuvant setting or these localized tumors, but now it's becoming essential.  And I think if you would have looked five years ago and you would say, yeah, these MSI tumors are important to find, it's a very small proportion of patients, in rectal cancer even lower than in colon cancer. But still, it has such a huge impact on what you're doing in these patients and your chances of cure. So I think that would be my most important giveaway to test for MMR deficiency before deciding on a treatment for your patients. And we're working on trials with neoadjuvant immunotherapy. Also in other tumor types, Dr. Cercek is also doing the same. I think those will be very important also outside of the GI field to see whether this approach works for a much larger patient population, despite the low incidence.  Dr. Andrea Cercek: Dr. Chalabi just made a critical point that that is most important is to remember that we do have biomarkers in colorectal cancer that, in the neoadjuvant setting and in the metastatic setting, especially MSI, that we need to test for. And then, just to add from a clinical perspective, in rectal cancer, the large majority of patients that have mismatch-repair deficient or MSI tumors actually have Lynch syndrome. So really, if you identify a patient that's mismatch-repair deficient or MSI-high anywhere, but especially in the rectum, they absolutely should get germline testing. Dr. Mohamed Salem: I echo that and second that. And Dr. Cercek, thank you, and I know you did a lot of work in colorectal cancer in the younger adult population, too, so I think you've had a huge impact on that area too. I would like to thank both of you again for being here today, but more for the great work you and your teams are doing to advance the field. It's really a very exciting time in GI cancers now, and thank you so much for your work and for sharing your insights with us today on the ASCO Daily News Podcast. Dr. Myriam Chalabi: Thank you so much for having me. It's been great. Dr. Andrea Cercek: Thank you for having me. Dr. Mohamed Salem: Of course, and thanks to our listeners for your time today. If you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Thank you very much. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:     Dr. Mohamed Salem @SalemGIOncDoc   Dr. Myriam Chalabi @MyriamChalabi   Dr. Andrea Cercek @AndreaCercek   Learn about other key advances in GI Oncology: SWOG 1815, PARADIGM, and Other Advances at GI23   Follow ASCO on social media:      @ASCO on Twitter    ASCO on Facebook    ASCO on LinkedIn      Disclosures:   Dr. Mohamed Salem: Consulting or Advisory Role: Taiho Pharmaceutical, Exelixis, Bristol-Myers Squibb, Exelixis, QED Therapeutics, Novartis, Pfizer, Daiichi Sankyo/Astra Zeneca Speakers' Bureau: Genentech/Roche, Taiho Pharmaceutical, Daiichi Sankyo/Astra Zeneca, BMS, Merck Dr. Myriam Chalabi: Consulting or Advisory Role: MSD, Bristol-Myers Squibb/Celegne, Numab Research Funding (Institution): Bristol-Myers Squibb, Roche/Genentech, MSD Travel, Accommodations, Expenses: Roche/Genentech, Bristol-Myers Squibb Dr. Andrea Cercek: Consulting or Advisory Role: Bayer, GSK, Incyte, Merck, Janssen, Seattle Genetics, G1 Therapeutics Research Funding (Institution): Seattle Genetics, GSK, Rgenix          

JCO Precision Oncology Conversations
KRAS Variants, G12C, TMB, high PD-L1 Expression in Solid Tumors

JCO Precision Oncology Conversations

Play Episode Listen Later Mar 15, 2023 23:03


JCO PO author Dr. Mohamed Salem shares insights into his JCO PO article, “Landscape of KRASG12C, Associated Genomic Alterations, and Interrelation With Immuno-Oncology Biomarkers in KRAS-Mutated Cancers” and the article's findings of a large-scale, pan-cancer genomic characterization of KRASG12C. Host Dr. Rafeh Naqash and Dr. Salem discuss KRASG12C mutation, KRASG12C -mutated tumors and comutation with STK11 and KEAP1. Click here to read the article!   TRANSCRIPT Dr. Abdul Rafeh Naqash:  Hello and welcome to JCO Precision Oncology Conversations, where we bring you engaging conversations with authors of clinically relevant and highly significant JCO PO articles. I'm your host, Dr. Abdul Rafeh Naqash, Social Media Editor for JCO Precision Oncology and assistant professor of Medical Oncology at the OU Stephenson Cancer Center.  Today I'm thrilled to be joined by Dr. Mohamed Salem, Gastrointestinal Medical Oncologist, and Research Director at the Levine Cancer Institute in Charlotte, North Carolina. Dr. Salem is the lead author of the JCO Precision Oncology article ‘Landscape of KRASG12C, Associated Genomic Alterations, and Interrelation With Immuno-Oncology Biomarkers in KRAS-Mutated Cancers'.  Our guest's disclosures will be linked in the transcript.  Dr. Salem, welcome to our podcast, and thank you for joining us today. Dr. Mohamed Salem: Thank you for having me. A pleasure and honor. Dr. Abdul Rafeh Naqash: For the sake of this podcast, we'll be referring to each other using our first names. So thank you for coming on to our podcast and discussing this very interesting paper. And one of the reasons why we decided to incorporate this is because, as you very well know, KRAS is one of the most common altered genes in cancer, and I'm pretty confident and sure that oncologists, whether it's academic oncologists or community oncologists, have treated patients in different settings having tumors that harbor KRAS alterations. So give us a little bit of a background on where KRAS alterations stand currently and where is drug development in the space of KRAS to give our listeners some idea of why we're interested in this gene. Dr. Mohamed Salem: Sure, thanks again for having me. And as you mentioned, KRAS mutation happens to be, I think, by far the most common oncogenic mutation we see in oncology and solid tumors. The problem with KRAS is that, for a long, long time, there was very much nothing we could do about it; it was, in fact, called an undruggable target. Until recently, we started to realize this might not be true, and, in fact, we start to see successful efforts trying to target KRAS mutation. Currently, there are several KRAS inhibitors. I think it started with G12C. I personally don't think there was anything specific about G12C, but it just happened to be one of the first targets that we were able to approach. And the initial result from using anti-G12C therapy that was published in the New England Journal of Medicine, I think, a year ago now, showed this is feasible and perhaps effective. Dr. Abdul Rafeh Naqash: Thank you so much, Dr. Salem, for that explanation. And being a Phase I trialist, I personally have seen a lot of exciting combination-based approaches in the setting of KRAS-altered tumors, especially KRASG12C.  Now, specifically delving into your paper, given the extensive length and breadth of data that you've covered here, could you tell us a little bit about why you decided to use KRAS as an interesting topic for your study and the kind of data set that you chose to explore this question?  Dr. Mohamed Salem: What happened once we started to realize how important it is to figure out which KRAS mutation we're dealing with because, at least in colorectal cancer, it's a very common mutation, almost like 40-50% of patients with colorectal cancer tumors carry KRAS mutation. Until very recently, we really didn't pay close attention to which variant it is. Is it KRAS G12D, 13, or G12C? And so on and so forth. And the reason we didn't really pay much attention to that is because there was nothing to do about it; whether the patient has this or that variant was really nothing therapeutically wise it really didn't have an impact. But once we started to realize now there is a therapeutic option and, in fact, now there is a change in the way we think about KRAS mutation, there is a proof of concept that we actually can target KRAS mutation, we started to pay closer attention to this.  And I think this was a paradigm shift in our thinking. So for patients who have KRAS mutation, now we have data showing that KRASG12C is something we can target, whether with single agent or with combination therapy. But it was a new era for us because most of us realized it's not going to stop there. It's not going to be just G12C; I think G12C is the tip of the iceberg, and likely the science is going to go forward, try to target the other variants. So one of the obvious questions was what are the other variants and how commonly those exist, and which tumor types also carry those variants. Because as we were talking before the recording for Phase I, now it is not like one approach fits all; it started to kind of like focus on either molecularly driven or disease-type approaches. And it was very important for us to try to figure out, okay, which tumor type carries the most KRAS variants and, within that tumor, which variants are the most common. And this is what we're trying to answer in this paper.  Dr. Abdul Rafeh Naqash: Thank you so much, Mohamed. I looked at your data set that you had access to, very large data set of around 79,000 tumor samples and close to 14,000 KRAS mutated tumors. Could you tell us a little more about this data set and how you started with looking at the distribution of KRAS across different tumors, and what were the kind of interesting results that you came across as far as KRAS distribution is concerned? Dr. Mohamed Salem: It's very obvious to all of us now that the field is moving from one size fits all to a targeted approach or treatment target approach. And this is very important and very interesting because usually, when we do that, we achieve better outcomes and lesser toxicity. But the problem that comes with this is that none of us, as a single, even two centers, will have enough data to ask and answer questions. And when you are talking about something like MSI-high or BRAF or KRAS, usually it becomes very challenging for one single institution, doesn't matter how big they are, to try to answer either prevalent or therapeutic approaches. Because of that, most of us now start to understand that cooperation is very important across centers and also across nations.  So, like as you see here in this paper, there was a global cooperation between investigators in the U.S. and in Europe and Austria, and other countries. And what we did as a group we worked with one of the third-party profiling companies. Our group tried to answer what is the prevalence, just a very simple question, what is the prevalence of KRAS mutation, and what is the prevalence of each variant type in each tumor? And none of us could have answered that question on their own. Because of that, we actually collaborated with one of the third-party companies that do next-generation sequencing for tumors, and we were able to collaborate with them to have access to that database and answer some of those questions.  Dr. Abdul Rafeh Naqash: Excellent. As everybody knows, NGS is a standard of care testing that oncologists do, especially for advanced settings, to identify driver alterations or therapeutic interventions that may be relevant for patients. So in this data set, it seems you had access to NGS data, tumor mutational burden, and PD-L1 data for these tumor types. Could you tell us about the differences in the distribution for KRAS and the KRAS subtypes that you identified in this data set? Dr. Mohamed Salem: Sure. So, as you mentioned, we looked actually at almost 79,000 tumor samples that underwent next-generation sequencing by our collaborator. And it appears that about 17% of the tumors or so had some kind of KRAS mutation. And then, after that, we start to see G12C when we start looking at each variant. G12C were about 11%, 12%, and about 88% of the remaining KRAS mutant tumors harbored some different kind of KRAS mutation.  The next question was, in general, in all tumors, what was the most common KRAS variant seen? I think it mimicked what was already out there. It appears that G12D happened to be perhaps the most frequent mutation seen in KRAS mutation tumors, followed by G12V, followed by G12C, and then G12/13, and then others. What was very interesting, actually, an observation we saw, is that we were able to realize the distribution of KRAS variants varies according to the tumor subtype. So, for example, in pancreatic cancer, we could see patients who had G12R KRAS mutation variants. This was not seen commonly in other tumors. And the reason that's important is because maybe that will be something in pancreatic cancer tumors that will be worth looking at and do therapeutic approach there. But also, I'm sure you're already dealing with this in your clinic quite often. It was interesting, obviously, that non-small cell lung cancer was the most common organ that actually carries G12C, followed by colorectal cancer; followed by a very interesting actual observation that was very interesting for us to see was in appendiceal cancer. As you know, appendiceal cancer is not a common disease; it's a relatively rare disease. And we were surprised to see some of them actually have G12C mutation. And again, the reason that's important is that it just opens the door for possible therapeutic options and in context of clinical trials. Dr. Abdul Rafeh Naqash: Excellent. Definitely, the advantage of having such a rich data set like you did enabled you to look into some of these unique distributions across rare tumors, which makes it very interesting.  Now, one thing that I realized in the paper is that these tumors of unknown origin, where you identified or your group identified that they had a certain percentage of KRAS alterations, suggesting maybe their tumor of origin is perhaps lung or upper diaphragm, which could have therapeutic implications. Could you tell us a little more about this? Dr. Mohamed Salem: Yeah, this was another very interesting observation we saw because it is not uncommon for us in the clinic, we get like a cancer biopsy, but we cannot tell where it's coming from. And there are multiple ongoing efforts to try to identify that for the obvious reasons. But it was very interesting when we looked at those groups that when you had cancer adenocarcinoma but of no identified origin, it was the fourth common tumor that we see G12C. I think if you can just make the assumption - I don't think we have proved that - but since lung cancer was the most common tumor that exhibited G12C mutation, and now we have tumors of unknown origin also, many of them exhibit G12C mutation, we thought this could be a lung primary. As you know, there are also now a few platforms trying to identify the tumor origin based on the agent sequencing, but we didn't try to associate it with that. Dr. Abdul Rafeh Naqash: Thank you for that explanation. Now, one of the other things I observed is you tried to delve into smoking status, very interestingly, and how that correlated with KRAS alterations. And as we know, lung cancer, obviously there is a strong predilection in patients who are smokers, but irrespective of smoking, there can be other alterations that drive lung cancer. But interestingly, in your paper, you identified a unique correlation between smoking and G12C and also found out something on those lines in colorectal cancer, which, to my understanding, has not been described before. What is your understanding of why that happens? What could be the mutational events that lead to something like that, and how could that be potentially therapeutically exploited? Dr. Mohamed Salem: I think this was one of the very interesting findings we observed. And you are right; just because the nature of lung cancer, we know many of patients are either active smokers or former smokers. So it was not a surprise for us to see that there is some kind of association with smoking status and lung cancer. But to your point, what was really surprising and, in a way, interesting for us to see, actually, that association for patients with colorectal cancer. Smoking actually happens to be one of the risk factors, like in colon cancer, but obviously not as high as lung cancer. But when we looked at the data, demographic, and clinical features, it was obvious actually that current smoking status, whether a current smoker or prior smoker, had an association with G12C. And also, with gender as well, females tend to have more G12C, or G12C mutation was more likely to be seen in females than males. So the fact that we were able to identify the smoking status and gender as more likely to harbor G12C mutation was interesting.  I have to tell you, the reviewer, when we submitted the paper for review, the reviewer came back and asked us, did this happen just because you had too many lung cancer, and most lung cancer patients smoke, that's why you're seeing that association? And we went back and looked at the data again and spoke with our biostat team in the study, and we were able to actually run the analysis and show that, no, it is not just because of the enrichment; it's actually a real association between the smoking status and G12C. It's very interesting to see, at least in colorectal cancer, it's following the same trend in lung cancer. Dr. Abdul Rafeh Naqash: Right. And one of the other things I remember when I was reading through your paper and smoking status, I remembered this paper that was published in Science Magazine 2016, looking at how mutational burden changes in patients that have a history of smoking. But when you connect the dots here, interestingly, it seems like, especially in lung cancer, from what you guys have described here, is that the smoking status impacts what kind of KRAS alteration is present. But at the same time, you didn't see a tumor mutational burden that was significantly higher in G12C, mutated non-small cell lung cancer, where you would expect a lot of these G12Cs to be related to smoking. But on the other hand, the tumor mutational burden was not necessarily increased. And I understand you may not have an explanation for that through the data that you've published on, but that was kind of an interesting observation that I had. I don't know if you have any specific comments on that. Dr. Mohamed Salem: No, it's absolutely correct. What we thought is that we should see that because the obvious rationale is just cited, but it wasn't. And until today, we're actually trying to figure out why the disconnect because you have people who smoke usually you expect like PD-L1 is positive, you expect higher tumor burden, but it didn't show at least a statistically significant correlation.  Dr. Abdul Rafeh Naqash: Thank you. And I guess it's notable to mention that you did have some interesting correlations for tumor mutational burden overall, and with PD-L1. Could you tell us about that for different KRAS genetic alterations?  Dr. Mohamed Salem: There were few papers published before by our colleagues trying also to understand the correlation between G12C mutation and immunostatus or immune microenvironment and some biomarkers. And I think, at least to my understanding, there was not one consensus. I think it was different findings to some degree. So, in general, when we actually looked at the entire cohort, regardless of the tumor type, it appears that tumors that carry G12C mutation also happened to have higher PD-L1 expression. What was very interesting was that once we started to look at different tumor types, this was not seen across all tumors. So some tumors did actually carry that, and some other tumor types didn't show that correlation. And to be honest with you, I'm still, until today, I'm not sure why. Is this just a function of number, or actually there is more tumor biology that reflects that? I have to say my own feeling, and that's something we need to study further, is that I think it is tumor biology. One thing was also very interesting to us from the clinical side. You have G12C mutation in lung, and you have G12C mutation in colorectal, and in the New England Phase I study, you could see very clearly that targeted G12C is more effective in the lung compared to colorectal. It's the same target, the same drug, yet the response is different once you start to have two different tumor types. So that just got me to think there must be something with the tumor type and microenvironment of the tumor and also associated co-mutations and other factors that impact that.  Dr. Abdul Rafeh Naqash: I couldn't agree with you more, and I totally have seen that in some of the work that has been published or data that I've been part of where different tumor biology, the tumor microenvironments, even sites of metastasis make a difference in how a certain mutation behaves. So definitely something that needs further validation with perhaps proteomic and transcriptomic data to understand functional characterization of the downstream consequences for some of these mutations. And you pointed out co-mutation status. That's an ever-emerging question for some of the potentially druggable alterations, whether combination approaches targeting some other co-occurring common co-mutation would have more benefit. Could you tell us about some of the unique, interesting commutations that you identified in your cohort that were more common in certain KRAS subtypes? Dr. Mohamed Salem: Sure. I think that's also something we try to look at for the reason I just mentioned. We know that tumor origin and tumor type influence response and sensitivity to therapy. I think the best example we have, at least in colorectal cancer, is the BRAF mutation. When we saw the BRAF inhibitor having very nice response rate and control of BRAF mutant melanoma in colorectal cancer, we saw that it's going to be the same thing, the same drug, the same target, same thing's going to happen. And obviously, it was not the case. And this was a lesson for all of us to understand. Even if it is the same target, even if it's the same drug, tumor origin matters, and that's likely because of the associated co-mutations that will influence the pathway of the tumor and perhaps either the sensitivity to the drug or maybe resistance to the drug.  So it was very important for us to look also at the associated co-mutations. And I think one of the KEAP1, and perhaps you will comment on this more than me, but the KEAP1 gene was likely to be mutated in those tumors who have G12C mutation than others. Another one was STK11. And there were a few other ones, it depends on which tumor type, but KEAP1 was a very interesting finding for us too. Because as you're aware, it's important, at least in lung cancer, and maybe will impact therapeutic approach too. Dr. Abdul Rafeh Naqash: You're definitely right. It is important in lung cancer, and there's data that has shown both the STK11 and KEAP1 tumors have inferior outcomes to checkpoint inhibitors and are partly involved in metabolic reprogramming of the tumors. So there's definitely emerging targets that are trying to see if combination approaches in STK11 mutant lung cancer will demonstrate some level of benefit. But I think the co-mutation status would potentially have some sort of impact. But again, functional studies that help us understand what are the downstream consequences of one mutation versus another need to be further performed to get a better understanding of this space.   But I think this is definitely interesting work and very interesting results. Hopefully, our listeners will feel the same and maybe even try to go through the paper to understand some of the other additional results that you have published as part of this extensive paper.  We thank you on behalf of JCO Precision Oncology for submitting your work to JCO Precision Oncology, and hopefully, you'll consider us for further subsequent work in this space. Thank you so much for being with us today. Dr. Mohamed Salem:  No, thank you for having me, and actually, on behalf of my co-authors, I also wanted to thank JCO Precision Oncology for their interest in our paper. And, of course, for the reviewers, because there was no doubt they actually made our paper a much better one. So thank you for having me today, thank you for the entire team. Dr. Abdul Rafeh Naqash:  Reviewers definitely remain the people hidden behind the scenes who help in getting work refined and eventually published. So thank you again. And thank you for listening to JCO Precision Oncology Conversations. Don't forget to give us a rating or a review, and be sure to subscribe, so you never miss an episode. You can find all ASCO shows at asco.org/podcasts   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experiences, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Guest Bio Mohamed E. Salem, MD, is Research Director, Associate Professor of Medicine, and Gastrointestinal Medical Oncologist in the Department of Solid Tumor Oncology at the Levine Cancer Institute.  Guest Disclosures (See also: Landscape of KRASG12C, Associated Genomic Alterations, and Interrelation With Immuno-Oncology Biomarkers in KRAS-Mutated Cancers) Mohamed Salem: Consulting or Advisory Role: Taiho Pharmaceutical, Exelixis, Bristol-Myers Squibb, QED Therapeutics, Novartis, Pfizer, Daiichi Sankyo/Astra Zeneca, Merck  Speakers' Bureau: Taiho Pharmaceutical, Daiichi Sankyo/Astra Zeneca, BMS, Merck, Pfizer 

Cancer Registry World
A Conversation with Shirley Dalrymple, BS, CTR, RHIT, Coordinator of Quality Review, Cancer Data Services at the Levine Cancer Institute

Cancer Registry World

Play Episode Listen Later Mar 7, 2023 17:00


In this edition of Cancer Registry World, we welcome Shirley Dalrymple, BS, CTR, RHIT, Coordinator of Quality Review, Cancer Data Services at the Levine Cancer Institute in Charlotte, NC. Ms. Dalrymple will discuss the importance of quality review in the cancer registry and strategies for improving registry quality. Please enjoy listening and learning!

Oncology Peer Review On-The-Go
S1 Ep63: Oncology Peer Review On-The-Go: Integrative Oncology in Young Population with Breast Cancer

Oncology Peer Review On-The-Go

Play Episode Listen Later Jan 16, 2023 16:52


Yancey Warren, Jr, MD, MAT, a breast surgery oncology fellow at Brown University, and Lejla Hadzikadic-Gusic, MD, MSc, associate professor of surgery, Division of Surgical Oncology at Atrium Health Levine Cancer Institute, spoke with CancerNetwork® about their study titled Integrative Oncology in Young Women with Breast Cancer, which was published in the journal ONCOLOGY®. In their study, the authors explored the potential benefit of integrative oncology strategies to better establish referral practices for Levine Cancer Institute and define optimal timing for treatment in young patients with breast cancer.  Don't forget to subscribe to the “Oncology Peer Review On-The-Go” podcast on Apple Podcasts,Spotify, or anywhere podcasts are available.

ASCO Daily News
What Challenges Will Oncologists Face in 2023?

