Podcasts about Duke Cancer Institute

Dr Leonard G Gomella from the Sidney Kimmel Cancer Center in Philadelphia, Pennsylvania, Dr Evan Y Yu from the Fred Hutchinson Cancer Center in Seattle, Washington, and Dr Daniel George from Duke Cancer Institute in Durham, North Carolina, discuss important clinical datasets and patient cases relevant to AKT inhibition in the care of patients with prostate cancer. CME information and select publications here.

This week on The Beat, CTSNet Editor-in-Chief Joel Dunning speaks with Tom D'Amico, professor and vice chairman of surgery and chief medical officer of the Duke Cancer Institute, about oligometastatic disease. They discuss the current updates of oligometastatic disease, The Society of Thoracic Surgeons (STS) guidelines on the surgical management of oligometastatic non-small cell lung cancer, and the importance of choosing the right patient. They also explore where the new boundaries of this procedure are, radiation therapy, and shared decision-making. Joel also highlights a surgical robot (spaceMIRA) at the International Space Station that completed its first surgery demo in zero gravity, the state of lung transplants in the United Kingdom, and the Priority Setting Partnership (PSP).   Joel also reviews recent JANS articles on perioperative extra corporeal membrane oxygenation in neonates with transposition of the great arteries, a randomized controlled trial on the effects of postoperative glucocorticoids on mitigation of organ dysfunction in patients with Type A aortic dissection, if socioeconomic factors impair uptake of neoadjuvant therapy for patients with locoregional esophageal cancer, and a nationwide analysis on malperfusion in patients with acute Type A aortic dissection.  In addition, Joel explores a case report on a chest injury with an arrow penetrating the right lung with rent in the right atrium, an interview with Marko Turina, and an Onyx mechanical mitral valve replacement after previous mitral repair. Before closing, he highlights upcoming events in CT surgery.   JANS Items Mentioned  1.) Perioperative Extra Corporeal Membrane Oxygenation in Neonates With Transposition of the Great Arteries: 15 Years of Experience  2.) Effects of Postoperative Glucocorticoids on Mitigation of Organ Dysfunction in Patients With Type A Aortic Dissection: A Randomized Controlled Trial  3.) Do Socioeconomic Factors Impair Uptake of Neoadjuvant Therapy for Patients With Locoregional Oesophageal Cancer?  4.) Malperfusion in Patients with Acute Type A Aortic Dissection: A Nationwide Analysis  CTSNET Content Mentioned  1.) Injury to the Chest With an Arrow Penetrating the Right Lung With Rent in the Right Atrium: A Case Report  2.) Giants in CT Surgery: An Interview With Marko Turina  3.) Redo Mitral Surgery: Onyx Mechanical Mitral Valve Replacement After Previous Mitral Repair   Other Items Mentioned  1.) The Society of Thoracic Surgeons (STS) Clinical Practice Guideline on Surgical Management of Oligometastatic Non-small Cell Lung Cancer  2.) Surgery in Space: Tiny Remotely Operated Robot Completes First Simulated Procedure at the Space Station  3.) Career Center   4.) CTSNet Events Calendar  Disclaimer The information and views presented on CTSNet.org represent the views of the authors and contributors of the material and not of CTSNet. Please review our full disclaimer page here.

Raising awareness about sarcoma is essential to reducing treatment delays and preventing misdiagnoses of this rare cancer with over 100 subtypes. The Association of Cancer Care Centers (ACCC) is dedicated to providing up-to-date information on sarcoma management and the unique challenges associated with diagnosis and treatment in community settings. In this episode, CANCER BUZZ speaks with Richard Riedel, MD, professor of medicine at Duke Cancer Institute, to explore the critical resources needed for sarcoma care, including psychosocial support and the financial difficulties often faced by patients. Dr Riedel also discusses the future of treatment options in community-based settings and the importance of collaboration between community providers and academic/specialty centers. Additionally, CANCER BUZZ speaks with Katie Wintergerst, a sarcoma patient, who shares her personal journey and the challenges she encountered on her path to diagnosis.   “It's critically important to partner with centers with disease-specific expertise, academic centers, for example, that are well-positioned to partner with community-based providers in providing optimal care for patients.” – Richard Riedel, MD   “What I've had to become comfortable with ... is that clinical trials can be tricky and they can be scary, but in the world of sarcoma, there haven't been a lot of new products FDA-approved for treatment. Clinical trials is where the work is going on.” -Katie Wintergerst   Richard Riedel, MD Professor of Medicine Duke Cancer Institute Durham, NC   Katie Wintergerst Sarcoma Patient   Resources: ACCC Sarcoma Resources for Providers and Patients SFA Clinical Trials Resource Center Sarcoma Treatment Centers

In today's episode, supported by Revolution Medicines, we had the pleasure of speaking with John Strickler, MD, about key considerations for pancreatic cancer management in honor of Pancreatic Cancer Awareness Month, which is observed every November. Dr Strickler is a professor of medicine in the Division of Medical Oncology, associate director of Clinical Research – GI Oncology, and co-leader for the Precision Cancer Medicine and Investigational Therapeutics Program at the Duke Cancer Institute in Durham, North Carolina.  In our exclusive interview, Dr Strickler discussed the challenges of targeting RAS alterations in pancreatic cancer, the importance of biomarker testing in this disease, and efforts to improve pancreatic cancer screening methodologies and rates.

Dr Angeles Alvarez Secord from the Duke Cancer Institute in Durham, North Carolina, provides her perspectives on recent datasets from ASCO 2024 on the management of ovarian and endometrial cancers.

Dr Angeles Alvarez Secord from the Duke Cancer Institute in Durham, North Carolina, provides her perspectives on recent datasets from ASCO 2024 on the management of ovarian and endometrial cancers, moderated by Dr Neil Love. Produced by Research To Practice. CME information and select publications here (https://www.researchtopractice.com/OncologyTodayASCOOvarianEndo24).

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.

Maintenance therapy for patients with acute myeloid leukemia, particularly those who are ineligible for transplant, can be critical to treatment outcomes and quality of life for patients. In this episode, CANCER BUZZ speaks with Thomas LeBlanc, MD, hematologic oncologist, associate professor of Medicine, and associate professor in Population Health Sciences at Duke Cancer Institute, about the importance of keeping patients with acute myeloid leukemia in first remission as long as possible through maintenance therapy.   “You have to be aware of the benefits of maintenance therapy…and for patients who are being considered for transplant but who do not end up getting a transplant, it should really be the default option that those patients receive a maintenance therapy.” –Thomas W. LeBlanc, MD   Guest:         Thomas W. LeBlanc, MD Hematologic Oncologist, Associate Professor of Medicine, Associate Professor in Population Health Sciences Duke Cancer Network, Duke Cancer Institute Durham, North Carolina   This is the fourth and final episode of a four-part series developed in connection with the ACCC education program Achieving and Maintaining Better Outcomes for Patients with Acute Myeloid Leukemia. This episode was made possible with support by Bristol Myers-Squibb.   Additional Reading/Sources Improving Care Delivery for Transplant-Ineligible Patients with AML AML Care Coordination in the Community Setting [Video Podcast] Critical Conversation Strategies for Patients with AML [Video Podcast] Strategies to Addressing Disparities in Patients with AML [Video Podcast] Shared Decision-making in Acute Myeloid Leukemia Achieving and Maintaining Better Outcomes for Patients with AML Talking about Acute Myeloid Leukemia (Cancer Support Community) Shared Decision-making: Practical Implementation for the Oncology Team (ACCC)

BUFFALO, NY- October 4, 2023 – A new review paper was published in Oncotarget's Volume 14 on September 28, 2023, entitled, “UDP-glucose dehydrogenase (UGDH) in clinical oncology and cancer biology.” UDP-glucose-6-dehydrogenase (UGDH) is a cytosolic, hexameric enzyme that converts UDP-glucose to UDP-glucuronic acid (UDP-GlcUA), a key reaction in hormone and xenobiotic metabolism and in the production of extracellular matrix precursors. In this review, researchers Meghan J. Price, Annee D. Nguyen, Jovita K. Byemerwa, Jasmine Flowers, César D. Baëta, and C. Rory Goodwin from Johns Hopkins Hospital, Duke University, Stanford University, Duke Center for Brain and Spine Metastasis, and Duke Cancer Institute classify UGDH as a molecular indicator of tumor progression in multiple cancer types, describe its involvement in key canonical cancer signaling pathways, and identify methods to inhibit UGDH, its substrates, and its downstream products. “As such, we position UGDH as an enzyme to be exploited as a potential prognostication marker in oncology and a therapeutic target in cancer biology.” DOI - https://doi.org/10.18632/oncotarget.28514 Correspondence to - C. Rory Goodwin - rory.goodwin@duke.edu Sign up for free Altmetric alerts about this article - https://oncotarget.altmetric.com/details/email_updates?id=10.18632%2Foncotarget.28514 Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ Keywords - cancer, UDP-6 glucose dehydrogenase, UGDH, oncology, cancer biology About Oncotarget Oncotarget (a primarily oncology-focused, peer-reviewed, open access journal) aims to maximize research impact through insightful peer-review; eliminate borders between specialties by linking different fields of oncology, cancer research and biomedical sciences; and foster application of basic and clinical science. To learn more about Oncotarget, please visit https://www.oncotarget.com and connect with us: SoundCloud - https://soundcloud.com/oncotarget Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Media Contact MEDIA@IMPACTJOURNALS.COM 18009220957

Dr Richard F Riedel from Duke Cancer Institute in Durham, North Carolina, discusses approved and novel treatment approaches for soft tissue sarcoma, moderated by Dr Neil Love.

Dr Richard F Riedel from Duke Cancer Institute in Durham, North Carolina, discusses approved and novel treatment approaches for soft tissue sarcoma, moderated by Dr Neil Love.

Dr Richard F Riedel from Duke Cancer Institute in Durham, North Carolina, discusses approved and novel treatment approaches for soft tissue sarcoma, moderated by Dr Neil Love.

Dr Richard F Riedel from Duke Cancer Institute in Durham, North Carolina, discusses approved and novel treatment approaches for soft tissue sarcoma, moderated by Dr Neil Love.

Dr Richard F Riedel from Duke Cancer Institute in Durham, North Carolina, discusses approved and novel treatment approaches for soft tissue sarcoma, moderated by Dr Neil Love.

Dr Richard F Riedel from Duke Cancer Institute in Durham, North Carolina, discusses approved and novel treatment approaches for soft tissue sarcoma, moderated by Dr Neil Love. CME information and select publications here (http://www.ResearchToPractice.com/MTPSarcoma23/Part2).

Dr Carlos de Castro from Duke Cancer Institute in Durham, North Carolina discusses the presentation, diagnosis and management of paroxysmal nocturnal hemoglobinuria. CME information and select publications here (https://www.researchtopractice.com/OncologyTodayPNH23)

This week, Dr. Daniel Correa sits down with Dr. Katy Peters, a neuro-oncologist and associate professor and director of supportive care at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at the Duke Cancer Institute. Drs. Correa and Peters talk about neurologic conditions and how they are depicted on TV as well as the importance of speaking with your doctor when you have questions about how certain medical conditions and brain marvels are portrayed in your favorite shows.  Additional Resources  Brain & Life Podcast: Timothy Omundson on Stroke Recovery and His Return to Television   Learn more about stroke  Learn more about brain tumor  Learn more about multiple sclerosis (MS)  Brain & Life: 14 Ways to Get Motivated to Exercise  Brain & Life: How Does Nature Affect Brain Health?    We want to hear from you!  Have a question or want to hear a topic featured on the Brain & Life Podcast?  Record a voicemail at 612-928-6206  Email us at BLpodcast@brainandlife.org  Social Media:    Guest: Dr. Katy Peters @KatyPetersMDPhD (Twitter)  Host: Dr. Daniel Correa @neurodrcorrea 

JCO PO authors Dr. Michael J. Kelley and Dr. Katherine I. Zhou share insights into their JCO PO article, “Real-world Experience With Neurotrophic Tyrosine Receptor Kinase Fusion–positive Tumors and Tropomyosin Receptor Kinase Inhibitors in Veterans.” Host Dr. Rafeh Naqash, Dr. Kelley, and Dr. Zhou discuss the robust Veterans Affairs (VA) National Precision Oncology Program (NPOP), accurate identification of gene fusions, and toxicities landscape of TRK inhibitors. Click here to read the article! TRANSCRIPT Dr. 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. Rafeh Naqash, Social Media Editor for JCO Precision Oncology, and assistant professor at the OU Stephenson Cancer Center in the Division of Medical Oncology.   Today, I'm thrilled to be joined by Dr. Michael J. Kelley. Dr. Kelley is the executive director of Oncology for the Department of Veterans Affairs. He's also the chief of Hematology-Oncology at the Durham VA Medical Center, and also a Professor of Medicine at the Duke University School of Medicine. And he's also a member of the Duke Cancer Institute. We are also joined by Dr. Katherine I. Zhou who is a Hematology-Oncology fellow at the Duke University. Dr. Zhou also spent time at the Duke Medical Center as part of her fellowship training, which I believe is how this project that was led by her came to fruition.  So thank you both for joining today. This is going to be, hopefully, of very high interest to our listeners and I look forward to chatting with you both. Dr. Michael Kelley: Great, thanks for having us. Dr. Katherine Zhou: Thank you for having us. Dr. Rafeh Naqash: Thank you so much for joining. So I was very intrigued with this paper, and this paper follows a recent podcast that we had with Dr. Alexander Drilon, who's led some of the NTRK tropomyosin receptor kinase inhibitor studies that have been published in the last several years. And we had a very interesting discussion a couple of weeks back and I felt this was going to be a very interesting subsequent discussion into what was also an interesting discussion with Dr. Drilon. So what caught my attention is obviously the fact that you guys in this report, which is a real-world report, did not exactly see what we generally expect from clinical trials as far as response to target therapies in NTRK fusions.  So before I ask you questions related to this project, one of the very interesting things at least I found was the fact is that the Veterans Health Administration is the largest integrated health system. Studies, whether conducted in the UK, for that matter European countries, or in Canada, they have integrated health systems which we do not. But we do have this advantage of the VA trying to do things in a very unique, centralized manner. So I wanted to ask Dr. Kelley first, how is it that you have implemented this National Precision Oncology Program, the NPOP as you call it, into the VA precision medicine workflow and how does it help in conducting research studies like the one that you published in the JCO Precision Oncology? Dr. Michael Kelley: Yeah, thanks for that question, Dr. Naqash. The NPOP started in 2016 as a national program and right from the beginning it grew out of an effort that was a joint collaboration between both clinical operations in the VA and the Research Office or the Office of Research and Development. It was designed from the very beginning to support discovery, new knowledge generation, and identifying patients for clinical trials in addition to bringing them best-in-class molecular testing and a consultation service.  So it was initially funded out of the Cancer Moonshot 1 in 2016 when President Biden was then Vice President. The VA endorsed the model going forward in 2019 and now it's continued on and grown even bigger, it's expanded both in terms of scope and the complexity of the testing that's been done. So it was offered as services to facilities. They didn't have to do this, but I think they all saw the value of using NPOP to provide this group of services and that's what led to the generation of the robust underlying dataset that Dr. Zhou has used for this paper. Dr. Rafeh Naqash: Definitely. Thank you so much for that explanation. I did not know, and was not well aware, of how robust this program is. So I think it's a great learning opportunity for our listeners to know that a program like this exists. As we all know, there are different platforms, sequencing platforms, that each institution uses, whether it's commercial or whether it's in-house based. But the fact is, until and unless we have big pool datasets like the ones that you have generated or have access to, it's not easy to answer real-world questions.  So first of all, I'd like to congratulate you and the rest of the VA administration to set up a program like this that hopefully is helping in matching the right patients to the right therapies and in clinical trial approvals. Now, before we take a deeper dive into the study that Dr. Zhou led, I did want to ask you, you have access to this amazing centralized platform, what are the kind of sequencing strategies or platforms that you use as part of this program? And is there an incorporation of molecular tumor boards to help understand some of these sequencing results that sometimes can be a little complicated to understand even for oncologists who look at these reports on a daily basis? So could you tell us a little bit more about that, Dr. Kelley? Dr. Michael Kelley: Yeah, certainly. So the VA contracts for the sequencing service, currently we're contracting with Foundation Medicine and Tempus for the comprehensive genomic profiling. There are some other services, and before we started using Foundation, there were two other companies that we used. There is a molecular tumor board. Our molecular oncology tumor board is designed primarily for case-based education. But there's also an asynchronous on-demand consultation service that occurs electronically because we have a unified electronic health record system. So any oncology provider in the country can enter a request through what's called an interfacility consult. It comes to a team, that team vets that, discusses it with the appropriate experts; that includes molecular oncologists, molecular pathologists. A lot of oncology pharmacists have been trained at a course that's at the University of Kentucky.  And we have a lot of experience in doing this since that service was set up in 2016 as well, right from the beginning, because we understood the complexity of the data and the need for every oncologist across our enterprise to have access to the very best interpretation of that.  We also have educational sessions that are integrated into the molecular tumor board time slot we call primers in terms of the underlying science of why you do the interpretations the way you do. And then there's also some additional education that we'll be endeavoring to offer to our staff and our oncologists coming up this year. Dr. Rafeh Naqash: Excellent. It sounds like you definitely have taken this into a very multidisciplinary approach where you're incorporating oncologists, pharmacists, and perhaps even genetic counselors and then, obviously, keeping the patient at the center and trying to find the best possible therapies that are most relevant for that individual.   Now, going to Dr. Zhou's study here. Dr. Zhou, first of all, it's great to see a fellow lead a study and then especially, I think you're our first fellow on the podcast. We've had a lot of different individuals, but we have not had a fellow before. So thanks for coming.  Could you tell us, for our listeners, what drove your interest into NTRK fusions? As we know, they are rare, something that is not commonly seen, and we do have clinical trial data in this space. So what was the idea behind looking at a real-world data set? Did you start out with a hypothesis or were you just interested to see how targeting these fusions in the real-world setting, actually, what kind of results does it lead to? Dr. Katherine Zhou: Yeah, well, first of all, thanks for the question. And I do just want to mention that although I did sort of bring this project to the finish line, it was started by another fellow, Vishal Vashistha. So just wanted to mention that. And I think the interest was really just that NTRK is such a rare fusion and just a difficult one to be able to study, like you said, in the real-world setting. And we have the advantage of having so much data through the VA and through NPOP, specifically. And so having seen such great results with the TRK inhibitors and clinical trials, I think there's this big question of how that translates into the real-world setting. We have the ability to do that with our large patient population. Dr. Rafeh Naqash: Excellent. And again, it's nice to acknowledge the support that you had from the other individual who co-led this study. Now, since you would have, I'm guessing, done most of the analysis here and looked into the whole idea of the kind of results that you saw—and from my understanding, you looked at the entire VA data set and tried to understand first the incidence or frequency of NTRK fusions and also responses to treatment, which I think is the main message—but could you tell us a little bit more about the data set? How did you acquire the data set, and what it took to analyze? Because obviously every project has a very unique story, and I'm guessing there's one very unique story here, since as a fellow you have limited time to do all this interesting work. So how did you navigate that and analyze and work with some of the things that you had to look at to get to the results? Dr. Katherine Zhou: Yeah, so again, this was work that was done with multiple people involved, of course. And we used what we had, the resources we had available, some tools we had available through the VA. So first, looking at NPOP and looking at patients who are sequenced through NPOP, we could just find all the ones who had an NTRK rearrangement of some kind. The second way we went about finding patients was through the CDW or the Corporate Data Warehouse where we could see which patients were prescribed larotrectinib or entrectinib and kind of go backwards from there and see which of those patients had NTRK alterations or specifically NTRK rearrangements. And so we combined the patients from both of those different methods to come up with our cohort at the end of 33 patients with NTRK rearrangements and 12 patients who are treated with TRK inhibitors. Dr. Rafeh Naqash: Excellent. Could you walk us through what was the subsequent analysis as far as how many NTRK fusions? I know you mentioned in the paper about DNA versus RNA-based testing. So how many were DNA-based, how many were RNA-based? I think there's some element of ctDNA-based testing also, or what tumor types those people had so that we get an understanding of what's the landscape of the findings that you had. Dr. Katherine Zhou: Sure. Since this is a real-world setting, as you may expect, the vast majority of the sequencing was done through tissue DNA sequencing, and that was the case. So for the 25 patients who were sequenced through NPOP that we found who had NTRK rearrangements, 23 of them had tissue DNA sequencing. And then one was tissue DNA RNA, and one was cell-free DNA sequencing. And so using that and being able to go back and look at how many patients have been sequenced in NPOP in total, we could kind of come up with a yield, although the numbers are very small. But we do see that there does seem to be probably a lower yield, for example, with cell-free DNA sequencing, as one might expect.  And then looking at our total group of 33 patients, if we look at what types of cancers they had, we did have quite a few patients just based on prevalent tumors at the VA, I think, and in the population, prostate cancer was common, lung cancer, and then we had smaller numbers of colon and bladder, and I think there's a pancreatic cancer patient. We did have some of these rarer tumor types that more commonly have NTRK fusions as well, so like papillary thyroid carcinoma, and salivary gland cancers as well as soft tissue sarcomas. Dr. Rafeh Naqash: Question for you, Dr. Kelley, related to this data set: do you think that given that the denominator that you have is a unique population, the VA population, that's often males, they're usually above the age of 18, could the frequency have been influenced by that denominator where you may not have been able to capture, let's say, some of the rarer tumors that happen in the younger patient population, for that matter? Could that be a little bit of a bias here?  Dr. Michael Kelley: Definitely. The population of veterans that have cancer that is treated in the Veterans Health Administration do represent generally adult males in the United States, but there is some skewing in certain regards. One of them is towards a higher frequency of smoking status. So not current smoking, which is actually about the same as the national average of about 11%, but the former smoking rate is about twice as high as it is in the rest of the United States. So we may have a lower frequency of some actionable variants in cancers in general because there's a higher etiological role for tobacco smoke in our population. But overall, looking at adult men if we look at like EGFR mutations, our incidence of EGFR mutations in adenocarcinoma is similar to what is reported in other real-world evidence bases from the United States, which is significantly lower than that which is found in academic medical centers. Dr. Rafeh Naqash: Thank you. I'm a big fan personally of real-world data sets. I do a lot of this with some other collaborators and generally, I do phase I trials, which is why I'm interested in precision medicine. And two weeks back, actually, I had a patient with prostate cancer, who ended up having NTRK fusion on a liquid biopsy. Now, you do talk about some of this related to in-frame or out-of-frame fusions and how that can have interesting aspects related to the kinase domain functionality and RNA expression. Dr. Zhou, for the sake of our listeners, could you briefly describe why understanding some of that is important and what implications it has? Dr. Katherine Zhou: Yeah, so I think the oncogenic NTRK fusion that we think of and that's being targeted by the TRK inhibitors is a fusion 5-prime of a protein that forms a dimer and on the 3-prime end is the kinase domain of the tropomyosin receptor kinase. And so you have to have some kind of a gene fusion that results in not only the transcription of that RNA fusion, RNA transcript, but then the translation of that fusion protein. So that needs to be, like you mentioned, that has to be in frame so that the entire protein is translated and expressed and it needs to include the kinase domain. It can't be the other end of the NTRK gene. And both of the genes need to be in the same orientation, of course. And then also the partner gene probably matters in that the ones that we know that actually cause activation of this oncogene are the ones that sort of spontaneously dimerize. And so that's a lot of requirements that we don't necessarily see when we just get, for example, a DNA sequencing result that says there's an NTRK rearrangement. Dr. Rafeh Naqash: Excellent way to describe the importance of understanding the functionality of the activated oncogenic fusion. Now, I know here in most of the patients that you have is DNA sequencing and I'm sure you'll talk about some of the results. And when you connect the results to the kind of data that you have, do you think not having the RNA assessment played a role in not knowing perhaps whether those fusions were functionally active?  Dr. Katherine Zhou: Yes, I think we can't know for sure without having the RNA sequencing data. But certainly, that is a pattern in our small number of patients that we saw and something that makes sense just in terms of the mechanism of this oncogenic fusion protein. So I think that is a question of when should we be doing RNA sequencing to confirm that a fusion that we see on DNA sequencing is actually transcribed into RNA and how do we use RNA sequencing in a cost-effective and useful way to be able to detect more of these NTRK fusions that are actually clinically relevant. Dr. Rafeh Naqash: I absolutely agree with you and this is an ongoing debate. I know some platforms, commercial platforms that is, have incorporated RNA sequencing both bulk or whole transcriptome as part of their platform assessments, but it's still not made inroads into some other sequencing platforms that are commercially used. So it's an ongoing debate, but at the same time helping people understand that certain fusions need some level of RNA assessments to understand whether they're functionally active or not. Which again has implications, as you pointed out in terms of therapies are extremely relevant.   Now, going to the results, which again was very interesting, could you tell us about the findings from the therapeutic standpoint that you observed and what your thoughts are about why you saw those results which were very different from what one would have expected?  Dr. Katherine Zhou: Right. So in the clinical trials of larotrectinib and entrectinib, there were quite high objective response rates on the order of 60%, 70%, even almost 80%. In our very small real-world group of 12 patients who were treated with TRK inhibitors, nobody had an objective response and five patients had stable disease and everybody else, the other seven patients, progressed.  And so the question is why did we see such a big difference compared to the trials? I sort of think of this as two big buckets. One is the population that we were looking at. So this is a real-world population. For example, in the clinical trials, there were almost no Black or African American patients, whereas here we had about 30%-40% Black or African American patients.  Because it's a VA population, it was very heavily male, of course, the age groups are also different in that we didn't have children in the VA population whereas children were included in the trials. And the tumor types also differed because I think in the trials, which makes sense, there's a bias towards tumor types that have more NTRK fusions, and some of the tumor types we were looking at are just common tumor types like prostate and lung cancer where NTRK fusions are not common. But just because there are so many patients with these cancers, we did see them. And so certain of these groups, particularly certain racial and ethnic groups as well as certain tumor types, were not really represented in the trial to the extent that we can make conclusions about whether TRK inhibitors are effective in this population. So that's one.  The second part, I think we've already talked about some, is just the method of detecting these NTRK fusions and how many of these NTRK fusions were actually truly producing oncogenic fusion proteins. And I tried to sort of categorize some of these fusions as being canonical in that they've been more studied. We know the partner gene, they are known to produce an oncogenic protein and to respond to TRK inhibitors. But actually of the four patients who had what we called canonical fusions, all four of them had stable disease at least, whereas the ones that were noncanonical mostly did not have a response or have even stable disease and mostly just progressed. And so then you wonder whether they even had the actual target protein we thought we were targeting. So this is where the real-world setting we're not doing the RNA sequencing or this additional testing to confirm that it's an oncogenic fusion protein. Dr. Rafeh Naqash: And I do see in your results there's a patient especially—you pointed out canonical and noncanonical fusions—you have a patient with a papillary thyroid cancer that I believe had a stable disease for close to two years plus. Is there anything interesting apart from an NTRK fusion in that specific patient where certain co-mutation could have played a role or certain other factors that do you think played into the fact that this patient had stable disease but didn't respond on the TRK inhibitor? Dr. Katherine Zhou: I don't have a great answer for that. I think this is one of the cancers that was well represented in the trials and that commonly has NTRK, or more likely has NTRK fusions. And this was a well-studied canonical NTRK fusion. So I think those are all reasons. The question of co-mutations I think is really interesting. We didn't have the data for every single patient, but for the ones we looked at a lot of the time, NTRK fusions are mutually exclusive with other driver mutations. So we didn't see a whole lot of commutations that we could sort of differentiate between responders or stable disease and progression.  Dr. Rafeh Naqash: Thank you. Going to the toxicities, as a phase I trialist myself toxicity is the bane of my existence where we have to label toxicities, attribute toxicities, understand toxicities. The trial, obviously, as you very well know, that in the trials, they didn't have a lot of toxicities that caused patients to come off or required significant dose reductions, which is not the case compared to what you saw. Could you tell us a little bit about the landscape of toxicities for TRK inhibitors and what you saw in your cohort? That, again, I feel was interesting.  Dr. Katherine Zhou: Of the 12 patients, I think two-thirds of them had either dose reduction or interruption or discontinuation, or some combination of the above. The toxicities we saw were more common than, or at least led to discontinuation and interruption and dose reduction more commonly than in the trials. But the toxicities we saw were also seen in the clinical trials. So LFT elevations, creatinine elevations, neurotoxicity, some cytopenias. We didn't actually see a whole lot of that, but those were present as well, and then some sort of nonspecific things like fatigue. And so, as much as we could tell from retrospective trial review, at least these were severe enough to lead to holding the drug. Dr. Rafeh Naqash: Thank you so much, Dr. Zhou. Question for you, Dr. Kelley. Putting this into perspective, the analysis that you did, how would you connect it to other real-world questions that one could answer using these kinds of data sets? So basically, what are the lessons learned from this amazing program that you guys have run successfully and are, I'm guessing, expanding in different directions? And how can you use a program like this to look at some of these unique questions using real-world data sets? Dr. Michael Kelley: There are a couple of, I guess, next steps for us that are based off this study and other information that we've gotten in other analyses from our NPOP data set. So, first of all, access to an RNA-Seq test. So that has been resolved to some extent, in that we now have two options for comprehensive genomic profiling, one of which does have RNA-Seq.  And then the other approach that we're doing is to do more robust data generation. So we're going to be launching a study to collect prospective data on patients who are treated with off-label drugs. And as part of that, we will also have an on-label cohort for rare populations or any investigator in the VA who's interested in a particular drug or a particular genetic variant. They'll be able to tie into this protocol, and we will then collect data from across the system prospectively, which we think will improve the quality to some degree.  And then thirdly, I think there's an opportunity to merge the initial generation of data in rare genetic types or other populations, which are highly selected by doing a distributed type of clinical trial where patients can be enrolled in prospective treatment trials. So we're not just generating data based on their real-world exposure to FDA-approved drugs, but we're generating data as we're developing the new drugs, we can have a much more heterogeneous and representative population of patients enrolled in clinical trials. So this is called the decentralized clinical trial model. We're starting to launch some trials with industry partners in this area to test out the model. If it works, I think we'll be able to help contribute to the knowledge that we all can use in terms of the patient types, the patient characteristics, but also some of the different tumor characteristics, and also to bring clinical trial opportunities to a more representative group. A lot of the initial clinical trials are done in urban areas, rural populations in VA are about a third of our patients live in rural areas, compared to only 14% of the country. So we think this is a very important diversity issue that should be addressed. Those are some of the ways that we're taking a lesson from this trial and other data that we have to sort of bring it forward. Dr. Rafeh Naqash: Those are excellent next steps and I think the kind of work that the VA is doing and this specific program, Precision Oncology Program, the NPOP program is doing, it's definitely setting up a unique standard in the United States where we have been limited by not having a centralized database. So setting something up of this sort hopefully will help answer a lot of these unique, interesting questions as you have access to data. And then the fact that you mentioned decentralized clinical trials and trying to cater to this access issue for patients in the VA system, I think that would be huge.  And again, I congratulate you and your team on these efforts, and once again, thank you for joining us today and making JCO Precision Oncology a destination for your interesting work. We hope to see more of this work subsequently and hopefully, I get a chance to talk to you more about all the exciting stuff that you guys are leading within the VA health system.  Thank you for listening to JCO Precision Oncology Conversations. Don't forget to give us a rating or review and be sure to subscribe so you never miss an episode. You can find all ASCO shows at asco.org/podcast.  The purpose of this podcast is to educate and 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. Bios: Michael J. Kelley, MD, is Executive Director of Oncology for the Department of Veterans Affairs, Chief of Hematology-Oncology, Durham VA Medical Center, Professor of Medicine at Duke University School of Medicine and Member of the Duke Cancer Institute. Katherine I. Zhou, MD, PhD is a hematology-oncology fellow at Duke University. She also spends time at the Durham VA Medical Center as part of her fellowship training. COIs: Michael J. Kelley, MD Research Funding: Novartis (Inst), Bristol-Myers Squibb (Inst), Regeneron (Inst), Genentech (Inst), EQRx (Inst) Katherine I. Zhou, MD, PhD: No disclosures  

“The bell can have so much more meaning and significance than just the end of treatment. So, work with your patients to define what the significance of that bell can mean,” ONS member Monica Cfarku, RN, MSN, BMTCN®, CCM, NE-BC, associate vice president and chief of oncology nursing at Duke Cancer Institute in Durham, NC, and member of the North Carolina Triangle ONS Chapter, told Jaime Weimer, MSN, RN, AGCNS-BC, AOCNS®, oncology clinical specialist at ONS. Cfarku discussed the ethics of the bell that patients with cancer ring following the completion of their treatment and how her institution has redefined the bell's ritual. You can earn free NCPD contact hours by completing the evaluation we've linked in the episode notes. 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 April 28, 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 treatment bell meaning and options. Episode Notes Complete this evaluation for free NCPD. Oncology Nursing Podcast Episode 78: Ethical Distress Impacts Nursing Practice ONS Voice articles: Four R's and Resilience Approach Help Oncology Nurses Respond to Morally Distressing Challenges Redefining the Bell Makes the Ritual Inclusive for All Patients With Cancer Use the Evidence to Integrate Ethics in Teleoncology Care How to Have Ethical Discussions in Your Practice ONS Moral Resilience Huddle Card™ MD Anderson Cancer Center: Ringing the Bell Marks a Milestone in Cancer Treatment Duke Cancer Institute To discuss the information in this episode with other oncology nurses, visit the ONS Communities. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From Today's Episode “The bell has typically been associated with completion of treatment, and the patient is now considered free of cancer. The challenge with that is when patients that will never get to experience that—because there are certain cancers now that are essentially chronic conditions—they hear that bell and that is not a good sound for them. That can bring a lot of emotions around how they're never going to get to that point.” Timestamp (TS) 02:19 “As nurses, it is our duty to recognize an ethical situation and help to determine what that next action or decision is in those situations. We really need to be applying our ethical sensitivity.” TS 04:06 “The bell doesn't just have to be for the end of treatment. It can be the end of a particular journey, or ringing the bell for courage before you walk in. It can be used for anything.” TS 13:14 “I've seen patients ring the bell before walking into the building. . . . I've been asked to meet patients at the bell on their last day of treatment so they can ring it in celebration. . . . I've seen non-oncology patients that are going into a different part of the campus and their family ring it, and I love to see that, as our bell is being used to inspire hope and courage to so many other patients across Duke University. . . . I've seen staff ring it. . . . This little project has really had a reverberating effect that we did not even anticipate.” TS 16:23 “The bell can have so much more meaning and significance than just the end of treatment. So, work with your patients to define what the significance of that bell can mean.” TS 20:45

This episode features an interview with Sandra Hillburn, who was diagnosed with glioblastoma in 2006, and Dr. Deborah Doroshow, an oncologist at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai. Doroshow, who is also a historian of medicine, is a member of the editorial board of the Cancer History Project. When Hillburn was first diagnosed, she was given two to three months to live. Then, she sought treatment at Duke Cancer Institute, where she underwent surgery to remove the tumor. Afterward, she began receiving an experimental CMV vaccine treatment. The treatment worked. Today, she continues to receive the vaccine once every six months. A transcript of this recording appears on the Cancer History Project.

The Mideastern Cruise-In in South Carolina is coming up fast. The event run by Mideastern Chrome Stop is an annual event that features a wide variety of semis including antiques and even cars. This year's event will benefit the Duke Cancer Institute. Joe Witt, founder of the event and owner of Mideastern Chrome Stop talks about the event with Shelley Johnson on The Truckers Network Radio Show that comes up in April. Be sure to tune into this episode to learn the cool things to expect this year at the annual truck show. https://www.mideasternchromestop.com/ https://tncradio.live/ #TruckShow #Truckers #BigRigs #Trucks #MideasternCruiseIn #MideasternChromeAndCruiseIn #MidEasternChromeStop #JoeWitt #ShelleyMJohnson #TheTruckersNetworkRadioShow #TNCRadioLive #CharityEvent #FundRaiser #CancerFundRaiser

Character Database: Biomedical EngineerAmanda Randles is a computer scientist who is the Alfred Winborne and Victoria Stover Mordecai Professor of Biomedical Sciences at Duke University. Randles has been an assistant professor of biomedical engineering and computer science at the university and works at the Duke Cancer Institute. Her research includes biomedical simulation and high-performance computing.For the full uncut video (36mins) and access to our entire character database become a Monthly or Pro member at The Successful Screenwriter.--> https://www.thesuccessfulscreenwriter.com

In the USA, Black  and Hispanic ovarian cancer patients experience much poorer outcomes than White patients, suggesting they have less access to quality care.  But why does this disparity exist, and what can be done to bridge this gap?Dr Akinyemiju, Associate Professor in Population Health Sciences at Duke University School of Medicine and Duke Cancer Institute, USA, is tackling these questions and  more in the Ovarian Cancer Epidemiology, Healthcare Access, and Disparities Study, or simply, ORCHiD.Read some of their latest work here:  http://dx.doi.org/10.1136/bmjopen-2021-052808

When it comes to metastatic breast cancer, clinical trials are the way we find new drugs, better therapeutic targets, and, hopefully, more time. There are many issues with how clinical trials are designed, who they recruit and who is excluded, but one of the most difficult to confront at least here in the US has been the failure of the entire system to address how Black women and men with MBC are so much less likely than non-Black patients to be on a clinical trial. Systemic racism has many tentacles and today's Black advocates and their allies are forcing transparency and change when it comes to clinical trials. This episode of Our MBC Life puts the focus on what we know is happening, why it happens, and actions to break down barriers to the best possible care.Co-hosts Sheila Pettiford, Martha Carlson, and Natalia Green, who also serves as OMBCL Executive Producer, took the Metastatic Breast Cancer Alliance BECOME project as the jumping off point. Led by advocate Stephanie Walker, BECOME found that only 36% of Black survey respondents received as much information about clinical trials as they wanted even though over 80% were likely to consider joining a trial. This failure to communicate is one of the first barriers that needs to be overcome, but Black women and men with MBC were also found to have significant concerns around access and trust that differed from non-Black survey respondents. Stephanie is also the lead of the Black Wo(Men) Speak Symposium, held the day prior to SABCS on December 5, which brings together Black-led advocacy organizations, with the MBCA, oncologists, industry, and nonprofits to address these issues head on. In this episode, Stephanie Walker talks about the BECOME findings and OMBCL uses her words to guide our interviews.We also talk to Rev. Dr. Tawana Davis for the Black patient perspective on clinical trials and MBC. Rev. Dr. Davis was on an immunotherapy clinical trial for about 1 year, ending in 2018, following her initial treatment. Our last guest is Valarie Worthy, MSN, RN, a Patient Navigator at Duke Cancer Institute, co-founder of TOUCH, The Black Breast Cancer Alliance, and 23-year cancer survivor.There is a lot of thought-provoking conversation in this episode. Make sure to follow the links below to learn more about our guests and their work.BECOME Project and Stephanie Walkerhttps://www.mbcalliance.org/projects/become/https://www.cancer.net/blog/2022-10/working-make-cancer-clinical-trials-more-inclusive-qa-with-researcher-stephanie-walkerhttps://www.mbcalliance.org/black-women-speak/Rev. Dr. Tawana Daviswww.thedrtad.comwww.soul2soulsisters.orgwww.carriestouch.orgValarie Worthy, MSN, RNhttps://touchbbca.orghttp://www.dukecancerinstitute.org

In this episode, Andy reflects on his HIPEC surgery from one year ago at the Duke Cancer Institute. The Winter Faith Podcast believes all people have seasons of Winter Faith and that doubt is an essential part of faith. Listen to The Winter Faith Podcast on Apple, Spotify, and all other major podcast sites. Support the show on Patreon for more in-depth content and full length interviews. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/winterfaithpod/message

Lisa is joined by Philanthropist/Model/Sports Illustrated Finalist and surviror Victoria Vesce is telling everyone who will listen. Ms. Vesce has a long history of advocacy and philanthropy with various organizations, but her advocacy took on new meaning when she became a cancer survivor at age 24. Today, Victoria is an advocate for the National Brain Tumor Society, an organization that helped her during her radiation treatments at Duke Cancer Institute.In 2017, Victoria was diagnosed with multiple Paraganglioma, a brain-skull tumor and a carotid body tumor that required surgery and pin-point radiation treatment. During her time at Duke University Hospital, she voluntarily participated in a study to help more patients overcome rare tumors.DiagnosisIn 2016 and 2017 while dancing in the NBA for the Charlotte Hornets, and studying for the LSAT, Victoria started losing her hearing and experiencing extreme headaches. She began experiencing symptoms like fainting, unexplained adrenalin rushes and dizziness. After a CAT scan and repeated visits to the doctor and ENT, she was diagnosed with a tumor.TreatmentVictoria was referred to Duke University Hospital, where they discovered another tumor (carotid artery) during an MRI. Surgery occurred 6 weeks later, and following that, Victoria underwent 30 rounds of experimental radiation treatment.RecoveryToday, Victoria is fully deaf in her right ear. She also suffers from tinnitus. At the same time, she enjoys a new perspective on life and has gratitude for the organizations and people who have helped her along the way."My motto in life now is that life is short. I have quit shaming myself or changing myself to please others. I own my life, imperfections and all. I want to help others to reach a point of good health, happiness and fulfillment - as I have," said Ms. Vesce. "Brain Tumor Awareness Month presents a chance to become educated about the issues that affect people with cancer diagnoses. It's also a chance to give to organizations that save lives."Ms. Vesce encourages others to donate to organizations like the National Brain Tumor Society. If you would like to interview her please let me know!For more information about how you can contribute to the National Brain Tumor Society, see their website, https://braintumor.orgAbout Victoria DeHart Vesce: now based in Miami, Florida, Victoria is a graduate of NC State University with a Bachelor of Arts in Media Communications and has obtained her Juris Doctorate from Charleston School of Law. She currently works with Berman Law Group in South Florida and continues to model and grow her social media platform. She is signed model with JL Model Management and Marilyn's Agency.In the past, Ms. Vesce has volunteered for and been a part of organizations such as Make-A-Wish, Toys for Tots, Relay for Life, Ronald McDonald House (Young Professional's Society) YMCA,

On this episode we hear from Thoracic Medical oncologist Dr. Thomas Stinchcombe. Dr. Stinchcombe is a member of Duke Cancer Institute, and Thoracic Oncology Program at Duke University in Durham, North Carolina. Dr. Stinchcombe explains whether or not they would recommend RET inhibitors as first line therapy for a RET-fusion positive metastatic Non-Small Cell Lung Cancer patient, what drugs are available to treat patients with Non-Small Lung Cancer and MET exon 14 skipping alterations, the significance of a metastatic Non-Small Cell Lung Cancer patient with a ERBB2 or HER2 alteration & whether there are specific mutations that are targetable for HER2. We conclude with a breakdown of the role of immune check point inhibitors in patients with resected Non-Small Cell Lung Cancer & the role of adjuvant therapy with atezolizumab. Visit www.precisca.com for more resources, content, and access to our entire catalogue of educational content. There you will have access to our complete library of educational videos. New episodes of the PrecisCa Oncology Podcast are released weekly. Please consider sharing our podcast, subscribing & turning on notifications to be the first to know about new releases. Together, we can raise the level of cancer care from diagnosis to recovery.

In this episode of ACM ByteCast, Rashmi Mohan hosts 2017 ACM Grace Murray Hopper Award recipient Amanda Randles, the Alfred Winborne and Victoria Stover Mordecai Assistant Professor of Biomedical Sciences at Duke University's Department of Biomedical Engineering. She is also Assistant Professor of Computer Science and Biomedical Engineering and a member of the Duke Cancer Institute. She has received the National Science Foundation Career Award and was selected as one of the 10 researchers to work on the Aurora Exascale Supercomputer. Her visionary work in simulating blood flow through the human body in a system called HARVEY, led her to be featured in the MIT Tech Review Innovators Under 35 list. Amanda talks about growing up in Michigan and being inspired early on by her high school computer science teacher. She talks about her passion, which lies in using the largest supercomputers in the world to answer questions otherwise left unanswered, and her Duke research group's focus on building large scale personalized blood flow simulations. She also discusses her 3-year involvement with IBM's Blue Gene Team, where she learned how to debug programs and identify and work through problems collaboratively, and her time at Harvard University, where she learned about fluid dynamics and started writing HARVEY from scratch. She also describes the fascinating contributions her team made to address ventilator shortages during the early days of the COVID-10 pandemic.

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. In this podcast, Dr. Tian Zhang and Dr. Afreen Shariff discuss common and sometimes serious side effects caused by a type of immunotherapy called “immune checkpoint inhibitors.” They also explain why it is important for people with cancer to track the side effects they experience and discuss them with their health care team. Dr. Zhang is an associate professor of Internal Medicine at UT Southwestern Medical Center and is a medical oncologist at the Harold C. Simmons Comprehensive Cancer Center. She is also a Cancer.Net Specialty Editor. Dr. Shariff is an endocrinologist and assistant professor of medicine at Duke University School of Medicine and the Associate Director for the Multi-Disciplinary Toxicity Program at the Center for Cancer Immunotherapy at Duke Cancer Institute. Together Dr. Zhang and Dr. Shariff host a podcast called Checkpoint NOW discussing a multidisciplinary approach to managing side effects of immunotherapy. Learn more and listen at www.checkpointnow.org. View full disclosures for Dr. Zhang and Dr. Shariff at Cancer.Net. Dr. Zhang: Hi, everyone. Thank you for joining. My name is Tian Zhang, and I specialize in treating patients with kidney, bladder, and prostate cancers. I'm happy today to be joined by my wonderful colleague at Duke, Dr. Afreen Shariff. Dr. Shariff: Hello, everyone. I'm Dr. Afreen Shariff, endocrinologist, assistant professor of medicine, and associate director at the Center of Cancer Immunotherapy at Duke Cancer Institute. We're happy to talk today on the podcast Cancer.Net about immune checkpoint inhibitors and associated side effects that many patients often are concerned about. Neither of us have any disclosures related to this podcast content. Dr. Zhang: Thanks, Afreen. With the increase in use of immune checkpoint inhibitors for patients with cancer and the prevalence of side effects and toxicities, we thought it was important for patients to understand what side effects to monitor for and when to contact their doctors for further guidance and management. We thought we would put together this particular podcast to focus on side effect monitoring from a patient perspective. Dr. Shariff: I agree. We have some side effects that can potentially be attributed to multiple toxicities, but there are others that can be pretty straightforward. These are times when referrals to subspecialists like myself are necessary. And at other times, the treating oncologist primarily manages toxicities. The more patients know, the better prepared they will be when starting on immune checkpoint inhibitors. Tian, let's get started. When you are introducing a new start for immune checkpoint inhibitors to a patient in your clinic, what is your overall advice? Dr. Zhang: Afreen, I think it's so important for patients to understand the general scope of side effects to monitor for. These include rashes and diarrhea, which are more common and relatively straightforward to attribute, but also other nonspecific symptoms like fatigue. I start with an overview about common side effects of rash and diarrhea, discuss a little bit more about rare side effects of inflammation in the lungs or liver, and then talk about potential endocrine side effects. And we do that all when the patient's starting immune checkpoint inhibitors in my clinic. Dr. Shariff: Oh, that's great, Tian. What should patients know about diarrhea? Dr. Zhang: Sure. So diarrhea is reflective of inflammation in the colon, what we call colitis. And this can occur in mild form or in a more severe form and is 1 of the most common side effects of immune checkpoint inhibitors. Changes in stool caliber, particularly loose or watery stools, and also frequency per day should be quantified and noted. Diarrhea does not often have blood, but bloody stools are also possible and should be reported. If bowel movements while on checkpoint inhibitors increase to 2 to 3 times more per day above baseline, patients should start reporting these to their treating oncologists for further management. Dr. Shariff: Well, I'm sure our audience and some of the patients on immune checkpoint inhibitors will find this very useful. Now, skin rashes are seen quite commonly as well. For patients being treated with immune checkpoint inhibitors, what would you like them to know about these rashes? Dr. Zhang: Sure. Of course, skin rashes vary from mild to severe and treatment varies with the diagnosis. If patients notice blisters and pain, this can certainly be an emergency and needs to be evaluated further by their oncologist who may then refer them to a skin doctor for more treatment. Large patches of red rashes can also be concerning. In general, we start with topical steroids for mild rashes and then add on oral steroids if topical ones are not controlling the rash. Afreen, we see fatigue so often in patients treated with immune checkpoint inhibitors. Can you share some insight into different side effects that can cause fatigue? Dr. Shariff: Tian, this is a very important question and common concern expressed by many patients. Now, often it is difficult to identify the cause if fatigue occurs in isolation without any other symptoms. Now, fatigue can result from immunotherapy and from cancer itself. But what I want to emphasize is the difference between ongoing fatigue and profound fatigue, which is a severe version affecting everyday activity levels. When patients experience profound fatigue, it's important to know what other symptoms are present that can help with identifying a cause. Dr. Zhang: Great. And what other symptoms should patients be aware of? Dr. Shariff: Sometimes this occurs with headaches and vision changes, indicating a side effect causing inflammatory changes of the pituitary gland in the brain. If this is a concern, your oncologist will advise further testing and a referral to a hormone doctor like myself called an endocrinologist. Now, if fatigue occurs with rapid weight loss, increased heart rate, and tremors, these can be signs of an overactive thyroid called hyperthyroidism. Now, in contrast, fatigue with weight gain can indicate an underactive thyroid. Both of these thyroid-related side effects will require lab evaluation to confirm a diagnosis. Dr. Zhang: Afreen, fatigue is so common and also a presenting symptom for diabetes, as well. Can you tell us more about this? Dr. Shariff: Yes. Fatigue and weight loss are common in new-onset or worsening diabetes. With immune checkpoint inhibitors, you can see a rare side effect of insulin deficiency, which is called type 1 diabetes. It's a rare side effect and needs treatment right away. What makes the symptoms a little different is that this fatigue is seen with increased thirst and appetite and a high blood sugar, which helps with the diagnosis. Now, Tian, we also see fatigue with shortness of breath. Now, what side effects can cause this? Dr. Zhang: When a patient comes in with shortness of breath, we're often thinking about heart and lung toxicities from immune checkpoint inhibitors. Measuring oxygen saturation helps. Sometimes patients who have inflammation in their lungs, what we call pneumonitis, will have decreased oxygenation levels. In the clinic, if patients report shortness of breath on exertion, we will also obtain EKGs, echocardiograms, and other labs to evaluate for heart dysfunction. And often, subspecialists will help us in managing lung and heart toxicities from immune checkpoint inhibitors. Dr. Shariff: Excellent. Now, what other complications can we see in a patient treated with immune checkpoint inhibitors? Dr. Zhang: Liver dysfunction is 1 that we haven't talked about yet, and liver dysfunction is often without symptoms. Oncologists will monitor liver function generally every few weeks when patients are treated with immune checkpoint inhibitors. An elevation from baseline will spark suspicion that the immunotherapy is responsible, or other drugs. And often we will involve a liver specialist. And if, due to the immune therapy, we'll often treat that with steroids. Dr. Shariff: That's very helpful. Now, what about other toxicities like kidney toxicity and toxicities to the nervous system? Dr. Zhang: Sure. Certainly, these are rare forms of toxicities, the ones that affect the kidneys or neurologic toxicities. But they can certainly happen. For kidney toxicities, we would monitor kidney function on labs and sometimes would need to involve a kidney specialist. These are often primarily treated with steroids. Neurologic toxicities are rare but can be disabling and dangerous if diagnosed late. So patients can experience symptoms ranging from mild, like numbness and tingling, to more severe symptoms of weakness and paralysis. These situations often involve the input of a neurologist. Dr. Shariff: Thanks, Tian, for your insight on these rare side effects. Interestingly, some side effects may be picked up on labs while patients may not have any symptoms. This is why oncologists are often checking blood work with every treatment. And it's important to bring up symptoms when you do experience them while on treatment. While these side effects are concerning, it's important to have a conversation with your treating oncologist to weigh your risk for each of these side effects. Most importantly, remember that a majority of these less severe side effects are manageable and do not need interruption of immune checkpoint inhibitors. This is a general guidance, and it's important to always refer to your treating clinician. Dr. Zhang: Thanks, Afreen. I hope this session helps bring awareness for symptom management and side effects management for patients on immune checkpoint inhibitors. For other information on specific toxicities, there are several resources. You can follow us on Twitter at CheckpointnowMD, check out our podcast, Checkpoint Now, on Apple Podcast or Spotify, or also go onto the Cancer.Net website with more information on disease-specific treatments and toxicities. ASCO: Thank you Dr. Zhang and Dr. Shariff. To learn more about immunotherapy and its potential side effects, please visit www.cancer.net/immunotherapy. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play. This Cancer.Net podcast is part of the ASCO Podcast Network. This collection of 9 programs offers insight into the world of cancer care, covering a range of educational, inspirational, and scientific content. You can find all 9 shows, including this one, at podcast.asco.org. Cancer.Net is supported by Conquer Cancer, the ASCO Foundation, which funds lifesaving research for every type of cancer, helping patients everywhere. To help fund Cancer.Net and programs like it, donate at CONQUER.ORG/Donate.

Everyone can make a difference in the life of someone living with the disease by donating to breakthrough research. Thousands of families lives will be changed forever by an NBC diagnosis this year. Sadly, 44,000 lives are at risk this year. And the five-year relative survival rate for metastatic breast cancer is only 27%. The Susan G Komen Metastatic Breast Cancer Collaborative Research Initiative is a first of its kind effort that is bringing together the best and brightest researchers at Duke Cancer Institute and UNC Lineberger Comprehensive Cancer Center to find breakthrough discoveries to end metastatic breast cancer. Research will cure this disease. Until then, research will transform MBC from a terminal diagnosis to a chronic disease, giving patients and their families the priceless gift of time. Today's guest, Pam Kohl is here to tell us more about the NBC Collaborative Research Initiative, as well as her own personal story of living with stage four metastatic breast cancer, Pam, welcome to the show!

In this episode, Mallory sits down with Dr. Shelley Hwang, Duke University's Vice Chair of Research in the Department of Surgery, Professor in the Departments of Surgery and Radiology, and Co-Leader of their Women's Cancer Program in the Duke Cancer Institute. Dr. Hwang discusses her many valued roles at Duke, her journey there, the deeply personal and rewarding mission of treating patients, and some of the obstacles she sees women facing in the fields of science and medicine.