ASCO Daily News

Play Episode Listen Later Dec 8, 2022 25:57


Dr. Derek Raghavan, president of the Levine Cancer Institute at Atrium Health, and host Dr. John Sweetenham, of the UT Southwestern Harold C. Simmons Comprehensive Cancer Center, predict the challenges oncologists will grapple with in 2023, including the cost-benefit of new treatments, how to retain the best talent, prioritizing health equity, and the future of home infusion for patients with cancer.   TRANSCRIPT Dr. John Sweetenham: Hello, I'm John Sweetenham, the associate director for Clinical Affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center, and host of the ASCO Daily News podcast. Today, I'm excited to welcome back Dr. Derek Raghavan, President of the Levine Cancer Institute at Atrium Health. And we'll be discussing some of the challenges that we anticipate are going to lie ahead for the oncology community in 2023. Our full disclosures are available in the transcript of this episode, and disclosures relating to all episodes of the ASCO Daily News podcast are available on our transcripts at: asco.org/podcasts. Derek, great to have you back on the podcast again today. Dr. Derek Raghavan: Thanks, John. Great to be back with you. Dr. John Sweetenham:  One of the issues that we believe is going to be a challenge for us in the oncology world during the coming year that you and I have discussed on a previous podcast is this issue of cost benefits of new therapies in oncology, and the need to compare new treatments against old established standard of care treatments, rather than against the most recent new treatment preceding the one that we have now if you see what I'm saying. This is clearly going to be an ongoing concern. Why do you think we should be thinking about cost benefits of new treatments? And clearly, I think we'd all agree that this matters, but I think maybe you could expand a little on why you think it is truly important that we kind of go back and make sure we're comparing these drugs with the more established standards of care. Dr. Derek Raghavan: You know, I think this is sort of a metaphor of modern oncology, John, because it brings in so many elements. As you've implied, the cost of cancer care and not just cancer care, I mean it's all medical care just going through the roof, and unfortunately, it's happening most particularly in the United States. And whether that's just because here the pharmaceutical industry and government seem to have a very tight relationship, or whether there's some other explanation that is not clear, but I would make the comment that a lot of the newer treatments that are horrendously expensive in the United States, may be purchased for half the cost or less in other OECD countries. And that suggests that at some regulatory level, one of the parameters is a little off in the United States. And the reason that this is such a big deal is that it ultimately is hitting patients very hard. I think everyone has agreed, and we've discussed it in some detail in the past, everyone is identifying financial toxicity as becoming one of the governing toxicities of cancer care, and we've talked about strategies of dealing with that. As you implied, you know, we have this sort of tendency to think that anything new is wonderful, and anything old is terrible. And often, that's true. But I think the problem is that often, we will test the brand new agent of today with last year's brand new agent, which hasn't necessarily been fully tested at the time. So, if you think about prostate cancer, you know, the Michael Hofman group tested against cabazitaxel, and I'm not quite sure why cabazitaxel suddenly became the only drug to use second-line in prostate cancer. You know, doxorubicin has been there for a long time. Mitoxantrone has activity, even the old chestnut oral cytoxan has some activity there. And each of the drugs I've just mentioned is way cheaper than cabazitaxel. I'm not implying cabazitaxel is a bad drug, I'm simply saying it's more expensive. And I think as patients are really being harmed by the cost of care, I think one of the things that's kind of a shame, and it goes to the way we were trained, is oncologists have been trained not to think about the costs of what they're doing because the thought is that if we're thinking costs, we will withhold the best treatment because of cost considerations. I think the other side of that coin is we need to be thinking about what is the damage to patients that the cost is doing, and if there is substantial damage, is the patient getting that much bang for the buck? In other words, say an old cheap drug gives you three months extra survival, and a brand-new, very expensive drug gives you four months extra survival, do we really want to be thinking that that somehow is a wash and we should use the newer drug? At the very least, physicians should now be trained to have that discussion with patients and raise the issues so that patients aren't embarrassed by their inability to pay. We do know the two areas that are really hard to get patients to confess about, as it were, financial toxicity, and sexual dysfunction. And if we as physicians don't address that, we are going to be complicit in making these sorts of problems worse. So, one of the things is the costs of care. I think one of the other issues that is a little troubling is how we're thinking about new standards of care. There is a growth industry of consensus guidelines, and the reality is that some of the consensus guidelines, I think particularly, ASCO's, are very meticulously done. I've had the privilege of being part of a couple of the panels, and they were very rigorously driven, and they were trying to identify level-1 data and trying to be honest about outcomes. But some of the consensus guidelines are basically a bunch of good old boys getting together, and just chatting about what they do, and if they all do the same thing, then that becomes a guideline. And that can be a flawed approach, so that we've got consensus guidelines that are terrific, and some consensus guidelines that might be terrific, but may not be predicated on the best evidence. And then finally, one of my bugaboos is this sudden emphasis on real-world data. And I tend to worry about the concept of 'garbage in, garbage out'. A lot of the real-world analyses are either looking at databases that weren't designed for the way they're being implemented, or there are very practical reports of stuff that has happened, but without the necessary scientific rigor, such as considering what are the case selection biases that have led to those sets of real-world data being produced? So, that sort of compounds the problem of the fact that we need to be focusing a little more on, "What are we doing? Why are we doing it, and how robust are the data that support our patterns of practice?" One of the real leaders in this space is Mark Ratain, who's gone right back to torts and has started to ask questions about the pharmacology of drugs. There are dosing schedules that come out of phase I and phase II trials. There are often schedules that will be of benefit to the pharmaceutical industry but may not be fully evidence-based. So, you know, with a drug like Radium-223, which is for prostate cancer, it is said that you should give 6 doses. I'm unaware of any robust data that say that 6 is better than 5 is better than 4. Dr. John Sweetenham: Yeah. Thanks, Derek. Great responses. And I particularly like your insight into real-world evidence. I know that there have been attempts by ASCO, and by FDA, to put some parameters around real-world evidence, and get some, I guess you'd call it quality assurance into this, but I do agree with you that it's a little bit uncontrolled at the moment, and I think if we are going to continue to use these very, very large real-world datasets as a comparator, particularly, for drug approval, as well for studies, then there's probably still significant amount of work to be done to make sure that those data are collected in a consistent and rigorous fashion. Dr. John Sweetenham: I'm going to change gear now and talk, for just a little while, it's a huge subject and the time constraints will prevent us from saying too much about this, but of course, you know, health equity continues to be a major concern across healthcare in general, and in oncology specifically. We've now seen, for example, the replacement for the Oncology Care Model, The Enhancing Oncology Model, which has been proposed by CMMI. And not surprisingly, I think they recognize the need for addressing health equity and are introducing some health equity components into that in the next phase of Oncology Care Models from that group. But I guess my question at this point is, do you think that this kind of approach whereby health equity is at least to some extent addressed in the context of, for example, an alternative payment model, is the way ahead in terms of actually bringing about effective change, rather than just recording that there are indeed disparities? Dr. Derek Raghavan: So, that's a complex question, and I think there are several strands to the answer. I think the first thing I would say is, it really is time for us to recognize that we are at an inflection point. And we need to move from analysis paralysis to a new paradigm, which I would call, equity of survival. I have to say, I'm really over the multiple meetings that most of the professional societies have where people seem to feel good about saying, "Yep, we've come together and we've decided there really are disparities." We've known that there were disparities of care for probably 20 years, and some of us have done something about it and others haven't. But I think it's time to define equity of survival, and you can certainly do it. And what I mean by that is as follows: so, if I could use an example of a study from our place at the Levine Cancer Institute, Dr. Bei Hu, who is a very talented young lymphoma specialist, analyzed our outcomes for poorly insured, or uninsured, predominantly black American populations versus wealthy whites. And she published in Cancer and also presented prior to that at ASH, the fact that we had identical outcomes for diffuse large B-cell lymphoma; our hypothesis is that we were able to improve the results by using nurse navigation to help the underprivileged patients be able to adhere to the rigorous constraints of cuff management of diffuse large B-cell lymphoma. But you know, the fact is we are able to show that survival is the same in those two population groups. So, it isn't a question of, "Did you do more? Did you spend more time?" At the end of the day, the parameter is, they lived the same, and the quality of their lives, as we've measured, it was the same. So, I think that's one piece. I'm a bit negative about the government's new EOM. I've kept my institute out of the first OCM model because I thought that they were going to waste our time, and they played with it, and they learned very little, and then they generated a new model. I am very happy that there are health equity components in it, but of course, what we already know is government doesn't enforce those very well. If you look at the National Cancer Institute, and from my time on the parent committee and doing reviews, I was constantly saying, "But we aren't seeing the appropriate representation of minorities." Journal editors are still allowing the NCI-designated comprehensive cancer centers to publish papers with less than 5% Black Americans. And the argument is, "Oh, that's not in our demographic." But that's nonsense because the demographic of Black Americans and Hispanics in most parts of the United States are pretty well known, and the centers that I'm thinking about have perfectly large numbers of Black American, and Hispanic, and Native American patients. You know, I think there are two dimensions; one is government actually has to mean that they want to see things happen and enforce it appropriately, but at the same time, the idea that we're checking a box by doing yet another study of underserved populations where we're looking at demography, and their eating habits, and so on, when we're not concentrating on treatment-based survival. And the journal editors are turning down papers as being too descriptive when they report smaller studies of African American or Native American patients. All of those things have to be fixed, in my opinion. Dr. John Sweetenham: Great, thanks. And I'm going to change gear again to another issue, which, certainly, at our center is becoming more prominent for us, and that's an issue of sites of care. So, we are increasingly becoming aware that reimbursement issues are driving where our patients receive certain components of their care, particularly their chemotherapy. At the same time, we're also seeing increasing interest, I think partly fueled by the COVID-19 pandemic towards home treatment, and specifically, home infusion. So, I'd be interested to know where you think the future lies in terms of; number one, how you think this dynamic is going to play out around payers to some extent driving sites of care. And then secondly, what you see as the future of home infusion for cancer patients and potentially the use of home chemotherapy. Dr. Derek Raghavan: Well, you know, I tend, as you know well, to be one of your more cynical friends. I have real trouble with the insurance companies declaring publicly that they're struggling to keep up with the cost of treatment, and therefore they need to influence treatment when despite this incredibly difficult situation in which they find themselves, they're able to give seven and eight-figure bonuses to their Chief Executives every year. So, they're not doing poorly, they're just crying poor. And so, when they claim that they're doing things for the benefit of patients, I just don't believe that. So, the first thing is, the imperative to move care from point A to point B is driven by people with self-interest rather than necessarily trying to do it for patients. Now, having said that, I actually think COVID has taught us a lot. We can do many things very effectively through telemedicine, and for example, at the Levine Cancer Institute, we surveyed our patients who are dealing with the Supportive Oncology teams, Psycho-Behavioral Medicine, and Complementary Integrative Medicine. And so, they've actually shown us that they would prefer to have video consultation, which saves them having to get dressed, jump in the car, drive into the city, or to their local branch of LCI and so on. And so, there are demands where it's quite clear that patients like telemedicine and home care, and we know that because the cancellation rate of these appointments has gone way down with the introduction of telemedicine. So, for certain things, it's really good. You mentioned the concept of home infusion, and I think that's a terrific idea, provided that you have the necessary checks and balances. You and I both know that patients will suddenly crash with an allergic reaction in response to a drug like taxol and taxotere, or even sometimes, cisplatin, so, you don't want to have the situation where the nurse is infusing at home by herself, and trying to manage someone who's just shut down with an allergic reaction without any help. So, you need to have standard operating procedures that maximize life safety. Having said that, the idea of making it easier for patients to have their treatment and having it close to home is really, I think something that I really support. Where I'm less enthusiastic is something that the insurance companies have started to play with, and I believe ASCO is opposing this, at an organizational level, and that's the concept of white-bagging and brown-bagging. The idea that the insurance companies will somehow supervise the preparation and distribution of drugs to their satisfaction, and then expect oncologists or hospitals to take those drugs and administer them on their behalf. There is no clear evidence of quality control; it's absolutely clear that this is being done in a fashion that will allow them to control costs, and maybe not in an appropriate fashion. And I think that should be really strenuously opposed. Now, they're not the only culprits. What we have found is many of the largest centers declining to use biosimilars, for no particularly good reason, other than the fact that they're not that familiar with them. Well, there are good data to suggest that many of the biosimilars have equal efficacy and equal toxicity to the parent compounds, and they're way less costly. And so, we need to be thinking through a whole paradigm of, where are biosimilars available, what is the track record for their safety and utility, and so on. So, I think there are a number of steps that we can actually be involved in that will improve the cost of care. But doing it just because the insurance companies are trying to save themselves money may not be the primary driver that would influence my thinking. Dr. John Sweetenham: Yeah. Thanks, Derek. I'm interested in your comments on biosimilars because, you know, at our center, at UT Southwestern, we have certainly embraced biosimilar usage. And one of the points of care challenges in that regard is knowing which biosimilar is covered by an individual patient's insurance. And I know at a number of centers, that's been a challenge, and it's something that our pharmacy team has worked on in order to find a more facile way for our clinicians to be able to understand coverage. And there are significant cost savings associated with that. So, I agree 100% And talking of costs, the final issue which we wanted to talk with you about briefly today is the issue of prior authorization. Many ASCO members in the United States spend a very large amount of time dealing with this, and in the community oncology practice, it's estimated as much as 25% of an oncologist's time is now spent dealing with these issues, and obviously is very negative in terms of job satisfaction, physician burnouts, and so on, as well as just making things very, very difficult for our patients. Do you see a resolution to this? Do you think it will continue to be a big challenge, or do you think there are solutions available to us which will make this much easier for physicians, and save them some time as well as money? Dr. Derek Raghavan: No, I think it's here to stay. I mean, I think it's honestly multifactorial. I think it begins with government in the sense that we've just, once again, declared war on cancer. It's the third or fourth war that's been declared during my career, and that's all well and good. But you know, the reality is that that sets expectations in the community that can often be unrealistic. And so, that puts the unfortunate community, or academic oncologist in the situation of really struggling to say to a patient, "We've done what we can, and it's time to bring in supportive oncology or hospice." So, there are unrealistic expectations in the community. I think the second piece that relates to this is, the purveyors of computerized record systems are actually contributing more to burnout than probably anything else in the land. We've got unregulated industry where the service delivery for most of these companies is poor. And I think it all connects really with a broader issue, which is, for whatever reason, post-COVID, there is this phenomenon internationally of the so-called Great Resignation. It's partly burnout, it's partly anger about the world, I guess, at large. But what we are finding is, one of the pivotal areas for the Great Resignation is medical and nursing staff. I've never seen as many physicians retiring early, as many nurses getting out of oncology, and either going into the pharmaceutical industry or into data management or just going into simpler types of nursing. And that reflects the resistance of the healthcare industry to recognize that there are different stresses in different types and parts of the healthcare industry, and not compensating appropriately, and putting in safety valves to help these people get off the line. And you know, your question was, "Do I think it's here to stay?" I really do. I think the younger generation has, in many ways, a much more sensible approach to work-life balance than we did. They also have less experience. So, every time a crusty old veteran doctor, or nurse goes, they're replaced by someone with two decades less experience, and somewhat a different work ethic. I'm not saying it's a bad work ethic, but it's changing the way healthcare is delivered. So, I think this is going to be a real issue. And then finally, you know, in terms of the actual business of prior authorization, which I view largely as a tool that the health insurance companies use to avoid payment, I think we mentioned in a previous discussion on our financial toxicity tumor board, we have a pretty standard algorithm where we call the insurance companies before starting chemotherapy or radiotherapy; check in with them that their reading of their rules allows approval, and then we document who we spoke to, and what time. That seems to be quite a good way of stopping the insurance companies denying payment at a later time based on the technicality on page 253, line 27. While we're talking, John, what's happening at the Simmons Center and UT Southwestern? Are you seeing a change in the pattern of resignation of nurses and physicians, or have you managed to figure out strategies to avoid that? Dr. John Sweetenham: At UT Southwestern and Simmons Cancer Center, in particular, what we've seen is very similar, I think, to the national trends. And so, I think what we've seen is three main groups affected; our nursing staff, and as you say, I think there are various reasons why that's happened, our clinical trials staff, in particular, we've had an increasing problem in hiring and have lost many to industry actually. And then, on the physician front as well, we have seen a number of our physicians move to industry, both in terms of drug companies, and also some data companies where, you know, I think there is clearly an interest in having physician leadership. And, you know, I do agree with you, and I think part of the challenge, and there's been quite a lot of literature about this, as you'll know, is, what are we going to do, particularly in the academic oncology community, what are we going to do for our younger faculty in terms of growth opportunities for them that keep them within academic medicine? And I think we probably really have to rethink the way academic oncology is running at the moment if we're going to retain the best people within our field. So, a short answer to your question is, yeah, we're seeing very similar trends to those that are reported nationally. We're planning interventions, but obviously, all of these things take quite a long time. It's been great talking to you as always, Derek. I think it's good to hear your insights on the podcast, particularly, with respect to what might happen in 2023. I think as always, it's important to remember that despite the challenges, I think if you look back year-on-year, there is for sure, going to be a lot to be excited about this year. And our patients, I think, can anticipate to see continued improvements in what we do, and hopefully improvements in their lives and the lives of the caregivers who take care of them. So, despite the challenges, I think we need to just remember that it's not all bad, and there are a lot of good things going on out there. Dr. Derek Raghavan: Yeah, I agree with that, John. One of the things we always forget, despite the fact that you and I were tasked with talking about the problems emerging, is, the most rapidly growing patient population in oncology is the long-term survivors, and we can both be justifiably proud of all the good things that have happened to create that scenario. Dr. John Sweetenham: Absolutely. So, thanks, once again. Always a pleasure to talk with you. And to you, our listeners, thank you for your time today. If you value the insights that you hear on the ASCO Daily News podcast, please take a moment to rate, review, and subscribe, wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy, should not be construed as an ASCO endorsement. Find out more about today's speakers: Dr. John Sweetenham Dr. Derek Raghavan Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. John Sweetenham: Consulting or Advisory Role: EMA Wellness Dr. Derek Raghavan: Consulting or Advisory Role: Gerson Lehrman Group, Caris

The Josh Boone Show
#25: Dr. Paulomi Campbell – Holistic Psychotherapy, Identity & Toxic Relationships

The Josh Boone Show

Play Episode Listen Later Oct 13, 2022 130:14


Dr. Paulomi Campbell, Ph.D. is a holistic psychologist based in Charlotte, NC. She received her Ph.D. in Counseling Psychology from University at Buffalo in 2007.Since then, she's served as a psychologist at Levine Cancer Institute and Columbia St. Mary's, as well as being an Assistant Professor at both Vanderbilt University Medical Center and Marquette University.Currently, she is the Founder of Inara Therapy + Wellness, where she has taken her experiences over the past 15 years in the healthcare field to offer a unique form of holistic psychotherapy which utilizes traditional and non-traditional therapies to help clients view themselves with compassion rather than judgment, and create a fuller integration between the body and mind.Some of the topics we dive into are:Expectations, identity, and repairing family relationshipsEmpathy, emotional isolation, repression & vulnerabilityThe science-practice gapNeuroplasticitySelf-work, toxic relationshipsHow one keeps themselves grounded as a therapistAnd much moreConnect with Paulomi:InaraTherapy.comPaulomi on LinkedInMusic by Kirby Johnston – check out his band Aldaraia on Spotify.

Oncology Peer Review On-The-Go
S1 Ep59: Oncology Peer Review On-The-Go: Cancer-Related Fatigue Outcome Measures in Integrative Oncology

Oncology Peer Review On-The-Go

Play Episode Listen Later Sep 19, 2022 20:02


Coauthors Dori Beeler, PhD, of the Levine Cancer Institute; Shelley Wang, MD, MPH, of The University of Texas MD Anderson Cancer Center; and Viraj A. Master, MD, PhD, of the Winship Cancer Institute of Emory University, spoke with CancerNetwork® about their review published in the journal ONCOLOGY® titled Cancer-Related Fatigue Outcome Measures in Integrative Oncology: Evidence for Practice and Research Recommendations. In the article, the authors and their colleagues explored negative impacts, mechanisms, and measurement concerns surrounding cancer-related fatigue. They also proposed strategies for standardization and future directions in the space.   