How Classical Music Benefits your BrainSubscribe: https://thingsyoushouldknow.supercast.techFacebook: https://www.facebook.com/groups/879254746173653The researchers speculated that the music put students in a heightened emotional state, making them more receptive to information.“It is possible that music, provoking a change in the learning environment, influenced the students' motivation to remain focused during the lecture, which led to better performance on the multiple-choice quiz,” they wrote.According to research from the Duke Cancer Institute, classical music can also lessen anxiety.Researchers gave headphones playing Bach concertos to men undergoing a stressful biopsy and discovered they had no spike in diastolic blood pressure during the procedure and reported significantly less pain.But make sure you are listening to classical music, because not all music aids blood pressure, a University of San Diego study found.Scientists at the university compared changes in blood pressure among individuals listening to classical, jazz or pop music. Those listening to classical had significantly lower systolic blood pressure when compared to those listening to other musical genres or no music at all.Buzzsprout - Let's get your podcast launched! Start for FREEDisclaimer: This post contains affiliate links. If you make a purchase, I may receive a commission at no extra cost to you.

In this episode of the IJGC podcast, Editor-in-Chief Dr. Pedro Ramirez, is joined by Drs. Rebecca Previs and Benjamin Albright to discuss primary cytoreduction for advanced endometrial cancer. Dr. Rebecca Previs is an assistant professor within the Division of Gynecologic Oncology and the Department of Obstetrics & Gynecologic at Duke University Medical Center, Duke Cancer Institute in Durham, NC. Her translational research interests include understanding how the immune microenvironment and molecular characterization of gynecologic cancers influences disease biology and treatment outcomes. Outside of medicine, she enjoys spending time with her menagerie of pets, gardening, hiking, harvesting honey from her bee hives, and playing the piano. Dr. Ben Albright is a second-year fellow within the Division of Gynecologic Oncology and the Department of Obstetrics & Gynecologic at Duke University Medical Center, Duke Cancer Institute in Durham, NC. His research interests include health policy and economics, health services research, systematic review, and cost-effectiveness analysis. Outside of medicine, he enjoys trail running, tennis, hiking with his wife and two big dogs, and University of Kentucky basketball. @BeccaPrevisMD / @BenAlbrightMD / @dukeobgyn / @DukeCancer Highlights 1. The objective of our study was (1) to assess the frequency of reported proportions of maximal (R0, no gross residual disease) and optimal (

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. In the Research Round Up series, members of the Cancer.Net Editorial Board discuss the most exciting and practice-changing research in their field and explain what it means for people with cancer. In today's podcast, 4 Cancer.Net Specialty Editors discuss new research in prostate, bladder, kidney, and testicular cancers presented at the 2021 Genitourinary Cancers Symposium, and 2021 ASCO Annual Meeting. This episode has been adapted from the recording of a live Cancer.Net webinar, held June 16th, 2021, and led by Dr. Neeraj Agarwal, Dr. Tian Zhang, Dr. Petros Grivas, and Dr. Timothy Gilligan. Dr. Agarwal directs the Genitourinary Oncology Program at the Huntsman Cancer Institute at the University of Utah. Dr. Grivas is the clinical director of the Genitourinary Cancers Program at University of Washington Medicine. He is also an associate member of the clinical research division at the Fred Hutchinson Cancer Research Center. Dr. Zhang is an associate professor of medicine at Duke University School of Medicine and is a medical oncologist at Duke Cancer Institute. Dr. Gilligan is an Associate Professor and Medical Oncologist at the Cleveland Clinic Taussig Cancer Institute. Full disclosures for Dr. Agarwal, Dr. Grivas, Dr. Zhang, and Dr. Gilligan are available at Cancer.Net. Greg Guthrie: So today, let's introduce our participants. First we have Dr. Neeraj Agarwal of Huntsman Cancer Institute and University of Utah and the Cancer.Net Specialty Editor for Prostate Cancer. Next we have Dr. Petros Grivas from Fred Hutchinson Cancer Research Center and University of Washington. He is the Specialty Editor for Cancer.Net for Bladder Cancer. Next we have Dr. Tian Zhang of Duke Cancer Institute. And she's our Cancer.Net Specialty Editor for Kidney Cancer. And last, we have Dr. Timothy Gilligan. He is with the Cleveland Clinical Taussig Cancer Institute and the Specialty Editor for Testicular Cancer. So to start off, we'll have Dr. Agarwal talking about prostate cancer. Dr. Agarwal: Thank you, Greg. It's such a privilege and honor to be here discussing these studies. So I would like to start with the first study, which was led by Dr. Stephen Freedland, a urologist at the Cedars-Sinai Medical Center in Los Angeles and was co-authored by me, Dr. Dan George, and many others. And here in this study, we present the utilization of therapies, which are associated and known to be associated with very significant, in fact, I would say dramatic improvement in overall survival, as shown by multiple randomized control trials over the period of the last 5 to 6 years. Just to take a step back for the audience, until 2014, standard treatment for metastatic castration-sensitive prostate cancer or newly diagnosed metastatic castration-sensitive prostate cancer used to be androgen deprivation therapy. And combining androgen deprivation therapy with those medications which were approved in the castration-resistant metastatic prostate cancer setting. So basically, using those drugs upfront led to dramatic improvement in overall survival with 33% to 35% reduction in risk of death across those clinical trials. So we actually wanted to look at the real-world utilization, so look at the real-world users of these medications in these patients who are being diagnosed with -- newly diagnosed metastatic prostate cancer in the United States. We also wanted to see how patients who belong to minority populations or racial minority populations, how they are being treated with these medications, which are backed by level 1 evidence. So this was a retrospective analysis of a Medicare database, more than 35,000 patients were included from 2009 to 2018. And we can see here a very representative patient population, predominantly white patients, 11.8% were African American, and 5% were Hispanic. And here are the results. From 2010 to 2014, the use of standard androgen deprivation therapy with bicalutamide, was used in 97% of patients. We did not have trials reporting by that. Let's go to 2015 to 2016. Docetaxel was already approved in this setting now, and we can see some patients received docetaxel, but a small minority of patients received docetaxel. And then let's move to 2018, which is 4 or 5 years after docetaxel data had been presented by Dr. Sweeney in the ASCO plenary session. And abirateron was approved in 2017, and we are still seeing even like almost 2 years after -- we are still seeing the vast majority of patients being treated with standard androgen deprivation therapy or standard deprivation therapy with bicalutamide. So 62% plus 19%, we are talking about almost 80% of patients still not being treated with standard of care treatment, which is androgen deprivation therapy plus docetaxel, or androgen deprivation therapy plus abiraterone at this point of time, and now we have 2 more drugs available, which include enzalutamide and apalutamide in this study. Another interesting thing was if you look at the patients who belong to minority populations, so let's look at African American patients compared to Caucasian patients. The use of intensified therapy was numerically lower. So in Caucasian patients, we are seeing higher use of intensified, as we call them, intensified therapy, or therapies which are considered standard of care, compared to African American men. So overall, the use was lower across the board, but if you look at African American men, the usage was even lower. So this is definitely concerning. I call it alarming, underutilization of life-prolonging therapy in patients who are being diagnosed with newly -- or new diagnosis of metastatic prostate cancer, and we definitely can improve this. We can definitely offer better care to our patients. It is not acceptable in my view to have 30% or less patients receiving standard of care therapies. So with that, I'll go to the next study.  Greg Guthrie: Great, thanks. And this study is, “Health-related quality of life and patient-reported outcomes at final analysis of the TITAN study of apalutamide versus placebo in patients with metastatic castration-sensitive prostate cancer receiving androgen-deprivation therapy.” And you were the presenting author of this, Dr. Agarwal? Dr. Agarwal: Yes, Greg, thank you for giving the opportunity to present this study. And this is basically the continuation of the previous trial. I will not delve into in-depth analysis of these data. I just wanted to show that quality of life is not being impacted adversely by using intensified androgen deprivation therapy, so if you are using these drugs, which improves survival in a very significant fashion, and they are not being used in our patients, as we just saw in the previous study, what could be the reason? Is it the concerns about quality of life or adverse impact on quality of life? If that is the concern, this study, I think, helps refute those concerns. And in this study, which was a large study known as the TITAN trial, which led to approval of apalutamide for patients with hormone-sensitive or castration-sensitive metastatic prostate cancer and showed improved survival and radiographic progression-free and overall survival. We looked at quality of life data as reported by these patients, and these quality-of-life data were assessed by very standardized, validated scales known as FACT-P, or Functional Assessment of Cancer Therapy Prostate scale, or Brief Pain Inventory tool. And there are many other tools. So I will show you the results. And we can see here consistently there was no difference in quality of life as reported by the patients, or I would say any adverse impact on quality of life for these patients in any of these questions. As they were taking these questionnaires. So whether it was physical wellness, emotional wellness, functional well-being, social, or family, we go in and look at fatigue and there was no adverse impact on quality of life. At least from this perspective, we should not be concerned about using these drugs up front in our patients who have newly diagnosed metastatic prostate cancer.  Greg Guthrie: Great. And so what does this mean for patients?  Dr. Agarwal: From patient perspective, we can see here very clearly that using standardized tools, very validated tools, which have been used in multiple trials in the past, patients are not reporting any adverse impact on their quality of life when being treated with intensified androgen deprivation therapy. In this context, apalutamide. Greg Guthrie: Great. Alright. So let's move on to our next study, which is, “Phase 3 study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer.” The VISION trial. Dr. Agarwal: Thank you. In my view, this is 1 of the most important studies presented in the 2021 ASCO Annual Meeting. This study was a phase 3 study where 7,000 patients were recruited, and they had metastatic castration-resistant prostate cancer and had disease progression on a prior novel hormonal therapy such as enzalutamide or abiraterone and the patients had received a taxane chemotherapy. So at least 1 taxane chemotherapy was required before the trial, and the patient had to have disease progression on a novel hormone therapy. These patients were randomized in 2 to 1 fashion to a novel drug, which is a type of radiation, intravenous radiation, as I would explain to my patients, and this is known as beta radiation. And this is a novel radiotherapy where radiation particle, which is delivering beta radiation particle to the cancer cells, is tagged to a molecule, which binds with the prostate cancer cells. So I'm simplifying it for the sake of our patients. And this particle or this compound was added to standard of care therapy and patients were randomized to standard of care therapy versus standard of care therapy plus this new compound. And standard of care therapy was a novel hormonal therapy or anything which did not include chemotherapy or radium 223, which is another type of radiation particle, but a different kind of particle known as alpha particle. So in this study, radiographic progression-free survival and overall survival were primary endpoints. We can see here that the study met both primary endpoints. There was a significant improvement in radiographic progression-free survival with an almost 5 month, 5.4 months, to be precise, improvement in radiographic progression-free survival, with a 60% reduction in risk of disease progression or death. If you look at overall survival, it was also improved in a significant fashion in patients who received the new compound known as lutetium-PSMA-617, and the median survival was improved by 4 months with an approximately 40% reduction in risk of death.  This was a well-tolerated drug overall, and if you look at hybrid side effects, treatment, and emergent side effects, there were 52.7% of patients in the experimental arm, and 38% in the control arm had those treatment-related side effects. So overall, Wwell-tolerated regimen with improved overall survival and radiographic progression. Thank you very much. Greg Guthrie: Thank you, Dr. Agarwal. This is really interesting, and it will be interesting to see if this treatment does change standard of care based on this research. Let's move on to Dr. Grivas and bladder cancer research. Let's see, so Dr. Grivas, your first study is, “Avelumab first-line maintenance for advanced urothelial carcinoma: analysis of clinical and genomic subgroups from the JAVELIN Bladder 100 trial.” And Dr. Grivas was a co-principal investigator in this trial and is senior author of the New England Journal of Medicine publication and co-author of this abstract. Go ahead, Dr. Grivas.  Dr. Grivas: Thank you so much, Greg, and thank you to Cancer.Net for the opportunity, and thanks to the audience. We welcome questions. I would like to update the audience today about the data we saw at the ASCO meeting, and I would like to place this data in context, and I would remind the audience the JAVELIN Bladder 100 trial that changed clinical practice was initially presented last year at the ASCO Virtual Meeting 2020 by Professor Powles. And this particular trial tried to answer the following question: does the immunotherapy, especially the PD-L1 inhibitor avelumab, add value in patients who completed chemotherapy in the first-line setting of metastatic urothelial cancer compared to just best supportive care in terms of longer life, in terms of overall survival, and time until the cancer grows or death, progression-free survival? This is important because until this study came about last year, the practice was, in the setting of spread metastatic urothelial cancer, when the chemotherapy stops, was we cannot give it for a long time because of potential side effects. Usually you used to wait until the cancer grows back, it progresses, or grows. So this trial compared this approach, the best supportive care, versus the immunotherapy with avelumab and the best supportive care. This particular trial, so the significant improvement of life expectancy and overall survival as well as progression-free survival, time until progression of the cancer or death, in the patients that received this immunotherapy drug avelumab as a way to maintain or sustain the benefit that is seen with chemotherapy. So we call this a maintenance therapy approach because we tried to maintain or sustain the benefit with chemotherapy. I want to highlight that this was published in the New England Journal of Medicine and the audience can retrieve that from PubMed if one wants to read the manuscript. The bottom line is this trial changed practice, and we can go now to updates. We saw this in this particular meeting, ASCO 2021, and I think the main question was, are there any particular subsets of patients, different categories of patients, who benefit more from the avelumab maintenance approach, or does this benefit all the patients? And we saw at the ASCO meeting, we saw that the benefit with this immunotherapy appears consistent across the board, across different subcategories of groups of patients. And I think that it's important to point out that we looked at patients who had what we call local disease around the bladder, that was invading this area, and the pelvic side wall that was not amenable to surgical rejection and also patients with spread of the cancer in distant sites, what we call metastasis. And we look at patients who had a primary origin in the bladder or higher up in the urinary tract, what we call kidney pelvis, or ureter, and we call this upper urinary tract, versus the lower tract, which is the bladder, and we also look at patients who had metastatic spread in the lymph nodes only or other parts of the body. And with the bottom line, we saw that the benefit with the immunotherapy was consistent across the different groups of patients. So many patients benefit from this treatment, again, with variable degrees, variable magnitude of benefit, but overall, the bottom line is, take home message is if you have clinical factors or other molecular factors, we do not have a reliable, accurate tool to select which patients should go with avelumab, so we offer it nowadays in every patient who has no contraindication to get immunotherapy and has received some disease control. Meaning a response of the cancer or stabilization of the cancer with the chemotherapy phase. So that has real clinical implications, and I encourage the audience to discuss with their oncologist about the optimal roles of immunotherapy with this maintenance setting after chemotherapy when this is controlled with chemotherapy. Just for context here, I want to highlight the options the patients have in clinical practice. And when someone is diagnosed with spread urothelial cancer, they can be offered nowadays avelumab as a maintenance strategy to maintain the benefit of chemotherapy, and the other options include immunotherapy up front, like drugs like pembrolizumab or atezolizumab, and I will come back to that question how to select your treatment in my last slide. And I want to point out these are the options, and obviously clinical trials are always a great option for patients, and they should ask their oncologist about those options. So since I talked about immunotherapy, I want to point out that the ideal chemotherapy is cisplatin-based chemotherapy. Not everybody has enough fitness of the body to tolerate cisplatin. For those patients, we think cisplatin may be too much, we use carboplatin/gemcitabine, and we use avelumab maintenance in that scenario. What about immunotherapy after that? Is there data supporting that use? And the answer is yes. There is some data suggesting that immunotherapy can be an option for some of the patients, and in this particular slide, we update the data from another clinical trial. And I will let Greg, you can read the title of that. Greg Guthrie: Sure, so this study is, “First-line pembrolizumab in cisplatin-ineligible patients with advanced urothelial cancers response and survival results up to 5 years from the KEYNOTE-052 phase 2 study.” Dr. Grivas, you're a co-author on this study. Dr. Grivas: That's right, thank you, Greg. This trial presented longer follow up to see what happened in patients who received the immune checkpoint inhibitor anti-PD called pembrolizumab because they were not fit enough to get cisplatin chemotherapy. Keep in mind this was designed before the previous study I showed you presented the results and included patients who were not fit for cisplatin, but some of them could have been fit for carboplatin. There was no comparison here, everybody received pembrolizumab as a single agent, alone, and in this particular study, we would try to see the degree of shrinkage of the cancer and the overall response rate as well as how long people lived over time. So with longer follow-up, by the way, we published this study in the Lancet Oncology years ago, and we have longer follow-up, and what you see here is a degree of shrinkage of the cancer, what we call overall response rate, was about 29% in what we call all comers, and it was higher size of tumor shrinkage in patients with high PD-L1 expression. PD-L1 is this brake of the immune system, the checkpoint of the immune system and highly expressive measured by particular assay that pembrolizumab works better in those patients. However, some patients even with low PD-L1 measured by this CPS score I put in the slide still might have benefits, so the take-home message here is there is a particular proportion of patients who can benefit from the checkpoint inhibitor pembrolizumab. PD-L1 can be used in that setting to help decide between chemotherapy and immunotherapy. However, we have not compared directly the chemotherapy followed by the available maintenance with immunotherapy up front, so this question is still lingering. However, if the patient has a response shrinkage to pembrolizumab, many of those patients may have a long-lasting response. We tried to figure out with research how can we predict who is going to benefit more from this treatment as a matter of ongoing research. Greg Guthrie: Dr. Grivas, can you really quickly define CPS for our audience? Dr. Grivas: Absolutely. Great question. CPS is a tool we use in the pathology labs to measure the PD-L1 expression. It can be measured by different assessing antibodies, and the pathologists use a score to define if the PD-L1 is high or low. In this particular study, CPS of 10 or higher defines PD-L1 high expression, CPS below 10 defines PD-L1 low expression, and this appears to have some association with a chance of the tumor shrinking with immunotherapy with pembrolizumab. Greg Guthrie: Great. Thanks, Dr. Grivas. So our last study is, “Pembrolizumab versus investigator's choice of paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer: 5-year follow-up from the phase 3 KEYNOTE-045 trial.” Dr. Grivas Very quickly, this study compared immunotherapy, pembrolizumab, the anti-PDL1, compared to chemotherapy with paclitaxel, docetaxel, or vinflunine, the latter one is in Europe, after progression of cancer growth on platinum-based chemotherapy. This was published in the New England Journal of Medicine a few years ago, and pembrolizumab prolonged survival, people lived longer compared to the chemotherapy. And this longer follow-up presented by Dr. Bellmunt and colleagues, showed the sustained results with follow-up, this population of patients had already received cisplatin-based chemotherapy and the cancer progressed, growth, despite that chemo, and in those patients, pembrolizumab appears to produce better results compared to this salvage chemotherapy shown in that slide. And this has implications because immunotherapy can be used in those patients after progression on platinum-based chemotherapy. And just to wrap up here the discussion, I just want to give the options to the patients, see if someone has a new urothelial cancer, options include cisplatin/gemcitabine, or if someone is not fit enough for cisplatin, carboplatin/gemcitabine, and both of those scenarios can be followed by avelumab, and those with shrinking or stable disease, patients who have progression on platinum-based chemotherapy can get pembrolizumab and of course other options available. We can go into another podcast, and I encourage the audience to look and discuss with their oncologist about those options, and the take home message, the clinical trials is what got us here, and I recommend clinical trials to be discussed with your oncologist. Thank you so much, and I'll be happy to take questions.  Greg Guthrie: Thanks, Dr. Grivas. So we're going to move on to Dr. Zhang, who is going to talk about kidney cancer. So our first study today is, “Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for patients with renal cell carcinoma: a randomized, double-blind, phase III KEYNOTE-564 study.” Dr. Zhang: Thanks, Greg. I'm really excited to be here today and thanks, everyone, for joining. KEYNOTE-564 was presented at the ASCO plenary by our colleague Dr. Toni K. Choueiri, and this is a highly anticipated study in the adjuvant space for kidney cancer and enrolled patients with high-risk clear cell kidney cancer who had undergone either nephrectomy or a metastastectomy, removing their few sites of metastatic disease and treating those patients with either pembrolizumab for up to a year or placebo. And the endpoint was disease-free survival, and enough events had occurred by this ASCO for us to see the primary results. So the overall -- the study was positive. For the primary endpoint, disease-free survival improvement was met with a hazard ratio of 0.68 and the estimated disease-free survival rate at 2 years was 77% for patients treated with pembrolizumab versus 68% for patients treated with placebo. The overall survival favored pembrolizumab, but it was not yet statistically significant, and follow-up will be needed. Overall, we see an improvement in disease-free survival delaying time until recurrence for patients treated with pembrolizumab, and this was the first study in this adjuvant space showing checkpoint inhibition has a role in adjuvant treatment of renal cell carcinoma.  Greg Guthrie: Thanks, Dr. Zhang. Our next study is, “Pembrolizumab plus axitinib versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma: results from 42-month follow-up of KEYNOTE-426.” Dr. Zhang: This study, KEYNOTE-426, we are all very familiar with. Pembrolizumab and axitinib has been used for the last 2 years in the first-line treatment of clear cell metastatic kidney cell cancer, and it's a longer-term follow-up, more events and more understanding of what happens to these patients once they're treated in a longer term, so primary endpoints of course of this phase 3 study were progression-free survival and overall survival. When we're looking at this medium duration of follow-up at 42 months, so about 3 and a half years, pembrolizumab and axitinib improved both median overall survival as well as median progression-free survival. We'd point out that the -- at the 3 and a half year mark, the overall survival rate for patients treated with the combination was about 57.5%. And the progression-free survival rate was about 25%, so about a third of patients had not had progression of disease at 3 and a half years. Which is quite meaningful if they can stay on their first-line treatment for that long. The objective response was 60%, and of note, the complete response rate had been updated to about 10%. So there are some patients that do have delayed complete responses. And no new safety signals were observed. So overall, certainly still provides a lot of evidence to treat with pembrolizumab and axitinib for patients in the front-line setting. Greg Guthrie: Great. And our last study here is, “Health-related quality of life analysis from the phase 3 CLEAR trial of lenvatinib plus pembrolizumab or everolimus versus sunitinib for patients with advanced renal cell carcinoma.” Dr. Zhang: This was the phase III trial in first-line treatment of metastatic clear cell kidney cancer that was reported at GU ASCO in February of 2020, and it was a 3-arm randomization to lenvatinib with everolimus in the standard study, and lenvatinib with pembrolizumab or sunitinib alone, and we saw the efficacy data in February, and here we're seeing the quality of life outcomes, and looking at how patients are doing, patient-reported outcomes on these treatments. And so with multiple quality of life measures, we're seeing improvements in patients that had better disease-related scores of symptoms when treated with lenvatinib and pembrolizumab versus sunitinib. We're seeing pain scores improve and patients having less diarrhea, appetite loss, when we're comparing against sunitinib. Of note, it's hard to specifically tie a particular symptom, if that's improved, because they've had better disease control or if it's more from the treatment side effect itself. So still hard to tease out a causality in these quality of life measures, but overall, improvement in patients' quality of life when treated with lenvatinib and pembrolizumab. And certainly provides some more data for patients receiving this combination. And so I just wanted to highlight our ongoing phase 3 combination trials and first-line metastatic kidney cancer. PIVOT-09 with bempegaldesleukin has completed accrual in the first triplet of COSMIC-313 with ipilimumab, nivolumab and cabozantinib has completed accrual, so the actively enrolling studies currently are PEDIGREE and PROBE. These are studies that are being carried out in the cancer cooperative groups, as well as a triplet belzutifan lenvatinib with pembrolizumab, a study that Merck is running and all 3 very important studies we will continue to learn from and answer some important, clinically relevant sequencing treatment discontinuation, nephrectomy side effect questions. Thanks to everybody. Greg Guthrie: We have 1 more. So, “Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer.” Dr. Zhang: Dr. Rodriguez from Spain presented this of papillary renal cell carcinoma treated with savolitinib and durvalumab, and specifically looked at the MET-driven subset of 14 patients out of these 42 patients. The efficacy primary end point was objective response rate. And of note, and median progression-free survival for the 42 patients who were all treated, it was 4.9 months and in MET-driven disease, so savolitinib targets MET, so MET-driven disease was 10.5 months and the median overall survival in everyone was 14 months, versus MET-driven was 27 months, and also higher response rates for patients with MET-driven disease. So I think personally, hypothesis generating, we will likely be seeing more trials with durvalumab and savolitinib in MET-driven papillary renal cell carcinoma. Greg Guthrie: Thank you, again, Dr. Zhang. And Dr. Gilligan, we're going to talk about some testicular cancer research now, and the first study is, “Testicular cancer in the cisplatin era: causes of death and mortality rates in a population-based cohort.” Dr. Gilligan: So this study was looking at what happens with testicular cancer patients who are cured of their cancer, are they at risk of dying of other causes? They looked at over 5,000 men treated between 1980 and 2009, so it's important to recognize that some of the treatments given back then are a little different than the way they're given now. And it looked at the risk of death from causes other than testis cancer compared to men without testicular cancer in the general population, and the concerning finding from this study, and it's not the first study to report this, was that the risk of non-testicular cancer death, that is, death from other causes, was increased by about 28% in men who had been treated with radiation therapy and about 23% in men treated with chemotherapy. There's a risk of non-testicular cancer death, the risk, excuse me, was doubled in those whose treatment included both. So it was higher with either radiation or chemo and it was actually 100% higher or double than both those who had chemotherapy and radiation. As you got more chemotherapy, the risk went up. There was no trend towards the increase with just 1 or 2 cycles. We started to see the increase with 3 cycles, and it became statistically significant with 4 cycles. But there wasn't much difference between 3 and 4 in terms of the absolute number that was seen. In terms of death from other cancers, so why is this happening? Other cancers are a major issue after chemotherapy or radiation. Again, the risk was increased 60% after radiation therapy and 43% after chemotherapy, and those who got both, the risk of cancer was 3 times higher than the general population. So that's in men who had chemotherapy plus radiation therapy. Fortunately, there are not a lot of men who get both of those treatments anymore. Non-cancer deaths increased 17% after chemo and 55% of treatment included both. So the risk for non-cancer deaths was not as high as the risk for death from secondary malignancies. Interestingly, the risk of suicide increased 63% in men treated with chemotherapy. That's not affecting as many men as those other numbers, even though 63% number looks high, but it is a concern. Those treated only with surgery did not have an increased risk of non-testicular cancer death. What does this mean for patients? It really means when we can use surgical treatments instead of chemotherapy or radiation as an additional incentive to try do that, and what that may mean is there should be a larger role for retroperitoneal lymph node dissection as an alternative to chemotherapy or radiation therapy. Secondly, for patients getting chemotherapy, it's important to minimize the number of cycles of chemo as long as we're not sacrificing long-term cure rates, because the biggest risk of death is dying from the cancer, but that means limiting to the 3 cycles instead of 4 cycles is probably a good idea, and I think it's an argument to use 3 cycles of BPE instead of 4 cycles of EP because it's really the etoposide and the cisplatin that is linked to the secondary cancer risk, not the bleomycin, as far as we know. And then lastly, we need to pay attention to the mental health needs of men treated with chemotherapy. That there is more emotional distress and we're seeing here a higher risk of suicide.  Greg Guthrie: So our second trial is the, “SEMS trial: result of a prospective multi-institutional phase 2 clinical trial of surgery in early metastatic seminoma.” Dr. Gilligan: So if we're going to use more retroperitoneal dissection and less chemotherapy or radiation, 1 place to do that is in stage 1 and stage 2 seminoma, and many centers around the country have started doing that, and this was a trial that looked at that approach. So these are men who normally would be treated with chemotherapy, 3 cycles of BEP, or radiation therapy to the back of the abdomen and part of the pelvis potentially. This study looked at the small number of patients, 55 men, low volume, stage 2 seminoma up to 3 centimeters of size and maximum dimension. And what they reported of those men undergoing retroperitoneal lymph node dissection, 10 relapsed, so 18% relapsed after median follow-up of 24 months, they were all alive at the end of the study. No deaths. 8 of 10 relapses were treated with chemotherapy, and 2 were treated with additional [surgery]. Out of the 55 men, 8 ended up getting chemotherapy. Normally, all of them would have gotten either chemo or radiation. Relapse-free survival was 87%, overall survival was 100%. Seven (7) patients developed complications after RPLND and 5 of them were mild. Two (2) were more severe. So it's a well-tolerated treatment, if it's done at a large volume center, it's worth noting that the centers participating in the study were large volume centers. Again, if not treated with RPLND, all of these men would have gotten chemo or radiation. The relapse rate after chemotherapy or radiation is about 5%. So the relapse risk is higher after surgery, but in the sense, if we take 100 men with early stage 2 seminoma and do an RPLND instead of chemo or radiation, we can spare 80% of them the long-term effects of chemotherapy or radiation. Alternatively, if the priority is simply to prevent a relapse, radiation therapy and chemotherapy are more effective at that, the relapse risk being 5% but at the cost of long-term side effects from chemotherapy or radiation. Bottom line there is an additional treatment option for low volume stage 2 seminoma for men who prioritize avoiding the complications of chemotherapy or radiation therapy. Both of which are associated with an increased risk of death from other causes. The price we pay for that is the relapse risk is higher with RPLND compared to the other approaches. Not all centers are going to be offering this, but major centers that do a lot of testicular cancer, this is becoming a new treatment option. With the caveat that we have less experience with this approach. This is a relatively small study. And we have a lot more experience with chemotherapy or radiation. I don't think there's a one size fits all here, but I think patients should talk about it with their doctor. If they have early-stage seminoma, they should talk about surgery as an alternative to radiation or chemo. Greg Guthrie: Here we go. “Surveillance after complete response in patients with metastatic non-seminomatous germ-cell tumor.” Dr. Gilligan: So this study is looking at the question, if you take a man who has retroperitoneal lymph nodes that are enlarged and metastatic non-seminomatous testis cancer with lymphadenopathy in the back of the abdomen and you put them through chemotherapy and at the end, all retroperitoneal nodes are now within normal limits, normal size nodes, and no bigger than 10 millimeters or 1 centimeter, do we need to do a retroperitoneal lymph node dissection on those patients? Some centers recommend it and some don't. This looked at 388 men in that situation. They were put on surveillance. These men did not undergo the post-chemo RPLND. Two years survival, overall survival was 97.8%. Two-year progression-free survival was at 90%, 34 patients relapsed, and 10 of the men died. Men who did relapse had surgery, chemotherapy, or both as subsequent treatment. There's a prior similar study that was multicenter that had longer follow-up of 5 years, and they reported of ;161 men who had a complete response to the first-line chemo, 10 relapsed (that's 6%) and none died. If we combine these 2 studies together, the bottom line is you would have to perform a post-chemotherapy retroperitoneal dissection, which is a big operation, on about 550 men to prevent potentially at most 44 relapses and 10 deaths. We don't know if we would prevent or how many of those relapses and deaths we would prevent. But there's a lot of operations with a relatively low yield. In the future, we hope to have blood tests that will tell us which men need surgery. And even right now, we're close to the point that we have blood tests that will detect residual cancer. And the chance is we worry about residual cancer in these patients and we don't have the blood test to pick it up. But the bottom line is in the meantime, the preferred management strategy is surveillance rather than surgery for most men. There's some men for whom RPLND may make sense in the center in this setting and some centers that will probably continue to recommend it for most men. I think this data really casts doubt on whether we ought to be doing this operation in these men as a routine practice as opposed to an exceptional practice for men who have particular characteristics. Thank you. Greg Guthrie: Thank you, Dr. Gilligan. And now we can move on to answering some questions. What is the average time expected to see a decline in PSA in patients treated with lutetium-177 PSMA? Dr. Agarwal: I think this a great question and I think we're waiting for the manuscript published to go through the nuances of those data. Right now, what Dr. Michael Morris from Memorial Sloane-Kettering presented were the high-level data on pre-survival and overall survival and some secondary endpoints. We are anxiously waiting the full data in the form of a manuscript. And until then, I will not be able to answer that question. I would like to add that usually the median time, if you look at how -- for how long patients were receiving lutetium, it was 5 to 6 months. If I -- if my recollection is correct. Greg Guthrie: Is radiation required prior to initiating chemo if there's tumor presence? And Dr. Gilligan, you responded. “We rarely use radiation therapy for testicular cancer at this time. Sometimes it is used for stage 1 or stage 2 seminoma as primary treatment instead of chemotherapy.” And I'll just read these aloud for our viewers here. If a patient has both prostate and bladder cancer, how do you decide which therapy should take priority, also, is the CPS typically included on the biopsy report? And Dr. Grivas, you responded, which I'll read here. “This is a bit of a complicated scenario that requires detailed discussion with a urologist and medical oncologist. Regarding CPS, the possible role is only in the first-line setting of metastatic disease to help somewhat decide between chemotherapy followed by avelumab maintenance and immunotherapy. However, it's not a perfect biomarker and not part of the pathology report, it's a special test that requires specific ordering.” I have a question for you, Dr. Zhang. Why do combination treatments seem to work better in kidney cancer? Wouldn't you have more side effects because you're taking 2 drugs at the same time? Dr. Zhang: It's an interesting question. You know, our immunotherapy backbones seem to have good treatment benefit for these immune responsive diseases. The VEGF inhibitors that blocked blood vessel formation for many of our patients with clear cell kidney cancer, they tend to have an immunomodulatory role, so if we normalize blood vessels in the tumor microenvironment, the thought is that the T cells and immune cells can actually get into that space more readily. And so many of these blood vessel blockers are hypothesized to have increased immunomodulatory times of behaviors and the combination actually can be more effective than either agent alone, and we've certainly seen that in practice and really excited to see these combination strategies thrive and be standard of care for our patients now and first-line treatment. For the side effect question, you know, I do think that sometimes we do have to tease out which of the side effects is related to the oral treatment, the blood vessel blocker versus the immune therapy. But it's often experienced oncologists who are able to manage these side effects. We can try to tailor and see which of the side effects is due to which treatment and how to reduce or hold treatments when necessary. Greg Guthrie: Great. I just got a follow-up question for you, Dr. Zhang. Are there any studies for papillary type kidney cancer with sarcoma? Dr. Zhang: I would assume you're asking about sarcomatoid renal cell carcinoma within papillary, so for papillary type of kidney cancers, there are ongoing studies. For example, with FH mutations and FMH loss. For sarcomatoid disease, this is a special type of histology that can occur with any of our actual histologies of kidney cancer. And we know from our phase 3 trials in clear cell sarcomatoid renal cells that these tend to respond to the immunotherapy combinations. And so I would urge using an immune therapy combination in patients who had sarcomatoid renal cell carcinoma. Greg Guthrie: Dr. Agarwal, here is a question for you. There were several studies in here that showed many patients did not receive combination ADT with other novel therapies, which you describe as the standard of care, including the one you discussed. Is this something that patients should proactively bring up with their doctors? Dr. Agarwal: Fantastic question. I'm so glad you asked. The answer is yes: It is our responsibility as physicians and providers, but it doesn't hurt if our patients are educated and challenge us in our decision-making. It is a shared decision-making, it is not the doctor's decision. In my view, it's the patient's decision with help from the doctors. So, yes, please go do it. Doctors usually welcome that. Greg Guthrie: Great. Dr. Grivas: I see one for Dr. Gilligan about surveillance imaging that just popped up. [Is there any data on the benefits vs. risks for imaging based surveillance (CT, MRI, none) for longer-term follow-up periods (e.g. 2+ years)?] Dr. Gilligan: Yeah, they're asking whether there's data on benefit versus risk for imaging-based surveillance and it's actually a very timely question in the sense that we're starting to get data that MRI is very accurate for this. And may likely become a substitute for CT scans at some point in the future. This is something we talk about a lot in terms of surveillance for testicular cancer patients, can we switch to MRI from CT because CT has ionization that can cause other cancers, and MRI does not. The good news is it looks like with current CT scanning, which is lower dose than older CT scanning, the risk of cancer from the CT scan seems really miniscule. Ultimately, it would be great to get it down to 0 and not do them, but we're still doing them. The switch to MRI is being held up by the fact that when you go in and get an imaging study for surveillance, your scans get looked at by a radiologist and also by the oncologist and all of us who do a lot of testicular cancer have multiple stories of catching stuff that the radiologist missed, and they also catch stuff that we miss. It goes both directions, and we're having 2 different people read the films to get a more accurate read. With MRI, most oncologists are not competent to read an MRI well and some radiologists are not great, and the centers where they have excellence have shown that MRIs are just as good as CT scans if read by fully qualified people. And the concern is: are they going to be skillfully read? So the switch to MRI will happen in the future, and I have spoken with people very recently about this that are practicing around the country and the people I talked to were not ready to make the switch because of the concern that stuff might get missed. And I think we can be reassured with the modern lower-dose CT scans, the risk seems to be quite small, and I look forward in the future to making that switch at some point.  Greg Guthrie: And I think that's going to be our last question this afternoon. Thank you to all our participants for sharing this great research with us, as well as your expertise, it's been a real pleasure on this live webinar here. ASCO: Thank you Dr. Agarwal, Dr. Grivas, Dr. Zhang, and Dr. Gilligan.  You can find more research from recent scientific meetings at www.cancer.net. And if this podcast was useful, please take a minute to subscribe, rate, and review the show wherever you listen to podcasts. This Cancer.Net podcast is part of the ASCO Podcast Network. This collection of 9 programs offers insight into the world of cancer care, covering a range of educational, inspirational, and scientific content. You can find all 9 shows, including this one, at podcast.asco.org. Cancer.Net is supported by Conquer Cancer, the ASCO 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/donate. This presentation is provided solely for informational purposes. The ideas and opinions expressed in this presentation do not necessarily reflect the views of the American Society of Clinical Oncology (ASCO) or its affiliates. The mention of any product, service, or therapy in this presentation should not be construed as an endorsement of any product, service, or therapy mentioned. The information herein does not constitute medical or legal advice, and is not intended for use in the diagnosis or treatment of individual conditions or as a substitute for consultation with a licensed medical professional. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of the presentation or any errors or omissions. © ASCO 2021, all rights reserved.

Increasing diversity and equity in clinical trials will require buy-in and commitment from all stakeholders in the research enterprise. In this episode, Colleen Lewis, MSN, ANP-BC, AOCNP, talks about the critical role oncology advanced practitioners can play in moving the needle on equity and inclusion in cancer clinical trials. In spring 2021, ACCC and Harborside hosted a Virtual Summit to Define on the Role Oncology Advanced Practitioners in Equitable Cancer Care Delivery. Each summit session focused one specific domain of care delivery—Care Coordination and Communication; Clinical Trials; and Acknowledging and Mitigating Implicit Bias. Look for more on the Summit findings coming soon to the ACCC website. Guest: Colleen Lewis, MSN, ANP-BC, AOCNPDirector of Clinical Operations, Phase I Program;Interim Director, Infusion Center CliftonThe Winship Cancer Institute of Emory University Related Content: ACCC Community Oncology Research InstituteASCO-ACCC Initiative to Increase Racial and Ethnic Diversity in Clinical TrialsReal World Lessons from COVID-19 [Video Podcast]Ep 52: End of Life Disparities [Podcast]Ep 51: Cultural Humility and Sensitivity [Podcast]Ep 49: Building Trust with Marginalized Groups [Mini-Podcast]In Pursuit of Equity: Diversity in Clinical Research Participation [Webinar]Practical Solutions to Better Engage Cancer Professionals with Communities of Color [Webinar]Implementation of a Health Disparities & Equity Program at the Duke Cancer Institute,Paving the Way for APPs in Clinical Research[Abstract 95] Role of Oncology Advanced Practitioners to Enhance Clinical Research  Research Review: Making Clinical Trials More Inclusive, Diverse, Accessible, and RepresentativePhase 1 Clinical Trials in the Elderly: Enrollment ChallengesBias and stereotyping among research and clinical professionals: perspectives on minority recruitment for oncology clinical trials  

melissa@blendedfamilypodcast.com www.blendedfamilypodcast.com   Kristin MacDermott is a licensed marriage and family therapist with a decade of research in resilience. Her resilience-training programs have been validated in four studies with researchers from the Duke Clinical Research Institute, published in peer-reviewed journals, and proven to improve key mental health and resilience outcomes, including anxiety, depression, distress, self-efficacy, and PTSD. Kristin has designed resilience-training programs for some of the highest-performing people on the planet, including Navy SEALS and the LAPD. Her programs have been used in more than 20 hospitals across the country, including at the Duke Cancer Institute and the National Institutes of Health. She has also designed programs for schools, corporations, non-profits, and mentors who support at-risk kids. Kristin is the author of It Takes Two Minutes to Shift Your Mindset and Build Resilience, a book that breaks resilience down into bite-size skills you can apply to your life immediately. She has recently launched two online courses for parents, one called Resilience-Based Parenting and the other called Parenting Through Divorce. She has a private practice in Palm Beach Gardens, Florida where she lives with her husband of 28 years and her three children. In this interview we discuss Her personal story Why conflict resolution and resiliency work well together The MacDermott Method, Kristin's unique practice Conflict between co parents and tips on managing it Why it's important to get your own needs met How to stay calm in conflict Teaching our children conflict resolution Kristin's offerings And much more! Connect with Kristin Website Facebook Instagram LinkedIn Twitter   Connect with me Join the Private Facebook Group Connect with me on Facebook Schedule an interview or coaching session HERE Send questions or feedback to melissa@blendedfamilypodcast.com Send me a voicemail at Speakpipe Visit the website at www.blendedfamilypodcast.com Sign up for my monthly newsletter Listen and Rate/Review on Itunes   Affiliate   Living the Good Life Naturally To receive discount, use promo code BLENDED                  

Julie Drew lost her husband to brain cancer. A grieving wife and mother - just 10 months later, she was diagnosed with breast cancer. Subscribe to the audio version of the Summits Podcast https://summitspodcast.fireside.fm Find out more about the Heroes Foundation https://www.heroesfoundation.org Find out more about The Brookfield Group https://thebrookfieldgroup.com Discover Platform 24 co-working https://www.platform24.co What's your cancer story? Hosted by cancer survivor and philanthropist Vince Todd, Jr., Chairman and Co-Founder of the Heroes Foundation, and Heroes Foundation Board Member Daniel Abdallah, the Summits Podcast is a place for people to share their stories. Everyone has a cancer story. From battling a deadly disease to caring for a loved one, when we rise up and face life's greatest challenges, we see with a new vision, feel with a greater passion, and think with a deeper perspective. Along the way, paths cross, journeys intersect, and missions converge. For Vince Todd, it was his own cancer diagnosis that led him and his wife, Cindy, to launch the Heroes Foundation to provide meaningful support to cancer patients, education to promote cancer prevention, and resources to advance research for a cure. What started with friends and family grew into a community. The Summits Podcast is an extension of that community. Our stories are what bring us together. Artists, athletes, doctors, business people - we're all family members, community leaders, and activists. Everyone has a story. Anyone can inspire. No one battles alone. Join the conversation. Let's climb the summit together.

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 clinical trials described here may no longer be enrolling patients, and final results are not yet available.  Before any new cancer treatment can be approved for general use, it must be studied in a clinical trial in order to prove it is safe and effective. In today’s podcast, members of the Cancer.Net Editorial Board discuss 3 clinical trials that are exploring new treatment options across kidney, bladder, and prostate cancer. This podcast will be led by Dr. Timothy Gilligan, Dr. Tian Zhang, Dr. Petros Grivas, and Dr. Neeraj Agarwal. Dr. Gilligan is an Associate Professor and Medical Oncologist at the Cleveland Clinic Taussig Cancer Institute. He has no relevant relationships to disclose. Dr. Zhang is an associate professor of medicine at Duke University School of Medicine and is a medical oncologist at Duke Cancer Institute. She has served in a consulting or advisory role for Bristol-Myers Squibb and Merck, and has received research funding from Astellas Pharma. Dr. Grivas is the clinical director of the Genitourinary Cancers Program at University of Washington Medicine. He is also an associate member of the clinical research division at the Fred Hutchinson Cancer Research Center. He has served in a consulting or advisory role for Bristol-Myers Squibb and Merck. Dr. Agarwal directs the Genitourinary Oncology Program at the Huntsman Cancer Institute at the University of Utah. He has served in a consulting or advisory role for Bristol-Myers Squibb, Merck, and Astellas Pharma. View full disclosures for Dr. Gilligan, Dr. Zhang, Dr. Grivas, and Dr. Agarwal at Cancer.Net. Dr. Gilligan: Hi. I'm Dr. Timothy Gilligan from the Cleveland Clinic Taussig Cancer Institute. I'm joined today by Dr. Tian Zhang from the Duke Cancer Institute, Dr. Petros Grivas from the University of Washington and Fred Hutchinson Cancer Research Center, and Dr. Neeraj Agarwal from the Huntsman Cancer Institute and University of Utah. Today, we're going to discuss 3 ongoing clinical trials in kidney, bladder, and prostate cancer. As you may know, clinical trials are the main way that doctors are able to find better treatment for diseases like cancer. Patient participation is vital for clinical trials. By participating in the clinical trial, you can directly help researchers develop better treatment, reduce side effects, or even reduce the risk of cancer altogether. The 3 trials we'll discuss today were chosen by members of the Cancer.Net Editorial Board Genitourinary Cancers panel from the Trials in Progress abstracts that were presented at ASCO's 2020 Annual Meeting. Because these are ongoing clinical trials, final results from these studies are not available yet. I'd like to note that none of us have any direct involvement with any of these trials. To view our full disclosures, please view the show notes for this episode on Cancer.Net. We're going to start with Dr. Zhang discussing the trial CheckMate 914. Why don't we begin with who the study is designed for? CheckMate 914 is a study in the adjuvant setting, so it's a study after patients have had their primary kidney cancers removed, and everybody needs to have a kidney tumor that's either 7 centimeters or larger or have extension beyond the kidney or any nodal involvement. So after their kidney tumors have been removed, this study really is in that timeframe after nephrectomy or after surgery with complete resection of their tumor. Dr. Gilligan: What's the current standard of care for these patients if they're not on a trial like this? Dr. Zhang: We often will compare against that standard which currently in the adjuvant setting we either do observation until disease recurrence or there is 1 oral treatment that's approved called sunitinib. But sunitinib really has some controversial data around it, and so it's not often used. And so currently, many patients are still observed as standard of care in the setting. Dr. Gilligan: And so if a patient goes on this trial, what can they expect?   Dr. Zhang: So patients who are enrolled to CheckMate 914 are randomized to either a combination immunotherapy called ipilimumab with nivolumab, which is approved in the metastatic setting for kidney cancer, or they're placed on placebo for these 2 treatments, or there is a third cohort that receives nivolumab alone with a placebo of ipilimumab. And so these patients are receiving either active immunotherapies or a placebo, which would be our current standard of care, sort of observation until disease recurrence. Dr. Gilligan: So patients will either get the current standard, which is observation, or else they'll have 1 drug or 2 drugs if I'm understanding correctly? Dr. Zhang: That's right. Dr. Gilligan: What is the hope of this study? What is the outcome that we're hoping to see? Dr. Zhang: The primary outcome of this study is disease-free survival, so that means time until disease recurrence for all comers. And we're really trying to prolong time until disease recurrence or time until metastasis for these patients. There are some secondary outcomes that are very important as well, so prolonging overall survival as well as the incidence of adverse events that are seen from these treatments. And then there is an independent radiographic assessment to look for disease-free survival intervals as well. Dr. Gilligan: And the hope is that these treatments will prevent recurrence or at least delay recurrence then? Dr. Zhang: That's absolutely correct, yes. And we have had 2 other adjuvant trials with immunotherapies in this space of atezolizumab and pembrolizumab, but those trials have finished accruing. And so this is the main ongoing and accruing trial that's looking at active immunotherapy options in this space. Dr. Gilligan: What risks should patients be aware of that they might encounter if they go on this treatment? Dr. Zhang: So with all immunotherapies, we talk a lot about the immune mediated adverse events and just the usual rundown of those. And in my clinic, we talk a lot about the common rashes. In the GI tract, it can cause some inflammation or colitis. Very rarely, it can cause some inflammation in the lungs or liver and then very commonly, endocrine dysfunction. So we watch pituitary, thyroid, adrenal, and pancreas function very carefully. But all of these side effects are well described for the ipilimumab, nivolumab combinations as well as nivolumab on its own in the metastatic setting. So most people should know what to monitor for and what we're looking out for and how to manage these toxicities. Dr. Gilligan: Right. So these are drugs that have been in wide use for some years now, so we have significant experience managing the side effects is what I'm hearing you say. Dr. Zhang: That's right. Dr. Gilligan: Is this trial still open to patients? Dr. Zhang: Yes. This trial is still accruing. It's a global study about to enroll up to 1,600 patients. So it's a very large global trial that is still active and still accruing patients. So I would encourage people and also oncologists to refer patients for the trial at a center close to them if possible. Dr. Gilligan: And when might we expect results for a study like this? Dr. Zhang: These adjuvant studies take a while to finish accruing and then it takes a while to finish seeing the data. So I would hazard a guess that we're still years away from seeing the data from this trial. Dr. Gilligan: So once again, this is for people who have had surgery to remove a kidney cancer and looking at ways to reduce the risk of subsequent relapse. Well, thank you for summarizing that so coherently and succinctly. Let's move on now, and we're going to talk about the trial KEYNOTE-992 with Dr. Grivas. Dr. Grivas, who is this study designed for? Dr. Grivas: So this is a clinical trial, a phase III clinical trial that applies to patients who opt to pursue what we call bladder preservation, which is an attempt to keep the bladder intact and still try to treat bladder cancer with concurrent use of chemotherapy and radiation. And this bladder preservation approach applies to a proportion of patients with bladder cancer still in the bladder but not spread. And as I mentioned before, the decision to pursue that strategy depends on particular patient characteristics, how the cancer looks on the CAT scans, and also how it looks under the microscope. Dr. Gilligan: What is the current standard of care for these patients? Dr. Grivas: So patients who are characterized as great candidates for this bladder preservation approach, because this does not apply to everybody with bladder cancer, the standard of care right now is patients undergo what we call a transurethral bladder tumor resection, which means that the urologists go through the urethra and they resect or remove or scrape, remove the visible bladder tumor, and then the patients undergo concurrent, meaning at the same time, chemotherapy and radiation. Dr. Gilligan: How does the study aim to improve or change the standard of care? What would be different as a result of the study if it's successful? Dr. Grivas: So this particular clinical trial, the KEYNOTE-992, is asking the question whether the addition of immunotherapy with 1 of those immune checkpoint inhibitors that activates the immune system, does this addition add value in the combination of chemotherapy and radiation? So the patients are being randomized by a computer system to either getting chemotherapy-radiation, as is the standard of care that we just discussed, or chemotherapy plus radiation which is standard of care, plus the addition of this drug called pembrolizumab, which is an immunotherapy aiming to activate the immune system. Dr. Gilligan: And it's given at the same time as the chemotherapy and radiation on the study? Dr. Grivas: That is correct. It's given at the same time. And then there is also some—what we call continuation of pembrolizumab for some time after the end of chemotherapy and radiation, and pembrolizumab in this study is given every 6 weeks. Dr. Gilligan: And what makes people think that this might be helpful to add this additional treatment? Dr. Grivas: The notion is that the addition of immunotherapy to chemotherapy-radiation therapy has the potential to make the chemotherapy, radiation therapy work better. What happens sometimes when you give chemotherapy-radiation, this can actually result in a killing of some cancer cells and the contents of those cancer cells can be released, and they may be recognized by the immune system and stimulate the immune response. So if you combine that chemotherapy and radiation with immunotherapy with this agent that stimulates the immune system, the assumption is that this may work better compared to chemotherapy and radiation alone. But we have to do this trial to confirm whether this is true or not. Dr. Gilligan: So patients going on the study, basically, either they'll get the standard of care, which is the chemotherapy and radiation, or the standard of care plus the addition of immunotherapy to see if that results in better outcomes. Am I understanding that correctly? Dr. Grivas: That's exactly right. And the outcomes are being measured by how many patients maintain the bladder intact, in place without the need to remove it, without the need for cystectomy. And also, at the same time, we want to see if those patients can maintain a cancer-free status, so whether the treatment results in a cancer-free state and whether we are measuring a recurrence as Dr. Zhang mentioned before, if the cancer comes back. And also, of course, we measure how many patients are alive over time. So the goal is to see if we can improve upon the rate of patients with no cancer coming back, no recurrence, and being able to keep the bladder intact if possible. Dr. Gilligan: So for both of these trials, the question seems to be if we intensify treatment, can we increase the cure rate and keep patients cancer-free longer? Dr. Grivas: That's exactly right, and that's the promise or the assumption of this trial, whether the addition of immunotherapy to chemotherapy and radiation can improve those chances. Dr. Gilligan: What are the known risks that patients should be aware of? Dr. Grivas: As Dr. Zhang mentioned before, every time we have the immunotherapy in clinical trials or in clinical practice, we have to do a good job educating, of course, all the medical providers, team members, and the patients for early recognition and reporting of what we call immunotherapy-related potential side effects. And as we discussed earlier, any organ of the immune system could be a target of an activated immune system. The reality is that if the side effects from immunotherapy happens, usually it's a mild to moderate degree and usually can be managed by holding of the immunotherapy drug and maybe sometimes give some steroids to cool down the immune system. Obviously, we need to be extra vigilant, and I always err on the caution of overeducated patients to avoid underreporting so we make sure we know ahead of time if a side effect happens. Dr. Gilligan: Is there any reason to be worried that immunotherapy could make the side effects of chemotherapy and radiation worse? Dr. Grivas: It's a great question, and we have to look in that during the course of the trial. The notion is so far, based on the available data, that it's safe to combine chemotherapy, radiation, and immunotherapy. There have been some early data suggesting that, and this is reassuring. At the same time, we need, again, to be extra vigilant, again, over-educating our patients to report any changes so we can be able to compare the potential side effects in the 2 groups. But so far, it seems to be a feasible strategy. Dr. Gilligan: Good. And is this trial still open for patients? Dr. Grivas: Yes, it is open and accruing patients actively, and I think it's a great opportunity for patients to discuss with their providers, urological oncologists, medical oncologists, radiation oncologists, whether they could be good candidates for this bladder preservation approach, if that's a good fit for them and the particular cancer at hand, and if so, whether they can be candidates for this trial or another trial called SWOG 1806, which is in the same space and setting. Dr. Gilligan: And when might we expect results from the study? Dr. Grivas: It may take time because this trial is still early in the accrual process. It may take a few years. The current estimate is probably 2026, so 5 years from now. However, the faster these trials accrue, maybe the faster is to have the results. So this might have been overestimation, but it depends with how quickly the study will accrue patients. It's a very exciting study and definitely, I encourage patients to discuss this and the SWOG 1806 with their providers. Dr. Gilligan: Thank you very much. We're going to move on now, and Dr. Agarwal will tell us about the KEYNOTE-991 study. Dr. Agarwal, who is this study designed for? Dr. Agarwal: This is a study which is designed for patients with newly diagnosed metastatic castration-sensitive prostate cancer. In simple words, this is for those patients who have been diagnosed to have a prostate cancer which has gone to different parts of the body. Dr. Gilligan: And what's the current standard of care for these patients if they don't go on the study? Dr. Agarwal: Fortunately, the current standard of care has gone through a paradigm shift in the last 5 to 6 years. It started with chemotherapy with docetaxel being approved for these patients in 2014 with 2 positive clinical trials showing benefit for docetaxel chemotherapy as far as improvement of survival is concerned. After that, 3 more drugs known as novel androgen axis inhibitors, so deeper blockade of androgen pathway, which is a driver behind prostate cancer progression. So these 3 drugs, abiraterone, or also known as Zytiga, enzalutamide, also known as Xtandi, and apalutamide, also known as Erleada. These 3 drugs and chemotherapy are currently approved agents for our patients with newly diagnosed metastatic prostate cancer. Dr. Gilligan: And what is this study looking at to potentially change that or to add another option? Dr. Agarwal: So this study is using the backbone of androgen deprivation therapy, which is standard testosterone suppression therapy, plus enzalutamide or Xtandi. And then patients who are receiving the standard of care therapy with standard testosterone suppression therapy, plus enzalutamide, they will be randomized to pembrolizumab versus placebo. Pembrolizumab is an approved immunotherapy for multiple cancer types and pembrolizumab, also known as Keytruda, works by activating our immune system to fight against cancer cells. In a way, this study is actually testing whether addition of this novel immunotherapy pembrolizumab to existing regimen of androgen deprivation therapy plus enzalutamide is going to improve survival outcomes. Dr. Gilligan: What do we know about immunotherapy and prostate cancer? Dr. Agarwal: So far, immunotherapy, as we call them, immune checkpoint inhibitors, many of them are approved for multiple cancer types. They have not been successful as single agents in the context of advanced prostate cancer. So this is a trial which is testing whether immunotherapy, the pembrolizumab is going to be effective in combination with enzalutamide and testosterone suppression therapy. Dr. Gilligan: So patients will get the standard of care therapy either way. And then the question is, does adding immunotherapy make it even more effective than it is without it? Is that correct? Dr. Agarwal: That's true. The primary end points of the trial are overall survival and radiographic progression-free survival, which basically means the investigators are going to look for improved survival, overall survival, and delaying of disease progression by adding pembrolizumab. Dr. Gilligan: And we've already discussed the risks of immunotherapy on the previous 2 trials, but can you tell us again for patients who are particularly interested in this study what risks should they be aware of? Dr. Agarwal: So pembrolizumab belongs to a class of drugs known as PD-1 or programmed death 1 receptor inhibitor. Usually, this class of drug, as a class, these are highly well-tolerated drugs and only a small number of patients, I would say less than 5% of patients, would develop grade 3 or 4 side effects which will require treatment with corticosteroids like prednisone. And those side effects usually happen when these immune checkpoint inhibitors are able to activate the immune system beyond desired limits. And when the immune system is activated to very high levels, the immune system can attack our own body and can result in diarrhea, skin rashes, liver enzyme abnormalities, and if not controlled in time can lead to hepatitis, which is inflammation of the liver, inflammation of the lungs causing pneumonitis or cough, dry cough mostly. So these are the common grade 3, 4 side effects which happen in up to 5% of patients with pembrolizumab.   Dr. Gilligan: Just for our listeners in case they're not familiar, when you talk about grades 3 and 4 toxicities, what should they understand that to mean? Dr. Agarwal: In simple words, I would say grade 1 and 2 side effects are the ones which do not require any systemic therapy with steroids. Patients can go on with their daily activities without much problems. And mostly, these are controlled with medications which are over-the-counter. Even if we use prescription medicines, they're usually not able to affect the patient's overall lifestyle or quality of life. So these are the side effects which are pretty easily manageable mostly with over-the-counter drugs, symptomatic drugs, and patients lifestyle and quality of life are usually not affected by the side effects. And grade 3 and 4 side effects are those which require intensive therapy, in this context, with prednisone or corticosteroids sometimes requiring hospitalization and requiring multidisciplinary care with other specialists who are specializing in gastroenterology or pulmonology or on many other specialties. So that's how I would like to simplify the definition of grade 1, 2 versus grade 3, 4 side effects. Dr. Gilligan: That's great. Thank you very much. Is the trial still open for accrual? Can patients still go on it? Dr. Agarwal: Yes. Yes. Trial actually just opened for accrual, which is good news for our patients. And I would like to highlight that patients who have been diagnosed with newly diagnosed metastatic prostate cancer and they have started hormonal therapy like androgen suppression therapy, they still have 3 months to enroll in the trial. So if you have been diagnosed with metastatic prostate cancer and if you have started the treatment with testosterone blockade therapy, you can still go on the trial. You have 3 months to go on this clinical trial. And if you have started chemotherapy with docetaxel, which is a standard of care for our patients with this diagnosis, you can still go on the trial after receiving up to 6 cycles of chemotherapy with docetaxel. So this trial allows actually patients to go on the trial for up to 3 to 6 months after being diagnosed with metastatic prostate cancer. Dr. Gilligan: So that's very helpful to know. At the conclusion of chemotherapy, they would then start the enzalutamide and either the pembrolizumab or placebo? Dr. Agarwal: That's correct. Dr. Gilligan: Well, great. And when do we expect to see results from the study? Dr. Agarwal: So as we know this, which is great news for our patients, survival has gone up by almost 2 to 3 fourths over the last 10, 15 years, and in this disease setting, any trial takes up to 5 to 6 years to show results. So I estimate based on the available information on the ClinicalTrials.Gov website, the trial is scheduled to finish in 2026. Dr. Gilligan: I see. Well, great. So thank you very much. Thank you all 3. That's hopefully a helpful summary of these 3 important new trials. Dr. Agarwal: Yes, it's a pleasure to be here, Tim. Dr. Grivas: Thank you so much. Dr. Gilligan: Thank you. Thank you for listening to this podcast. There are many different clinical trials currently enrolling people with genitourinary cancers. If you're wondering whether participating in a clinical trial might be right for you, please talk to your health care team. ASCO: Thank you, Drs. Gilligan, Zhang, Grivas, and Agarwal. Visit www.cancer.net/clinicaltrials to learn more about participating in clinical trials. All treatments have side effects—please talk to your health care team about possible side effects to watch out for. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play.