ASCO Daily News
A Novel Approach to Address Financial Toxicity

ASCO Daily News

Play Episode Listen Later Jul 28, 2022 13:14


Host Dr. John Sweetenham, of the UT Southwestern's Harold C. Simmons Comprehensive Cancer Center, and Dr. Bridgette Thom, of the Memorial Sloan Kettering Cancer Center, discuss a novel intervention to address financial toxicity and social need using the Electronic Medical Record.   TRANSCRIPT Dr. John Sweetenham: Hello. I'm Dr. John Sweetenham, the associate director for clinical affairs at UT Southwestern Harold C. Simmons Comprehensive Cancer Center and host of the ASCO Daily News podcast. My guest today is Dr. Bridgette Thom, a researcher at Memorial Sloan Kettering (MSK) Cancer Center. We'll be discussing a novel approach to address financial toxicity that uses the electronic medical record to streamline referrals to financial assistance and counseling for high-risk patients. Our full disclosures are available in the show notes, and disclosures of all guests on the podcast can be found on our transcripts at asco.org/podcasts. Dr. Thom, it's great to have you on the podcast today. Dr. Bridgette Thom: Thanks so much for having me. Dr. John Sweetenham: Dr. Thom, the high costs of cancer care have caused major financial distress for many patients and their families. And this, of course, has been the subject of a great deal of literature in recent years. As you noted in your poster presentation at the recent ASCO Annual Meeting, there are limited interventions, despite a need for patient level and system-based solutions (Abstract 6596). Listeners to our podcast will remember a previous discussion that we had with Dr. Derek Raghavan from the Levine Cancer Institute, where they had instituted financial toxicity grand rounds to partially address this problem. Can you tell us about the novel approach that you and your colleagues explored using the electronic medical record to streamline referrals for financial assistance and counseling? Dr. Bridgette Thom: I first have to credit our team for this work. Dr. Emeline Aviki, who is a gynecological surgical oncologist with keen interest in affordability and payment models, founded the MSK affordability working group several years ago. The first priority of the group was to determine the scope of financial hardship at our institution. At the time, we were absent a systematic screening process. So she, our data analysts, and representatives from our Patient Financial Services Program, developed proxy measures to figure out which patients might be having financial issues. Looking through the medical record, we found those patients who had used one of our Patient Financial Services assistance programs, those who had billing issues, and those who had been referred specifically to social work for a financial issue. And in doing so, we found out that about 25% of our patients over a 2-year period were facing some sort of financial issue. Looking closer at that data, patients experiencing financial hardship weren't necessarily being connected to the resources that we had available, which include copay assistance programs, financial assistance programs, and support for non-medical essential needs. So, for example, we had about 1 in 6 patients who had some sort of payment issue, but only about 20% of them had applied for financial assistance. And we wanted to figure out why this was happening and review the process. In doing so, we discovered that too much burden was being placed on already burdened social workers who had to triage all those issues. So Dr. Aviki in her wisdom realized that care providers, physicians, advanced practice providers (APP), nurses needed to make direct referrals to the resources that we had. So we had a place for patients to go, we just needed an easier mechanism for them to get there. And that was the birth of the financial toxicity order set. And she and her team really powered through the developmental and testing phases working with IT, our strategy administration groups, clinical end users, our PFS team, that's Patient Financial Services. We built this order set that allows clinicians directly to refer to our resources. So clinicians, either through their discussions with patients or if patients bring up an issue, through the order set they can select a reason for a referral, the urgency of referral, the clinical location, etc. And then those orders go directly to our Patient Financial Services staff who then contact patients. We piloted this program in late 2020, early 2021 on 1 service, and then used that feedback to roll out the program first to our outpatient clinics and then to inpatient. That process involved a lot of educational efforts, getting the word out, and working with IT and our strategy team to stay on top of the data and monitor referrals over time. Dr. John Sweetenham: Thanks. Could you say just a little bit more about the educational process that you use? I noticed in looking at your poster that the bulk of referrals came either from the clinic nurse or from the APP. Did you tailor your education in any way to the specific provider that was involved? How did you do that piece? Dr. Bridgette Thom: Our affordability working group is an interdisciplinary team and we have nurses, social workers, physicians. So we did a lot of grand rounds work tailored to the audience be it by disease type or clinical role. Dr. John Sweetenham: Great, thank you. This is clearly great work. There's a lot of useful and helpful information in your abstract and in your poster. What would you say are the key takeaways from the intervention? What would you say about the scalability of this approach into community practice as opposed to a very large institution such as yours? Dr. Bridgette Thom: One key takeaway from a process perspective was the need, like I said, for an interdisciplinary approach to handling the issues. That might seem obvious, but it was really crucial to the success of the project to engage key departmental stakeholders and decision makers very early in the process and keep them informed throughout the development of the order set. That definitely helped us to smooth a potentially bumpy road when we're dealing with big systems change. From an outcomes perspective, a key takeaway is the importance of having actionable items to empower the care providers. So while our institution has this amazing program, our Patient Financial Services program which provides counseling, and connects patients to tangible resources, this type of intervention I think could be scalable or applicable to a community practice or smaller hospital, provided there's somebody, a social worker, patient navigator, [or] nurse, that can be a connection for patients and those potential resources that do exist out there. For us going forward, we're going to continue to evaluate the order set, both from the clinical end user and then also the Patient Financial Services staff to learn more about their perspectives and what can be adapted in the order. We also, of course, want to learn from our patients about their experience with the process, and so we have projects, both research and program evaluation, in the works to consider their perspective. Dr. John Sweetenham: Great, thank you. And I guess 1 of the other aspects of this where there is obviously substantial opportunity is that, of course, currently, you're still reliant upon the provider to place the order. And I wonder whether you feel that some form of screening for social need and financial hardship could be embedded within the electronic health record as a key next step, so that you proactively identify those high-risk patients. Dr. Bridgette Thom: Definitely. And that is, in fact, our next step. We are currently piloting our financial hardship screening tool on 4 large services at our institution. The objective here is to, like you said, proactively identify patients who might be at risk and connect them to resources, be it tangible resources, or just counseling or insurance guidance, [and] do that before the hardship can occur. And the goals of our pilot phase are to (1) develop and refine a tool that's both predictive, but also feasible to administer within a busy clinic setting. And then also (2) to work with our interdisciplinary team to adapt the workflow. We can have a great tool, but if we don't have a way to administer it in a clinic, it's not going to do us any good. So for us, that means listening to feedback from, first and foremost, our patients and then the key stakeholders in the process. Our nurses have been integral to this process. We also, of course, our Patient Financial Services, staff, the clinical operations staff, obviously, IT, social work. And once we have these processes figured out and we have our tool solid, we will hopefully expand the screening to all services, and then use data to figure out the optimal screening interviews by disease and treatment type because we feel that this could vary by a patient's treatment trajectory. Dr. John Sweetenham: You note in your poster that additional multilevel interventions are needed to address the problem of financial toxicity at a systems level, and of course, what you have done here is a really great and important step in helping to identify those patients. But identifying those patients who are at particular risk is only beginning of addressing the issue. Could you elaborate a little bit more on other areas that you're exploring in terms of the interventions that you're using? Dr. Bridgette Thom: Sure. And this idea of multi-level interventions comes from my social work training, where there's an emphasis on viewing the individual as being part of a series of dynamic and interconnected relationships and systems: the social ecological theory. So if we think of concentric circles with the patient at the center, there are cascading relationships that are going to impact the course of their care. We radiate out to families and caregivers, a patient's workplace if they're employed, the hospital and the providers there, and then look to bigger systems where a patient lives, their town. If it's in an urban setting or a rural setting, the type of insurance that they have, if it comes from their employer, or if it's a different insurance system, their community and then of course, broader, social, societal, more macro issues. My point and that of many others who work in this space is that we have to consider the context. We can't just build and test interventions that focus on a patient because the patient isn't existing in a bubble. They're existing in relationships with their caregivers, their health care providers, their health care system. And all of that exists in, for lack of a better word, a broken system of structural inequality, systemic racism, and conflicting values about health care as a right. Patient-level interventions are indeed important, but we can't place the burden solely on the patient. And we, as researchers and clinicians in this space, really need solutions that are going to reach across systems. I think, like you said, this project demonstrates that and this is something that I hear from patients in other work that I'm doing. For example, I'm working on a digital intervention to help young adult cancer survivors to build their financial capability and build their understanding of the health care system and insurance systems and financing and all of that. As I co-develop this intervention with patients and survivors, I'm hearing, 'This is great. I'm glad I'm learning these things, but at the same time, my co-pays are unmanageable,' Or, 'I might have to skip my survivorship appointment because I can't afford to take off work that day.' I think we have to really think about, like I said, the context and the bigger picture of the scope of the problem and build and develop interventions that acknowledge that. Dr. John Sweetenham: Well, as you say, very complex, multi-level problem and many interventions needed. But congratulations and kudos to you and your colleagues for addressing one component of this. And we're really looking forward to seeing how this develops and progresses in the coming years. And I'd like to thank you, again, for sharing your insights with us today on the ASCO Daily News podcast and telling us a little bit more about this great work. Dr. Bridgette Thom: Thank you so much for having me. I want to just acknowledge all of the work of our team. It has really been a team effort. We're looking forward to our next steps. Dr. John Sweetenham: And thank you to our listeners for joining us today. You'll find links to the poster discussed today on the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. You can hear more about the MSK Affordability Working Group's efforts on the podcast, Cancer Straight Talk from MSK.   Disclosures: Dr. John Sweetenham: Consulting or Advisory Role: EMA Wellness Dr. Bridgette Thom: Stock and Other Ownership Interests (Immediate Family Member): Caladrius Biosciences, Mediwound, Sierra Oncology, Lipocine, MEI Pharma, Oncternal Therapeutics, Avadel Pharmaceuticals, Chimerix, Avidity Biosciences, Sutro Biopharma, Adma Pharma, Concert Pharmaceuticals, Processa Pharmaceuticals, Curis           An, IMV, Arcus Biosciences, Iovance Biotherapeutics, Qiagen, Revance Therapeutics, DermTech, Zimmer BioMet, Axonics Modulation, Halozyme, Autolus, Pavmed Inc       , Mereo BioPharma, and AADi Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.    

Cancer Registry World
A Conversation with Mellisa Wheeler, MHA, Director of Community Outreach at Atrium Health Levine Cancer Institute

Cancer Registry World

Play Episode Listen Later Jun 7, 2022 15:39


In this segment, Mellisa Wheeler, MHA, Director of Community Outreach at the Atrium Health Levine Cancer Institute in Charlotte, North Carolina, discusses the role of cancer registry data in the design and implementation of successful community outreach activities for the prevention and screening of cancer. Enjoy listening and learning!

Caris Molecular Minute Podcast Series
Interview with Dr. Jimmy Hwang: Author to ASCO Provisional Opinion on Genomic Testing

Caris Molecular Minute Podcast Series

Play Episode Listen Later May 25, 2022 22:30


Caris Precision Oncology Alliance™ Chairman, Dr. Chadi Nabhan, sits down with Dr. Jimmy Hwang, Chief, GI Medical Oncologist at the Levine Cancer Institute. Dr. Hwang recently contributed to a JCO publication titled, “Somatic Genomic Testing in Patients with Metastatic or Advanced Cancer: ASCO Provisional Clinical Opinion.” Together, Dr. Nabhan and Dr. Hwang discuss the recommendations made in this article and the impact genomic testing can have on patient outcomes. To access this article, please visit: https://ascopubs.org/doi/full/10.1200/JCO.21.02767 For more information, please visit: www.CarisLifeSciences.com

Francene Marie
Cycle with us with at 24 hours of booty

Francene Marie

Play Episode Listen Later Mar 10, 2022 17:36


What a fun event that helps friends and family through their cancer journey. Francene Marie interviews the founder of 24 Foundation, Spencer Lueders regarding the most popular 24 hours of booty around the booty loop. Registration opens March 24th for the 21st year of 24 Hours of Booty. www.24froundation.org  The event is presented by Levine Cancer Institute will take place from 7 p.m. Friday, July 29 to 7 p.m. Saturday, July 30. Participants have the opportunity to sign up for the in-person or virtual “UnLooped” event. The in-person event will take place on the “Booty Loop” in Charlotte's Myers Park neighborhood.

DocTalk Podcast
The Cultural and Clinical Challenges of Sickle Cell with Ifeyinwa “Ify” Osunkwo, MD

DocTalk Podcast

Play Episode Listen Later Feb 9, 2022 20:00


Though sickle cell disease had been present in Africa for over 5000 years, it was first “discovered” in 1910 when a dental student named Walter Clement Noel became the first patient to be formally diagnosed. From there, more would be uncovered about the disease in the decades following his diagnosis, such as how it disproportionately affects patients of African descent. According to the Centers for Disease Control and Prevention, about 1 in every 13 Black infants in the US are born with the trait for sickle cell disease. Additionally, diagnosis and screening for sickle cell are still lacking in lesser-resourced regions of Africa and the US alike. Ifeyinwa “Ify” Osunkwo, MD, director of Sickle Cell Disease Enterprise at the Levine Cancer Institute and Professor of Medicine and Pediatrics at Atrium Health, spoke of advancements in the field of sickle cell disease including chronic disease-managing therapies, and how physicians unfamiliar with the disease could collaborate with hematologists to provide the best care for those affected by sickle cell.

Multiple Myeloma Hub
Daratumumab as maintenance therapy for transplant-eligible patients with NDMM: What have we learned from GRIFFIN and CASSIOPEIA trials?

Multiple Myeloma Hub

Play Episode Listen Later Jan 14, 2022 13:24


During the 63rd ASH Annual Meeting and Exposition, the Multiple Myeloma Hub was pleased to speak to Jacob Laubach, Dana-Farber Cancer Institute, Boston, US, and Peter Voorhees, Levine Cancer Institute, Charlotte, US. We asked, Daratumumab as maintenance therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM): What have we learned from GRIFFIN and CASSIOPEIA trials?In this podcast, Laubach and Voorhees discuss the findings from the randomized phase II GRIFFIN trial (NCT02874742) and the CASSIOPEIA trial (NCT02541383). Hosted on Acast. See acast.com/privacy for more information.

ASCO Daily News
Confronting Challenges in Oncology in 2022 With Dr. Derek Raghavan

ASCO Daily News

Play Episode Listen Later Dec 16, 2021 26:40


Guest host, Dr. John Sweetenham, associate director for Clinical Affairs at the UT Southwestern Harold C. Simmons Comprehensive Cancer Center, and Dr. Derek Raghavan, President of the Levine Cancer Center at Atrium Health in North Carolina, discuss some of the major issues ahead for the oncology community in 2022, including tension caused by the COVID-19 pandemic, achieving true equity of care, how to use molecular testing in an optimized fashion, and the future of the oncology workforce. Transcript  Dr. John Sweetenham: Hello, and welcome to ASCO Daily News podcast. I'm John Sweetenham, the associate director for Clinical Affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center and guest host of the podcast. Today, we'll be discussing the challenges ahead for the oncology community in 2022 with Dr. Derek Raghavan, President of the Levine Cancer Institute at Atrium Health in North Carolina. Our full disclosures are available in the show notes, and disclosures relating to all episodes of the podcast can be found on our transcripts at asco.org/podcasts. Derek, always a pleasure to have you here, and great to have you back on the podcast again.   Dr. Derek Raghavan: Hey, John. Always enjoy chatting together.   Dr. John Sweetenham: Derek, we're interested today to get your insights into what you think are going to be the major challenges facing the oncology community in 2022. I think each of us could come up with a pretty substantial list, but very interested to hear what you think are going to be those issues which are going to be uppermost in our mind as we move into the new year.   Dr. Derek Raghavan: Well, I think there are a number of important issues, John. I think everybody in clinical practice, medical or nursing, or whatever, have been brutalized somewhat by the COVID-19 pandemic, and I think everyone's tired and a bit cranky, and they're upset with a schism between the fringe and the science-based clinicians. So, I think that underscores everything. And there's an anxiety and a tension that I think is just new.   From the practical standpoint, which is where I think your question is directed, yeah, I think there will be issues that relate to achieving true equity of care. And I think hopefully, the focus will move from analysis paralysis to actually doing things and measuring outcomes. I think there will be the tension between value, price, and cost. People are spending an awful lot of money on health care. That's going to be an issue.   We have very good information on molecular prognostication, but a lot of the data that are coming out are from technologies that are not fully validated and not even standardized. There's a lot of disinformation and misinformation coming out, and I think we're going to have to address that. I think those are 3 themes that could keep us talking for quite a while.   I think the other thing, which is more up your alley than mine, is we've been watching CAR T[-cell therapy] emerge. I think we've got a beginnings of a pretty good handle on how CAR T[-cell] relates to hematological malignancy. It's much less clear in the solid tumors, and there is a bit of a tendency to do what used to happen in the 1970s and '80s, which is here's a new treatment. Let's give it a whack and see what happens.   But this is very expensive. We don't want to fall into the trap of how bone marrow transplant was introduced as a standard of breast care management for nearly a decade, based on somewhat flimsy evidence. So, we need to be a little more thoughtful about how we introduce CAR T[-cells] into the solid tumors.   Dr. John Sweetenham: Thanks. Yeah, plenty to discuss there, as you say. And what I'd like to do just because it is such a topical issue and continues to be at the moment is just pick up a little on the COVID-19 theme. I think that we've all seen a great deal of discussion in recent months about many of the consequences of COVID-19, including delayed screenings, late diagnosis, clinician burnout, and so on. But I'm interested in your insights on a couple of things.   Number 1, since we're now seeing the emergence of further new variants, what do you think that this is going to mean for the oncology community in terms of handling these new variants within the context of our patients with cancer? And then secondly, because I'm intrigued by one of the things you mentioned in our discussions about this podcast, you mentioned the changed relationship between health professionals and parts of the community as a consequence of COVID-19. And interested to hear you expand just a little bit on that. So, kind of 2 questions wrapped up in 1 there.   Dr. Derek Raghavan: Yeah. Well, I think the 2 are connected. The old style of physicians has always liked to be sure of their ground and to have a firm database when they talk about things. Particularly with the new variants, while it's completely appropriate to be transparent about the fact that they knew that they seemed different and so on, I think there is the problem that there are a lot of physicians who are now becoming TV personalities as much as physicians and who are talking all the time.   I'm not critical of that, but the problem is that they're being honest in saying we don't really know this, but this is what I think, and then they have to change direction. So, what's happening is, for the first time in a long time, physicians are regularly being quoted and being seen as saying things that are not necessarily correct, and that reduces confidence by the community and the physicians. At the same time, COVID-19, in my view, highly, inappropriately became a political football.   You have people who have absolutely no training, so radio hosts, football quarterbacks, basketball stars making extraordinary statements about COVID-19 and their approach to vaccination, masking, and other things where they have absolutely no business doing it. But they are people who are believed. They're high profile. And so, there's now a schism emerging between patients who listen to people who have no medical training at all and no basis for what they say and those particularly in the political domain who have politicized this and created a situation where, once upon a time, a physician was at least seen as coming from the right place and with good intent.   But we've both seen so many of these public demonstrations where physicians and public health physicians are being castigated for simply espousing good practice. Now, with respect to managing the variants, I think the fact is we have some basic principles that I have believed now for 2 years. Masks reduce the chance of getting any type of COVID-19. They just do. If you wear a mask most of the time when you're out and about, you're going to cut your chances down. Vaccination reduces the chance of ending up in the ICU unless you have some sort of immunological deficit.   Dr. John Sweetenham: Yeah. I'm going to switch gears now and return to the first thing that you mentioned right up front, which is the issue of equity and how we are going to address equity issues in the coming year. I think that in many ways, 2020, going into 2021, has been 2 years where issues of equity in health care have really come to the fore. And of course, there's been a great deal of discussion around this.   And I think you'd agree with me that we've seen, at the same time, that some of the strategies that we have been using during the COVID-19 pandemic, including telehealth, which one would have hoped would be a great equalizer, actually has the potential to exacerbate some of the disparities that we've been seeing in health care. But you mentioned analysis paralysis, and just to pick up on that theme, despite the huge amount of coverage that equity has received in medical journals and the media, where do you think we actually are in finally truly addressing some of the cancer care disparities that we see?   Dr. Derek Raghavan: Well, I think, John, you know that I was one of the early chairs of the ASCO Task Force. Otis Brawley and I chaired that task force together. Very early in the piece, I'm going to say probably 15 years ago, we wrote really quite a strong position paper on this whole issue. And so, we got started early in doing stuff on what we thought would be important, and we did, with support from the Komen Foundation, was to start training people of color in the oncology space and keeping them working in underserved communities by paying off their college loans for the period of time that they did that.   So, people have been doing stuff for a while. I think what's happened in the last decade, and it has been a slow change, is that there's been more a move to saying, let's get started. So, if you look at Chris Lathan up at Harvard, at one of their underserved hospitals, if you look around the country, consider the Bristol Myers Squibb Foundation, which puts money into active projects that are about doing stuff rather than having meetings to consider doing stuff. I think there's been that swing.   Dr. John Sweetenham: When we think about equity and disparities of care, we're often drawn towards the cost of cancer care and how much that plays into disparities and inequity in the delivery of cancer care. And picking up on that theme that you mentioned around value, cost and price, and maybe we could think about linking that with the use of CAR T-cell therapy and the application of CAR T-cells in the solid tumor world, if that is going to happen, what do you think we can do during 2022 to confront some of the cost and price issues that we're seeing within our cancer care environment right now?   Dr. Derek Raghavan: Well, I sometimes think in a utopian fashion, which doesn't get me very far, I have to say. What I'd love to see in the United States, because we spend far more money on everything health-wise than any other country in the civilized or uncivilized world, but what I'd like to see is a bipartisan initiative run by people who actually understand health care and health care economics that would go to the issue of, how do you get better bang for your buck? And it would include doing some tough things.   We waste money outrageously. We'll treat third-line metastatic pancreas cancer off trial. Nothing works in third-line metastatic pancreas cancer off trial. It's worth maybe a clinical trial to help the next person in line. That's how we make progress. But just to keep giving the same old litany of drugs in the hope that it might work is a waste of money. As I talked about before, BMT for breast cancer turned out to be a huge waste of money over a long period of time. So, if you can actually create a scenario where government set some rules and took the courageous, and this why it would have to be bipartisan, it would actually start to rationalize health care.   You know, John, the Oregon experiment many years ago, where one party started to rationalize care, and the other party accused them of rationing care. I mean, you can't have that happen. We've also seen both sides allocate the task of developing health care algorithms to people who are great politicians but know nothing about health care or economics. So, I mean, there are easy ways to do it. What we can do ourselves is be honest. Tell people what bang they'll get for their buck.   The person who is likely to have, say, an 80% chance of being dead within 4 months may not wish to mortgage his house if he's told that. On the other hand, he might well want to mortgage his house if he thinks that a very expensive treatment will give him the chance of being alive in 5 years. So, we, as physicians, shouldn't make that decision. It's the patient's right to be able to choose life versus the life of their offspring and spouse and future generations. So, I think it's not that complex, and I think if we brought more transparency about good expectations versus poor expectations, gave a better reason for patients getting more involved in trials, we're still at less than 15% of patients with cancer in the USA getting involved in trials, and that's a tragedy.   Dr. John Sweetenham: Yeah, I think also, the other thing that's occurred to me in this context, is the fact that while we tend to hone in on costs of treatment when we get into these discussions, I've been seeing some emerging literature around the cost of follow-up and unnecessary follow-up and imaging and so on in those patients who are in survivorship part of their cancer journey. And there's a huge opportunity there, I think, for us to reduce costs of care with no impact whatsoever on survival, no difficult treatment decisions to be made because we're simply doing an enormous amount of unnecessary testing in these patients who have completed treatment that we know doesn't impact survival. So, I do think that we could take a really serious look at that and make very significant savings. So, I think there's lots of potential there too.   Dr. Derek Raghavan: Yes. I agree, John. And I'd actually give kudos to ASCO in this space because they were early adopters of the Choosing Wisely campaign. They wrote two sets of guidelines about stupid things that we do that make no difference. And to be honest, I think that--I was on that committee, and the committee got tired.   I was one of the few people that actually felt we should keep going and very actively keep issuing guidelines of things that just aren't worth doing and having symposia at the ASCO ASM say that the symposia that are entitled “How to Waste Money” or alternatively entitled “How to Stop Doing Dumb Stuff” would be really quite important. And it would give the basis for sensible medicine to people who do medical legal protection work. So, most people who do multiple PET scans on lymphoma where the patient is completely well and blah, blah, blah are doing it for medical-legal reasons. They're not doing it because they think it will make a huge difference.   And I, of course, am not talking about the people where they're following PET scans as markers of response. So, I think we can do this work. I'd love to see a presidential campaign which is about not doing dumb stuff and where ASCO takes the bully pulpit and says, “we're spending a year policing ourselves, talking about all the things we do that don't actually make things better for patients.”   Dr. John Sweetenham: So, let's extend this theme of expensive therapies. And you mentioned CAR T-cell therapy. And in the hematologic malignancy world, we're now just beginning to see 1 or 2 results, which will be presented at the American Society of Hematology meeting in a couple of weeks from now, positive results from a couple of randomized clinical trials in hematologic malignancy with CAR T-cell therapy. So, what are your thoughts on the application of this treatment in the solid tumor world, and where do you think we are, what do you think we might see during 2022?   Dr. Derek Raghavan: Well, let's talk strategy first. I think a good place to begin is with a good scientific hypothesis. So, we both know how CAR T[-cells] work. We don't have to have a long discussion here about them. It would be patronizing to the audience. But you might think about, what solid tumor is actually going to benefit from immunological manipulation? Where have the checkpoint inhibitors been helpful, and where have they not been helpful? And so, you might focus the initial part of CAR T[-cells] and solid tumor work on those where there's a hypothesis that makes sense.   Then the second thing you could do would be to actually come to the companies that make all their money from CAR T[-cells] and say, perhaps you could invest in this research with us, and we'll do a couple of Hail Mary passes. So, let's look at the tumors where there isn't a good hypothesis, but nothing works, and see if we can get an experience. So, that'd be a nice, simple, easy way to do it. And then measure tight outcomes, have very robust entry criteria so you don't get confused about various toxicities because you're actually starting with patients in reasonable shape and then expanding to all populations.   So, the first part would be phase 1 and 2. Then you, early in the piece, make sure that you have inclusiveness so that you know all the population groups that might benefit from the treatment. I think that'd be a reasonable way to go.   Dr. John Sweetenham: Talking about identifying targets appropriately and target populations for treatment, you had mentioned as one of your other challenges for 2022 the concept around identifying molecular subgroups and molecular prognostication as a way of patient selection. So, could you say a little bit more about that and what you think we're going to need to do in the coming year in terms of refinement of targets?   Dr. Derek Raghavan: Well, John, this is an area of your expertise as well, coming from the hematological malignancy world. Now, I hope we would both agree that having robust reproducible technology is important. The fact that there are so many molecular diagnostic companies that hype their product doesn't necessarily mean that the product is good. So, there needs to be standardization of approaches to using technology, to measuring outcomes.   We need to have comparative sets of data, looking at different technologies to see how they work, and those sorts of studies need to be funded by government because there's no particular reason for the companies to agree to perhaps show that their diagnostic technology is not as good as somebody else's. But this would be a good initiative for the government to actually start to rank order of the products that are out there. I, frankly, think when you think of the impact of all of these molecular diagnostic tests, I've never understood why so many of them are out there without tight U.S. Food and Drug Administration (FDA) regulation. So, I think that's a place to begin.   If you think back to the old breast cancer days when there was immunohistochemistry and a bunch of molecular technologies, the outcomes were so varied when compared on common tumor samples. So, we just seem to be quite comfortable to make the same set of mistakes again. I do think there are responsible investigators doing excellent work in the space, so I'm not critical of the space. I'm answering the question, which is we need now to bring some regulation in to ensure that the quality of the work, reproducibility of the work. You'll even see, and I know you and I have talked about this in the past, there'll be Mr. X who has prostate cancer and gets his PSA measured, which is Prostate-Specific Antigen, looking at how active the cancer is regularly in different labs. That makes absolutely no sense. There's no common standard. PSA in my lab is going to be different from PSA in your's. And so there just should be some nice, simple rules of how to use molecular testing in an optimized fashion.   Dr. John Sweetenham: Yeah, and I wonder also whether we need to be looking a little bit more closely at point of care clinical decision support for some oncologists who may not be as molecularly literate as others because I do think that's another real challenge at the moment is giving guidance to everyone who might see these patients in terms of treatment selection.   Dr. Derek Raghavan: Well, I agree with you completely. I mean, kudos to the major companies because most of them provide pretty good decision support. One with which we worked tended to be a little too positive about its product, and we worked to change that. And now they're actually very useful. We have a big series from our molecular tumor board here that runs over I think a 5-year period that Carol Farhangfar, PhD, has just submitted for publication, which shows that you can heavily influence people who are out in the community by providing centralized support for their use of molecular diagnostic tests. But again, we only deal with the major companies so that we think there's good quality control there. And we don't flip back and forth in an individual patient between one company and another.   Dr. John Sweetenham: Right. Well, I think we're almost out of time, Derek, but I did want to ask you one more question, and it's a real change of gear. But over the last year or so, I think that probably largely because of the COVID-19 pandemic, we have seen some exacerbation of workforce issues in the oncology workforce that we knew already existed. I think there is undoubtedly more burnout being reported than there was before. Certainly, within our own organization, we have seen some increased staff turnover and a number of people who I think, frankly, have realized that they want to move closer to their families.   And so, there's been a certain amount of churn, which I think many of us in cancer centers are experiencing. Interested to know whether you've seen anything similar and what strategies you're using in terms of staff retention and oncology clinician burnout at your center.   Dr. Derek Raghavan: I think this is a difficult problem. The morale at the Levine Cancer Institute, much like the Simmons Cancer Center, is high, and that's driven by the leadership cadre being out there with their troops, visible and actively engaged so that the troops on the line feel that the bosses are part of the deal. And we do silly little things that matter, which is parties and celebrations and thank yous and all that sort of stuff. We get the staff to thank each other. We encourage the patients to thank the staff just with an attaboy or something that just says we appreciate the care.   So, I think this is a challenge. I do think work-life balance in old geezers like you and me has been a slightly different thing from some of the younger physicians who are spending, I think sensibly, more time with their families and don't want to spend these long hours. I think the other thing is there is still a town-gown issue where there are people who can make a lot more money much more quickly in some parts of non-academic practice, and it's getting harder to publish in academic practice, so the rewards for that are slipping a little.   I actually don't really have a solution. I think that the august colleges drawing to the attention of the world that this is a big deal and engaging bipartisan support from the political machinery will be important. I think ASCO can, through its government relations people (ASCO Advocacy), continue to prosecute these issues, which they do. I think there is the mistake that we make in the cancer space is we do still tend to compete between societies.   I've always thought it would be much healthier to have ASCO, ASTRO, ACS, SUO, SSO and all those people having a common council that speaks on this sort of issue with one voice and draws to attention of the people out there that this is a big issue. The best of the doctors (docs) are getting older. The younger docs come through the Taylor laws are less experienced and less well-trained and have a different ethos. So, we're going to lose an aspect of practice that's been part of the tradition of medical practice since the time of Osler, and it's definitely going away.   I have a superb physician fellow working with me at the moment who I would rate as one of the best 3 in 10 years. The reason she's one of the best 3 in 10 years is she practices the style of medicine that my fellows did 25, 30 years ago, most of whom are now professors of medicine somewhere. And good with patients, knows her staff, does research, and somehow manages to have reasonable time for a family. That tradition is starting to go away, and I don't think there is a simple change. And then the final point, the people who run health care today see it as a business. I was in a meeting recently outside my own domain where someone said, you know, I have to figure out whether medicine is really importantly a health care business or whether it's an IT business focused on health care. And that's going to start to lose the human side of medicine. We spent some time on that today. The outcomes will go down if this is just a business.   Dr. John Sweetenham: Well, thanks, Derek. Really appreciate all of your insights today. I think there's no doubt that 2022 is going to be a year of many challenges for those of us in the oncology community and for our patients, but I think it's also inevitably going to be a very exciting year in terms of new developments.   And hopefully, if we're recording another podcast like this in a year from now, the COVID-19 pandemic will be a little bit more in the rearview mirror, and we will be able to focus on many of the other important issues that face us. So again, really appreciate your sharing your insights with us, and wish you all the best for 2022.   Dr. Derek Raghavan: John, always a pleasure chatting, and the same to you and Caroline and the family.   Dr. John Sweetenham: Thank you. And thanks to our listeners for your time today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclosures: Dr. John Sweetenham: Consulting or Advisory Role: EMA Wellness   Dr. Derek Raghavan: Consulting or Advisory Role: Gerson Lehrman Group, Caris Life Sciences   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guests' statements on the podcast do not express the opinions of ASCO.  The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Rx for Success Podcast
79. The Game-Changer: Russel Greenfield, MD

Rx for Success Podcast

Play Episode Listen Later Nov 29, 2021 62:55


Russell H. Greenfield, M.D. serves as Sr. Director of Employee Whole Health for the Whole Health Institute. He is responsible for partnering with individual employers in the strategic development of Whole Health programming and associated data analysis to capture and communicate impacts on employees and operating costs. Most recently, he was the medical director of Integrative Medicine for Novant Health, with headquarters in Charlotte and Winston-Salem, N.C. Dr. Greenfield completed residency training in Emergency Medicine at Harbor/UCLA Medical Center as well as a Chief Resident Fellowship at the same institution. After moving to Charlotte, he became involved in the Emergency Medicine residency program at Carolinas Medical Center and was subsequently honored as the inaugural recipient of the Golden Apple Award for Excellence in Teaching. He was one of the first four physicians to graduate from the Fellowship in Integrative Medicine at The University of Arizona College of Medicine in 1999. Dr. Greenfield was founding medical director of Carolinas Integrative Health, a freestanding center owned and operated by Carolinas HealthCare System (now Atrium Health), and a consultant in the development of U.S. national model guidelines for the use of complementary and alternative therapies. He has worked with a variety of organizations promoting employee and community integrative well-being initiatives including Harris Teeter supermarkets, the Veterans Health Administration, Levine Cancer Institute, and Wake Forest Baptist Health. He is co-author of Healthy Child, Whole Child, named “Best Parenting Guide 2001” by the editors at Amazon.com, and editor of Dr. Andrew Weil's book, Mind Over Meds (2017). Dr. Greenfield was a medical reviewer for Reader's Digest and has consulted with the National Basketball Player's Association (NBPA) Unlock Bonus content and get the shows early on our Patreon Follow us or Subscribe: Apple Podcasts | Google Podcasts | Stitcher | Amazon  | Spotify --- Show notes at https://rxforsuccesspodcast.com/79 Report-out with comments or feedback at https://rxforsuccesspodcast.com/report Music by Ryan Jones. Find Ryan on Instagram at _ryjones_, Contact Ryan at ryjonesofficial@gmail.com

Becker’s Healthcare Podcast
Derek Raghavan, President of Levine Cancer Institute at Atrium Health

Becker’s Healthcare Podcast

Play Episode Listen Later Nov 11, 2021 16:05


This episode features Derek Raghavan, President of Levine Cancer Institute at Atrium Health. Here, he discusses his pride in the institute, putting patients first, and more.

ASCO Daily News
Tackling the Increasing Incidence of Early-Onset Colorectal Cancer

ASCO Daily News

Play Episode Listen Later Nov 4, 2021 21:09


Dr. Mohamed Salem, gastrointestinal medical oncologist at the Levine Cancer Institute at Atrium Health in North Carolina, tells guest host Dr. John Sweetenham, associate director of clinical affairs at the UT Southwestern Harold C. Simmons Comprehensive Cancer Center, about the disturbing rise of early-onset colorectal cancer, the impact of socioeconomic disparities on patient outcomes and potential interventions to improve detection.   Transcript Dr. John Sweetenham: Hello, I'm John Sweetenham, the associate director of Clinical Affairs at UT Southwestern Harold C. Simmons Comprehensive Cancer Center and guest host of the ASCO Daily News podcast today. I'm delighted to welcome Dr. Mohamed Salem, a gastrointestinal medical oncologist at the Levine Cancer Institute at Atrium Health in North Carolina. Dr. Salem is going to be discussing with us the disturbing rise in early onset colorectal cancer and the impact of socioeconomic disparities on patient outcomes and potential interventions to increase screening, particularly in younger populations. Mohamed, many thanks for joining us on the podcast today. Dr. Mohamed Salem: Thank you, Dr. Sweetenham for the kind invitation. And I have to tell you, I'm very grateful for this invitation to cover this topic. And also, thanks to the ASCO Daily News team for shedding the light on this. Dr. John Sweetenham: Great. Before we start, I should mention that my guest and I have no conflicts of interest relating to the topic today. Full disclosures of all guests on the ASCO Daily News podcast are available on our transcripts at ASCO.org/podcast. Mohamed, low socioeconomic status has been associated with worse survival in patients with colorectal cancer, otherwise known as CRC. But there hasn't been as much focus on the impact of socioeconomic status for those patients who have early onset colorectal cancer and, specifically, I guess, we mean by that, those patients who develop this condition in early adulthood. Of course, it's quite well known, generally, that adolescents and young adult patients who develop various types of cancer appear to have worse outcomes than both their childhood and their adult counterparts. Your study, published in The Oncologist, looked at the impact of sociodemographic disparities and insurance status on survival of patients with early onset colorectal cancer and, maybe not surprisingly, in some respects, based on experience in other diseases, demonstrated worse outcomes. Could you talk to us a little about the data in your study and how that might inform programs to improve early detection and treatment of patients with colorectal cancer? Dr. Mohamed Salem: Sure. As you mentioned, Dr. Sweetenham, there are two problems. A socioeconomic problem, which is, by itself, a huge challenge we are facing as a community. On the other hand, two, this colorectal cancer problem in younger adults is another issue that we have been facing now for maybe a decade or two. Rebecca Siegel just published a paper a couple of years ago showed that the increased incidence of [colorectal] cancer in adults, it's on the rise. And it brings many challenges to this population in terms of the diagnosis, their care, and their outcome. But when you couple this with the challenge that socioeconomic status impact on the outcome of our patient, this becomes a very, very complicated problem. So, our group wanted to look not only on the impact of socioeconomic status, but the impact on that problem on patients with early onset colorectal cancer and see how complicated this will be to their outcome. We examined more than 30,000 patients, and we chose the cutoff [at age] 40. Early onset definition could vary a little bit, so you have 40, you have 45, some people think even 50, but we choose 40 just because we wanted to focus on the very young group. We utilized National Cancer Database and we obviously thank them for giving us access to this data. And we tried to look at the impact of socioeconomic status, and it was stunning. We found that survival decreased with the decrease of socioeconomic status. So, the patient who carried the best survival was those with highest socioeconomic status and then the lower SES goes, the worse is their survival outcomes. And also, not just survival. We found that if you have low socioeconomic status, you are more likely to have stage III or IV tumors, which is, as you know, more advanced cancer, you're more likely to have node-positive disease, and also, you're more likely to present with stage IV colon cancer. So, just to highlight how impactful the socioeconomic status or factor in the presentation in disease and the outcome, and not only this one. We will also looked at insurance status. It was very clear that patients with no insurance or Medicaid, they do much worse. They had the higher risk of mortality compared to patients with commercial private insurance. And you have to wonder having this issue with being young adult and having a cancer and then having no insurance, have no means to access care. That's something, as you mentioned, perhaps we could, as a community, look into it and try to remove those barriers, to hopefully improve the patient outcome. Dr. John Sweetenham: Yeah, one of the things that struck me from looking at your paper was the fact that stage to stage, age for age. If patients had insurance, it did mediate some of the adverse prognostic effects of socioeconomic status, if I read the paper correctly, which does suggest to me that part of the problem at least is access to care. Would you agree with that? Dr. Mohamed Salem: I totally agree, 100%. And it's also interesting that we even looked at multiple angles. We looked at uninsured, by itself. We looked at Medicaid insurance. We looked at private versus not private. And it doesn't matter how we look at it, and adjusting for all other co-founders and stage, insurance status played a significant role on the impact of survival for those patients. Dr. John Sweetenham: Very interesting that I think that there are several other studies in other diseases which are beginning to show very similar emerging patterns. Just moving on from that a little, I think remarkable numbers that stood out from the studies which you cite in your article in The Oncologist is that 2015 study by Bailey et al. which was predicting that, by 2030, the incidence rates will have increased really quite substantially. And for the younger age group, those aged 20 to 34, the estimate was at a 90% increase in incidence. And for those in the 35 to 49 year age group, the suggestion was that incidence rates would increase by almost 28%, so I think there are a couple of questions that I have regarding that. The numbers are pretty sobering. Can you talk to us a little bit about what we know about the factors that are driving this increase in incidence? Dr. Mohamed Salem: Sure. I do agree with you, Dr. Sweetenham. I think this are very alarming numbers and very alarming phenomena. I'm sure you remember when we're in medical school and fellowship, we used to think colorectal cancer is a disease of older people. Unfortunately, now, we're seeing younger patients getting this. Not the age of 50 or 40 or 30 as you mentioned, even 20 years old. My youngest patient is 17-years-old. And it's not uncommon for me to see patients who are like 20-21 years old coming with this disease. There are many risk factors for colorectal cancer, as you know, obesity, diabetes, tobacco, alcohol, exercise, and other genetics and hereditary reasons. But the truth is that many of those patients come to our clinic are fit. They eat well, they don't smoke, they don't drink, so it appears there is something else going on. And there are many theories going into this, but the truth is that we're actually not sure 100% what are the exact reason for that rise in incidence among young adults. Some people think microbiome might have a role here. Some people think obesity, as I mentioned, has more impact on younger people than older people, but I think also is this is an area of research now. And we hope they'll continue to look into this and try to identify the exact reason why this is happening. But I also wanted to touch base a little bit about an important issue, because the paper you cited, both the American Cancer Society and the task force took the screening or issued recommendations regarding the screening to be from [age] 50 to go now to 45. We used to have a screening recommendation at age of 50 for average risk. Now, as of 2018, the American Cancer Society said you should be screened at 45, and most recently, the task force said the same thing. However, if you think about it, our study looked at patients who are [age] 40. So, the change in the screening really is not going to impact them, because it's still not even at the age of screening and, therefore, education, outreach and educating our patients, our population about the risk and the symptoms and signs of this disease is extremely important  because it makes a huge difference if the cancer gets detected at stage I, which most of the prime surgery is enough and 99% of patients or more than 90% of patients would be cured and don't even need anything besides surgery, versus, as I mentioned, when they start to come into the office with stage IV disease. Now, it's a totally different story and totally different outcome. Dr. John Sweetenham: Yeah, and I guess one of the other questions, the whole screening strategy issue is obviously a very big issue right now and I guess somewhat controversial as well. But I think it's true to say, and if I'm wrong, I stand corrected, that in general, compliance with screening as a whole tends to diminish with age. So, I'm sure, for all kinds of reasons, many of which may be kind of socioeconomic, financially-related, younger individuals are less likely to get screened, either because of insurance or what other issues they may have. And so, I wonder as age goes down, and I'd make the assumption that it may be true, that compliance with screening protocols also goes down. It'll be interesting to speculate on what are going to be useful interventions, particularly in that very young age group, might lead to earlier detection of colorectal cancer in, let's say, a 22-year-old. It can be a difficult issue to unravel, I think. Dr. Mohamed Salem: I totally agree. I think it gets very complicated very quickly because, one, as you mentioned, access to care and coverage and being able to afford this is one issue. But also, if you think about it from logistics, younger people need to work. Maybe they have kids, they need to take care of them. They already have a busy schedule and busy life going on to begin with. So, for them, to take the time off and start to do this office visit takes away time from them, so it affects the compliance. So, hopefully, more awareness and more recognition and encouraging each other to take a day off and just go to get screened might actually result in life saving. Also, I would like to say something important. Most of us, as physicians, when we see an older patient with rectal bleeding, for example, we always think about, OK, maybe he has colon cancer, maybe she has colon cancer. But we don't think the same way when we see a 25 year-old old bleed. So, I think, as a family doctor or somebody who is a medical doctor that will actually seeing that patient, the threshold should be lowered for symptoms and also for early referral. And the other thing I would like to encourage your viewer is that none of us would be excited and happy to talk to their loved one or their friend about his or her old habits as having their rear bleeding, abdominal colics, or so on, and so forth. But sometimes, those symptoms are the symptoms because of colon cancer. I always say, you know your bodies are best, so if you thinks there's something wrong, don't be embarrassed to talk about that. You have to share those symptoms with your family doctor, or at least your loved one to get an advice and get evaluated. And this gets complicated among minorities, because somehow there is a shame in this. And I think looking for safe environment, community network, as you mentioned at the beginning, easy access to medical care is crucial. You're not going to be able to get screened if you don't have the bus ticket to get to the center to be screened there. The last thing I would just like to stress also, if I may, most people think a screening is connected to colonoscopy, which is partially true, but colonoscopy is not the only way patients can get screened. There are many, many other ways that people can get screened including stool tests that you can do at home and send it to your doctor. So, colonoscopy is not the only way you can get screened. You can also discuss with your family doctor or even loved one about other means that you can get screened. Dr. John Sweetenham: Yeah, I think that's a really important point, and it raises another question actually, which may be difficult to answer in this specific age group. But I just wonder, in general terms, whether you can make any comments about how much ground do you think we may have lost during the pandemic in terms of delayed screening and delayed diagnosis. Are you are you seeing evidence of that in the literature or in your own practice and your own institution now? Dr. Mohamed Salem: I think that's a pretty important question. I would say yes to both. Last year, there was data showing that colorectal cancer cases declined. All of us know nothing had change. I mean, the cases are the same out there. It's just not been diagnosed yet because most hospitals obviously, including ours, and many, many other hospitals throughout the country were trying to survive the COVID-19 pandemic, and that got a lot of patients to be delayed for screening. Many patients didn't feel comfortable going to the hospital to get either their colonoscopy or even to the family doctor visit, and so on, and so forth. So, I think this delay in the detection of the cancer. The cancer did not didn't appear. It just was not detected yet. And the risk of that, as I mentioned earlier, the more time passed without intervention, if someone has a cancer, that means more advanced stage. It goes from stage I to II and III and IV with time, and with that, the survival and outcomes get worse. So, that also brings another point that we think, it's that younger patient has more aggressive disease. I think there is some data about that. But also, I wonder if is this really more aggressive disease or just delayed in diagnosis. When you go to your family doctor or even get it checked then they say they're having rectal bleeding. This could be, yes, because of hemorrhoid, but also, it could be because of colon cancer. And I'm not saying everyone with rectal bleeding has colon cancer, but I'm saying that could be one of the reasons. And I would say you really have to seek medical advice if you have symptoms because, again, early detection is the best part about this, and it really saves lives and it changes a lot of things. So, yes, it's a pandemic. It had definitely, no doubt, impact on the colorectal cancer care. And I would predict is that we're going to start seeing more and more patients with more advanced disease in the coming months and years. Dr. John Sweetenham: Yeah, that's an alarming prediction. Of course, taken in conjunction with the other prediction that we mentioned earlier from the study by Bailey et al., it really should give us cause for concern. And I think, maybe my final question to you would be, given what you've just said, plus those data in somewhat dire predictions for 2030, what do we need to do now to prevent that prediction from Bailey et al. from coming true, do you think, if there's anything we can do at this stage? Dr. Mohamed Salem: I think that's a very complex question. But I think, the way I think about this, every one of us, as an individual and organization and even in government and political entity, we really have a role to play. As an individual, I would say, as I mentioned before, you know your body well, so I always say this phrase, 'If you feel something, say something.' This could be a life changing behavior. So, if you feel like there's something wrong with you, please don't be embarrassed to share this. Talk to your family doctor, talk to your friend, and seek medical advice. As a community, we have to encourage each other to share this information, to teach each other certain habits that might help early detection. And if you are at risk, please go ahead and get screened. As I mentioned, colonoscopy is one mean, but there are many others. As an institution, I think raising awareness is important. I think providing easy access to care, that's also very important. And from the government and political entity, I think looking at those people with diversity and disparity, and people with no insurance, people who need special support and need to get help, I think we should have a community program out there. Some help out there, whether this comes through insurance, means, or other programs that we need to look at. And I think this might have some impact on our ability to detect this cancer early on. I always say, which, I think maybe some people might think is an exaggerated statement, but no one really should die from colorectal cancer. Because again, if you detect the cancer early, minimal care should take care of that. The problem happens when we don't detect it early and the patient presents with stage III or IV disease. Dr. John Sweetenham: Yeah, so it's kind of a multifaceted approach, everything from the personal right through to the political aspect is involved in what we all need to do to contribute to this. So, I really appreciate your time today and sharing your insights, and congratulations on the study, which, I think, highlighted actually not just one, but several really important issues in this kind of growing incidence of colorectal cancer and what appeared to be growing disparities as well. Thanks so much for joining me on the podcast today. I hope that you continue to make an impact on these disturbing trends in the years to come. Dr. Mohamed Salem: Thank you, Dr. Sweetenham, for having me, and it's a pleasure to be with you tonight. Dr. John Sweetenham: And thank you also to our listeners for your time today. If you enjoyed this episode, please take a moment to rate and review us wherever you get your podcasts.   Disclosures:  Dr. John Sweetenham: None disclosed.  Dr. Mohamed Salem: Consulting or Advisory Role: Taiho Pharmaceutical, Exelixis, Bristol-Myers Squibb Speakers' Bureau: Genentech/Roche, Taiho Pharmaceutical   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Medical Rehab Matters
Medical Rehab Matters Highlights