This podcast is all about you! We’re sharing our conversation with resilience and emotional intelligence expert Kristin MacDermott who says anyone can learn resilience, emotional intelligence and conflict management and she shows us how. She is the founder and President of the MacDermott Method, which provides resilience-based resources for individuals and organizations. She is a licensed marriage and family therapist with over a decade of research in resilience. Her resilience-training programs have been validated in four studies with researchers from the Duke Clinical Research Institute, Duke Cancer Institute and the National Institutes of Health. They have also been published in peer-reviewed journals, and her methodology has been shown to improve key mental health and resilience outcomes, including anxiety, depression, distress, conflict management and PTSD.  We think you’ll agree she part of the Crazy Amazing Humans (CAH) tribe because she has taken her expertise and applied it to help others by designing resilience-training programs for some of the highest-performing people on the planet and beyond; including Navy SEALS, LAPD, schools, corporations, non-profits, and mentors who support at-risk kids. Kristin is the co-founder of Pathfinders, an Aspen-based nonprofit dedicated to improving the lives of people living with cancer as well as those experiencing grief. She also helped start Zero Hour Expeditions, a nonprofit that helps combat veterans reintegrate into civilian life and overcome the effects of PTSD by experiencing 30-day wilderness trips.  Kristin is the author of It Takes Two Minutes to Shift Your Mindset and Build Resilience, a book that breaks resilience down into bite-size skills you can apply to your life immediately. She has recently launched two online courses for parents, one called Resilience-Based Parenting and the other called Parenting Through Divorce. She has a private practice in Palm Beach Gardens, Florida where she lives with her husband of 28 years and her three children. Tune in and have fun listening! Please feel free to share it with anyone you know who would benefit from this episode. Remember that every small kindness has the potential to create a Crazy Amazing Human experience, one person at a time. You have the power to create that every day. And we, at Crazy Amazing Humans, are in your corner, we’re rooting for you, and really appreciate you as part of our community and we think YOU are crazy amazing! Subscribe to Our Newsletter: https://bit.ly/3hGk32N Our Linktree: bit.ly/CAHLinktree Be Part of the Crazy Amazing Humans Community: Instagram: https://bit.ly/2Zkk06V Facebook: https://bit.ly/2ZpA2wq Website: https://bit.ly/2Zqypyi Twitter: https://bit.ly/2ZnCymMWebsite: http://www.katrinacarlson.com iTunes: https://itunes.apple.com/us/artist/katrina-carlson/3563718 Facebook: https://www.facebook.com/katrina.carlson/

From unethical experimentation to systematic exclusion, racism has played a terrible role in the development of American healthcare. On this mini-podcast, we discuss how the legacy of clinical trials continues to affect today’s research, and share strategies for cancer programs to effectively communicate with underrepresented and marginalized populations. Guest: Christopher Lathan, MD, MS, MPH, Medical Director, Dana-Farber Cancer Institute at St. Elizabeth's Medical Center; Associate Medical Director, DFCI NetworkRelated Content:Mini-Podcast: Building Trust with Marginalized GroupsBuilding Trust with Patients: Importance of Cultural Competence in Cancer Care Delivery (webcast)Community Outreach to Address Disparities in Cancer CareEating the ElephantImplementation of a Health Disparities & Equity Program at the Duke Cancer Institute, by Nadine J. Barrett, PhD, MA, MS, et al.Research Review: Making Clinical Trials More Inclusive, Diverse, Accessible, and RepresentativeThe views and opinions expressed herein are those of the author(s)/faculty member(s) and do not reflect the official policy or position of their employer(s) or the Association of Community Cancer Centers.

After a few weeks of a much needed break, Dana and Jessica were ready to roar when they got back in the studio.  From coin carvings to plastic money from Canada, we have all the unnecessary info you never knew you needed.  Would you drive back to a restaurant if they made a mistake with your order and excluded the thing you craved the most?  Or do you hyper organize to the point where you can no longer find the very thing you put away so you would have no issue finding it?  What the What Corner features a man who hid in one of the busiest airports in the world for 3 months.  Weirdo of the Week is a bloke who lived as a naked fugitive in a crocodile infested area.  Rant #1 is Caring House, a non profit in North Carolina that provides comfortable, supportive and affordable housing to patients undergoing treatment at the Duke Cancer Institute.  Rave #2 is Pandemic of Love, a mutual aid community of care that connects people in need with patrons who can help with that need, that was started in response to the Covid 19 epidemic.  Caring House - https://caringhouse.org/ Pandemic of Love - https://www.pandemicoflove.com/  

In healthcare, Implicit and unconscious bias can manifest in many ways. On this mini-podcast, discover what steps cancer programs can take to build trust with patients from marginalized and underrepresented groups and ensure a more equitable and accessible healthcare environment.Guest: Nadine Barrett, PhD, MA, MS, Director, Office of Health Equity and Disparities, Duke Cancer Institute; Director, Duke Community Connections Core, Duke CTSARelated Content:Community Outreach to Address Disparities in Cancer CareEating the ElephantImplementation of a Health Disparities & Equity Program at the Duke Cancer Institute, by Nadine J. Barrett, PhD, MA, MS, et al.Research Review: Making Clinical Trials More Inclusive, Diverse, Accessible, and RepresentativeUnconscious Bias Resources for Health Professionals, Association of American Medical CollegesImplicit Association Test, Harvard UniversityThe views and opinions expressed herein are those of the author(s)/faculty member(s) and do not reflect the official policy or position of their employer(s) or the Association of Community Cancer Centers.

Carla Tardif, CEO and founder of Family Reach, as well as Yousuf Zafar, MD, Chief Quality and Innovation Officer at Duke Cancer Institute—who also works with the charity—joined me on the podcast to discuss the pandemic, COVID's impact on cancer treatments, and the other big problem with cancer that doesn't get as much attention: the often insurmountable financial burden the disease places on patients and their families. 

We are looking at 2020 in our rear-view mirror, but we’re still in the thick of COVID.  With lockdowns, social distancing, virtual work and online schooling, some of us are experiencing higher levels of stress and finding both parenting and leadership challenging.  On this episode of Authentic Living with Roxanne, we welcome Marriage and Family Therapist, Kristin MacDermott to share some of her ideas about how resilience can help to improve relationships with your kids, spouse, family and team members.      Quote: “The root of most interpersonal conflict is unmet needs.”  Kristin MacDermott Kristin is a licensed marriage and family therapist with a decade of research in resilience. Her resilience-training programs have been validated in four studies with researchers from the Duke Clinical Research Institute, published in peer-reviewed journals, and proven to improve key mental health and resilience outcomes, including anxiety, depression, distress, self-efficacy, and PTSD. Kristin has designed resilience-training programs for some of the highest-performing people on the planet, including Navy SEALS and the LAPD. Her programs have been used in more than 20 hospitals across the country, including at the Duke Cancer Institute and the National Institutes of Health. She has also designed programs for school, corporations, and non-profits that support at-risk kids. Authentic Touch Points: Scale it down to make it accessible.  2:00 Unplug to find your inner wisdom.  6:00 Use resilience to build relationships.  10:30 Have meaningful conversations.  15:00 Teach your kids responsibility early.  20:15 Resiliency strategies for parenting.  25:30 COVID is affecting everyone!  30:00 Ask what others’ need.  33:00 Kristin is the author of It Takes Two Minutes to Shift Your Mindset and Build Resilience, a book that breaks resilience down into bite-size skills you can apply to your life immediately. She has recently launched two online courses for parents, one called Resilience-Based Parenting and the other called Parenting Through Divorce. She has a private practice in Palm Beach Gardens, Florida where she lives with her husband of 28 years and her three children. With many of us working from home and feeling the pressure of the pandemic, I encourage you to reach out with thoughts or questions about creating a healthier mindset.  Click here to contact me at your convenience or click here to book a complementary call with me.   You can find more information about me and how I can help you live a more authentic and resilient life at RoxanneDerhodge.com Thank you, Roxanne Links: Kristin’s website:  https://www.macdermottmethod.com/ Kristin’s Special Offer and Free ResourcesKristin’s books:  It Takes Two Minutes Canada It Takes Two Minutes USA Two Minute Mindset Shifts CanadaTwo Minute Mindset Shifts USARoxanne’s email:  roxanne@roxannederhodge.com Book a complementary call with Roxanne Roxanne’s previous podcasts

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 clinical trials described here may no longer be enrolling patients, and final results are not yet available.   Before any new cancer treatment can be approved for general use, it must be studied in a clinical trial in order to prove it is safe and effective. In today’s podcast, members of the Cancer.Net Editorial Board discuss 3 clinical trials that are exploring new treatment options across prostate, bladder, and kidney cancer. This podcast will be led by Dr. Timothy Gilligan, Dr. Neeraj Agarwal, Dr. Tian Zhang, and Dr. Brian Shuch. Dr. Gilligan is an Associate Professor and Medical Oncologist at the Cleveland Clinic Taussig Cancer Center. He has no relevant relationships to disclose. Dr. Agarwal directs the Genitourinary Oncology Program at the Huntsman Cancer Institute at the University of Utah. He has served in a consulting or advisory role for Janssen and Bristol-Myers Squibb. Dr. Zhang is an assistant professor of medicine at Duke University School of Medicine and is a medical oncologist at Duke Cancer Institute. She has served in a consulting or advisory role for Janssen and Bristol-Myers Squibb. Dr. Shuch is the director of the Kidney Cancer Program at UCLA Health and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at the institution. He has served in a consulting or advisory role for Bristol-Myers Squibb. View full disclosures for Dr. Gilligan, Dr. Agarwal, Dr. Zhang, and Dr. Shuch  at Cancer.Net. Dr. Gilligan: Hi, I'm Dr. Timothy Gilligan from the Cleveland Clinic Taussig Cancer Institute. I'm joined today by Dr. Neeraj Agarwal from the Huntsman Cancer Institute and the University of Utah and Dr. Tian Zhang from the Duke Cancer Institute and Brian Shuch from the UCLA Institute of Urologic Oncology. Today, we're going to discuss 3 ongoing trials in prostate cancer, bladder cancer, and kidney cancer. As you may know, clinical trial are the way that doctors are able to find better treatment for diseases like cancer. Patient participation is vital for clinical trials. By participating in the clinical trial, you can directly help researchers develop better treatment, reduce side effects, and even reduce the risk of cancer altogether. The 3 trials we'll discuss today were chosen by members of the Cancer.Net Editorial Board Genitourinary Cancers Panel from the trials in progress abstracts that were presented at ASCO 2020 Genitourinary Cancers Symposium. Because these are ongoing clinical trials, final results from these studies are not yet available. I'd like to note that none of us have any direct involvement in any of these trials. To view our full disclosures, please visit the show notes for this episode on Cancer.Net. We're going to start with Dr. Agarwal and a study looking at prostate cancer, the MAGNITUDE trial. [A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer (MAGNITUDE)] Dr. Agarwal, can you tell us a little bit about this study? Dr. Agarwal: This is a large phase III trial of 1,000 patients. This trial includes patients who have progressive, metastatic, castrate-resistant prostate cancer and have never received any other systemic therapy for their castrate-resistant prostate cancer. Dr. Gilligan: Why don't we clarify for listeners what we mean by castrate-resistant prostate cancer? Who are these patients? Dr. Agarwal: When patients present with advanced prostate cancer which has [spread] to different parts of the body, that is called metastatic prostate cancer. And the most effective strategy, which is the backbone of treatment of these patients, is androgen deprivation therapy or castration therapy, which blocks the production of testosterone from the gonads. At this point of time, utilizing medical castration [with drugs] or surgical castration can effectively slow down the progression of cancer. Dr. Gilligan: So these are patients who are already on first-line hormonal therapy to lower their testosterone level? Dr. Agarwal: Yes. Once they start progressing on this first-line castration therapy, we call this state to be castrate-resistant prostate cancer. So this is the patient population which is having disease progression on first-line therapies for the advanced prostate cancer, and now, testosterone levels are low, but still, the prostate cancer is progressing. Dr. Gilligan: So what's the current standard of care for this population of patients who are progressing on first-line hormonal therapy? Dr. Agarwal: In the last 2, 3 years, the treatment of castration-sensitive prostate cancer, which is the newly diagnosed advanced prostate cancer we were just talking about, has changed dramatically. Multiple drugs which are being used, or were being used, in the castrate-resistant prostate cancer have moved to the setting of castration-sensitive prostate cancer. Having said that, many patients with castration-resistant prostate cancer have not yet received any of those drugs. So as an example, in this clinical trial, a patient could have received chemotherapy with docetaxel in the first-line therapy setting or a newly-diagnosed metastatic prostate cancer setting. But then when they have disease progression, the most commonly utilized medications are either abiraterone or enzalutamide, both are oral pills, we call them novel hormonal therapies. So those are still the backbone of treatment for castrate-resistant prostate cancer. Dr. Gilligan: So for patients going on this study, what would the treatment be on the trial? Dr. Agarwal: Patients will be randomized to treatment with abiraterone, which is a novel hormonal therapy, plus prednisone, which is utilized with abiraterone to negate the side effects of abiraterone, plus/minus a new class of drug known as a PARP inhibitor. And in this trial, the drug which is being used is called niraparib. Niraparib is a novel drug, a PARP inhibitor, and just to elaborate a little bit more on PARP inhibitors, this class of drug have recently been approved [to treat patients with] the later phases of castrate-resistant prostate cancer. So 2 drugs, olaparib and rucaparib, were recently approved by FDA in those patients who have had disease progression on novel hormonal therapy plus/minus docetaxel chemotherapy, so for pretty late phases of prostate cancer or castrate-resistant prostate cancer. In this trial, a PARP inhibitor is being moved upstream so that patients don't have to wait for disease progression or novel hormonal therapy or chemotherapy in metastatic castrate-resistant prostate cancer, and they will have the availability of this drug upfront in this setting of newly diagnosed metastatic castrate-resistant prostate cancer. Dr. Gilligan: When this drug is used in the more advanced setting, it's limited to patients who have particular mutations. Is that the case in this study as well? Dr. Agarwal: This trial is targeting the strategy to 2 different patient populations. So 1 patient population is that [in which the] tumor has defects or mutations in the DNA repair genes. We call them homologous recombination repair mutations. I put it simply, DNA repair gene mutations. So there is a cohort of patients, a group of patients, among these 1,000 patients, who will harbor DNA repair gene-related defects in the tumors. And there is another cohort of patients who do not have to have those defects, and we call them unselected patients. This trial is enrolling both groups of patients, and, in fact, the patients' unselected cohort has actually completed accrual. So the trial is now only looking at those patients who are harboring DNA repair gene-related defects in the tumors. Just to complete the story in this context, as you said, the drugs olaparib and rucaparib, which have already been approved in the later phases of castrate-resistant prostate cancer, they are only approved for patients who are harboring DNA repair defects. Dr. Gilligan: So for the patients who can go on the trial now, who have these defects, the question this trial is asking then is, does it help to use this treatment earlier on rather than waiting until later? Dr. Agarwal: Absolutely. So given these are oral therapies, reasonably well tolerated, better tolerated than traditional chemotherapies, it makes sense to move these oral pills to upfront or earlier settings where more patients can be candidates for these drugs which can be taken at home, and these patients don't have to have disease progression on chemotherapy to [receive] these medications. Just to complete, Tim, I just want to add that there are 2 endpoints of this trial. One is radiographic progression-free survival, which is the primary endpoint, and the secondary endpoint is overall survival and many other endpoints we'd like to see, like pain progression or toxicities and so on. Radiographic progression-free survival means how long these drugs or drug combination is able to contain the disease from progressing [or worsening] as detected by the scans. We hope that this trial will show delayed progression on the novel combination compared to abiraterone. Dr. Gilligan: Thank you. So one last question, are there any known risks that patients should be aware of? What are the side effects of this class of medication? Dr. Agarwal: Yes. Two major side effects. Every drug has side effect. And so do niraparib and abiraterone. So abiraterone is already approved for patients with metastatic castrate-resistant and castration-sensitive prostate cancer. So I'm not going to elaborate much on abiraterone. Regarding niraparib, this class of drug, including olaparib and rucaparib which I earlier mentioned, they have this class of side effects, which belong to this class of drugs. And 1 of the most common side effects is anemia, which is low hemoglobin, and which happens because these drugs can also slow down the replication of red [blood] cells. Other less common side effects are decrease in the platelet counts and decrease in the white cell counts. But they happen with much lesser degree compared to anemia. Another common side effect is nausea. Nausea and vomiting can happen, and we have to keep an eye on nausea and vomiting because the side effect can easily be prevented or treated with anti-nausea medications. There are many other side effects which are less common, and I won't get into them, but these are the 2 most common side effects, which are fortunately easy to handle in the clinic. Dr. Gilligan: And I just want to repeat what you said before that there is accrual still going on for the study, but it's limited to patients who have particular mutations in their cancers. Dr. Agarwal: Yes. So currently the study is not accruing for those patients who do not have those DNA repair general-related events. But it is still accruing patients, looking for patients who are known to have those mutations in the prostate cancer. Dr. Gilligan: What proportion of patients with prostate cancer have these kinds of mutations? Dr. Agarwal: Depending upon the study, I would say up to 20% of patients can have DNA repair gene-related defects in their tumors. So it is very important to bring this up with our clinical or medical oncologists who are treating patients with metastatic or advanced prostate cancer, and especially with approval of 2 drugs, it is very important that every single patient who is deemed to be a candidate for treatment with this class of drug, PARP inhibitor, undergoes comprehensive genomic profiling or simply speaking, mutation testing of their prostate cancer tumors. Dr. Gilligan: Thank you. And I think that's worth emphasizing. This is an example of personalized cancer care based on the genomics of the individual's tumor which is happening more and more, and as Dr. Agarwal said, if you have metastatic prostate cancer, we are recommending a standard of care that people get genomic testing now. So this is an example of a step in that direction. So thank you, Dr. Agarwal. Dr. Zhang, why don't we move on and talk about the bladder cancer trial that you were going to discuss, the PROOF 302, that also has a personalized genomic component to it, I believe. [Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations] Dr. Zhang: In bladder cancer, we've come to a place where the genomic profiling is very important to find FGFR mutations or fusions, and this subset of patients that have FGFR mutations or fusions, these patients tend to have good responses to now standard of care treatments in the metastatic setting. And this particular trial is looking at using a drug called infigratinib in this patient population, specifically targeting that FGFR and inhibiting it. This is a trial in the adjuvant setting for patients who have urothelial cancer of either the bladder or of the ureters and upper tract who received surgery and then go onto this trial or treatment with infigratinib versus a placebo. Dr. Gilligan: Can you spell out for our listeners who the group of patients are who are going to be eligible for the study? Dr. Zhang: Sure. These are patients who have already undergone surgery for either their bladder cancer or an upper tract tumor. And so these are patients in that 4-month window after surgery, who have already had their surgeries, and it's either for patients who have had prior chemotherapy before their surgeries or not with higher-risk features defined based on each of those populations. But it is for a higher-risk patient population that have a higher risk for having disease recurrence and spread of their urothelial cancers after surgery. In this setting, we really don't have any approved adjuvant treatments. And so the point of this study is really to try to prevent disease recurrence. Dr. Gilligan: I want to clarify 1 thing. My understanding was for these patients who have not had preoperative chemotherapy, they are not patients who were considered eligible for postoperative cisplatin-based chemotherapy since that is often used in the adjuvant setting. Is that correct? Dr. Zhang: That's absolutely correct, Tim, and thanks for pointing that out. So if patients had not received preoperative chemotherapy, they have to be ineligible for cisplatin-based chemotherapy, which we would often recommend in the postoperative setting. But if they are not eligible for chemotherapy after surgery and have these higher-risk features, then they would qualify for this study. Dr. Gilligan: I think it's important for patients to understand that because if considering going on this trial, the standard of care would be just to watch. And so what it's asking is, can we do something instead of just watching that would lower the risk of relapse or worse outcome with the cancer? Dr. Zhang: Absolutely. I think we always try to recommend proven strategies first, and in this particular case, the recommendation for somebody who is a candidate for chemotherapy after surgery would still be to go with chemo first. Dr. Gilligan: The genetic testing that will be done to determine eligibility for the study, can you say a little bit more about that? Dr. Zhang: Sure. My understanding is that the study will take most genomic tests that are currently commercially available, but they have to fulfill the criteria of having FGFR mutations and/or fusions in the tumor in order to go on the study. So we often now will send the surgical specimens for genomic testing, especially in our higher-risk patients that are defined like the study defines. And so that particular patient population, because they're at higher risk for recurrence, we try to identify these FGFR mutations and fusions early on so that we can know whether the standard treatment for these patients would be an option later on. Dr. Gilligan: Are there cost implications of that for the patients? Dr. Zhang: Certainly, now some of the commercially available genomic testings are approved by insurance and are billable through insurance, but patients may be responsible for a copay. I want to add 1 more thing about the drug itself because I do think there's some interesting activity of infigratinib that has been published in the last year, and that is in the earlier-phase studies of infigratinib in the metastatic setting, in the more advanced urothelial cancer settings, we saw pretty high response rates as well as disease control rates, particularly in patients who had disease in the upper tracts, so in the ureters and above. And so I think it's promising and potentially very interesting to study this for patients who have had disease removal, and surgeries. Dr. Gilligan: That's an important point for listeners to understand, that this is an exciting new class of drugs and in patients for whom this treatment is appropriate, we're seeing very good response rates in more advanced disease settings, and there's a natural progression. When we see it work in the advanced setting, we try to move it to an earlier setting to see if we see a similar or greater benefit. As Dr. Agarwal was saying about prostate cancer, we've found a number of times that using drugs earlier works better. This is another example of studying that to see if that's the case here. Dr. Zhang: I absolutely agree. Dr. Gilligan: What should listeners know about potential risks or side effects for this class of treatment? Dr. Zhang: FGFR inhibitors like infigratinib have a class effect, and I think the main toxicities that we've come to see are skin toxicities and nail toxicities, as well as there are some eye toxicities as well. So particularly for patients who are going on these types of treatments, we often will recommend baseline eye exams, and then to follow them on treatment, particularly for any blurry vision or other vision changes that arise. And 1 of the class effects of these FGFR inhibitors is also to cause increases in phosphorus levels [in the blood], and that is due to their inhibition in the renal tubules to prevent phosphorus excretion. And so there was a recent publication also that for patients who develop high phosphorus levels, while getting infigratinib or these FGFR inhibitors, that these patients actually have potentially a higher response rate as well. So I think that has to be proven more in these bigger trials, but it's an interesting biomarker potentially for patients who might have good responses. Dr. Gilligan: So for patients who had urothelial cancer resected or at high risk for relapse, this is an exciting new option for them, if they have the right genomic composition of the cancer and would not otherwise receive chemotherapy. So thank you for the summary. Okay. So now we're going to talk about kidney cancer and the CYTOSHRINK discussion. [SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer (CYTOSHRINK)] And we have Dr. Brian Shuch with us to discuss that. Brian, can we start off with who this study is designed for? Dr. Shuch: It's really designed for patients with metastatic kidney cancer. Could be any type of kidney cancer, presenting with metastatic disease. We call that de novo metastatic disease. So they would have their primary tumor still in place in their kidney, with disease outside of that organ in other locations. Dr. Gilligan: So these are patients with-- they have the tumor in their kidney, it's spread somewhere else, and they haven't had any other treatment so far? They haven't had any surgery or any drugs? Dr. Shuch: Correct. These will be patients that are treatment-naïve that are going to start on their first course of treatment, which, in general, would be a discussion of either surgery or systemic therapy. Dr. Gilligan: So at this point in time, what's the standard of care for such patients? Dr. Shuch: We used to take every patient to surgery upfront. We call that a cytoreductive nephrectomy. Since we've had much better agents in recent years, and these agents have a lot of activity, we've done less upfront surgery as it appears that some patients may not benefit from racing off to the OR. So these are patients that generally would get started on systemic therapy first because this population, and this trial, has some risk factors for worse disease. We call that intermediate- or poor-risk features. Dr. Gilligan: So these are patients who we would not normally do surgery on because it doesn't seem to help them, unlike some of the other patients who we do, the good-risk patients. Dr. Shuch: Well, we are investigating that in other trials, but there are plenty of patients who are not going to run right to surgery, and these are the ones that we would consider deferring surgical management of the primary tumor. We would get started on systemic therapy, and we would reassess how they would be [treated] in the future, whether surgery was an option. But there are emerging entities such as radiation, which we'll discuss, which could be another exciting approach. Dr. Gilligan: So if a patient that was going to go on this trial didn't go on the trial, they would most likely be treated with medications at this point in time. Is that correct? Dr. Shuch: Correct. There'd be standard medications which are available off clinical trial which are right now dual therapy with 2 immune agents, or an immune agent and a tyrosine kinase inhibitor. So these are standard drugs that are available off a trial. Patients get started on therapy, and we see how they do later for other treatment options. Dr. Gilligan: So what is this study looking at? What's the new thing that it's introducing and the question that it's asking? Dr. Shuch: So kidney cancer, 10, 15 years ago, there was never really any role for radiation except for very rare circumstances. But now we have newer types of radiation where we're doing radiation at much higher doses in shorter time periods, and we call that ablative dosing. And as we've used that in brain and bone lesions for kidney tumors, and with excellent efficacy, with great—what we call local control. That has been applied to the primary tumor as well, and that's been used in many fields, that type of alternative radiation approach. We call that stereotactic radiation or the term radiosurgery, which is really a misnomer. It's just high dose ablative radiation, and it can be used in the primary tumor as a way maybe to kill the tumor. Dr. Gilligan: And what is that outcome that we're hoping for? How would success be measured if this trial is positive? Dr. Shuch: Well, we do know for small tumors, it seems to be a fairly effective measure at stopping tumors from growing. In this situation, it's employed after initiation of systemic therapy. Half the patients will get this radiation therapy to that primary kidney tumor, and the goal is to see if it delays progression of the disease. What we call progression is generally growth of lesions that are existing, or development of new lesions, new spots around the body. So the goal is to see if radiation with the standard immune therapy would delay progression versus the standard immune therapy alone. Dr. Gilligan: So just to reiterate then, I guess for patients who are on this trial, normally they would get treated just with the immunotherapy or combined immunotherapy and targeted therapy, and what we're asking here is, if we give them radiation too, do they do better? Do we delay progression of disease? That we keep things under control longer, that they live longer? Dr. Shuch: Correct. Obviously, living longer is a major factor. That's another objective of the study, but the study doesn't have enough patients or enough power to kind of detect that. The real issue is, does it delay the progression? And progression is important because if you have progression, often patients will progress to another line of therapy, meaning disease is not under good control. Dr. Gilligan: Are there any known risks from the radiation therapy the patient should be aware of? Dr. Shuch: Depending on the size of the tumor and the location to other organs, radiation could have some local effects. Obviously, there's some potential damage to surrounding structures such as the skin. There's some radiation that potentially could stray into other surrounding organs like the duodenum on the right side or the liver, the colon, small bowel, the ureter. And those organs generally can have some degree of toxicity. Generally, it's self-limiting with minor long-term effects, but we haven't done this for many, many years because it's a newer emerging modality. We do believe it's safe with large studies of smaller tumors, but patients do need to be aware that there could be some local irritation from radiation. Dr. Gilligan: Is this trial still open to patients? Dr. Shuch: So this is a trial based out of Canada by 1 of their cooperative groups in Ontario. It's a small study - only 78 patients - that opened this year. In discussion with the investigators, this study is accruing well, but it is anticipated to be open for another year. Because they're looking at what's called progression-free survival, we're hoping we can have results of this study within the next 2 years. Obviously, it is something open only to Canadian residents right now, but I will tell you that there are other groups in the U.S. that are considering similar types of trials in the Cooperative Group Network. Dr. Gilligan: There's 1 final point I wanted to give you an opportunity to clarify for our listeners who may not be familiar with the idea of cytoreductive nephrectomy or cytoreductive treatment. So this is a treatment where we are targeting the primary tumor, even though there's other cancer elsewhere in the body that we can't remove. Can you just talk a little bit about the rationale for that, and why we're doing that? Dr. Shuch: Historically in kidney cancer, when we had no effective therapy, we would have this phenomena: we removed the big bulky tumor, and 1% to 2% of patients would have their distant sites shrink, okay? And whether that was related to an immunologic phenomenon, maybe the tumor was secreting something, or maybe it was just overwhelming the body's defense mechanisms because they had a big tumor making them sick, it was kind of unclear. But we did know in larger trials with immune therapy, when we gave immune therapy in the old days, the agents like interferon-alpha or IL-2, we gave these agents, the primary tumor wouldn't shrink. Sometimes the distant sites could shrink, but it would not lead to what we call complete responses. So anyone who wanted to have a home run therapy where it was hoping to cure them, they would have their primary tumor removed first, and then they would potentially have the systemic immunotherapy. We've done 2 trials which showed, early in the 90s, that if you were able to remove the primary tumor and treat with these older immune agents, patients would have better outcome. And as those agents were pretty ineffective, we thought the survival benefit was really due to removing the big bulky primary. So the rationale for this trial is, you're not removing the big bulky primary tumor, you're potentially killing it with radiation, so you're overall reducing the burden of disease. There are some theoretical benefits of radiation where you kill tumors, and the tumors release what we call antigens. Basically, I try to explain that to people it's basically like a patch. Like a Boy Scout or Girl Scout has a new patch on them, and you'd recognize them as maybe having a badge of like hunting. So the tumor potentially might expose some of these bad patches, and the immune system might wake up and recognize them, and hopefully, then attack other sites of disease. So, again, the goal is either you're reducing the overall burden of disease in the body, or you're maybe allowing the body's immune system to kick in because you're killing a [tumor] there. We're just not sure really the mechanism, but it's been long used in kidney cancer, this idea of reducing the burden of disease. Dr. Gilligan: Thank you for listening to this podcast. There are many different clinical trials currently enrolling people with genitourinary cancers. If you're wondering whether participating in a clinical trial might be right for you, please talk to your health care team. ASCO: Thank you, Drs. Gilligan, Agarwal, Zhang, and Shuch. Visit www.cancer.net/clinicaltrials to learn more about participating in clinical trials. All treatments have side effects—please talk to your health care team about possible side effects to watch out for. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play. This Cancer.Net podcast is part of the ASCO Podcast Network. This collection of 9 programs offers insight into the world of cancer care, covering a range of educational, inspirational, and scientific content. You can find all 9 shows, including this one, at podcast.asco.org. Cancer.Net is supported by Conquer Cancer, the ASCO 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/donate.