Medical Rehab Matters

Play Episode Listen Later Oct 14, 2021 35:55


Welcome to Medical Rehab Matters. In the weeks since this podcast began, we've learned a lot inpatient medical rehabilitation and about podcast production, including that it's not always possible to include everything we record. In this episode, we're going to present some of the things we couldn't earlier – from our episodes on stroke, cancer, and amputation. We hope you enjoy this episode and it inspires you to go back and listen to the full episodes on these topics. Guests: Dr. Vish Raj, a cancer rehab specialist at Carolinas Rehab, and Sarah Mullan, an occupational therapist and Manager of Cancer Rehabilitation at the Levine Cancer Institute. Dr. Michael Stubblefield, Director of Cancer Rehab at Kessler. Roseann Sdoia, who lost her leg in the Boston Marathon Bombing in 2013,  David Crandell, MD, Medical Director of the Amputee Program at Spaulding in Boston. Scott Riddle, Vice President of Orthotics, Prosthetics and Bionics at Mary Free Bed. Dr. Jaclyn Barcikowski from Moss Rehab, Dr. Argye Hillis, Director of the Center of Excellence in Stroke Detection and Diagnosis, at the Sheikh Khalifa Stroke Institute, Brian Reid, a patient who suffered a stroke in May 2020, and his wife Veronica. Cohosts Dr. Robert Krug, immediate past chairman of the AMRPA Board and Vice President of Medical Affairs for Mary Free Bed Rehabilitation Hospital Advisory Group and Patricia Sullivan, AMRPA director of communications.

OnCall
Paradigms, Policy and Pharmacogenomics: What community oncologists need to know

OnCall

Play Episode Listen Later Oct 11, 2021 23:54


The evolution of cancer care is advancing so quickly, it's nearly impossible to keep up. Genetic sequencing has radically improved our ability to get the right drug to the right patient—improving outcomes for both patients and practices. But policy is unclear, lab testing is interpreted differently, and funding is available—but how do you get it?In this episode, we are joined by Dr. Howard McLeod (internationally recognized expert in precision medicine and medical director for precision medicine at the Geriatric Oncology Consortium) and Dr. Jai Patel (chair of the department of cancer pharmacology and pharmacogenomics at Atrium Health's Levine Cancer Institute) who dive into the paradigm shift in cancer care, the role of genomic testing and sequencing, and navigating policy to your practice's advantage.Learn more about our partners at VieCure.The content and information contained in this podcast is provided [exclusively or solely] by VieCure and AmerisourceBergen is not responsible and does not verify for accuracy any of the information contained in the podcast. The primary purpose of the podcast is to educate and inform. This podcast does not constitute medical or other professional advice or services.

Medical Rehab Matters
Cancer and Inpatient Medical Rehabilitation

Medical Rehab Matters

Play Episode Listen Later Sep 16, 2021 48:06


In this episode of Medical Rehab Matters, we talk about cancer and inpatient medical rehabilitation. The American Cancer Society estimates that there will be 1.9 million new cancer cases in the U.S. this year. Many of them will benefit from inpatient medical rehab at different points during and after their cancer treatment. Our guests are Vishwa Raj, MD, a cancer rehab specialist at Carolinas Rehab, Sarah Mullan, MS, OT, an occupational therapist and Manager of Cancer Rehabilitation at the Levine Cancer Institute, and Michael Stubblefield, MD, Director of Cancer Rehab at Kessler.  Cohosts: Patricia Sullivan, director of communications for the American Medical Rehabilitation Providers Association and Robert Krug, MD, immediate past chairman of the AMRPA Board and Vice President of Medical Affairs for the Mary Free Bed Rehabilitation Hospital Advisory Group.

ASCO Daily News
Dr. Derek Raghavan Has a Remedy to Mitigate Financial Toxicity in Cancer Treatment

ASCO Daily News

Play Episode Listen Later Aug 19, 2021 24:53


Transcript: Dr. John Sweetenham: Hello, I'm John Sweetenham, Associate Director of Clinical Affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center, and the guest host of ASCO Daily News Podcast today. I'm joined by my friend and colleague, Dr. Derek Raghavan, President of the Levine Cancer Institute to discuss a new study that he and his group published in JCO Oncology Practice outlining a novel approach adopted by his institution to address financial toxicity caused by the rising costs of cancer care. Dr. Raghavan is going to tell us about the creation of a Financial Toxicity Tumor Board, which shows promise as a potential solution to significantly ease the financial burden of cancer treatment on patients and their families (DOI: 10.1200/OP.21.00124). Dr. Raghavan's full disclosures are available on our show notes, and disclosures relating to all episodes of the podcast can be found in our transcripts at asco.org/podcasts. Derek, it's always a pleasure to be speaking with you again on the podcast. Dr. Derek Raghavan: Hi, John. It's a pleasure to have time with you again. Dr. John Sweetenham: You know, I've had an opportunity to read the publication in JCO Oncology Practice, and it really is fascinating and a very interesting new approach. We know from many studies that financial toxicity is among the most rapidly growing adverse effects of cancer treatments. And patients report financial distress is a major hurdle to the quality of life. And its association with worse outcomes is now very well documented. At the Levine Cancer Institute, as your paper describes, you created a Financial Toxicity Tumor Board, which you abbreviate to FTTB, to address this problem. And I wonder if you'd be able to describe a little bit about this tumor board, and perhaps in particular which components of this you feel are really a new approach to addressing the issue of financial toxicity. Dr. Derek Raghavan: Thanks, John. Yeah. I mean, I guess it's important just to define what we're talking about because there are still people, particularly clinicians, who don't really understand the concept. So, I think it was probably Jonas de Souza, among others, from Mark Ratain's group, who were early in both identifying this as an issue and studying it. And so, the concept of financial toxicity is really pretty simple. And that is that people are struggling to pay their bills and the bills are going up. With the way the pharmaceutical industry is able to set prices ad libitum, the fact that there's a lot of lobbying that goes on in Washington, and elsewhere, the prices that people have to pay can be really quite extreme. People that are insured are, perhaps in this domain, particularly at risk because if you have, for instance, a good insurance policy with a 10% copay, and think about the cost of maybe half a million or a million dollars a course of targeted therapies or for CAR T treatment, or whatever, 10% of $500,000 is an awful lot of money for someone to come up with unexpectedly. So, the whole idea of financial toxicity is something that has emerged with the rising costs, and more particularly, the rising prices of health care. I think the other thing that that's important is while we are seeing this reported more, and you know this from your experience, as to why, patients really protect their financial status almost more than anything else. They don't like to admit that they're struggling financially. And there will be people who are mortgaging the house, but who don't share with the medical team that they've run out of money, that the health insurance plan isn't working. And so, they're really making choices that are very tough. If you have no income and no insurance, I'm not implying that it isn't a problem. There are people who will still have bills to pay and have to make choices between buying food and buying their drugs. And in your practice and in mine, we both know that sometimes patients select in favor of food, which makes perfect sense, because they can't afford food and drugs. So, the whole concept of the Financial Toxicity Tumor Board came from understanding that. At the Levine Cancer Institute, we have a big commitment to outreach and underserved populations that the team that's led by my colleague, Melissa Wheeler, last year had 68,000 people that they saw at outreach. And that included a lot of uninsured or underinsured people. And they were bringing back to me stories of the difficulties these folks were having in terms of why they weren't seeking medical care. Given that we are the safety net in this part of North Carolina, that's particularly troubling. And then the final thing that I'd say is with respect to underreporting, we here use a system called Tridiuum, which is an electronic system that asks patients about their quality of life. And one of the cases--one of the questions that is asked is, are you having difficulty paying your bills? And when we compare what we've learned at the FTTB, the Financial Toxicity Tumor Board, with the answers on Tridiuum, it's quite clear that patients, while they'll talk about nausea, and vomiting, and pain, and things like that--depression--they will often say, no, I'm not having trouble financially. They'll answer to the question, no, I'm not having trouble. But we actually find out they are. And the final point I'd make--and I suspect that because you and I went through medical school a couple of decades ago, we were both taught that it's rather inappropriate to discuss something as unpleasant as money with patients because it will make them feel that we're judging them or that we're withholding treatment. As a consequence of that, physicians have been trained really not to discuss the costs of care. And that becomes a pretty big deal when you're actually going to have a patient that might give up little Johnny's college education for a new treatment. I mean, it might be worth it if it's going to cure them. It might be worth it if it's going to give them a 10-year survival. But if you're talking phase I study, or a drug in the third or fourth line, which might give 2 or 3 months of extra survival, giving up little Johnny's education might be a bad trade-off. And so, the whole concept of the FTTB was to get us to do things to help patients, but also to get a physicians and the advanced practice nurses and the whole team to be focusing a little more carefully on the whole issue of this problem for patients. So, coming back to your core question, we developed a tumor board, much like breast cancer tumor board, or GI, or whatever, that is multidisciplinary. It has all the service chiefs at our institute, several of the physicians from different domains, the nurse navigators--we have about 40, 45--our financial counselors, the people in the billing office--so administrators. I'm at present, at these finance people. We get together and identify the worst of the problems. We have a couple of our finance people and a couple of our financial counselors who triaged the cases. If it's something simple--so Mr. Smith is age 70 and hasn't managed to get Medicare for some reason. That's not an FTTB problem. That just gets handled by the financial counselor or the navigator. But if it's one of the big problems that we found, like people who don't have insurance, people who are getting impediments from the payers, issues that relate to coding and billing, problems of precertification, that's the time when the FTTB becomes involved. Dr. John Sweetenham: That's great. Thanks. And I think that the point you make about these are issues which affect the insured as well as the uninsured are really important. And interesting that you have--it sounds like you have a pretty systematic way in which you can identify and engage those patients who might be embarrassed or reluctant to disclose that they have some level of financial distress. Dr. Derek Raghavan: Yes. That's correct, John. We have some signs posted. All of our staff are trained to raise the issue in as nonjudgmental and as engaging and passionate as they can. Interestingly, it's often the front-line staff at the front desk or the nurse navigators that get the information. A proportion of our patients will actually just ask for help and see a financial counselor. But the whole group has been trained to be as empathetic as possible and to create a scenario where it's kind of put to the patient that we understand this is not on you. This is the way health care is today. There are gaps that relate to how we pay for it. So, let us try to help you. And I think for that reason, patients are much more comfortable to address the issues once they understand how this works. Dr. John Sweetenham: Right. Could you say just a little bit more and expand on how the patient assistance program kind of fits into this model? And then as a follow-on question to that, could you tell us a little bit about what the cost savings for your patients have been and how many patients have been impacted by the tumor board so far? Dr. Derek Raghavan: Sure. Well, the process, as I explained, is multidisciplinary with a whole bunch of different people. We've folded all the bits together. So, we have social workers and financial counselors who can access philanthropic support for the people where we simply can't figure out an answer. And so, in that context, that'll be copay assistance or other philanthropic things. We actually measured this in 2020 and 2019. And so, in 2019, we gave out about $1.4--a little bit more--million to about a little over 1,200 patients. In 2020, it was about $1.39 million, and it was about 1,000 patients we helped. In terms of saving out-of-pocket expenses, I was surprised when we actually measured it and looked at it. So, in 2019, we helped nearly 600 patients. And we saved them out of pocket expenses of $55 million. Dr. John Sweetenham: Wow. Dr. Derek Raghavan: In 2020, it was 749 patients. And there, to my surprise, it was $60.7 million. So, this is not chump change. This is really big sums of money. We did an analysis and we reported this in JCO OP and found that 29% of the patients just were dealing with lack of insurance or under insurance. Oftentimes, a policy that had fine print that said, while you're well, we'll cover you. And when you're sick, we won't. So, we had to deal with that. There were payer impediments. And you and I both--I know we've chatted about this over the years. There are wonderful payers and health insurance companies and there are some that are pretty tough. They all pay their insurance executives seven or eight-figure sums--and claim to be struggling. But the payer impediments will relate to changing their rules, having fine print that doesn't cover the rules. One month, you'll have to get--so for example, at one point, we discovered that they were turning down rituxan for diffuse large cell lymphomas. And there was one word in the diffuse large cell that was missing from what the doctors might have been writing. And so, they were denying payment for that and sending bills to patients. There will be coding or billing complexities. That's, again, at about 20% of the cases we've seen. The toughest one is only a small proportion at the moment because we've worked on it, but it's variable--and that's precertification. And the problem there is the companies change their rules for who needs it and who doesn't. For example, in North Carolina, Medicare recently required precertification for chemotherapy that didn't require it previously. And they set a start date and suddenly we had to cancel a bunch of patients for that date because the website to allow precertification didn't open until the day began. And so, we had to just defer by 24 hours chemotherapy so that we could get the patients precertified to avoid them getting bills. And then I have to say--I mean, 20% of our problems have been inadequate internal processes. And that means if we'd done things better internally, we could have avoided problems. And so that brings in the way we approach management of denials. We've become very proactive. So, I now have a team of pharmacy techs who, for example, chemotherapy will go through the rules for each health plan for the individual patient to make sure that we're actually doing the precertification correctly as of the day of treatment because the rules may have changed. So that's pretty much how it works. We've got pharm techs who work the cases in advance. We often spend an awful lot of time talking to insurance companies. As you know, they can make it very difficult to get to the right point with the recent changes with white bagging and brown bagging where they're deflecting and deferring referrals of treatment to their own pharmacy companies, that will often not be patently obvious till we have a patient here ready to go, and we suddenly discover that they want us to get the drug from a specialty pharmacy that's their special one. So, all of this requires an awful lot of advanced planning. Now I think if government took a little more interest in the way the insurance companies work, it would make life easier--but they don't. And so, we have used this strategy of Financial Toxicity Tumor Boards to move this forward. And I will say that one of the very useful things it's done, it's sort of like ripping a Band-Aid off. It's created a scenario where we are now able to educate our physicians about things that they simply didn't know existed in terms of problems of reimbursement insurance and so on. Dr. John Sweetenham: Right. And so, the process and the success that you've described with this tumor board is really pretty remarkable. I'm quite struck by the fact that this requires a lot of resource-- particularly, human resource--and a lot of organization to make it work. So, we often talk about whether a new initiative is something that's scalable. Do you think that this FTTB model is something that's scalable down, if you see what I mean, so that it could be successful in relatively small practices as it has been in a large system such as the one that you operate? Dr. Derek Raghavan: Yeah, John, I think that's a really good question. So, if you're thinking about scalability, if you're thinking about a place like the Simmons Cancer Center at UT Southwestern led by Carlos Arteaga and yourself, I'm sure that you could do something similar. It's a big center, it's a national referral center, it's NCI designated, and you've got reasonable support and philanthropy. So, you could do this, if you wanted to, easily.   If you then scale it down to a private practice or an office oncology practice, I think the answer is, you can do much of it. You might not be able to do everything that we do. But it's certainly reasonable that if you have, say, 30 patients coming up over 5 days for chemotherapy, your chemotherapy nurses can be rostered to actually do some of the work that we do in terms of checking insurance situations and so on. Many of the smaller practices worked predominantly with two or three health insurance companies, so therefore there are less sets of rules. I think the other thing is a lot of the stuff is repetitive. So, I gave you an example of rituxan and lymphoma. So, if you've got people focusing on those who can send a note around the practice to say, moving forward, if you want to prescribe rituxan, is the phrase that needs to be there to describe the type of diffuse large cell lymphoma you're addressing. So, I think it is scalable. It's more a question of changing attitudes and accepting that medicine has changed, people are struggling to pay their bills. And physicians--particularly in an oncology space--can actually spend a little time going through the cost of care with patients, thinking about the alternatives. We use biosimilars a lot. We're very careful to use biosimilars where the evidence really supports the fact that they are an equivalent product. Occasionally, we struggle with that because the insurance companies obviously are doing deals with some of the biosimilar companies, and we may be at short notice discovering that we need to prescribe biosimilar number two rather than number three when we thought number three was the best drug. That becomes an ethical issue. And then I think you just have to look at the quality of the data and decide whether it's reasonable or not. Some of the biosimilars, I think, are ones where we're not sure that they're equivalent and then we do not use them. Dr. John Sweetenham: So, we've talked a lot at a system level and the kind of global problem that we all face now with the financial toxicities. But ultimately, this is an issue for individual patients. And with the system that you've put in place, the ultimate beneficiary of this, of course, is the patient. And I just wondered if you may be able to share perhaps one example or a couple of examples of patients whose stories kind of exemplify how helpful this can be. Dr. Derek Raghavan: Yeah. Yeah. I think in the story that we told; we described a patient where there was confusion on the explanation of benefits that was provided to the patient. This was a person with--who'd had adjuvant chemotherapy following surgical treatment of pancreatic cancer and then suddenly got a whole bunch of bills because it was noted that one of the drugs--just one of the drugs in the chemotherapy regimen--required specific precertification, which actually was not clearly seen in most of the documentation that was available. So, in that situation, our financial counselor actually talked to the company and was able to make things better. In the situation of patients with malignant lymphoma heading to bone marrow transplantation, that's been one where various companies have used denials as a mechanism of creating leverage for contracting. There, what we've done is generally approach doctor-to-doctor to the physicians who work for the companies. As a general rule--and I don't think this is an overstatement--I think it's easier if you talk doctor-to-doctor to a company that will employ an oncologist or a retired oncologist. Unfortunately, sometimes it'll be a retired surgeon or an internist who's punching well above his or her weight. And that's a little bit more tricky. Frankly, I in my own practice in the past have used politicians. When we get finally to a dead end, I will provide a letter that describes what we've done, give it to the patient, and say I suggest you go and see your local congressman or senator. It's amazing how quickly payers respond to a phone call from a politician. And that's because there's an awful lot of lobbying that goes on in Washington. The companies certainly don't want to bring attention on themselves. But I think, generally, it can be quite a good partnership if the physicians are doing their part and thinking about the bang for their buck. In other words, are they providing treatment that's going to make a difference? They make sure they're following the rules, and that requires proactive management. Develop a good relationship--the companies certainly respond to a group that are trying to provide cost-effective care. Dr. John Sweetenham: Thanks. And just one last question before we wind up. And that is, I think this wasn't the primary motivator for setting up your tumor board, but what do you think the impact of this kind of approach--if we were all to adopt this more formalized approach, what do you think might be the impact that it would have on cancer care disparities? Dr. Derek Raghavan: I think it can help. I think the biggest problem--and John, you'll roll your eyes because you've heard me say it before--I have a problem with analysis paralysis. So many people working in the NCI-designated network and beyond it love to do studies of underserved populations. And my thought is, why don't you start trying to problem solve and tweak it as you go along? And so, I think what this sort of approach does is it makes physicians and advanced practice nurses, and oncology pharmacists think more about the issue of the cost versus outcome. It allows us to help patients to deal with the problem. And because we're trying to bring all the costs down, it really goes to the value proposition. As I think you know, we have electronically accessible pathways that are evidence-based, but certainly looking at the costs of care for equi-active and equitoxic drugs is a big piece of that. That's why we sometimes use biosimilars. So, it will generally bring the costs and prices down while also trying to help reduce the out-of-pocket costs for our patients and make us more value-orientated in terms of the whole product. And the other thing I think is really important is if we can do it in oncology, then the cardiovascular people, and the neuroscience people, and so on can equally be thinking along these lines. Dr. John Sweetenham: Yeah, absolutely. I agree with you. And I'd have to say, I really appreciate having an opportunity to talk with you about this. When I read the article, I immediately fired it off to our leadership team here to take a look at because I think there is much to learn and commend this particular article and the application of this type of tumor board to everyone who's listening. It's a really very, very interesting and novel approach to what is clearly going to become an increasing problem for our patients with cancer. So, in conclusion, I would just like to say, thanks again, Derek, for sharing some time with us and sharing your insights into the tumor board. Dr. Derek Raghavan: John, it's always a pleasure to chat with you, and especially to be interviewed by, and I've enjoyed this discussion. I hope it's been helpful to your audience. Dr. John Sweetenham: I'd also like to thank our listeners for joining us today.  You'll find a link to Dr. Raghavan's study in the transcript of this episode. And finally, if you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Thanks, and goodbye.   Disclosures: Dr. John Sweetenham: None disclosed. Dr. Derek Raghavan: Consulting or Advisory Role: Gerson Lehrman Group, Caris Life Sciences Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Journal of the Advanced Practitioner in Oncology Podcast
A Review of the Bruton Tyrosine Kinase Inhibitors in B-Cell Malignancies

Journal of the Advanced Practitioner in Oncology Podcast

Play Episode Listen Later Aug 3, 2021 25:16


Donald C. Moore, PharmD, BCPS, BCOP, DPLA, of Atrium Health, Levine Cancer Institute, in Concord, North Carolina, talks with host Wendy Vogel, MSN, FNP, AOCNP®, on recent data and strategies for managing adverse events of ibrutinib, acalabrutinib, and zanubrutinib in the treatment of B-cell malignancies. Related Content:A Review of the Bruton Tyrosine Kinase Inhibitors in B-Cell Malignancies. J Adv Pract Oncol 2021;12(4):439–447. https://doi.org/10.6004/jadpro.2021.12.4.8

Pharmacy Podcast Network
The Pharmacogenomics Fellowship| PGX For Pharmacists

Pharmacy Podcast Network

Play Episode Listen Later Jun 4, 2021 34:30


Dr. Jai Patel, PharmD, BCOP, CPP Chair of Department of Cancer Pharmacology & Pharmacogenomics Dr. Jai Patel is a pharmacist who help create a pharmacogenomics fellowship which was not available at his school. He finished the Oncology/Pharmacogenomics Postdoctoral Fellowship at the UNC Eshelman School of Pharmacy. Dr. Patel: “I approached my mentor and said, ‘this is what I want to practice. I have the ambition and drive.' I had to convince him I was a good investment. Just because something doesn't exist, doesn't mean it isn't possible. That's what will set you apart from others when trying to build something new. Health care is always changing. Position yourself to be in the forefront of medicine. Dr. Patel serves as Chair of the Department of Cancer Pharmacology and Pharmacogenomics at Levine Cancer Institute. He is also the associate Professor in the Division of Hematology/Oncology. Dr. Patel's research focuses on translational and clinical pharmacogenomics and pharmacokinetics of anticancer therapies.  Behnaz Sarrami, MS, PharmD Pharmacogenomics (PGx) coach and consultant | MSL at Atheadx Behnaz Sarrami is the co-host to the PGx for Pharmacist Podcast. She is an expert in the field of PGx and mentor to pharmacist who are establishing their own PGx consulting business. She believes in personalizing a patient's medication based on each individual's genetic makeup and is keen in helping overcome barriers for both pharmacist and providers who want to implement PGx in any clinical setting. Behnaz received her Master's degree in Biochemistry from Georgetown University and her Doctorate in Pharmacy from Creighton University. Behnaz has been a contributor of Washington University's Public Health blog. She also serves as a consultant for a grant-funded research project which aims to increase medication adherence in older adults who suffer from mental health. This episode is sponsored by the Ultiguard Safe Pack. UltiGuard Safe Pack is the only pen needle product that comes with an all-in-one sharps container. Learn more about why UltiGuard Safe Pack is the best choice for your patients and your pharmacy.,  Learn more about the UltiGuard Safe Pack:  https://www.ulticare.com/ultiguard-safe-pack/podcast See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Pharmacy Podcast Network
The Pharmacogenomics Fellowship| PGX For Pharmacists

Pharmacy Podcast Network

Play Episode Listen Later Jun 4, 2021 33:16


Dr. Jai Patel, PharmD, BCOP, CPP Chair of Department of Cancer Pharmacology & Pharmacogenomics Dr. Jai Patel is a pharmacist who help create a pharmacogenomics fellowship which was not available at his school. He finished the Oncology/Pharmacogenomics Postdoctoral Fellowship at the UNC Eshelman School of Pharmacy. Dr. Patel: “I approached my mentor and said, ‘this is what I want to practice. I have the ambition and drive.’ I had to convince him I was a good investment. Just because something doesn’t exist, doesn’t mean it isn’t possible. That’s what will set you apart from others when trying to build something new. Health care is always changing. Position yourself to be in the forefront of medicine. Dr. Patel serves as Chair of the Department of Cancer Pharmacology and Pharmacogenomics at Levine Cancer Institute. He is also the associate Professor in the Division of Hematology/Oncology. Dr. Patel’s research focuses on translational and clinical pharmacogenomics and pharmacokinetics of anticancer therapies.  Behnaz Sarrami, MS, PharmD Pharmacogenomics (PGx) coach and consultant | MSL at Atheadx Behnaz Sarrami is the co-host to the PGx for Pharmacist Podcast. She is an expert in the field of PGx and mentor to pharmacist who are establishing their own PGx consulting business. She believes in personalizing a patient’s medication based on each individual’s genetic makeup and is keen in helping overcome barriers for both pharmacist and providers who want to implement PGx in any clinical setting. Behnaz received her Master’s degree in Biochemistry from Georgetown University and her Doctorate in Pharmacy from Creighton University. Behnaz has been a contributor of Washington University’s Public Health blog. She also serves as a consultant for a grant-funded research project which aims to increase medication adherence in older adults who suffer from mental health. This episode is sponsored by the Ultiguard Safe Pack. UltiGuard Safe Pack is the only pen needle product that comes with an all-in-one sharps container. Learn more about why UltiGuard Safe Pack is the best choice for your patients and your pharmacy.,  Learn more about the UltiGuard Safe Pack:  https://www.ulticare.com/ultiguard-safe-pack/podcast See omnystudio.com/listener for privacy information.

PGX for Pharmacists
The Pharmacogenomics Fellowship| PGX For Pharmacists

PGX for Pharmacists

Play Episode Listen Later Jun 4, 2021 33:16


Dr. Jai Patel, PharmD, BCOP, CPP Chair of Department of Cancer Pharmacology & Pharmacogenomics Dr. Jai Patel is a pharmacist who help create a pharmacogenomics fellowship which was not available at his school. He finished the Oncology/Pharmacogenomics Postdoctoral Fellowship at the UNC Eshelman School of Pharmacy. Dr. Patel: “I approached my mentor and said, ‘this is what I want to practice. I have the ambition and drive.' I had to convince him I was a good investment. Just because something doesn't exist, doesn't mean it isn't possible. That's what will set you apart from others when trying to build something new. Health care is always changing. Position yourself to be in the forefront of medicine. Dr. Patel serves as Chair of the Department of Cancer Pharmacology and Pharmacogenomics at Levine Cancer Institute. He is also the associate Professor in the Division of Hematology/Oncology. Dr. Patel's research focuses on translational and clinical pharmacogenomics and pharmacokinetics of anticancer therapies.  Behnaz Sarrami, MS, PharmD Pharmacogenomics (PGx) coach and consultant | MSL at Atheadx Behnaz Sarrami is the co-host to the PGx for Pharmacist Podcast. She is an expert in the field of PGx and mentor to pharmacist who are establishing their own PGx consulting business. She believes in personalizing a patient's medication based on each individual's genetic makeup and is keen in helping overcome barriers for both pharmacist and providers who want to implement PGx in any clinical setting. Behnaz received her Master's degree in Biochemistry from Georgetown University and her Doctorate in Pharmacy from Creighton University. Behnaz has been a contributor of Washington University's Public Health blog. She also serves as a consultant for a grant-funded research project which aims to increase medication adherence in older adults who suffer from mental health. This episode is sponsored by the Ultiguard Safe Pack. UltiGuard Safe Pack is the only pen needle product that comes with an all-in-one sharps container. Learn more about why UltiGuard Safe Pack is the best choice for your patients and your pharmacy.,  Learn more about the UltiGuard Safe Pack:  https://www.ulticare.com/ultiguard-safe-pack/podcast See omnystudio.com/listener for privacy information.

Myeloma Crowd Radio
HealthTree Podcast for Myeloma: Peter Voorhees, MD, Levine Cancer Institute

Myeloma Crowd Radio

Play Episode Listen Later May 18, 2021 64:00


Myeloma experts are beginning to use antibodies in earlier lines of myeloma treatment, even for newly diagnosed patients. Learn what recent clinical trials are using antibody therapies such as daratumumab and isatuximab in early quad (four) drug combinations for newly diagnosed patients. Peter Voorhees of the Levine Cancer Institute joins Myeloma Crowd Radio to share his experience and findings from these clinical trials. He will discuss the early use and their use as maintenance therapy following stem cell transplant. Is earlier use better? Should they be "saved" for later? When should patients consider using the monoclonal antibodies as maintenance therapy with or without traditional drugs like lenalidomide? Dr. Voorhees will help answer these very practical questions for the myeloma community. Thanks to our episode sponsor, Karyopharm Therapeutics.

Myeloma Crowd Radio
Myeloma Crowd Radio: Peter Voorhees, MD, Levine Cancer Institute

Myeloma Crowd Radio

Play Episode Listen Later May 18, 2021 64:00


Myeloma experts are beginning to use antibodies in earlier lines of myeloma treatment, even for newly diagnosed patients. Learn what recent clinical trials are using antibody therapies such as daratumumab and isatuximab in early quad (four) drug combinations for newly diagnosed patients. Peter Voorhees of the Levine Cancer Institute joins Myeloma Crowd Radio to share his experience and findings from these clinical trials. He will discuss the early use and their use as maintenance therapy following stem cell transplant. Is earlier use better? Should they be "saved" for later? When should patients consider using the monoclonal antibodies as maintenance therapy with or without traditional drugs like lenalidomide? Dr. Voorhees will help answer these very practical questions for the myeloma community. Thanks to our episode sponsor, Karyopharm Therapeutics.

ASCO Daily News
Celebrating Dr. John Sweetenham: On Being an Oncologist and Leading ASCO Daily News

ASCO Daily News

Play Episode Listen Later May 13, 2021 35:08


In today’s episode, we celebrate Dr. John Sweetenham, outgoing Editor-in-Chief of ASCO Daily News after nearly a decade of service. He is also the associate director for Clinical Affairs at the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern. This episode brings together Dr. Sweetenham and his longtime friend, and today’s guest host, Dr. Derek Raghavan, President of the Levine Cancer Institute. They discuss the luminaries who shaped Dr. Sweetenham’s career path, practicing oncology on both sides of the Atlantic, and editorial roles in oncology publications.

The Healthcare QualityCast
Jaspal Singh, MD MHA MHS FCCP FCCM FAASM Medical Director of Innovation and Quality Improvement for Pulmonary Oncology

The Healthcare QualityCast

Play Episode Listen Later May 11, 2021 45:01


Jaspal Singh is a Professor of Medicine at Carolinas Medical Center and the Levine Cancer Institute of Atrium Health in Charlotte, NC. He serves as the Atrium Health Medical Director of Adult Critical Care Practice and Education, as well as Director of Innovation and Quality Improvement in Medical Oncology. He is a practicing physician in pulmonary, critical care, and sleep medicine but also teaches locally and nationally. He has several scholarly and professional interests, mainly related to how to advance care in an era of increasing physician shortages. Here in Episode #117, Jaspal starts our show with a leadership mindset that it takes a village to move forward as quality leaders. He shares his impressive and inspirational career path through patient care, administrative leadership, and quality innovation. Jaspal gives us a great introduction to the Sikh community. He shares a dark moment story connected with personal growth gained after being passed over for a promotional opportunity. Jaspal shares how his resiliency throughout covid has made him a better healthcare leader. His advice to simply check in with team members to keep relationships strong resonates well with my keep it simple mentality. Jaspal teaches us the power of fully committing; as well as an Ah-Ha moment that doubles down on the focus for building diverse teams. He highlights the focus and progression of Tele-Medicine as an area of opportunity for quality professionals. And gives us great insight into how quality people can get to know their patients better. • Connect with Jaspal on LinkedIn • Access the Healthcare QualityCast LinkedIn Group • Leaves Us a Rating • Earn Your Lean Six Sigma for Healthcare Certification • Book a Discovery Call and OpEx Strategy Call Today

If Buildings Could Talk
Levine Cancer Institute

If Buildings Could Talk

Play Episode Listen Later May 5, 2021 36:30


A world-renowned doctor and six-time cancer conquerer join John and Kelly to discuss The Levine Cancer Institute, recognized as one of the top cancer centers in the nation for its patient-centered approach and experience mapping process designed to ensure the highest quality care.

Get in the Know with your CMO!
CoronaWarUS - Dr. Derek Raghavan - Levine Cancer Institute

Get in the Know with your CMO!

Play Episode Listen Later Mar 19, 2021 26:10


You'll enjoy this honest conversation where we review 2020, the pandemic and now look forward to 2021.  Dr. Raghavan discusses our local efforts by Levine Cancer Institute but brings in his global expertise...

Blood & Cancer
Managing pain in sickle cell crisis with Dr. Ifeyinwa Osunkwo

Blood & Cancer

Play Episode Listen Later Feb 25, 2021 26:05


Ifeyinwa (Ify) Osunkwo, MD, MPH, joins us to talk about her approach to pain management in patients suffering from sickle cell crisis as well as the cognitive and behavioral effects of long-term opioid use in these patients. She and our host David H. Henry, MD, cover these topics and more in this episode. Dr. Osunkwo is a professor of medicine at Atrium Health and the director of the Sickle Cell Enterprise at the Levine Cancer Institute, part of Atrium Health, in Charlotte, N.C. Over the course of a decade, the life expectancy of patients with sickle cell disease has increased. Today 99% of children with sickle cell disease will live to become adults. When treating patients with sickle cell pain it is important to consider their disease trajectory, and to weigh the pros and cons for initiation of opioid therapy. Management of sickle cell disease in the acute setting: In children, therapy usually includes use of intravenous fluid and intravenous opioids, then an eventual transition to oral opioids and NSAIDS. In adolescents, exposure to a prolonged course of high-dose opioids actually has been shown to exacerbate their pain. PCA (patient-controlled analgesia) versus “PRN” or as-needed medications removes the dependency on the external environment to receive pain medications and lessens the degree of psychological stress in these patients. Use of intravenous ketamine as an adjuvant to opioids in patients with an acute exacerbation has been shown to improve outcomes in patients (i.e., better pain control, decreased hospital stay, and management of anxiety and stress of a pain crisis.) In the acute pain setting, it is important to go through all differentials to get to where you are treating the right cause of pain. Following hospitalization, these patients often present back to the hospital in subacute opioid withdrawal. The key here is to engage patients in long term treatment plans. For opioid-induced itching, it has been shown that in patients who receive intravenous Benadryl have worse outcomes than in patients that receive oral Benadryl. Long-term side effects of chronic opioid therapy use: Psychological and behavioral side effects including insomnia, reduced libido, tolerance, oppositional behavior, poor memory, psychosis, paranoia, increased depression/anxiety and confusion. The opioid risk score is a helpful screening test that looks at the risk of adverse opioid outcomes. Specifically, family history of substance abuse, personal history of substance abuse, history of person abuse or psychological diagnosis results in a higher score which correlates with a higher risk of negative outcomes. Use of suboxone has proved to be very beneficial in patients on chronic opioid therapy in preventing frequent hospitalizations. Show notes written by Alesha Levenson, MD, a resident with Penn Medicine, Philadelphia. Disclosures Dr. Mintzer and Dr. Henry have no relevant disclosures. *  *  * For more MDedge Podcasts, go to mdedge.com/podcasts Email the show: podcasts@mdedge.com Interact with us on Twitter: @MDedgehemonc David Henry on Twitter: @davidhenrymd

ASCO Daily News
Dr. Derek Raghavan on Challenges Facing the Oncology Community in 2021

ASCO Daily News

Play Episode Listen Later Dec 29, 2020 29:36


In today's episode, we hear from the internationally renowned medical oncologist and researcher, Dr. Derek Raghavan, President of the Levine Cancer Institute. He reflects on the extraordinary events of 2020 amid the COVID-19 pandemic and discusses the challenges that will confront the oncology community in 2021.

Oncology Today with Dr Neil Love
Novel Agents Under Investigation in Multiple Myeloma with Dr Peter Voorhees

Oncology Today with Dr Neil Love

Play Episode Listen Later Dec 1, 2020 49:54


Dr Peter Voorhees from the Levine Cancer Institute in Charlotte, North Carolina, discusses novel agents under investigation in multiple myeloma. CME information and select publication here (https://www.researchtopractice.com/OncologyTodayMMNovelAgents20).

The Oncology Nursing Podcast
Episode 129: Safely Use Acupuncture as Integrative Care for Symptoms and Side Effects

The Oncology Nursing Podcast

Play Episode Listen Later Nov 13, 2020 33:08


ONS member Susan Yaguda, RN, MSN, nurse coordinator of integrative oncology at Levine Cancer Institute in Charlotte, NC, and member of the Greater Charlotte Area ONS Chapter, joins Stephanie Jardine, BSN, RN, oncology clinical specialist at ONS, to discuss acupuncture and acupressure and what nurses need to know about those integrative therapies for patients with cancer.  Music Credit: "Fireflies and Stardust" by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0 Earn 0.5 contact hours of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at myoutcomes.ons.org by November 13, 2022.  The planners and faculty for this episode have no conflicts to disclose, and the episode has no commercial support. ONS is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation. Episode Notes Check out these resources from today's episode: Complete this evaluation for free nursing continuing professional development. ONS Voice article: Acupuncture for Cancer-Related Fatigue ONS Voice article: Evidence Is Building for Acupuncture as an Opioid Alternative for Cancer Pain ONS Voice article: What the Evidence Says About Acupuncture and Cognitive-Behavioral Therapy for Insomnia ONS Voice article: The Role of Acupuncture in Treating Hot Flashes in Breast Cancer Survivors American Holistic Nurses Association Beyond Conventional Cancer Therapies (BCCT) Center for Integrative Medicine Integrative Oncology Scholars Society for Integrative Oncology

Let's Talk America With Shana Thornton
Health News: What You Should Know About Multiple Myeloma

Let's Talk America With Shana Thornton

Play Episode Listen Later Nov 11, 2020 11:00


Each year, more than 32,000 people in the U.S. are diagnosed with multiple myeloma, a cancer of plasma cells. Relapsed refractory multiple myeloma is complex because as patients relapse they can become resistant to therapies. Medical expert Dr. Saad Usmani with the Levine Cancer Institute and survivor Robert Pugh join Let's Talk America for a timely interview. Listen in with someone you love.    #LTARadio 

Health Professional Radio - Podcast 454422
Living With Multiple Myeloma

Health Professional Radio - Podcast 454422

Play Episode Listen Later Nov 3, 2020 7:54


Dr. Saad Usmani, a specialist in hematology and oncology at Levine Cancer Institute in Charlotte, NC, discusses multiple myeloma and relapsed refractory multiple myeloma. He talks about signs, symptoms, and risk factors. He is joined by Robert Pugh who was diagnosed in 2014 and he shares how his life has been impacted by living with this disease.

6-minute Stories
"Flying South" by Patricia Joslin

6-minute Stories

Play Episode Listen Later Sep 16, 2020 8:02


Patricia A. Joslin lives in Charlotte, North Carolina, where she mingles with other new writers at Charlotte Lit. Raised in the Midwest, she learned to brave the winters but now prefers to spend her days under Carolina blue skies. Dr. Joslin is a retired educator who has published professionally. She has journaled for over 30 years, dabbled in poetry, and now participates in a writing group affiliated with Levine Cancer Institute. This is her first creative nonfiction publication.

The Surgical Palliative Care Podcast
Dr. Rick Greene: Integrating Palliative Care into Surgical Oncology

The Surgical Palliative Care Podcast

Play Episode Listen Later Aug 10, 2020 39:00


#016 - Join host Dr. Red Hoffman as she interviews Dr. Rick Greene, a surgical oncologist and a champion of palliative care for surgical oncology patients.  Rick currently serves as the medical director of the Cancer Data Registry at the Levine Cancer Institute in North Carolina.  As a past president (and founding member) of SAGES, past president of the Southeastern Surgical Society, past chair of the American College of Surgeons Commission on Cancer, past chair of the American Joint Committee on Cancer and past Chair of Surgery at Carolinas Medical Center, Rick can certainly be described as accomplished.  However, what is perhaps even more striking about Rick is how thoughtful and insightful he is, about both medicine and life.  In this episode, he shares his early experiences as a young surgeon aboard the USS Nimitz and discusses the influence of beshart (a Yiddish word which means inevitable or preordained) in his life.  Rick also offers his advice on how best to approach and talk about surgical complications.   Lastly, he discusses how important it is for surgeons to plan for life after surgery and recounts the necessity of always reinventing oneself (Rick is a writer and a radio host!) Articles discussed in the episode:Patient Loss: Surgeons Describe How They CopeThe Joys of Creative WritingCheck out The Recovery Room, a podcast hosted by Dr. Greene and supported by the American College of Surgeons here.To learn more about the surgical palliative care community, visit us on twitter @surgpallcare.

Becker’s Healthcare Podcast
Derek Raghavan, President of the Levine Cancer Institute

Becker’s Healthcare Podcast

Play Episode Listen Later Jul 19, 2020 14:49


This episode features Dr. Derek Raghavan, President of the Levine Cancer Institute. Here, he discusses how he has utilized both his PhD and MD, the most recent developments in his area of expertise, and more.

Multiple Myeloma Hub
Hot topics in MM: quadruplets and anti-BCMA therapy

Multiple Myeloma Hub

Play Episode Listen Later Jun 24, 2020 6:16


During the 25th Congress of the European Hematology Association (EHA), the Multiple Myeloma Hub was pleased to speak to Saad Usmani, Levine Cancer Institute, Atrium Health, Charlotte, US. In this podcast he discusses data from three clinical trials, which address the use of quadruplet treatments and anti-BCMA therapy for multiple myeloma.He describes the progression free survival, overall survival and safety profile of the 100 patients that were evaluable from the SWOG 1211 trial. This was a randomized, phase II trial, which evaluated lenalidomide, bortezomib and dexamethasone (RVd) induction followed by dose-attenuated RVd maintenance until disease progression with or without elotuzumab, in patients with high risk, newly diagnosed multiple myeloma.He then talks about the dose escalation results of first-in-human trial of teclistamab, a BCMA bispecific antibody, in terms of overall response rates and safety profile. He then mentions the randomized phase III study looking at belantamab mafodotin in combination with RVd in patients with transplant ineligible newly diagnosed multiple myeloma. Hosted on Acast. See acast.com/privacy for more information.

Get in the Know with your CMO!
CMO Podcast - Dr. Raghavan

Get in the Know with your CMO!

Play Episode Listen Later Jun 21, 2020 29:51


Dr. Raghavan - President of Levine Cancer Institute, shares an update on the efforts to care for some our most vulnerable (cancer) patients and how LCI has responded to continue providing care through the fear of the surge, as well as, safely re-opening services very systematically!  Learning from our international colleagues and harnessing our LCI talented professionals, our patients benefit from compassionate and coordinated care - delivered as safely as possible. 