First, Emily Maxfield, a clinical research nurse, shares her experiences working for Duke Cancer Institute in a unique role that focuses on oncology treatment trials. She's interested in improving patient outcomes by enhancing direct patient care by offering treatment options that better suit the individual's needs. Maxfield loves being a part of the research that gives patients more options and serving as a resource to patients as they navigate the complex world of modern-day healthcare. Then, Cherie Frame shares her experience working as an infection preventionist with Intermountain Healthcare. She talks about using data and knowledge to give her role power and explains some of her work highlights. Last, we get a bit personal with Dr. Jeanette Drake, a new professor at BYU College of Nursing. The College of Nursing at Brigham Young University presents nursing careers and professional insight to undergraduate students. This is the fourteenth show in The College Handoff series and was recorded in October of 2020.

In this episode, we review how PD-L1 inhibitors and COVID-19 have changed the management of non-small cell lung cancer (NSCLC). Jeffrey Crawford, MD, and Susan Blackwell, PA, both of Duke Cancer Institute, join host David H. Henry, MD, to discuss the use of pembrolizumab in NSCLC, two studies of PD-L1 inhibitors presented at ESMO 2020, and how COVID-19 has affected NSCLC care, particularly the use of granulocyte colony-stimulating factor (G-CSF). Diagnosis and treatment of NSCLC What information should be obtained from a biopsy? Is this lung cancer? If so, what kind of lung cancer is it: Small-cell lung cancer or NSCLC? Which subtype? Molecular studies for targets, including ALK, KRAS, EGFR, PD-L1. Treatment with pembrolizumab: If, for example, a patient has NSCLC and is positive for PD-L1, the treatment of choice is pembrolizumab. A multidisciplinary approach is essential to provide comprehensive education and care to patients taking pembrolizumab (and other immunotherapies). Pembrolizumab can have many side effects, including itching, fatigue, thyroiditis progressing to hypothyroidism, hypophysitis, or another off-target “-itis.” Ms. Blackwell and Dr. Crawford recommend listening to patients, checking the thyroid routinely, and checking cortisol based on index of suspicion. NSCLC studies presented at ESMO 2020 KEYNOTE-024 5-year OS update: First-line (1L) pembrolizumab (pembro) vs platinum-based chemotherapy (chemo) in patients (pts) with metastatic NSCLC and PD-L1 tumour proportion score (TPS) ≥50%. The 5-year survival is greater than 30% with pembrolizumab in this study. Historically, 5-year survival has been 1% to 2% in patients treated with chemotherapy alone, Dr. Crawford said. In the control arm of this study, patients received chemotherapy and then crossed over into the pembrolizumab arm, so overall survival was 16% at the 5-year mark. The results suggest immunotherapy should be used first-line if patients meet criteria, Dr. Crawford said. Source: Abstract LBA51. https://bit.ly/3mMYLTK. EMPOWER-Lung 1: Phase III first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%.  The PD-L1 inhibitor cemiplimab improved overall and progression-free survival in NSCLC patients when compared with chemotherapy alone. Abstract LBA52. https://bit.ly/3mLT6xb. The effects of COVID-19 on NSCLC care Logistically, it’s more difficult to see patients during the pandemic, Dr. Crawford noted, but the many potential side effects of immunotherapy make it necessary to see patients regularly in person. How has COVID-19 affected the concern of febrile neutropenia and the use of G-CSF? Dr. Crawford said the pandemic has heightened the concern about infection risk. Prior guidelines for G-CSF: Before the pandemic, guidelines suggested routine prophylactic G-CSF in patients with a greater than 20% risk of febrile neutropenia. In patients with 10% to 20% risk, the recommendation was to consider the use of G-CSF based on the patient population and risk factors. Pandemic-specific guidelines for G-CSF: The National Comprehensive Cancer Network (NCCN) recommended relaxing guidelines during the pandemic. If the risk is greater than 20%, NCCN still recommends giving G-CSF. If the risk is 10% to 20%, NCCN recommends giving G-CSF even in the absence of additional risk factors. Dr. Crawford noted that lung cancer patients receiving chemotherapy are typically in the 10% to 20% risk category. Download the COVID-specific NCCN guidelines: https://bit.ly/3jQIco5. G-CSF biosimilars The most common complaint with biosimilars is bone pain. Ms. Blackwell advises first treating bone pain with acetaminophen or ibuprofen and warm blankets. For refractory pain, she suggests a low-dose narcotic or dexamethasone. Consider an antihistamine for prophylaxis, as patients report this can help with symptoms. Show notes written by Ronak Mistry, DO, a resident at Pennsylvania Hospital, Philadelphia. Disclosures: Dr. Crawford is on advisory boards at Amgen and Merck, makers of Onpro/Neulasta (pegfilgrastim) and Keytruda (pembrolizumab). Ms. Blackwell and Dr. Henry have no conflicts of interest. * * * 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: 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 clinical trials described here may no longer be enrolling patients, and final results are not yet available.   Before any new cancer treatment can be approved for general use, it must be studied in a clinical trial in order to prove it is safe and effective. In today’s podcast, members of the Cancer.Net Editorial Board discuss 3 clinical trials that are exploring new treatment options across prostate, germ cell, and kidney cancer. This podcast will be led by Dr. Sumanta (Monty) Pal, Dr. Neeraj Agarwal, Dr. Timothy Gilligan, and Dr. Tian Zhang. Dr. Pal is co-director of City of Hope's Kidney Cancer Program and is the head of the kidney and bladder cancer disease team at the institution. He has served in a consulting or advisory role for Astellas Pharma, and Bristol-Myers Squibb. Dr. Agarwal directs the Genitourinary Oncology Program at the Huntsman Cancer Institute at the University of Utah. He has served in a consulting or advisory role for Astellas Pharma, Bristol-Myers Squibb, Nektar Therapeutics, and Merck. Dr. Gilligan is an Associate Professor and Medical Oncologist at the Cleveland Clinic Taussig Cancer Center. He has no relevant relationships to disclose. Dr. Zhang is an assistant professor of medicine at Duke University School of Medicine and is a medical oncologist at Duke Cancer Institute. She has served in a consulting or advisory role for Bristol-Myers Squibb and Merck. View full disclosures for Dr. Pal, Dr. Agarwal, Dr. Gilligan, and Dr. Zhang at Cancer.Net. Dr. Pal: Hi. I'm Dr. Monty Pal from the City of Hope. I'm joined today by Dr. Neeraj Agarwal from the Huntsman Cancer Institute and University of Utah, Dr. Timothy Gilligan from the Cleveland Clinic Taussig Cancer Institute, and Dr. Tian Zhang from Duke Cancer Institute. Today we're going to discuss 3 ongoing clinical trials in prostate, germ cell, and kidney cancer. As you may know, clinical trials are the main way that doctors are able to find better treatment for diseases like cancer. Patient participation is vital for clinical trials. By participating in a clinical trial, you can directly help researchers develop better treatment, reduce side effects, and even reduce the risk of cancer altogether. The 3 trials we'll discuss today were chosen by members of the Cancer.Net Editorial Board Genitourinary Cancers Panel from the trials in progress abstracts that were presented at ASCO's 2020 Genitourinary Cancers Symposium. Because these are ongoing clinical trials, final results from these studies are not available yet. I'd like to note that none of us have any direct involvement with any of these trials. To view our full disclosures, please visit the show notes for the episode on Cancer.Net. Now, the first trial we're going to discuss is the KEYNOTE-641 trial for prostate cancer.  [Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)] Dr. Agarwal, can you tell us who this study is designed for? Dr. Agarwal: This trial is designed for patients with advanced prostate cancer, or metastatic prostate cancer, who are experiencing disease progression on standard androgen deprivation therapy, a state known as castrate resistant prostate cancer. Dr. Pal: And if you see these patients in your clinic right now, what is the current standard of care? Dr. Agarwal: The most commonly utilized [treatments for] these patients include drugs which block androgen signaling inside the prostate cancer cell. And one of the most commonly utilized drugs is enzalutamide followed by abiraterone. Dr. Pal: Tell us a little bit about how this particular study aims to improve or change the current standard of care. Dr. Agarwal: Early clinical data showed that adding the immunotherapy agent pembrolizumab to enzalutamide may improve survival outcomes. The response rates in that smaller study were meaningful and were very promising. Based on those earlier data, this trial has been designed and is asking two main questions. Number one, whether adding the immunotherapy agent pembrolizumab to enzalutamide will improve overall survival. And the second question is, whether adding pembrolizumab to enzalutamide will delay disease progression. Dr. Pal: Are there any risks that patients should be aware of with this regimen? Dr. Agarwal: Both agents are very commonly utilized for many years now in oncology clinics. Enzalutamide is an oral pill which blocks androgen signaling and is associated with side effects such as fatigue, muscle loss, bone loss, falls, and many others which are relatively easy to manage over time. Pembrolizumab is an intravenous therapy approved for multiple cancer types, and is associated with immune-related side effects. Many of these can be severe in 4 to 5 percent of patients receiving pembrolizumab. These can include diarrhea, abnormal liver function tests, or liver toxicity, a skin rash, lung toxicity, which can include pneumonitis [or lung inflammation]. But most of these side effects can be managed as long as they are promptly detected. So I think education and close monitoring with oncologists is the key for early prevention and management of the side effects. Dr. Pal: Those are great tenets, not just for this clinical trial but in using these agents in general. Thanks a lot. And final question for you, Dr. Agarwal. Is this trial still open right now? And if so, when do you think we might see some results from it? Dr. Agarwal: This trial is open across the United States and different parts of the world. And the primary results, early results, will be available, I'm hoping, in 2023, in the middle of 2023. Dr. Pal: Well thank you for that excellent overview, Dr. Agarwal. I'm going to turn my attention now to Dr. Gilligan to discuss a topic that we don't often have on this podcast. But this is nonetheless a critical disease space for us to discuss. Dr. Gilligan is going to tell us about the P3BEP clinical trial in testicular cancer. [Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours (P3BEP)] Dr. Gilligan, can you tell us a little bit about who this study is designed for? Dr. Gilligan: Yes, germ cell tumors are cancers that start in the reproductive cells, most commonly in testicles of adolescent or adult men. But germ cell tumors can also start in children - typically not in the testicles but elsewhere in the body - and they can start in women in the ovaries or elsewhere. In children, we sometimes see [germ cell tumors starting in the brain]. Those are not included in this trial. But basically, everybody else with germ cell tumors are eligible for this - men, women, and children - if they have a poor or intermediate prognosis. And just to clarify one more piece about that, this is for people who have advanced stage disease. Again, men, women, or children with advanced stage metastatic germ cell tumors, as long as it didn't start in the brain. And as long as their prognosis is in the intermediate or poor risk category, not the good risk category. Dr. Pal: So glad that you pointed that out, Tim. I have to tell you that I gave this incorrect label of a testicular cancer study, but critical for our listenership to know the germ cell tumors can occur both in males and females. Can you tell us a little bit about the current standard of care for the patients that are being [included] in this study? Dr. Gilligan: Absolutely. Chemotherapy for germ cell tumors has been one of the huge success stories of modern oncology, and the cure rate is extremely high. Overall, [we cure about 96% of men with testis cancer.] However, when you start to look at advanced stage disease in intermediate and poor risk patients, the success rate goes down. It's about a 75% cure rate for patients with intermediate risk tumors and 60% for [those with] poor risk tumors. The standard of care has been the same for a long time. It's 4 cycles of chemotherapy called BEP, and that's what has produced those results. And while those results are good, we would like them to be a lot better. Dr. Pal: So Dr. Gilligan, you've used this term intermediate and poor risk in the context of patients with germ cell tumor. Can you tell us a little bit about what intermediate and poor risk [means]? Dr. Gilligan: Yes, it's based mostly on where the cancer has spread to and how high certain blood tests are. There are things called tumor markers which are proteins in the blood that are made by the cancer, and the higher those levels, the worse the prognosis. Similarly, if the cancer has spread to certain organs, such as the liver or the bones or the brain, organs other than the lungs, then patients have a poorer outcome and a poorer prognosis. The last category is men and women who have certain germ cell tumors that grow in the chest called extragonadal tumors. They also have a prognosis that's not as good as other germ cell tumors. So it's a little bit complicated, and for patients, when you see your oncologist, they can clearly tell you which prognostic category you fall into. Dr. Pal: How does this study aim to improve or change the standard of care? Dr. Gilligan: So mainly we'd like to get those numbers better. And I think the key idea in this study is that with chemotherapy, which is different than the kinds of drugs we talked about in the prior conversation, the philosophy is to basically give patients as much of a dose as they can safely tolerate. And the idea of this trial is that if we give the chemotherapy more frequently - if we kind of squeeze together the cycles so that rather than every 3 weeks we're repeating it every 2 weeks - can we get a better response in killing the cancer without having too much toxicity? Dr. Pal: So they use this term in the title “accelerated.” Is that what you're referring to there? Dr. Gilligan: Yes. So if you think of chemotherapy as something that is repeated, we're repeating it sooner. And we used to give the patient 3 weeks to recover. On this trial, they're comparing that standard approach every 3 weeks to giving it every 2 weeks. In other words, we're making it denser. You get the chemotherapy faster. And the question is, will we cure more people that way or not? Dr. Pal: And Dr. Gilligan, any known risks that patients should be aware of as they [consider] a study like this? Dr. Gilligan: Well I think the risk with this approach is that we may increase toxicity without improving outcomes. Past attempts to do better than the standard treatment have not been successful. And the current standard treatment has been the standard for a long time as a result. We are hoping the new approach will be better, but we don't know until we try it, and it's possible that it will be more toxic. Dr. Pal: When do you think we might see some results from this? Dr. Gilligan: I don't know when we will see results. My guess is that it will be within a few years. Germ cell tumors grow quickly; they're aggressive cancers, so you tend to get your results pretty quickly, but I don't know exactly. Dr. Pal: Dr. Gilligan, thank you for that excellent overview. Last, but certainly not least, we're going to turn our attention to Dr. Tian Zhang for discussion of a very important study in kidney cancer. [A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)] Tell us a little bit about this study and who it's designed for. Dr. Zhang: PIVOT-09 is a study of a combination of a [novel] immunotherapy called bempegaldesleukin in combination with nivolumab compared to investigator-selected sunitinib or cabozantinib. So these are standard blood vessel blockers. The study is designed for patients with metastatic clear cell kidney cancer who have had no prior medication treatments and also measurable disease that can be followed on subsequent scans. Dr. Pal: And when you're seeing these patients in clinic with metastatic kidney cancer, what is the current standard of care? What are you using to treat patients these days? Dr. Zhang: We've known for a long time that kidney cancer will respond to these immune activating therapies, and [it has been demonstrated that a drug called IL-2, when given in high doses,] improved the overall survival for a subset of patients with metastatic kidney cancer and [produced] really durable complete responses for a small number of patients. However, it was highly, highly toxic, and there were lots of patients who ended up in the hospital. It had significant toxicities and patients were treated in the hospital for about a week at a time. So since about 2018, our standard of care immunotherapy options [have included] agents like ipilimumab and avelumab or the combination of pembrolizumab or avelumab with a blood vessel blocking agent. This is an easier way to give immune activating treatments in a more targeted fashion. [With this study we are testing] whether the IL-2 cytokine can be modified and given more in a more safe and effective manner. Dr. Pal: This is an interesting drug. If I understand it correctly, we're taking IL-2 from yesteryear, a drug that we used more than a decade ago to treat patients with advanced kidney cancer, and we're retooling it a bit for patients to really enhance the efficacy, maybe really enhance the safety of the compound as well. Can you tell us how this compound's doing that? Dr. Zhang: Right so bempegaldesleukin is a special formulation of IL-2. It's actually a pegylated form of the IL-2 cytokine, so it includes this polyethylene glycol molecule around the IL-2. And this pegylation allows that cytokine to be released slowly [in the bloodstream] so that in itself may improve the side effect profile. And then it also activates the tumor fighting subset of immune cells, T cells and natural killer cells in the tumor microenvironment, without activating other suppressive T cells. So the thought from preclinical studies is that bempegaldesleukin, because of its pegylated form, will actually decrease the side effects while activating the tumor fighting cells in the tumor microenvironment. Dr. Pal: And in this trial, how will success be evaluated? How will we know the treatment is working, that it's positive? Dr. Zhang: So the primary objective for this particular trial is a composite of objective responses as well as overall survival, and then secondary objectives include progression free survival - so lengthening time until disease progression - as well as evaluating the safety of the combination and the quality of life for patients who are treated on this combination. Dr. Pal: Now I remember IL-2, the drug that you referred to, from more than a decade ago, giving it to patients and certainly it came with a lot of toxicity. What are some of the toxicities of patients receiving bempegaldesleukin should be aware of? Dr. Zhang: Some of the early phase 1 trials that evaluated bempegaldesleukin found that some of the toxicities included low blood pressure as well as syncope where patients would feel lightheaded [or faint,] headaches, edema, swelling in their legs and fluid buildup, as well as infusion reactions. And I think we should also think about the immunotherapy-related toxicities of nivolumab where we're giving it in combination. So diarrhea, rashes, endocrine dysfunction are pretty common. So those would be some of the expected side effects of the immunotherapy cohort. And then we shouldn't forget about the control cohort treated with standard sunitinib or cabozantinib, and those side effects would include hypertension, hand foot syndrome or other rashes, diarrhea, nausea, hypothyroidism, and loss of protein in the urine. Dr. Pal: Right. Well a final question for you Dr. Zhang. Is this trial still open to patients, and if it is, when do you think we might see some results from it? Dr. Zhang: Yes, the trial is still open. It's enrolling up to 600 patients total and it's currently open globally in the U.S., Mexico, South America, Asia, Russia, and Australia. I'm hoping we will see results from this phase 3 trial in the next 2 to 3 years. Dr. Pal: Well thank you very much, Dr. Zhang, Dr. Gilligan, Dr. Agarwal. There are many different clinical trials currently enrolling people with genitourinary cancers. If you're wondering whether participating in a clinical trial might be right for you, please talk to your health care team. Thanks so much for listening. ASCO: Thank you, Drs. Pal, Agarwal, Gilligan, and Zhang. Visit www.cancer.net/clinicaltrials to learn more about participating in clinical trials. All treatments have side effects—please talk to your health care team about possible side effects to watch out for. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play. This Cancer.Net podcast is part of the ASCO Podcast Network. This collection of 9 programs offers insight into the world of cancer care, covering a range of educational, inspirational, and scientific content. You can find all 9 shows, including this one, at podcast.asco.org. Cancer.Net is supported by Conquer Cancer, the ASCO 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/donate.

Dr Akila Viswanathan and Dr Junzo Chino from the Duke Cancer Institute examine the American Society for Radiation Oncology Clinical Guidelines on Radiation Therapy for Cervical Cancer. To read the full guidelines, click here: https://www.astro.org/Patient-Care-and-Research/Clinical-Practice-Statements/Cervical-Cancer-Guideline

In this episode, Dr. Susan Dent, a breast cancer oncologist at the Duke Cancer Institute and Co-Director of the Duke Cardio-Oncology Program, discusses how to optimize cardiovascular health in patients with cancer and survivors as well as strategies to mitigate cardiovascular toxicity during and following completion of cancer treatment.   Transcript ASCO Daily News: Welcome to the ASCO Daily News podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. Joining me today is Dr. Susan Dent, a medical oncologist at the Duke Cancer Institute and co-director of the Duke Cardio-Oncology Program. Dr. Dent will discuss how to optimize the cardiovascular health of patients with cancer and survivors. Her research on this topic will be presented during the ASCO20 Virtual Education Program. Dr. Dent receives grant funding from Novartis.  Full disclosures can be found on our episode pages.   Dr. Dent, welcome to the ASCO Daily News podcast.   Dr. Susan Dent: Thank you.   ASCO Daily News: Dr. Dent, there are 16 million cancer survivors in the United States. And as the survivorship population continues to grow, the association between cancer treatments and the development of serious cardiovascular complications has become more evident. Can you tell us more about this?   Dr. Susan Dent: Thank you. Yes, you're right. We are certainly seeing more survivors of cancer, which is very encouraging. However, as a consequence of that, we are now seeing more cancer survivors either develop cardiovascular disease or present with an exacerbation of preexisting cardiovascular disease. And the question is, why are we noticing that now?   I think as oncologists, we used to focus solely on the treatment of an individual's cancer and trying to cure that cancer and promote for survivorship. But what is clear now is that as individuals come to us for treatment of their cancer, they have preexisting cardiovascular risk factors. We know our population is aging. They come to us with preexisting hypertension, diabetes, or maybe even cardiovascular disease. We then treat them with cancer therapy that may exacerbate that or contribute to that. And then as they survive longer, we're seeing the cardiovascular consequences of preexisting risk factors in combination with cancer therapy that may promote the emergence of the cardiovascular disease.   So it's not as simple as just seeing a cancer patient and giving them cancer therapy anymore. We have to consider that cancer therapy in the context of the individual that we're treating and their preexisting cardiovascular risk factors to try and really prevent long-term cardiovascular disease. So while we're curing them of their cancer, we also want to try and make sure we promote good cardiovascular survivorship and cardiovascular health.   ASCO Daily News: Can you tell us about the patient populations that are presenting with more serious cardiovascular complications? Are breast cancer patients more likely to develop cardiovascular problems than patients with other cancers?   Dr. Susan Dent: That's a very good question. I think that a lot of the attention has been on the breast cancer population because we know that this is a population that's been exposed to anthracyclines in the past. We've used anthracycline sort of as a backbone of many of our therapies and then subsequently with the introduction of HER2 targeted therapies. So there was a lot of focus on this population, and that's where a lot of the research is looking at the risk of developing cardiovascular complications.   But it's not specifically the cancer per se. It is what we're treating those individuals with. So, for instance, if it's someone with renal cell carcinoma who is given tyrosine kinase inhibitor, that could lead to hypertension. And if they have preexisting hypertension, perhaps now it's exacerbated by the drug that we give them.   So the cancer is important in the context of the cancer therapy that we are offering them. And what we've learned over the last decade is that there are many cancer therapies that we offer our patients that can have cardiovascular consequences, not just on the heart. We think of the heart and heart failure. But sort of modern cancer therapies can lead to increased risk of hypertension, increased risk of arrhythmias, increased risk of prolong QTC, which is sort of a big issue right now, and in rare cases with immunotherapy, for instance, rarely myocarditis.   And so the cancer therapy that we deliver impacts the whole cardiovascular system, not just the heart, which is sort of where many of us think about heart and heart failure. So it's complex. And so we have to think about that whole individual. What are they coming into the cancer treatment with? What are their preexisting cardiovascular risk factors? What are we going to be giving them in terms of their cancer therapy, including radiation? And putting those together, what are the potential complications from that combination for that individual and their cancer?   ASCO Daily News: Right. It is very complex, indeed. So what is your recommended approach for monitoring cancer survivors and reducing their cardiovascular risk?   Dr. Susan Dent: I think it really starts at the beginning when we see these patients in our clinic and we start thinking about what we're going to offer them for cancer therapy. So survivorship really starts from the beginning when we first see these individuals. And the most important thing I think we need to think of as oncologists is thinking about what their risk factors are upfront when we're considering their cancer therapy.   So if I have someone coming into my practice, a breast cancer patient, and they have already have preexisting diabetes and hypertension, and I'm going to offer them an anthracycline and maybe HER2 targeted therapy, I need to think about optimizing those cardiovascular risk factors before, or at least as we start, the cancer therapy, because if we don't, we may get into trouble either during their cancer therapy or certainly after their cancer therapy. So it really needs to start at the beginning.   I think as oncologists, what we often do is we give our cancer therapy, and then when patients develop cardiovascular issues or problems, we then sort of refer them or ask for help from our cardiology colleagues. However, this is a very, I would say, reactive approach. We have to be more proactive in thinking about these things upfront.   You know we've now seen, for instance, with breast cancer survivorship improving, we're now seeing that those patients route seven, eight, nine years from the breast cancer diagnosis, more women are dying of cardiovascular disease than recurrence of their breast cancer. And I think as a breast cancer oncologist, that was a real eye opening study for me to see is that we're doing great in terms of the cancer survivorship, but we don't want to cure their cancer only to have them die of cardiovascular disease a couple years down the road.   ASCO Daily News: So what are the proactive steps that should be taken then so that a breast cancer patient, for example, has that attention that is required by the oncologist at the start, at the beginning of her cancer treatment if she has hypertension - addressing that issue at that point while she's getting her chemotherapy, so that she is not one of those tragic cases seven years post-treatment who has serious cardiovascular problems and potentially a fatality?   Dr. Susan Dent: That's a very good question. I think that, first of all, as oncologists, we need to be more aware or just to think about assessing patients as they come into their treatment. And I would have to say I don't think we're quite there yet. I don't think as oncologists that we're actually thinking about assessing cardiovascular risk factors when we start cancer treatments. So the first thing is to think about it.   The second thing is that we then have to start thinking about how we can look at assessing the risk factors. So there's a very sort of simple ABCDE approach to this that Dr. Michael Fradley will be speaking about in our educational session. A stands for just awareness of some of the cardiovascular risk factors. B, blood pressure monitoring, we know that hypertension is a big issue for almost half the US population. C stands for coronary artery disease screening. And D stands for diabetes control, healthy dietary choices, an E for exercise. And you'll hear more about this in our session, but just thinking about these things.   So how can we, as oncologists, even drill that down more? I can tell you what we're doing here at Duke is that we are trying to set up a screening process for all of our patients, starting out with the breast cancer population to begin with, so that we are building in our electronic health record-- we use Epic at Duke-- a screening process before patients start their treatment to try and identify those patients who might be at high risk of experiencing complications based on their history of risk factors, including, for instance, their BMI, body mass index, smoking history, diabetes, and so on.   And if those patients are deemed to be at high risk, we are trying to bring them into see a cardiologist with some interest in this area, cardio-oncologists to see if we can optimize any risk factors as they're starting their cancer treatment. I think this is the way that we have to move towards more proactive approaches, rather than waiting until these individuals run into problems with their uncontrolled hypertension or uncontrolled diabetes, because we certainly know that when they're on their cancer therapy, these things can occur. So this is a real shift I think for oncologists to try and consider of this approach. But I think it really is where we need to go.   There's also some research going on in the area of primary prevention. In other words, if there is an individual that you think might be at risk or if they're undergoing cancer therapy, that might place them at higher risk. There have been a number of studies looking at can we prevent them from developing cardiotoxicity based on cardiovascular medications that are out there?   ASCO Daily News: Well, there are a lot of interesting clinical trials underway in the cardio-oncology space right now. Can you tell us about some of these?   Dr. Susan Dent: My talk at the educational session will focus on some of the prevention trials. And most of the literature actually is on breast cancer. But there have been several trials that have looked at can we actually prevent cardiotoxicity or cardiovascular toxicity? These trials have essentially all been in the breast cancer population. They've been in patients who've been exposed to anthracyclines and in some cases HER2 targeted therapies, such as trastuzumab. And what they did is they randomized patients to receive cardio protective medications, such as an ACE inhibitor or a beta blocker or an ARB versus placebo. And they looked to see if they could prevent drops in the left ventricular ejection fraction, because as we know, this can occur with anthracyclines and HER2 targeted therapies.   Now, these studies, five of them in particular, three of those, three showed a positive benefit to giving these medications upfront versus two studies which showed no benefit. However, I have to say that how they measured benefit was as an attenuation in drop of LVF. And they were able to prevent a drop, but only in about three or four-- actually, I should say only about 3% to 4% prevention in drop. So in other words, if you had an LVF of 60%, it would prevent your ejection fraction dropping to 56%.   And so while that is encouraging, I would say, is it clinically meaningful? And so I think we need to do studies that include larger populations and populations at risk. Most of the individuals in these studies were healthy women in their mid 50s with very few cardiovascular risk factors. So moving forward, there is interest in trying to identify those patients at greater risk and then looking at the potential benefit from giving them cardiovascular medications upfront prior to starting their therapy.   ASCO Daily News: Are there any other trials that we should be keeping an eye on at the moment?   Dr. Susan Dent: There is another interesting study called UPBEAT. And what this study is it's looking at women with stage 1 to 3 breast cancer. And they are going to be looking at the cardiovascular health of these women, not only during the course of their therapy, but well into survivorship. So as women are starting the cancer therapy, they will undergo fitness testing. They will have cardiac MRI to look at their cardiovascular function. They will also be doing cognitive testing to look at the impact of cancer therapy on cognition. And these tests will reoccur throughout their treatment and then well into survivorship for several years.   And the reason why this is important is that we do not have any long-term data on the cardiovascular and cognitive effects of cancer therapy on patients. There's been a lot of literature in this space in the pediatric population where they've followed children for many years, but not in adult cancer survivors. So I'm really excited about this study. It's being done at a number of studies throughout the US. The PI is Dr. Greg Hundley. And we are certainly doing this study at Duke. And it will really provide some important insight into the long-term consequences of cancer therapy for patients.   ASCO Daily News: What role can exercise and diet modification play in improving the cardiovascular health of patients with cancer and survivors?   Dr. Susan Dent: We have always talked about exercise, but I don't think in the oncology world we've been as committed to it as we should. If you look at cardiovascular disease when individuals have a cardiovascular event, whether it be myocardial infarction or angina, they'll often be put into an exercise rehab program. We don't think about that after an individual goes through their cancer therapy. However, I think there is now clear evidence that exercise can be beneficial for our patients. In fact, it could be beneficial while they're going through their cancer therapy. And clearly, it can be beneficial into survivorship.   So the American Heart Association came out with a statement last year advocating for the benefit of exercise in our patient population. And subsequent to that, there are some ongoing studies looking at a combination of exercise and diet modification to try and deal with some of the risk factors, such as blood sugar control and hypertension. And I think all of these are actually combined when we look at overall risk. So I think that's a very exciting area is the whole field of exercise and I'll say exercise rehab for our patient population. I know at M.D. Anderson, for instance, many of their patients will be offered an exercise rehab program.   It also speaks to mental health I think as well in dealing with some of the fatigue that patients experience after they complete their cancer therapy. There's some also studies going on looking at drugs like statins, which we typically think of for the treatment of hypercholesterolemia. But certainly, these studies are looking at can statins actually benefit patients in preventing cardiovascular toxicity?   And finally, the other thing I'd like to say is that-- which we haven't touched upon-- is cardiovascular imaging. So there is research going on out there to try and determine what are the best cardiovascular cardiac imaging strategies that we can use to detect early evidence of cardiovascular toxicity. So Dr. Ana Barac is going to speak to that at our educational session. And she's going to discuss in what patients should we be using certain cardiovascular imaging techniques, such as echocardiograms, such as cardiac MRIs? When should we be using these? How should we be using these to either detect cardiovascular toxicity early? And can these techniques help us, I should say, even into survivorship? That along with cardiac biomarkers and how can they help us detect cardiotoxicity at an earlier stage?   So as you can see, there's lots going on in this space, not only from drugs that we can potentially prevent these toxicities, to exercise and lifestyle intervention, to cardiac imaging strategies, really looking at it from the very beginning prior to starting cancer therapy through their cancer therapy well into survivorship. Lots of opportunity to sort of look at different points where we can try and help individuals to really promote cardiovascular health.   ASCO Daily News: Excellent. I'd like to remind our listeners then that Dr. Dent's research on optimizing cardiovascular health in patients with cancer and survivors will be presented during the ASCO20 Virtual Education Program. And her article, "Optimizing Cardiovascular Health in Patients with Cancer, A Practical Review of Risk Assessment Monitoring and Prevention of Cancer Treatment Related Cardiovascular Toxicity," has been published in the ASCO Educational Book. Thank you, Dr. Dent for this insightful conversation today.   Dr. Susan Dent: Thank you.   ASCO Daily News: And thank you to our listeners for joining us for this episode of the ASCO Daily News podcast. Please take a moment to rate, review, and subscribe.   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.   COI Disclosure:  Dr. Susan Dent Honoraria: Novartis Canada Research Funding: Novartis US  

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 clinical trials described here may no longer be enrolling patients, and final results are not yet available.   Before any new cancer treatment can be approved for general use, it must be studied in a clinical trial in order to prove it is safe and effective. In today’s podcast, members of the Cancer.Net Editorial Board discuss 3 clinical trials that are exploring new treatment options across prostate, bladder, and kidney cancer. This podcast will be led by Dr. Timothy Gilligan, Dr. Sumanta (Monty) Pal, Dr. Petros Grivas, and Dr. Tian Zhang. Dr. Gilligan is an Associate Professor and Medical Oncologist at the Cleveland Clinic Taussig Cancer Center. He has no relevant relationships to disclose. Dr. Pal is co-director of City of Hope's Kidney Cancer Program and is the head of the kidney and bladder cancer disease team at the institution. He has served in a consulting or advisory role for Astellas Pharma, Exelixis, and Pfizer. Dr. Grivas is the clinical director of the Genitourinary Cancers Program at University of Washington Medicine. He is also an associate member of the clinical research division at the Fred Hutchinson Cancer Research Center. He has served in a consulting or advisory role for Exelixis, Merck, and Pfizer. Dr. Zhang is an assistant professor of medicine at Duke University School of Medicine and is a medical oncologist at Duke Cancer Institute. She has served in a consulting or advisory role for Exelixis, Merck, and Pfizer. View full disclosures for Dr. Gilligan, Dr. Pal, Dr. Grivas, and Dr. Zhang at Cancer.Net. Dr. Gilligan: Hi. I'm Dr. Timothy Gilligan from the Cleveland Clinic. I'm joined today by Dr. Monty Pal from the City of Hope Cancer Center, Dr. Petros Grivas from the Fred Hutchinson Cancer Research Center and University of Washington, and Dr. Tian Zhang from Duke Cancer Institute. Today, we're going to discuss three ongoing clinical trials in prostate, bladder, and kidney cancer. As you may know, clinical trials are the main way the doctors are able to find better treatment for cancer and other diseases. Patient participation is vital for clinical trials. By participating in a clinical trial, you can directly help researchers develop better treatment, reduce side effects, or even reduce the risk of cancer all together. The three trials we'll discuss today were chosen by members of the Cancer.Net Editorial Board Genitourinary Cancers Panel from the trials and progress abstracts that were presented at ASCO's 2020 Genitourinary Cancers Symposium. Because these are ongoing clinical trials, final results from these studies are not available yet. I'd like to note that none of us have any direct involvement with any of these trials. To view our full disclosures, please visit the show notes for this episode on Cancer.Net. So to get started, the first study we'll discuss is the TALAPRO-2 trial for prostate cancer, [Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC (TALAPRO-2)] and Dr. Pal is going to discuss this. So if we could get started, just to begin with, who is the study designed for? Dr. Pal: Thanks a lot, Dr. Gilligan. Well, this study addresses a unique disease population. It's patients with prostate cancer that's metastatic, and that implies that the cancer has migrated out of the prostate to other organs. But beyond that, it also implies that these patients have also developed some resistance to first line hormone treatment. So patients in this study [have] so-called hormone resistant or castration resistant [prostate cancer]. Dr. Gilligan: So if a patient was in this situation, and they weren't going on this trial, what would be the standard treatment for them at this time? Dr. Pal: There are several options for these patients. Hormone therapies like abiraterone and enzalutamide could be considered. Chemotherapy is also a consideration. Dr. Gilligan: And can you say a little bit more about what the patients would receive if they went on it? The subjects of the study, what they'll get? Dr. Pal: Some patients with prostate cancer may have [a deficiency in their cancer’s ability to repair damage to DNA]. This is something that we've seen in other tumor types, breast cancer perhaps being the most notable example. Pancreatic cancer being another one. In this particular trial, [the researchers] try to exploit that by using a class of drugs called PARP inhibitors. In this case, a drug called talazoparib. So patients in this study receive a standard hormone therapy called enzalutamide. And they receive that with or without this drug, talazoparib. Dr. Gilligan: So they will get either-- what you described before is the standard of care—hormonal therapy, or that combined with this new drug. Dr. Pal: That's exactly right, Dr. Gilligan. Dr. Gilligan: I wanted to make that clear because this is a trial that has placebo, and sometimes research [participants] have concern about, "Do I want to be on a trial that has a placebo?" Do you want to say anything about that? Dr. Pal: It's very important to bear in mind that every patient that enrolls in this study is going to get the standard treatment in this setting. As I've mentioned before, enzalutamide represents one of those options. And, of course, in this trial above and beyond that, they have the possibility of getting talazoparib or a placebo. So certainly patients won't be receiving placebo alone in this trial. Dr. Gilligan: Do you want to say anything more about what's kind of interesting about this new approach to treating prostate cancer? Dr. Pal: What I think is quite inventive about this study is that talazoparib, the PARP inhibitor, is being combined with hormone therapy. And I think that's the real difference in what this protocol offers versus the treatment strategies that now represent a standard option for patients. Dr. Gilligan: Right. And my understanding is that the hope is that by using this combination, we'll be able to make treatment more effective. Dr. Pal: Absolutely. When we talk about PARP inhibitors and prostate cancer currently, we're typically restricting it to patients who have these so-called DNA damage repair mutations. And that's certainly a finite group of individuals. In this particular trial, we're actually going to look not just at those patients, but all patients within this disease state. So we go beyond the 25 to 30 percent of patients who are estimated to have alterations in DNA damage repair. Dr. Gilligan: Right. I think that's an important point: to get on this trial, patients don't have to have a particular genetic profile. So how will success be evaluated? How will we know if it's working? Dr. Pal: In this case, we're going to be looking at the delay in cancer growth as the primary outcome measure. We're certainly hoping that the combination of enzalutamide with talazoparib is going to slow growth relative to enzalutamide plus placebo. The innovative endpoint that's explored in this study is also diving deeper and looking at those patients who have these DNA damage repair mutations that's going to also reflect one of the primary outcome measures in this study. And that's something quite important to bear in mind. Dr. Gilligan: So we have some experience with PARP inhibitors. Can you say something about what we know about the side effects? Dr. Pal: Fatigue is a relatively common side effect. Decreases in blood counts is another potential side effect. And in particular in my clinical experience, I've seen drops in the white blood cell counts. That of course makes patients more susceptible to infection. Diarrhea may also be one of the consequences within this class of drugs. And certainly, I would refer patients to a more comprehensive discussion of these side effects with their clinicians before entering into the study. Dr. Gilligan: Is the trial still accruing patients? And do we know when we might expect results? Dr. Pal: I think that there are many trials within this particular space. This one is ambitious in that it hopes to accrue over a thousand patients. I don't have a good finger on the pulse of when results will report. But I'm sure that'll be the subject of future podcasts for us.  Dr. Gilligan: Well, thank you very much Dr. Pal. It's a very exciting study and exciting new area of research in prostate cancer. Dr. Pal: Definitely. Dr. Gilligan: We're going to move on now to the second study we want to talk about, which is the KEYNOTE-905 study. [Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)] And Dr. Grivas is going to talk to us about that. Can you orient us, Dr. Grivas, to what this study is, for which group of patients, and what it's looking at? Dr. Grivas: This clinical trial is applicable to patients with localized, meaning not spread, bladder cancer. And when the bladder cancer has invaded the muscle layer of the bladder, we call this muscle invasive bladder cancer. And these patients usually go for cystectomy, the removal of the bladder. And ideally, they get chemotherapy before, but some patients may not be fit enough for chemotherapy. So those patients go straight to cystectomy, the removal of the bladder. So this clinical trial is trying to evaluate whether immunotherapy with this drug, called pembrolizumab, helps these patients before they get the cystectomy. Dr. Gilligan: Can you tell us a little bit more about pembrolizumab and what we know about it? Where it's used currently in bladder cancer? Dr. Grivas: Pembrolizumab has three different indications for patients with bladder cancer. The first one is in an earlier stage, what we call non-muscle invasive bladder cancer, which is a very superficial cancer, when the cancer is not invading through the muscle layer. And there's a specific indication for those patients who get therapy with BCG, which is a form of immunotherapy given inside the bladder. And if the cancer is not responding well to this BCG, usually, they go for removal of the bladder. But some of them may not be able to do that or do not want that. And pembrolizumab has a track record in those specific scenarios of BCG-unresponsive tumors as we call them for those patients who cannot get cystectomy or don't want to have it. The other two indications are for patients who have metastatic, [meaning bladder cancer that has spread to other organs.] And there are two specific indications of pembrolizumab immunotherapy in that particular setting. So this trial is trying to expand upon the role of pembrolizumab in bladder cancer. Dr. Gilligan: So it's been shown to be a benefit when the disease is more advanced and now we want to see if it's helpful earlier on in the period of time around surgery. Dr. Grivas: Right. And it's interesting in a particular setting we're looking at this trial, because we have indications literally before and after in an earlier states, the non-muscle invasive disease setting. And also as you mentioned, Dr. Gilligan, in the more advanced setting. So we're trying now to see whether this middle setting of muscle invasive bladder cancer, whether there's a role of pembrolizumab by itself before removing the bladder. Dr. Gilligan: Are patients who are eligible to get chemotherapy prior to cystectomy able to go on this trial or is it only for patients who are not [well enough] to get chemotherapy? Dr. Grivas: This is for patients who are not in good condition to undergo chemotherapy. So if someone is in good condition to undergo chemotherapy, then the trial does not apply to them. This is only in those who cannot safely receive chemotherapy before the cystectomy. Dr. Gilligan: Thank you for clarifying that. What data do we have that makes us think that it may be a good idea to give immunotherapy prior to cystectomy? Because this has been looked at a little bit already, and I think it's why this trial is being done. Can you say a little bit about that? Dr. Grivas: Sure. I would like to underline that as you alluded before, the standard of care therapy for patients who undergo cystectomy, the removal of the bladder, is to undergo chemotherapy with a drug called cisplatin before cystectomy. But as we discussed before, this is the standard of care with a high evidence. However, many patients, maybe 50, maybe 55 percent of patients may not have enough condition to undergo this chemotherapy safely. And that is the population we would try to capture. And to answer your question, there have been so far, four clinical trials looking at immunotherapy before cystectomy. And all of those four clinical trials look very promising in that regard. So based on this promising information, this new trial the KEYNOTE-905 is a phase III trial trying to confirm the promising data from the previous phase II trials and help us make a final decision whether this should be the standard of care or not in patients who cannot undergo safely chemotherapy in that setting. Dr. Gilligan: What are the known side effects and risks of immunotherapy? Dr. Grivas: Immunotherapy overall is much better tolerated than chemotherapy. However, it can still cause significant side effects, especially in a small proportion of patients. So the main thing we need to keep an eye on is if the immune system gets too overstimulated, it can cause what we call immunotherapy-related adverse events or side effects. And any organ of the body could in theory be attacked by an overstimulated, overactive, immune system. So they are different forms of “-itis.” For example, if you have inflammation in the lungs, it's pneumonitis. In the liver, hepatitis. So we have to be careful and educate our patients, educate our medical providers and the teams, follow the patients and then report any new symptoms for changes in order to be able to recognize early and manage properly these side effects. As I mentioned, it's not common to have a severe reaction, but it can happen. So education helps, and I recommend to the patients to discuss with a medical provider the potential of those immunotherapy-related adverse events that usually, if they occur, can be managed with proper treatment to try to suppress, “cool down,” the immune system. So education is important. Dr. Gilligan: So just to summarize then, this is a trial for patients who would normally be treated with surgery alone, and we're looking at whether adding immunotherapy before and after surgery can improve those outcomes. Dr. Grivas: That's exactly right. Especially for those patients who cannot safely undergo chemotherapy before the surgery. Dr. Gilligan: And how are we going to measure whether it's successful? Whether that immunotherapy has improved outcomes or not? Dr. Grivas: The two measures that we're are looking at in this particular trial are the following. Number one, we tried to see how many patients--what is the proportion of patients from everybody who gets in the trial—who has no residual cancer cells at the time of the removal of the bladder, at the cystectomy. When the pathologist looks at the cystectomy sample in the lab after the bladder is removed from the body, what is the proportion of patients with no cancer inside the bladder after the immunotherapy compared to no immunotherapy at all? So we're going to compare these. We call this “complete response,” meaning no cancer is found in the bladder after its been removed, after the immunotherapy. And we're going to compare this complete response in the two groups. The other metric we use is to see how many patients have no recurrence regardless, meaning the cancer came back after the treatment. After the cystectomy, how many of those patients either had the cancer come back later or died from another cause. So we use these metrics and we compare the two metrics in the two populations in the trial with and without immunotherapy before the surgery. Dr. Gilligan: And currently, the relapse rate's roughly 50 percent, so we're hoping for a lower number than that. Dr. Grivas: Correct. We try to look for a lower number, and we try to see to compare these two populations with and without immunotherapy and see if immunotherapy adds value in that particular setting. Dr. Gilligan: Is this trial still open and do you know when we might see results from it? Dr. Grivas: The trial is open. It started recently, so I will strongly encourage the patients to discuss with their providers and look at particular locations where this trial is open. So definitely, there is room to go. And I think the trial will take a few years to complete and then report the results. So definitely an ongoing trial options for the patients. Dr. Gilligan: Great. Well, thank you very much. So an exciting trial for patients with localized bladder cancer going through surgery to see if we can improve outcomes, increase the cure rate, by adding this interesting new immunotherapy. Thank you, Dr. Grivas. Dr. Grivas: Thank you so much. Dr. Gilligan: So now we're going to move on and talk about the COSMIC-313 trial with Dr. Zhang from the Duke Cancer Institute. [Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (COSMIC-313)] Can you tell us who this trial is designed for, or which group of patients? Dr. Zhang: Absolutely. We know that for patients with kidney cancer with a clear cell component and intermediate or poor risk by IMDC criteria, that both immunotherapy combinations with ipilimumab and nivolumab as well as the targeted therapy blocking blood vessel formation, called cabozantinib, have both demonstrated significant benefit for these patients. And these are approved treatments. So this particular trial is attempting to combine these starting as a triplet of ipilimumab, nivolumab, cabozantinib for four cycles and then maintenance nivolumab with cabozantinib. And this triplet treatment is compared to a placebo-controlled regimen of the same immunotherapies without the targeted therapy. Dr. Gilligan: So if a patient weren't going to go on this trial, what's the current standard of care? Dr. Zhang: Both the immunotherapy combination as well as having the cabozantinib by itself, are our standard of care therapies for these patients in these categories. Dr. Gilligan: Is this restricted to any particular group of kidney cancer patients? Dr. Zhang: These patients must have at least one of the IMDC criterion. So these are markers of inflammation, like high neutrophil count, low hemoglobin, or high platelet levels, high calcium levels, as well as poor performance status in less than one year from diagnosis to needing these type of treatments. Patients have to have kidney cancer that spread to other sites of their body or locally advanced disease which is not surgically resectable. And as a note, other treatments that are approved in patients who have intermediate poor risk disease include combinations of immunotherapies with targeted therapies like pembrolizumab with axitinib or avelumab with axitinib. Dr. Gilligan: So then just to be clear, these are drugs that are already being used, have already been shown to work, and we're trying to see if we combine them do we get a better result than using them by themselves. Dr. Zhang: That's right. And I think that's a main point. If two agents work on their own, can they be combined to work better? It is important to note that we must follow these patients for their side effects to make sure that the benefit of the triplet therapy would be worth the potential added toxicity of this combination. Dr. Gilligan: So as you mentioned, there's already a standard treatment that includes targeted therapies, immunotherapies, axitinib and pembrolizumab. What do you think is the interesting or different about the approach in this study? Dr. Zhang: The main difference of this triplet combination is the addition of ipilimumab which is a CTLA 4 inhibitor. This is even a bit of a stronger immunotherapy, which targets the dendritic cell interaction with cells to activate the immune cells even more. And so we know that ipilimumab in kidney cancer does drive increase the ability for us to achieve a complete response, meaning that this combination is a really active immunotherapy combination for metastatic kidney cancer. So if we can add the ipilimumab effect with a very strong targeted effect of the cabozantinib the thought is that this triplet might be even more effective than the current standard of care, pembrolizumab-axitinib or avelumab-axitinib combinations. Dr. Gilligan: Thank you for clarifying that. Just to make sure our listeners are clear on this. They're two doublets that are already approved—two kinds of immunotherapy or immunotherapy combined with targeted therapy. This will be the first triplet, if I understand correctly, that if this is shown to be more effective, it would be the first triplet therapy where we're using three different agents, our strongest immunotherapy combined with targeted therapy. Is that a fair summary? Dr. Zhang: Absolutely. I think that's a great summary. Dr. Gilligan: So how will success be evaluated? What are the endpoints for this? Dr. Zhang: Success for this particular study will be evaluated by improving time until tumor growth and the safety of the triplet combination so the primary outcome of this particular study is improving progression free survival. But one of the key secondary endpoints, of course, is to make sure that the benefit of this triplet is worth the potential combined side effects. And then also to follow patients and see if it also improves survival to make patients live longer. Dr. Gilligan: Do we have any sense of how long it'll be before we see outcomes from this? Or results? Dr. Zhang: This is an ongoing international trial enrolling in the US but also spanning Europe, Asia, South America, Australia, and New Zealand sites. It will enroll up to 676 patients, and it's open currently. And patients should discuss it with their oncologist and see if it's open in a site close to them. Dr. Gilligan: Dr. Grivas earlier told us about some of the side effects or risks with immunotherapy. This is combining immunotherapy with targeted therapy. Can you say a little bit about what we're gonna be watching for in terms of side effects or what we might expect? Dr. Zhang: Sure. I think all of the immunotherapy side effects that Dr. Grivas told us about pertain to this study as well. The rashes, the diarrhea, inflammation of the lungs or liver, and affected endocrine dysfunction. But the targeted therapies can also have high blood pressure, rashes on the hand and feet, so called hand foot syndrome, also diarrhea, and elevation of liver enzymes, as well as the loss of protein in the urine. I think the one overlapping toxicity of cabozantinib with a combination of ipilimumab and nivolumab, the immunotherapy combination, is the diarrhea. So patients who start on this trial should be careful to report any diarrhea early on so that their oncologist and their investigators on the study can get an early handle and manage their diarrhea well. Dr. Gilligan: Thank you. That's very helpful. One last question, I want to get back to that issue of eligibility. Sometimes when cancer patients want to go on a trial and they find that they are told they're not eligible to go on, this trial looking at intermediate risk patients specifically so a good risk patient might want to go on it and couldn't. Can you say a little bit about how those decisions are made and what the rationale for selecting groups of patients for trials is? Dr. Zhang: Sure. We know that the IMDC criteria were really made in the setting of targeted therapies, and they were a set of prognostic markers and markers of inflammation, for example, and of time from initial diagnosis to treatment. But now they've been used often as stratification markers in our treatment trials and as selection now for eligibility. In particular for this patient population, ipilimumab, nivolumab seem to have more benefit in this intermediate and poor risk population. And so that's why, for this particular study, they're selecting specifically those patients with intermediate poor-risk disease. Dr. Gilligan: So we want to focus on the patients who are most likely to benefit, it sounds like you're saying. Dr. Zhang: That's right. So the favorable risk patient population do have a better prognosis in general, but those patients may not have as much benefit from the immunotherapy doublet. Dr. Gilligan: All right. Thank you. Well, that brings us to the end of this podcast. Thanks for listening. There are many different clinical trials currently enrolling people with genitourinary cancers. If you're wondering whether participating in a clinical trial might be right for you, please talk to your health care team. This is Timothy Gilligan. Thank you very much. ASCO: Thank you, Drs. Gilligan, Pal, Grivas, and Zhang. Visit www.cancer.net/clinicaltrials to learn more about participating in clinical trials. All treatments have side effects—please talk to your health care team about possible side effects to watch out for. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play. This Cancer.Net podcast is part of the ASCO Podcast Network. This collection of 9 programs offers insight into the world of cancer care, covering a range of educational, inspirational, and scientific content. You can find all 9 shows, including this one, at podcast.asco.org. Cancer.Net is supported by Conquer Cancer, the ASCO 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/donate.