ASCO Daily News
Leading Oncology Teams and Patient Care in a Pandemic: A Conversation With Dr. Derek Raghavan

ASCO Daily News

Play Episode Listen Later May 30, 2020 20:18


In today's episode, we hear from Dr. Derek Raghavan, an internationally renowned cancer researcher and medical oncologist.  He is President of the Levine Cancer Institute in North Carolina and professor of medicine at UNC Charlotte.  Dr. Raghavan discusses the critical decisions that his institution took regarding clinical trials, and safeguarding patients and staff during the pandemic.    

Career Exploration Spotlight
Interview with Whitney, a Nurse with the Levine Cancer Institute

Career Exploration Spotlight

Play Episode Listen Later Apr 23, 2020 12:09


In this interview, we learn more about Whitney's job as a nurse with Levine Cancer Institute. She also gives advice for what to do while going outside during the current health crisis.

Creating a New Healthcare
Episode #89: ‘How COVID-19 is Reframing Healthcare in America' with Dr. Ify Osunkwo of the Levine Cancer Institute at Atrium Health

Creating a New Healthcare

Play Episode Listen Later Apr 8, 2020 41:14


Dear Friends & Colleagues, On Friday March 27th 2020, I launched a limited podcast series addressing how the COVID-19 pandemic is reframing American healthcare.  You can find the introduction episode ...

Creating a New Healthcare
Episode #89: ‘How COVID-19 is Reframing Healthcare in America’ with Dr. Ify Osunkwo of the Levine Cancer Institute at Atrium Health

Creating a New Healthcare

Play Episode Listen Later Apr 7, 2020 41:14


Dear Friends & Colleagues,On Friday March 27th 2020, I launched a limited podcast series addressing how the COVID-19 pandemic is reframing American healthcare.  You can find the introduction episode here.  In this series, I’ll be interviewing future-facing, courageous healthcare leaders and entrepreneurs - asking two questions: (1) How is the COVID-19 pandemic immediately changing the way you’re delivering healthcare?   (2) How will COVID-19 reframe American healthcare for years to come? In this episode, we’ll be speaking with a colleague of mine, Dr. Ifeyinwa (Ify) Osunkwo, MD, MPH.Dr Ify Osunkwo - or Dr. Ify, as her patients refer to her - is the Director of the Sickle Cell Disease (SCD) Enterprise at Levine Cancer Institute at Atrium Health.  She is a Professor of Medicine at Atrium Health and a Clinical Associate Professor of Medicine at UNC Chapel Hill.  Dr. Ify earned her MD from the University of Nigeria and a Masters in Public Health from Johns Hopkins University.  She completed a pediatric residency at the University of Medicine & Dentistry of NJ, followed by a pediatric hematology-oncology fellowship at Columbia University.  She founded the SCD program at Atrium Health.  This program has been instrumental in improving the quality of life of persons living with SCD in North & South Carolina; and has also demonstrated positive health outcomes in terms of reduced mortality rates, reduced health care costs and hospital readmission rates, and increased patient engagement and satisfaction with care.  Dr Osunkwo has dedicated her career to providing equitable, comprehensive, compassionate and evidence based care for individuals living with SCD.  She serves on numerous national committees for the American Society of Hematology and is the Editor-In-Chief of Hematology News.I felt compelled to share this interview because Dr. Ify is offering a number of humanistic approaches to her patients that are especially important in the COVID-19 era.  They are important from a provider/patient relationship perspective in that they directly address the issues of social isolation, loneliness and anxiety that people with chronic medical conditions are experiencing.  They are important because they address the concrete issue of chronic disease management, which are disproportionately affected by the social distancing and sheltering-in-place public health efforts.  There is little doubt that people with chronic medical conditions and people who are socio-economically vulnerable are impacted upon much more severely than others.  I’m posting this interview with the intention and hope that providers from across the country will be inspired by Dr. Ify’s example and adopt these and/or other similar offerings for their patients; and that healthcare systems across the country will support these providers with resources.  All of this is said with the grateful understanding that so many providers and healthcare systems are focused right now on emergency preparedness for the pandemic surge and on treating patients with COVID-19.  What I’m sharing in this interview is what I would call 2nd, 3rd and 4th wave issues - addressing the pandemic’s impact on social determinants of health and on the mental health of patients - which, as Dr. Ify points out, has a significant impact on the course and treatment of chronic disease.  But, these are issues that we need to begin to address now, even as we battle the 1st wave of the pandemic. I’ve known Dr. Ify for a number of years.  She is a wonderful physician who has a refreshing public health perspective that she applies brilliantly in her practice of medicine.  It’s clear that Dr. Ify is incredibly devoted to her patients and is an exemplary role model.  Her accomplishments and her positive impact are also a credit to the Levine Cancer Institute and the Atrium Health system that support her in this critically important, meaningful and innovative work.   These are unprecedented times, so I hope you find valuable information, guidance, and inspiration in listening to these experts and entrepreneurs share how they are adapting to this pandemic (in real time); and how they’re thinking about and planning for the future.Until next time, be safe and be well,Zeev Neuwirth MD

Blood & Cancer
Sickle cell update: Treating pain and progress toward cure

Blood & Cancer

Play Episode Listen Later Jan 23, 2020 25:44


When it comes to treating pain related to sickle cell disease, consider the underlying factors, from constipation to compression spine deformity. That’s just some of the advice from Ifeyinwa Osunkwo, MD, of Atrium Health and Levine Cancer Institute in Charlotte, N.C. She joins host David H. Henry, MD, of Pennsylvania Hospital, Philadelphia, to discuss her tips for treating pain and other complications of sickle cell disease. Dr. Osunkwo also provides an update on progress toward a cure in sickle cell disease that could be available to a large number of patients. Plus, in Clinical Correlation, Ilana Yurkiewicz, MD, of Stanford (Calif.) University, talks about why treating patients with cancer doesn’t make her sad. *  *  * Treating pain in sickle cell: In sickle cell disease, patients have acute episodes of vaso-occlusive crisis, as well as chronic pain. Consider whether the pain symptoms are an acute exacerbation of their chronic pain, an independent acute episode of pain, or chronic pain. In her practice, Dr. Osunkwo has moved to less chronic opioid use and more adjuvant use. She says treat the pain but look for the reason underlying it. The pain could be a result of bone damage, a compression spine deformity, constipation, or other factors related to their disease or the treatment. Consider the impact of opioid withdrawal after receiving a high dose in the hospital. Treating acute chest syndrome: Acute chest syndrome is usually not subtle in its presentation. It is acute and includes fever, pain, difficulty breathing or shortness of breath, hypoxia, and the patient looks sick. Consider their last chest x-ray and look for changes. Is this a new pulmonary infiltrate? This is a patient who should be transfused to get them out of distress. Most of acute chest syndrome cases happen 3 days into a hospital admission. Developments in sickle cell treatment: Two new drugs to treat sickle cell symptoms were approved in the United States in 2019: voxelotor (Oxbryta) to increase hemoglobin and crizanlizumab-tmca (Adakveo) to reduce the frequency of vaso-occlusive crisis. What is coming next? Researchers are working on potential cures for sickle cell that would be available to patients on a widespread basis. That includes haploidentical transplant and gene therapy. American Society of Hematology guidelines on the treatment of sickle cell complications. *  *  * For more MDedge Podcasts, go to mdedge.com/podcasts Email the show: podcasts@mdedge.com Interact with us on Twitter: @MDedgehemonc David Henry on Twitter: @davidhenrymd Ilana Yurkiewicz on Twitter: @ilanayurkiewicz

Get in the Know with your CMO!
Dr. Ed Kim - Chair of Solid Tumor Oncology @ Atrium Health

Get in the Know with your CMO!

Play Episode Listen Later Sep 5, 2019 24:59


Meet Dr. Kim, a Midwesterner, who's found himself in Charlotte with Levine Cancer Institute.  This Chair of Solid Tumor Oncology is not only creating Clinical Pathways but also Dancing with the Stars.  

Blood & Cancer
Cancer trials in the community

Blood & Cancer

Play Episode Listen Later Aug 1, 2019 35:58


Edward S. Kim, MD, of Levine Cancer Institute at Atrium Health in Charlotte, N.C., chats with David H. Henry, MD, host of Blood & Cancer, about how to perform clinical trials in the community oncology setting. Plus, in Clinical Correlation, Ilana Yurkiewicz, MD, of Stanford (Calif.) University, discusses a byproduct of our fragmented health care system – patients having to hear the same bad news repeated over and over. Show notes  Only 3%-4% of adult oncology patients are enrolled in clinical trials. Most patients diagnosed with cancer are seen in community settings (as opposed to academic centers). Oncologists in the community setting face significant obstacles to enrolling their patients in clinical trials: Communication between academic and community centers often is lacking, especially in more rural areas of the country. Community-based oncologists usually are not compensated for time spent on research or academic work. Treatment pathways used by many oncologists may not offer any information regarding clinical trials. The traditional infrastructure of a community practice may not have the necessary experts to facilitate clinical trial participation. Community oncologists may not feel comfortable talking to their patients about a novel drug of which they have little knowledge. How can community oncologists facilitate participation in clinical trials? There must be a cultural change, starting with the organization’s leadership. A study coordinator is crucial. Data, finance, and regulatory individuals are likely required. Coordination with pharmacy and pathology usually is necessary. Electronically Accessible Pathways (EAPathways) is a tool developed by Dr. Kim’s team. It is available and allows any oncologist to input a patient’s information to determine if there is an appropriate clinical trial available. Show notes by Sugandha Landy, MD, a resident in the department of internal medicine, University of Pennsylvania, Philadelphia Dr. Kim can be reached at Edward.Kim@atriumhealth.org   Additional reading Patronik KE and ES Kim. A novel clinical pathways approach to delivering regional-based clinical trials and patient care in a hybrid academic- community-based system. J Clin Pathways. 2018 May;4(4):52-5. Ersek JL et al. Implementing precision medicine programs and clinical trials in the community-based oncology practice: Barriers and best practices. Am Soc Clin Oncol Educ Book. 2018 May 23:38:188-96.   For more MDedge Podcasts, go to mdedge.com/podcasts Email the show: podcasts@mdedge.com Interact with us on Twitter: @MDedgehemonc David Henry on Twitter: @davidhenrymd Ilana Yurkiewicz on Twitter: @ilanayurkiewicz  

CURE Talks Cancer
35: Oncology Nurse Helps Patients Be Brave

CURE Talks Cancer

Play Episode Listen Later Jul 12, 2019 11:56


After being inspired by one of her patients, Harding Cranford, RN, OCN, an oncology nurse at the Levine Cancer Institute, wanted a way to connect the community with the patients she treated on the oncology unit.  So, the nurse started "Bravery Bags," a program where people can donate items to those going through cancer that can act as a pick-me-up during treatment. What started as a small grassroots campaign spanned into donations coming from across the nation, brightening the days of hundreds of patients. Read more: https://www.oncnursingnews.com/web-exclusives/educating-the-community-while-helping-patients-with-cancer

Get in the Know with your CMO!
Podcast 3: Dr. Raghavan - Part 2

Get in the Know with your CMO!

Play Episode Listen Later Jul 8, 2019 16:40


The continuation of our conversation with Dr. Derek Raghavan, President of Levine Cancer Institute.  Find out "what keeps him up at night", the symphony and what new, exciting things should we look forward to in the Cancer arena.  

Get in the Know with your CMO!
Episode 2: Dr. Raghavan - Part 1

Get in the Know with your CMO!

Play Episode Listen Later Jul 5, 2019 17:39


A delightful conversation to get to know Dr. Derek Raghavan, President of Levine Cancer Institute.  Find out why you should strive to leadership and what he learned while driving a Taxi in Australia.  

A Sherpa's Guide to Innovation
E43: Turning Information into Innovation – Health Datapalooza Conference Recap

A Sherpa's Guide to Innovation

Play Episode Play 30 sec Highlight Listen Later Apr 25, 2019 44:37


Episode 43 features perspectives from Atrium Health teammates who attended the 10th anniversary Health Datapalooza conference on March 27-28 in Washington, DC. Hosted by AcademyHealth, Health Datapalooza brings together a diverse group of healthcare leaders, policymakers, entrepreneurs, and data analysts to discuss collaboration opportunities at the intersection of policy, data, and innovation. A sponsor at this year's event, Atrium Health also sponsored the attendance of several Charlotte-area patients who were able to contribute their insights to the national conversation on how to harness the power of data to improve the health of our country. Our very own Dr. Rasu Shrestha, EVP and Chief Strategy Officer, kicks off our interviews. You'll also hear some new voices, including Dr. Ed Kim, Chair of the Department of Solid Tumor Oncology at Levine Cancer Institute; Jason Schneider, Senior Director of Corporate Communications; and Allyson Cochran, Senior Clinical Data Manager for the Carolinas Center for Surgical Outcomes Science. Tune in and . . . #pinksocks! @hdpalooza @AcademyHealth @RasuShrestha @AtriumHealth @LevineCancer @EdKimMDLCI ‏ @theNCI @CancerResrch @ASCO@JSchneide12 Atrium Health Datapalooza site. Learn about the Pink Socks movement.  - A Sherpa's Guide to Innovation is a proud member of the Health Podcast Network @HealthPodNet -Support the show

Cancer.Net Podcasts
Social Media for People With Cancer, with Merry Jennifer Markham, MD, and Danielle Gentile, PhD

Cancer.Net Podcasts

Play Episode Listen Later Mar 5, 2019 19:07


ASCO: You’re listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the world’s leading professional organization for doctors who care for people with cancer. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Cancer research discussed in this podcast is ongoing, so the data described here may change as research progresses. Monika Sharda: Hello. I'm Monika Sharda, an editor on the Cancer.Net team and your host for today's podcast. In this episode, I will be talking with two guests about how cancer patients use social media. Our first guest, Dr. Merry Jennifer Markham is a hematologist at the University of Florida in Gainesville. Welcome, Dr. Markham. Dr. Markham: Hi. Good morning. Thanks for having me. Monika Sharda: We also have with us Dr. Danielle Gentile, who is a researcher at Levine Cancer Institute in Charlotte, North Carolina. Hi Dr. Gentile. Dr. Gentile: Hi Monika. Thank you for having us this morning. Monika Sharda: My pleasure. Drs. Markham and Gentile recently published a study in the Journal of Oncology Practice that describes potential benefits and drawbacks of people with cancer using social media. Today, I'm going to discuss with them some of the findings from their study, as well as what people with cancer should know about using social media and how it can provide support. First off, I want to know what sparked your interest in studying social media and its use for people with cancer. Dr. Markham, let's start with you. Dr. Markham: Sure. So I have had an interest in social media for several years. And some of that stems from my own personal and professional use of social media, primarily platforms like Twitter. And one thing that I've noticed is that I've connected on Twitter with a lot of patient advocates and colleagues and sometimes people who identify themselves as patients, as well. And there's a lot of searching for information that happens, I think, on social media. So that has really stemmed my interest in exploring it further as a potential tool for patients, as well as researchers and oncologists and other health professionals, to take advantage of what's out there. Monika Sharda: And what about you, Dr. Gentile? Dr. Gentile: I'll echo many of the things that Dr. Markham shared. And there's ways to find so much information through social media, things that a person may not even be directly seeking. They can come across things indirectly and learn that way. So it's quite interesting to see how people are able to make connections across the country and across the world with people who are in similar situations that they are. And social media is a way to gain some social support in ways that may not be possible in person. So if a person is not feeling well from their cancer diagnosis or treatments, they can reach out online. And through Twitter or Facebook, they're able to meet others who can share in the experience with them. Monika Sharda: So what I took away from your study is that social media can sort of be a double-edged sword. There's potential benefits for patients, but then there are also potential drawbacks. So let's start by talking about some of the pros. How can social media be helpful to patients? Dr. Gentile: So there's a few ways that patients can use social media to their benefit. And one is that it's great for engagement and empowerment. So it provides a platform for patients to talk about their diagnoses, to search for information, digest what is happening in the world of cancer research as well. And through all of that information and connection with others, it can provide psychosocial support too. So those who are able to disclose some of their thoughts and their feelings and meet with others who share similar stories and are in the same boat, it can be helpful for them to make those connections. Dr. Markham: I think that that source of support is really one of the invaluable pros to social media. I am a medical oncologist and see patients who have gynecologic cancers. And we live in an area where there's not a lot of in-person access to support groups. I am never offended when my patients come to me with things that they've read on the internet because, unfortunately, it really is a resource that a lot of people rely on. And I think that when my patients are able to connect on social media to other patients with similar diagnoses or similar health experiences, it really allows me to have a better conversation with that patient in the exam room. She can bring me information about what she's read or what she's heard from a friend of hers across the country. And then we can have a conversation and I can take care of her better knowing what she knows. Dr. Gentile: So another pro coming from me from a research perspective is that social media can be a valuable recruitment tool for researchers who are looking for demographics of patients that are pretty specific. So if you imagine a rare cancer diagnosis, it can be hard to find those patients in any small geographic area. But by using social media, those groups can cluster online. So it could be a Facebook support group for a certain diagnosis and a researcher could post on that group and ask if anyone is interested in a potential research study or a trial. And so it's a way of connecting patients to opportunities to participate in research that their home oncologist and their support team may not be aware of. Monika Sharda: Absolutely. And what are some of the cons? What should patients be cautious about when using social media? Dr. Markham: I think one of the real risks of social media is misinformation. It's very easy for false information or altered information to spread widely on social media, either Twitter or Facebook or otherwise. And sometimes it's hard for people to distinguish what's the good information, what's a quality piece of research, or a true statement about health that can be trusted, versus what is myth and what's not to be trusted. So distinguishing between good information and reliable health information is certainly one of the risks that I do worry about with, not just patients, but with their caregivers, and, truthfully, health professionals as well. Dr. Gentile: And another, with all of that information that patients can find online, is they're trying to decipher what's good information, what's misinformation, and what to act on. It can result in what we call information overload. And that's when a person has gathered so much information that they become overwhelmed by the amount of the information and they're not sure how to act on it. So it can lead to this feeling of paralysis or being stuck. And something that we recommend for that is always talking with the clinician. Like Dr. Markham said, she's not offended when her patients bring her information they've learned online. And that's one of the best resources to determine if information is worthy or not. And I'll share another potential con for social media and that is privacy concerns. So pretty much anything that goes onto the internet is for public use. And folks will think about their privacy filters. Do they want only their connections to see it? Do they want it to be widely, publicly available? But one can never be sure, even with those privacy filters, that their information won't go somewhere they don't intend it to. So if a person posts on Twitter in a private group thing that they have a certain diagnosis, it can never be for certain that someone in their daily social connections might see that. So anything a person posts online, I would advise make sure that's something you feel comfortable with everyone knowing. Monika Sharda: Going back to the idea of misinformation for a minute, you mentioned one way for it to help patients differentiate between what's worthy information and isn't is, of course, to talk with your oncologist about it. Talk with your healthcare team. Are there any other tips you can provide patients with how they can differentiate between reliable and unreliable information? Dr. Markham: So I think looking for the source of information can be helpful. Information that's put out by American Cancer Society or by ASCO or Cancer.Net, for example, is vetted by clinicians and physicians who, I think, lend some support to that information being trustworthy. There are other sources, such as the National Cancer Institute that shares information regularly on social media. I think it's when there's an article in a non-medical journal or not one of these professional organizations that is sometimes hard to see today whether it's true or not true. And I think in those situations, it really is advisable for patients to take that information to their doctor, to ask more questions about it. I've encouraged my patients to go to certain resources online for information. And I've also encouraged them to bring me information that they want to know more about. And it's not infrequent that I have my patients come to me with things that they've seen online, whether on social media or otherwise, and it allows us to have a good conversation about what's true and what's myth. Dr. Gentile: It can also be important to think, "What is the motivation behind whomever has posted the certain piece of information?" So if it's a reliable source, like ASCO or Dr. Markham is posting it, she is a hematologist, she is likely doing that because she wants to share the information for educational purposes and to help the lives of her patients. But there are plenty on social media who have profit motives for sharing information. So it might be some type of miracle cure where taking this product would completely take care of the cancer. And something my mom told me, is true in this situation: if it sounds too good to be true, it is. So be cautious and think about why a person might post something on social media. Monika Sharda: Those are some really great tips. And Dr. Markham, I think it's really great how you encourage your patients to talk with you about what they've read, what they've seen on social media and really encourage that conversation instead of them trying to figure out on their own whether the information that they're seeing is worthy, is reliable. What would you say is the most effective way for patients to use social media to communicate? Dr. Markham: So the most effective way, that's a bit of a hard question because I think there's probably multiple ways for patients to use social media. I think one reason that I like Facebook for health information, actually, is because there are a variety of groups that are closed and private that patients may discover for health information and, primarily, for support. So I think those are sometimes opportunities. The challenge of those, of course, is is there reliable information being shared. Some groups have healthcare moderators within them and some do not. So that is one of the risks of participating in a group. I think if a patient feels uncomfortable or overwhelmed, they should remove themselves from that situation. I think on Twitter, there's an opportunity to participate around hashtags. Hashtags are terms that you can plug into Twitter using the hashtag or pound sign with a phrase behind it, such as #breastcancer. And that is a good way of sort of filtering out information that's targeted to that type of health problem. And there's a lot of communities, actually, in the Twitter space built around these hashtags for healthcare where there are routine chats that may happen. Breast cancer actually has a good advocacy group on Twitter centered around the #bcsm, which stands for breast cancer social media. And there are physicians within that community and patient advocates and patients themselves. And it's, I think, a good starting point for a patient who may be on Twitter and wants to connect with others who have similar interests or similar desires to connect. Dr. Gentile: And I think it's also important for any patient who wants to access social media in relation to their cancer diagnosis to spend some time before they enter these platforms and ask themselves, "What are they hoping to get out of the experience?" Is their primary motivation to get social support and meet others in social support groups, or is it looking for new, reliable information? Is it a mix of the two? And then, again, checking in with oneself periodically and asking, "Am I getting what I need, what I was intending to get?" For example, Dr. Markham was saying that if a person becomes uncomfortable or they find the situation overwhelming within social media, fielding many messages, then they can just remove themselves. And one should really go at their own pace and do what makes them feel comfortable and beneficial. There's no real obligation to respond to folks if you're not finding it to be beneficial. Monika Sharda: For someone that's not too comfortable with social media or has trouble finding relevant hashtags or Facebook groups, do you have any tips for them on how they can seek out these groups and what the relevant hashtags are for them? Dr. Gentile: Sure. So I'd recommend that a patient get started with some platforms that they know are reliable, valid, good information sources. So, for example, Dr. Markham mentioned the #bcsm, breast cancer social media. And just starting with one hashtag or one support group on Facebook can lead a person down the line to other places to explore. So starting small and then branching out, I think, would be helpful for most cancer patients. Dr. Markham: ASCO has some good resources, both for patients and for caregivers, I believe. There's something called Social Media 101 for Patients that ASCO has published. So that's a good starting point for people who may want to jump into social media period. Also, I think patients who are interested in finding groups may be able to reach out to their oncologist or other physicians to inquire if those physicians know of reputable groups that they could join. What I find, though, is that a lot of the networking that my patients experience in social media has come from their online sort of word of mouth, which is a little harder to know about. Our social worker in my own clinic is sort of compiling a list of places where patients tend to congregate online so that she can point other patients in the right direction. But I think we still have a lot of work to do in this area to help really guide our patients well. Monika Sharda: And that actually leads me to my next and final question. I was going to ask you to share some resources for patients to learn more about using social media safely and effectively. So you've already mentioned ASCO and the resources they have and also, talking to your healthcare team and your oncologist. Do you have any other resources that you can share? Dr. Gentile: So I think those are probably two of the most important. I know that I have had patients who have reached out to organizations on social media, such as American Cancer Society and, probably, Cancer.Net may have had this experience as well, asking for information from those groups on who to recommend and how to approach things. So I think that Cancer.Net certainly has lots of good resources. But, really, I think ultimately, just conferring with a physician at the end of the day, to make sure that the space that is being found and using social media in a safe way as a patient, can be a discussion with the physician and patient together. Monika Sharda: Right. Well, that's all of the questions I have. Is there anything that, perhaps, we didn't touch on already that you'd like to talk about? Dr. Gentile: I'd like to say that it's going to be different for every patient or every loved one who is caring for someone with cancer, when it comes to social media. And to feel okay with taking it at your own pace. And if you find that you have a piece of information that you are unsure about, the take-home message is to share that with your healthcare team and get that checked out. And to not make big decisions on how you're going to care for yourself or your loved one solely based on a piece of information from social media. Dr. Markham: I think that's an excellent point. And the only other thing I would add is that social media can be scary for those who are just diving in, and I don't think it necessarily has to be. It's just a matter of taking it slow, at your own pace, as Dr. Gentile said. And just testing the waters. Monika Sharda: That's really great advice. Drs. Markham and Gentile, you've shared a lot of great tips with our listeners on using social media and provided additional resources where they can learn more about the topic. It's been a pleasure having you on this podcast. Thank you so much for joining us today. Dr. Markham: Thank you so much for having us. Dr. Gentile: It's been a great pleasure for me too. ASCO: Thank you, Dr. Markham and Dr. Gentile. Find more resources on using social media at www.cancer.net. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play. Cancer.Net is supported by ASCO’s Conquer Cancer Foundation, which funds breakthrough research for every type of cancer, helping patients everywhere. To help fund Cancer.Net and programs like it, donate at conquer.org/support.

Journal of Oncology Practice Podcast
Financial Toxicity in Adults With Cancer: Adverse Outcomes and Noncompliance

Journal of Oncology Practice Podcast

Play Episode Listen Later Dec 21, 2018 15:05


Dr. Thomas Knight talks to Dr. Pennell about a major issue in cancer care: financial toxicity. Read the related article.   Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. The rising costs of medical care is on everyone's mind these days. But while policymakers or physicians tend to discuss this more of as a societal or economic problem, the real consequences of the high costs of cancer care are ultimately being felt by our patients. But how do we measure the financial burdens of cancer care? And how does this impact our patients' lives and ultimately their outcomes from treatment? Today, we're going to be talking about a new paper titled, Financial Toxicity in Adults With Cancer Adverse Outcomes in Noncompliance, published in the November 2018 JOP. Joining me for this podcast is Dr. Greg Knight, medical oncologist at the Levine Cancer Institute in Charlotte, North Carolina. Greg, thanks so much for joining me today. Thank you so much for having me. So I thought this was a really interesting paper. Can we just start with a little bit of terminology? So what do you mean when you're talking about financial toxicity? I've heard people use this term bandied about. I think it's a term that oncologists are used to dealing with. And obviously, we know that health care is expensive. But this implies that there is a harmful element to this. Yeah, sure. The term financial toxicity is still a relatively new term. We first started to use it probably around 2013. Dr. Zafar at Duke published a paper first looking at this in terms of the costs and the harm to patients. And the idea behind it is we want to be able to quantify what we're doing in terms of harm to the patient with the costs of treatment. As oncologists, one of the things that we're really good at is grading toxicities. So we worry about nausea. We worry about neuropathy. We worry about hair loss. But one of the things that we weren't very good at was also looking at the harm we were doing to patients with the costs of our treatment. And when I refer to cost of treatment, this term actually encompasses a lot, in terms of not just what we usually think of, which is offices, it's medications, hospitalizations, all those bills that they get from us, but there's other costs that go along with having a cancer diagnosis. Those are things like transportation, clothing, lost wages, child care. All of these things are impacting our patients. And we need to quantify this because it does have implications on their treatment and how they're going to do. Well, that makes perfect sense. And I think that's something relatable to everyone who's treating cancer patients today. Can you give us a little bit of an idea of the magnitude of this issue in the United States? Is there existing data before your particular study came out? There were some both small scale papers and some large database looking papers. And the general consensus was, at the time when we started this study was about 1/3 of patients are going to have severe or catastrophic financial difficulties associated with their treatment. Wow. That's a huge number. So why don't you tell me a little bit about your study and what was the intention of the study and how did you go about it. One of the things we really wanted to do with this study, which was part of a much larger study we had at the University of North Carolina, was we wanted to evaluate both prevalence of this financial toxicity. Because again, there had been some database studies. There had been some smaller scale studies. But we wanted to get actual patient reported data on the prevalence of this financial toxicity and in a wide variety of cancers. But we also really wanted to look and see other things. How did it impact health services? Basically what are targets that we could intervene on to try to improve this? And so really with this study, what we did was we went into the clinics of all of the oncology clinics at UNC, and we embedded researchers in there and approached pretty much any patient that came to the clinic. Wildly successful actually, we had over 52% of our approached individuals actually enrolled in our study. And then within two weeks of that enrollment, we had interviews conducted by our staff using basically a computer assisted telephone interview. Now as I said, this was part of a much larger project. And what we were trying to do was basically get this comprehensive database of both clinical and interview data. And then we paired that with biologic specimens and tumor tissue. However, our piece of it was we were really trying to delve down on this financial question and then look at quality of life and how it impacted their care. Are their existing instruments that look at financial toxicity? Or is this built into existing PRO surveys? At the time when we started this, there actually was not. Dr. De Souza at the University of Chicago actually developed the cost measure, basically posted that after we had started with us. Having said that, and I love the cost measure. I think it's a fantastic. It's a nine question survey basically looking at grading financial toxicity. One of the things that we really were hoping to do with our primitive attempts at this was to find maybe one question things we can do in a busy clinic to try to identify high risk populations. And so with this one what we used was actually a statement from the PSUA team, which was, you have to pay for more medical care than you can afford. And then patients were asked to respond to the statement basically strongly agree, agree, uncertain, disagree, or strongly disagree. And we dichotomized them as basically exhibiting financial toxicity if you strongly or agreed with that statement, or not exhibiting financial toxicity with any other response. That sounds like a pretty clear and straightforward question. Was there like a free form portion where they could talk about, did this affect their ability to take their medicines, or go to doctor visits, things like that? There was. And we actually did a couple of different things. So we both did standardized questionnaires, so we did things like the fact GP, which is looking at multiple facets of patient well-being. We also looked at other health related quality of life issues. We also had developed our own access to health care questionnaire, which was looking at certain things like, were you having problems getting to your appointments? Are you being able to pay for your medications? We did several questions about paying for lab tests, paying for office visits. And then also, we really wanted to make sure that we knew if the reason you were missing these things was because of cost, or if there were other reasons. Because obviously, we don't want to attribute this all to cost if that's not what's causing the harm. OK, yeah. So it sounds like a lot of information gathered. So what did you find? In our study, we had almost 2,000 participants. And we had over a quarter, so 26% agreed or strongly agreed that they had to pay more for medical care than they could afford, which is in line with other studies. I would have thought it might have been higher than that. But it sounds like this is a nice validation that your survey was a pretty accurate instrument, even with such a simple question. Unfortunately, what we found is that when you take this population, the population that tells us that they are having financial toxicity by our definition, what we were finding was much higher rates of noncompliance. And that was a very scary thing when you're talking about cancer patients. Our patients who had reported financial toxicity were much more likely to report needing but unable to afford prescriptions, over-the-counter medications. They were also reporting noncompliance due to cost concerns for medical care like doctor's visits, medical tests, mental health care. All these things for the majority of patients undergoing active chemo is a really scary thing. And there's been some really good research in this area recently. There was a recent study where they were looking at imatinib and CML, and it found that individuals who had copayments greater than $53 a month were 70% more likely to discontinue within six months. So it's real world implications of this concept. Absolutely. And were there any other factors that were associated with financial toxicity, things that you might be able to use to screen or predict for this? In terms of the predictor, we basically validated what it had been thought of before, which is that there were certain factors that seem to be more predictive for exhibiting financial toxicity. The ones that we really know of are age less than 65 years, being non-white race, less education. All of those things had been previously described. It was nice to see with a large population model that we could validate those findings that would have been found in smaller studies. But it does seem that those patients are at much higher risk for financial difficulties. Yeah, and the less than 65 is interesting to me. So I assume that that's probably related to Medicare coverage, that that somehow makes it less of a financial burden. That's what it looks like. And I think that, obviously, Medicare is a nice protection for a lot of our patients over the age of 65, in that they don't see a lot of some of the costs our younger patients, especially our underinsured patients see. However, there was a recent study where individuals with cancer that were insured by Medicare alone were incurring mean out-of-pocket costs that were 1/4 of their household income. So I would say even though they have probably less bills for a lot of those patients, they're on fixed income. There is not other income coming in. So a lot of the folks over the age of 65 are still having financial toxicity even with the better insurance coverage. Did you look at insurance coverage in this? Was that a variable in the analysis? It was not. It was one of those things that when you go back and you wish you would have done it at the time. We felt like we had covered every single base. And it actually was a thing where we thought we were going to be able to pull that data from a database. But ultimately, we were unable to do it. It's now built into every model going forward. But we unfortunately did not have that data. So you did a great job of identifying these patients and all the consequences of the financial toxicity. So what are we to take from this? Presumably, the idea would be to try to figure out a way to intervene on these patients. So what can we do? Yeah, I think that, I mean, obviously, the first step is to identify the problem. And I think that that's always an issue. There's been multiple surveys of oncologists who feel it feels very wrong to discuss costs with patients. I think that we get very wrapped up in the science. And we have the latest and greatest drug that we just know is going to work. But obviously, drugs are getting more expensive plus all the treatment time and coming to and from the hospital, and basically outpatient versus inpatient chemotherapy. All these things need to be thought of when you're thinking about your treatment plans. Having said that, once identified, if you're screening your patients for this, there are specific areas it seems like we can intervene. In our study, what we found was there were pretty interveneable reasons people were saying that they were having problems with their care. They include things like not having transportation, a lack of insurance, the inability to pay for travel. They can't take time off work. They don't have child care. These are things that are specific issues that they're having, that with foundational support, with local and community support, you can usually intervene on. But you really do need to identify them. I know our group and the group out in Washington has done some research in the use of trained financial navigators to help patients. And that group in Washington has shown fantastic results saving a lot of money annually for these patients. And in our group, we've also done things like treatment plans based on where you live. So can we get you treatment close to home? And if not, how can we get ride share? How can we get gas cards? Can we do things to help you? And then also, I mean, again, there are actually a decent amount of foundational money out there if you're looking for it. There are groups out there that are there to help. But again, like I said, a lot of times, we just miss the problem. Yeah. I mean, I know that I feel vastly unqualified to discuss costs of care with my patients. Oftentimes, I really don't even have a good idea of how much things cost. But it sounds like there ought to be a way to screen patients right up front beyond simply what their level of insurance is to see if they might benefit from these extra services. And then it's important for cancer centers to have these kind of interventions to be able to help provide with transport and identify patients who would benefit from that foundational help. So I don't know how broadly available those kinds of services. I know we have them there. And your cancer center is actually run by our old boss, who used to run our cancer center, Dr. Raghavan. So I'm not surprised that you might have those as well. Is this something that is broadly available in oncology offices throughout the country? It's not. I mean, honestly, it is not. And one of the things that I'm kind of one of my big pushes in terms of the research is that I think that everyone has their own issue that they're very passionate about. And I think that we could survey patients until the cows come home about different issues and try to identify patients at risk. And so one of things we've really tried to do is a couple of things. Number one is to identify specific questions, especially in this case and some of our other studies, one or two question surveys where we can identify patients that are at very high risk for having these difficulties and identify that subset of population. And then one of the things that we're actually also working on in association with a couple other foundations and a couple of national organizations is we are actually hoping at some point to be able to start to roll out telemedicine, tele financial counseling basically and internet and other programs. There's a pilot going on in Boston right now. There's another program we're going to be rolling out here in January, where we are trying to intervene on the problem even just from financial planning standpoint. There's a large amount of patients who it doesn't matter where you are in terms of your financial situation, financial planning is incredibly important. You could have a lot of money in the bank and good insurance, and then you get hit with a cancer diagnosis. And you're trying to figure out what you're going to do with your assets, versus a lot of our patients, which are you now can't work. And there's no money coming in. How are the bills going to be paid? How are you going to basic budget? Again, I think this is going to resonate with everyone who treats cancer, no matter where you are. Because a big segment of our patients really struggle with this. And while it might not be immediately visible, if you dig down a little bit, it's not hard to find. Well, Greg, thanks so much for talking to me today. Thank you. And I also want to thank all our listeners out there who joined us for this podcast. The full text of the paper is available online now at ASCOpubs.org/journal/jop in the November 2018 issue. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

ASCO in Action Podcast
Increasing Patient Inclusion in Cancer Clinical Trials

ASCO in Action Podcast

Play Episode Listen Later Jun 26, 2018 28:47


In the latest ASCO in Action Podcast, Dr. Edward Kim, Chair of the Department of Solid Tumor Oncology at the Levine Cancer Institute, joined ASCO CEO Dr. Clifford A. Hudis to discuss eligibility criteria for cancer clinical trials.

GRACEcast ALL Subjects audio and video
What is the Role of Molecular Marker Testing in the Adjuvant or Post-Op Setting?

GRACEcast ALL Subjects audio and video

Play Episode Listen Later Jan 29, 2016 4:43


Dr. Edward S. Kim from the Levine Cancer Institute in Charlotte, NC discusses the feasibility of molecular marker testing and targeted therapy in the adjuvant or post-operative setting.

GRACEcast Lung Cancer Video
What is the Role of Molecular Marker Testing in the Adjuvant or Post-Op Setting?

GRACEcast Lung Cancer Video

Play Episode Listen Later Jan 29, 2016 4:43


Dr. Edward S. Kim from the Levine Cancer Institute in Charlotte, NC discusses the feasibility of molecular marker testing and targeted therapy in the adjuvant or post-operative setting.

GRACEcast
What is the Role of Molecular Marker Testing in the Adjuvant or Post-Op Setting?

GRACEcast

Play Episode Listen Later Jan 29, 2016 4:43


Dr. Edward S. Kim from the Levine Cancer Institute in Charlotte, NC discusses the feasibility of molecular marker testing and targeted therapy in the adjuvant or post-operative setting.

GRACEcast ALL Subjects audio and video
Can Serum Tumor Markers Be Used in the Management of Lung Cancer?

GRACEcast ALL Subjects audio and video

Play Episode Listen Later Jan 27, 2016 2:51


Dr. Edward S. Kim from the Levine Cancer Institute in Charlotte, NC describes the use of serum tumor markers in various types of cancer, and the lack of a useful serum tumor marker in lung cancer.

GRACEcast Lung Cancer Video
Can Serum Tumor Markers Be Used in the Management of Lung Cancer?

GRACEcast Lung Cancer Video

Play Episode Listen Later Jan 27, 2016 2:51


Dr. Edward S. Kim from the Levine Cancer Institute in Charlotte, NC describes the use of serum tumor markers in various types of cancer, and the lack of a useful serum tumor marker in lung cancer.

GRACEcast
Can Serum Tumor Markers Be Used in the Management of Lung Cancer?

GRACEcast

Play Episode Listen Later Jan 27, 2016 2:51


Dr. Edward S. Kim from the Levine Cancer Institute in Charlotte, NC describes the use of serum tumor markers in various types of cancer, and the lack of a useful serum tumor marker in lung cancer.

GRACEcast Lung Cancer Video
Different Lung Cancer Subtypes - Histology

GRACEcast Lung Cancer Video

Play Episode Listen Later Jan 26, 2016 2:53


Dr. Edward S. Kim from the Levine Cancer Institute in Charlotte, NC defines the concept of cancer histology and gives examples of several lung cancer subtypes.

GRACEcast
Different Lung Cancer Subtypes - Histology

GRACEcast

Play Episode Listen Later Jan 26, 2016 2:53


Dr. Edward S. Kim from the Levine Cancer Institute in Charlotte, NC defines the concept of cancer histology and gives examples of several lung cancer subtypes.

GRACEcast ALL Subjects audio and video
Different Lung Cancer Subtypes - Histology

GRACEcast ALL Subjects audio and video

Play Episode Listen Later Jan 26, 2016 2:53


Dr. Edward S. Kim from the Levine Cancer Institute in Charlotte, NC defines the concept of cancer histology and gives examples of several lung cancer subtypes.

GRACEcast ALL Subjects audio and video
Blood-Based Mutation Testing: Circulating Tumor Cells and Tumor DNA

GRACEcast ALL Subjects audio and video

Play Episode Listen Later Jan 19, 2016 2:49


Dr. Ed Kim from the Levine Cancer Institute reviews the potential advantages and current limitations of blood-based testing for molecular markers using circulating tumor cells and circulating tumor DNA in identifying clinically important mutations.

GRACEcast
Blood-Based Mutation Testing: Circulating Tumor Cells and Tumor DNA

GRACEcast

Play Episode Listen Later Jan 19, 2016 2:49


Dr. Ed Kim from the Levine Cancer Institute reviews the potential advantages and current limitations of blood-based testing for molecular markers using circulating tumor cells and circulating tumor DNA in identifying clinically important mutations.

GRACEcast Lung Cancer Video
Blood-Based Mutation Testing: Circulating Tumor Cells and Tumor DNA

GRACEcast Lung Cancer Video

Play Episode Listen Later Jan 19, 2016 2:49


Dr. Ed Kim from the Levine Cancer Institute reviews the potential advantages and current limitations of blood-based testing for molecular markers using circulating tumor cells and circulating tumor DNA in identifying clinically important mutations.

GRACEcast ALL Subjects audio and video
What Is Next-Gen Sequencing?

GRACEcast ALL Subjects audio and video

Play Episode Listen Later Jan 18, 2016 4:13


Dr. Ed Kim from the Levine Cancer Institute in Charlotte, NC summarizes the mechanism of next generation sequencing (NGS), how it can potentially be used, and its limitations in clinical practice today.

GRACEcast
What Is Next-Gen Sequencing?

GRACEcast

Play Episode Listen Later Jan 18, 2016 4:13


Dr. Ed Kim from the Levine Cancer Institute in Charlotte, NC summarizes the mechanism of next generation sequencing (NGS), how it can potentially be used, and its limitations in clinical practice today.

GRACEcast Lung Cancer Video
What Is Next-Gen Sequencing?

GRACEcast Lung Cancer Video

Play Episode Listen Later Jan 18, 2016 4:13


Dr. Ed Kim from the Levine Cancer Institute in Charlotte, NC summarizes the mechanism of next generation sequencing (NGS), how it can potentially be used, and its limitations in clinical practice today.

Joni Aldrich SOS: Supporter of Survival
CancerSOS: Multiple Myeloma Expert Care

Joni Aldrich SOS: Supporter of Survival

Play Episode Listen Later Mar 18, 2015 51:01


Catching up on the latest research and advances in Multiple Myeloma, the cancer that took my husband's life. It isn't often that I get to do that firsthand with one of amazing oncologists that was part of the effort to save Gordon's life, especially one that now practices in my home state of North Carolina. Multiple Myeloma is a difficult cancer to treat, so specialists such as Dr. Saad Z. Usmani, Levine Cancer Institute, Charlotte, N.C., are very important to survival of patients. Listen live M-T 2:00 pm ET www.W4CS.com, Joni at www.JoniAldrich.com

Myeloma Crowd Radio
HealthTree Podcast for Myeloma: Dr. Saad Usmani, MD, Levine Cancer Institute

Myeloma Crowd Radio

Play Episode Listen Later Jun 27, 2014 78:00


Join us as we talk with Dr. Saad Usmani, MD about his new position as Director of Clinical Research for Hematologic Malignancies and Director of Plasma Cell Disorders at the Levine Cancer Institute and his clinical trials for high-risk myeloma patients. Dr. Usmani was formerly at UAMS. 

Myeloma Crowd Radio
mPatient Myeloma Radio: Dr. Saad Usmani, MD, Levine Cancer Institute

Myeloma Crowd Radio

Play Episode Listen Later Jun 27, 2014 78:00


Join us as we talk with Dr. Saad Usmani, MD about his new position as Director of Clinical Research for Hematologic Malignancies and Director of Plasma Cell Disorders at the Levine Cancer Institute and his clinical trials for high-risk myeloma patients. Dr. Usmani was formerly at UAMS. 

Frankly Speaking About Cancer with the Cancer Support Community

“I won't let a brain tumor defeat me or the people I love. It's a scary diagnosis but now I know the facts.” This is a quote from Frankly Speaking About Cancer: Brain Tumors. Currently there are more than 688,000 people living with a brain or central nervous system tumor in the United States, and this year alone an estimated 23,380 adults will be diagnosed with a primary, cancerous brain tumor according to the American Society of Clinical Oncology. To help us learn more about brain tumors this Brain Tumor Awareness Month, the show is joined by Deanna Glass Macenka, Program Coordinator the Neurosurgical Oncology Program at Johns Hopkins Hospital, and Dr. Ashley Love Sumrall, Neuro-Oncologist at the Levine Cancer Institute.