Answering your listener submitted questions about the American genetic counseling board exam is the ABGC President, Adam Buchanan, MS, MPH, CGC!Aside from this role at American Board of Genetic Counseling, Adam is an associate professor, genetic counselor and Director of the Geisinger Genomic Medicine Institute. Previously, he was a research associate at Duke Cancer Institute. His clinical expertise includes intimate knowledge of recommended risk management for hereditary cancer syndromes. He is co-leading Geisinger’s MyCode genomic screening program for medically actionable genomic results, and is helping to develop a health services research portfolio on patient-participant, family, and system outcomes of this program.This episode is sponsored by PhenoTips. If you are still drawing pedigrees by hand, you are overdue for an upgrade! PhenoTips provides a free digital pedigree drawing tool. Not only is it intuitive and easy-to-use, it’s 2.5 times faster than your pen and paper. And we all know time is very valuable in the clinic. Give it a try at phenotips.com/signup.On This Episode We Discuss:Timeframe for the boardsStructure of the examStudy resourcesContent on the examStrategy to approach questionsPercentage passing rate (Is there one?)Results and CGC statusAccommodating for COVID-19 (Possible Remote Test Taking)Inclusivity boards price and questionsUpdate: As teased by Adam in this episode, ABGC officially announce the boards exam is also being offered with remote proctoring in August 2020. Read more on their website here.Learn more on ABGC’s website, here is the content outline that was referred to throughout this interview. Here is the practice exam for purchase ($55) to access your strengths and weaknesses. Here is a page to learn more about the scoring of the exam and here is a page to see specific passing rates over the last few years.During the interview we also reference #ABGCListens tweetchat, which you can read here on Twitter. For other genetic counseling conversation read and participate in #gcchat on Twitter. You can also follow Adam directly on Twitter.Next episode of DNA Today is launching the brand new Direct-To-Consumer Genetic Testing series on July 17th! This series will be sponsored by Fulgent Genetics. New episodes are released on the first and third Friday of the month with some bonus episodes thrown in there. In the meantime, you can listen to over 125 other episodes on Apple Podcasts, Spotify, or streaming on the website including the previous series about infertility.See what else we are up to on Twitter, Instagram, Facebook and iTunes. Questions/inquiries can be sent to info@DNApodcast.com.

Yousuf Zafar, MD, MHS, is a physician scientist whose research is focused on the cost of cancer care, specifically the patient-level impact of the cost of cancer care and what he calls financial toxicity: “Any time a patient experiences costs related to his/her cancer care, whether that’s a cost of drug, a co-pay, time off work, parking, or any of the multitude of costs that our patients face—any time those costs result in harm to the patient—that in my mind is the financial toxicity of cancer care.” Yousuf Zafar, MD, MHS, is Associate Professor of Medicine at Duke Cancer Institute. He’s also a practicing oncologist who treats patients with GI cancers. 2:22 - What is financial toxicity? 3:58 – What he means by, “We must make the invisible, visible.” 7:36 – How the Affordable Care Act impacted the financial toxicity of cancer 11:00 – On the very important findings from the “natural experiment” that’s happened with Medicaid eligibility expansion: “37 states have passed Medicaid expansion, increasing the eligibility threshold allowing more people to get coverage, while remaining states have not.” 15:02 – What’s next? What are the next questions researchers need to investigate in this area? 17:10 – How can we get together as a community to impact patient care? 21:33 – On the impact of ACS funding on his career 23:07 – His message for cancer patients and caregivers

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 clinical trials described here may no longer be enrolling patients, and final results are not yet available.   Before any new cancer treatment can be approved for general use, it must be studied in a clinical trial in order to prove it is safe and effective. In today’s podcast, members of the Cancer.Net Editorial Board discuss 3 clinical trials that are exploring new treatment options across prostate, bladder, and kidney cancer. This podcast will be led by Dr. Sumanta (Monty) Pal, Dr. Neeraj Agarwal, Dr. Petros Grivas, and Dr. Tian Zhang. Dr. Pal is co-director of City of Hope's Kidney Cancer Program and is the head of the kidney and bladder cancer disease team at the institution. He has served in a consulting or advisory role for Novartis, Genentech Roche, and Bristol-Myers Squibb. Dr. Agarwal directs the Genitourinary Oncology Program at the Huntsman Cancer Institute at the University of Utah. He has served in a consulting or advisory role for Novartis and Bristol-Myers Squibb. Dr. Grivas is the clinical director of the Genitourinary Cancers Program at University of Washington Medicine. He is also an associate member of the clinical research division at the Fred Hutchinson Cancer Research Center. He has served in a consulting or advisory role for Genentech Roche and Bristol-Myers Squibb. Dr. Zhang is an assistant professor of medicine at Duke University School of Medicine and is a medical oncologist at Duke Cancer Institute. She has served in a consulting or advisory role for Genentech Roche and Bristol-Myers Squibb. View full disclosures for Dr. Pal, Dr. Agarwal, Dr. Grivas, and Dr. Zhang at Cancer.Net. Dr. Pal: Hi, I'm Monty Pal from City of Hope. I'm the Associate Editor for Genitourinary Cancers for Cancer.Net, ASCO's patient education website.  I'm really excited to be here with my colleagues: Dr. Petros Grivas, Dr. Neeraj Agarwal, and Dr. Tian Zhang. We're really excited about this effort. We're hoping it brings some salient details about clinical trials straight to you, our most important audience. Keep in mind that clinical trials are the main way that doctors are able to find better treatments for diseases like cancer. And before any new drug can be approved by the FDA, it must be studied in the context of a clinical trial. Patient participation is vital for clinical trials. By participating in a clinical trial, you can directly help researchers develop better treatments, reduce side effects, or even reduce the risk of cancer altogether. While you may receive new treatments within a clinical trial, the primary purpose of these studies is to move the field of cancer research forward. Keeping participants safe is probably the most important concern in clinical trials, and there may be some risks involved. Because of that, your healthcare team is going to discuss with you in detail these risks before you join on to a clinical study. Now, at this point in time, we're going to discuss 3 studies that are being done in the area of kidney, bladder, and prostate cancer. These studies were chosen by members of the Cancer.Net Editorial Board Genitourinary Cancers panel from the Trials in Progress abstracts that are going to be presented at ASCO's 2020 Genitourinary Cancers Symposium. I'd like to note that none of us have any direct involvement with any of these trials. Each one of us will post our disclosures on the ASCO website if you'd like to see them. We'll certainly have them posted on the Cancer.Net website. I'd like to begin by introducing my very esteemed panel.  First, is Dr. Tian Zhang, who's an expert in kidney, bladder, and prostate cancer from Duke Cancer Research Institute. We have Dr. Neeraj Agarwal, who heads up the Genitourinary Cancers Program at the Huntsman Cancer Institute at the University of Utah. And last, but not least, we have Dr. Petros Grivas from the Fred Hutchinson Cancer Research Institute in Seattle, Washington, an expert in many disease types, including bladder cancer. I'd like to bring on my first guest, Dr. Neeraj Agarwal, to discuss the VISION study. [VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)] Neeraj, this is a study in prostate cancer. What particular patient population within prostate cancer are we focused on here with this study? Dr. Agarwal: So this is a patient population with advanced prostate cancer where prostate cancer has gone beyond prostate to different parts of the body. In technical terms, we call it metastatic prostate cancer. The usual treatment paradigm for these patients is to be treated with hormonal blockade therapies, which can include injections and oral pills, which have different mechanisms to prevent stimulation of testosterone to the prostate cancer cells. However, every patient with metastatic prostate cancer eventually are failed by these treatment options, and the next commonly used treatment option is chemotherapy, which usually controls the disease for a period of many months, up to one year. And after, patient's disease progresses on these 2 different therapeutic options, which include hormonal therapies and chemotherapies. And this is the patient population in which this novel type of radiation therapy or radiation particle treatment is being tested. Dr. Pal: Tell us about what question this study aims to answer. Dr. Agarwal: This study is testing a novel medication, which is a type of a radiation particle, which is supposed to target prostate cancer cells. So whether using this kind of radiation particle in patients with advanced prostate cancer, who have been failed by previous chemotherapy and novel, hormonal therapies. The study is asking whether using this radiation particle as a treatment may improve overall survival. Dr. Pal: Now, this compound is called 177Lutetium-PSMA-617. It's a long name. Tell us about what it actually does. What's the rationale for using this particular drug? Dr. Agarwal: I would like to divide this long name into 2 parts to make it simple. So 1 is the lutetium particle, which is the radiation particle, is a type of radiation known as beta radiation. So lutetium is tagged onto a PSMA-identifying agent known as PSMA-617. So if we just inject PSMA-617, it will go and seek prostate cancer cells, which are expressing PSMA on their surface. If you tag this radiation particle lutetium to the PSMA-617, what essentially happens is that PSMA-617 takes this radiation particle directly to the prostate cancer cells. Dr. Pal: Now, what is this study attempting to demonstrate? Dr. Agarwal: This study is specifically looking at 1 question, which is whether using this radiation particle can improve survival in patients with metastatic prostate cancer who have had disease progression on novel hormonal therapies and chemotherapies. Dr. Pal: And again, it's hard to be comprehensive in a podcast like this, so of course, we refer patients to their physicians for a discussion around safety of these drugs. But could you tell us about any known risks that patients should be aware of in the context of this agent? Dr. Agarwal: Yes. So as you can imagine, this PSMA-617, which is loaded with this radiation particle, is looking for those cells in our body which are expressing PSMA. So of course, the PSMA is expressed highly by prostate cancer cells. But there are also normal cells which express PSMA to a lesser degree. And those cells may also have the potential to be targeted by this radiation particle. So technically, their other cells which may express PSMA, or which are in the vicinity of these cancer cells in the bone, such as bone marrow, these can be targeted to a much lesser degree because of the specificity of this compound. We can see some off-target toxicities, as we call them, but given the highly targeted nature of this compound, those toxicities are usually very well tolerated, except in rare circumstances. Dr. Pal: Excellent, Neeraj. Now, for a little additional commentary on the VISION trial, I'm going to throw it to Dr. Tian Zhang, again, an expert at the Duke Cancer Research Institute Tian, you've had some experience enrolling patients on VISION, correct? Dr. Zhang: That's right, Monty. Thanks so much for having me on. And VISION has actually completed accrual. It was open for a few months here at Duke. We were able to enroll about 10 patients and we're really looking forward to seeing the results of VISION over the next year or 2. And I think it'll be quite applicable to clinical practice. Now, I want to mention that although VISION has completed enrollment, there are other clinical trials that are using PSMA-targeted Lutetium-617 agent as a possibility for other patients to enroll on to other trials in clinical development as we speak, and so there will be other opportunities to receive this agent. Dr. Pal: We're going to shift gears now from prostate cancer and move on to the topic of bladder cancer. And again, I'm thrilled to have Dr. Petros Grivas from the Fred Hutch Cancer Research Institute to discuss a very important trial called INTACT. [Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806)] Petros, the study INTACT really addresses a very important question. Can you tell us a little bit more about it? Dr. Grivas: Thank you, Monty. I think this trial is very important for a number of reasons. Number 1 is trying to address an important clinical question, which is the following: Patients who we consider candidates for bladder-preservation approach, meaning, we try to keep the bladder in place and still kill the cancer, which is not a good option for everybody with bladder cancer. But the proportion of patients after discussions of pros and cons with their providers could be offered this bladder-preservation approach, which is consisted of an optimal resection of the tumor through a procedure called transrectal bladder tumor resection, which means try to remove the bladder tumor through a procedure that is similar to cystoscopy, when you look inside the bladder. And after this tumor is removed, then there is a combination of chemotherapy and radiation, at the same time—we call this concurrent or concomitant—at the same time, chemotherapy and radiation. This approach, which involves the collaboration between the urologic oncologist, medical oncologist, and radiation oncologist, is the standard of care, the standard approach, how we try to preserve the bladder and still kill the cancer in those patients who are considered good candidates for this approach, which, as I've mentioned, is not for everybody. The clinical question is can we improve upon this backbone of chemotherapy and radiation, which is current standard of care, by using a third modality, a third type of treatment, which is immunotherapy? And immunotherapy is known to improve how people live in patients who have metastatic bladder cancer. For example, there's this particular drug called atezolizumab, which is already having FDA approval for patients with metastatic bladder cancer. The question is can we add this drug, the immunotherapy drug, that is activating the immune system, into the backbone of chemotherapy and radiation and use all three approaches, chemotherapy, radiation and immunotherapy together? And if that's the case, is that triplet combination better or not to the current standard of care, which is chemotherapy and radiation? So the INTACT trial is chemotherapy, radiation, plus immunotherapy with this drug called atezolizumab, together, all 3 of them compared to chemotherapy and radiation alone, in order to see whether we can improve upon the results we're getting with chemotherapy and radiation. The primary end point of this particular trial is what we call bladder intact disease-free survival, which means the proportion of patients who have no cancer coming back after treatment. They have what we call a complete response, remission of the cancer, and they still have the bladder intact, in place. And this is what we call a metric of success. This is a huge effort among different investigators across the country. These studies open in multiple cancer centers and sites across the nation. And I think it's a very good example of what can happen in terms of a clinical trial design that is applicable to many patients when different collaborations take place and when people put their minds together. So we're really very enthusiastic about this study, and we'll try to support the accrual and offer this option to the patients who are considered to be good candidates for this attempt for bladder preservation. Dr. Pal: Petros, thanks. That was a great overview of the study. You've really highlighted the rationale and some detail and the metrics for success of this trial. Now, on the subject of this approach, are there any risks that you think patients should be particularly aware of? And again, we leave it to the discretion of treating physicians to have that very thorough discussion of risks and benefits. But off the top of your head what would you counsel patients, in general? Dr. Grivas: I think, Monty, that's a great question, in general, because when a patient is undergoing evaluation for a clinical trial, it's important for them to understand thoroughly the pros and cons of this particular therapy and other procedures and what those mean for the patient's logistical, day-to-day schedules, as well as potential short-term and long-term side effects. In that particular study, I think the important take-home message is we're trying to evaluate the additional role of immunotherapy to the backbone of chemotherapy and radiation. So potential side effects of immunotherapy are something that are very important to be discussed with the patient. Some of the patients may develop fatigue or some degree of occurrence of what we call immune-related adverse events, which means the immune system gets activated, stimulated against the cancer but can, potentially, in a small proportion of patients generate a significant reaction, an immune system activated related reaction against different parts of the body or some parts of the body. So I think it's very important for the patients to discuss carefully with the providers what are those uncommon, but sometimes significant, immune-related adverse events, and have a very good understanding of what symptoms [to] look for in order to be able to communicate or recognize early those potential side effects and have a proper management plan. Because most of those side effects could be managed properly, and with good success, especially if they're caught up early. So I think it's important to have these thorough discussions with the provider. And of course, the side effects of chemotherapy and radiation should be discussed in thorough detail. This is the standard of care, but still is important to delineate what potential side effects can happen. At the end of the day, it's in the balanced discussion about pros and cons. This is a very exciting trial, but I think good education for the patient and their families and their caregivers are very important and critical for the successful detection or diagnosis of any potential side effects. Overall, I think this is a very relevant discussion to have with the provider and a very exciting trial to be involved in. Dr. Pal: Excellent, Petros. Well, great discussion of some of the risks associated with this approach. Neeraj, any thoughts on INTACT? Why should patients be excited about this particular trial? Dr. Agarwal:  I was recently talking to one of my patients about this upcoming trial, who is preparing to go on radiation therapy plus chemotherapy as a treatment option for his muscle-invasive bladder cancer, and cystectomy is not an option. And the way I explained this to the patient is 95% of the work he will have to do will be done by the time he's getting radiation therapy and chemotherapy. And after that, 5% of the work, as far as patient's effort, side effects, toxicities, impact, and quality of life, all are concerns, 95% of that, in my view, is coming from radiation therapy and chemotherapy. And after that, little work from that perspective by the patient has to be done by atezolizumab, as far as getting treatment with atezolizumab is concerned. So as Petros said, this is a highly well-tolerated treatment, which is immunotherapy. And if you look at the potential of this drug to control the recurrence of the disease and allow our patients to maintain their bladder—it’s tremendous. So I think the expected returns are very high, and how much effort patients will have to put on the trials are not as high as you would expect if you are thinking about a trial. Dr. Pal: That was an excellent discussion of toxicities associated with this particular regimen, Neeraj. Petros, before we move on any closing thoughts? Dr. Grivas: No, I agree completely with Neeraj. I think these are important points. I just wanted to add a couple of key take-home message for the patients. Number 1, this trial is available for patients who either are or are not candidates for radical cystectomy, which is the removal of the bladder and again, it has to be a discussion with the providers whether they're good candidates for the attempt for bladder preservation. Half of the patients get the standard of care, which is chemotherapy and radiation at the same time, and the other half get chemotherapy and radiation, plus this immunotherapy called atezolizumab. And again, I think the last point to make is that chemotherapy and radiation have to happen at the cancer center, and some of the patients live far away, so I think it's important to discuss with the patients the pros and cons of the trial because it might entail some back and forth transportation for them if they have to get the radiation and the chemotherapy in the cancer center that is offering the trial. But overall, as Neeraj pointed out, we are very enthusiastic, and I'm personally enthusiastic about the study. Dr. Pal: That's great Petros, appreciate that. Now, in the final portion of our program, we're going to shift gears and talk about the type of cancer that I actually focus on personally in the clinic, and that is kidney cancer. And we have our resident expert in kidney cancer on the Cancer.Net panel, Dr. Tian Zhang from Duke here to discuss the PROSPER study, a very important national effort. [A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)] Tian, can you tell us about PROSPER? Dr. Zhang: PROSPER is a phase III trial that's open currently for patients who have locally advanced kidney cancer, and we know that in this population of patients who have locally advanced kidney cancer who undergo their surgery, there's still a high rate of recurrence up to about 50% with many dying, unfortunately, from disease recurrence. And so the question that PROSPER aims to answer is can we prevent disease from recurring, and thereby, can we allow patients to live longer from giving up-front systemic therapy in addition to their surgery? And so in kidney cancer, we know that patients will benefit from immune checkpoint inhibitors, and the big question of the study is that with the primary kidney cancer in place, what is the effect of this immunotherapy called nivolumab before and after surgery compared to surgery alone, and how should we use these immunotherapy agents in the perioperative setting to improve overall survival? Dr. Pal: That's very interesting. Of course, in kidney cancer, just as we discussed with prostate cancer, you've got patients who have the disease confined to the kidney. You have patients where the disease has spread. What particular patient population does this study focus on? Dr. Zhang: This study is enrolling patients with locally advanced disease, so either clinical stage II or higher. So that's patients who have primary tumors of greater than seven centimeters, or if they have positive lymph nodes on their scan, so clinical detection of lymph node-positive cancer. Or the study, actually, also allows cancer that has spread to no more than three, so one, two, or three, other sites, which can also be definitively treated at the time of the primary surgery. Patients who have disease spread to the lung, adrenal gland, lymph nodes, pancreas, or soft tissue are allowed. Patients who have spread to the liver or bone are not allowed. And the study is currently ongoing, Monty. It is randomizing up to 805 patients total. As of late January 2020, they're currently at about 390 patients already enrolled. So there's plenty more, about 400 more patients to go on the study. And it is an open and enrolling study. Dr. Pal: That's really interesting. Now, Petros gave us some insights as to the rationale for using immunotherapy in cancer. Is it the same rationale for using this treatment strategy in kidney cancer? Dr. Zhang: Sure. So our standard of care in this setting, as you know, for locally advanced disease is truly just nephrectomy alone to remove the kidney, usually without treatment afterward. And there are multiple adjuvant studies using immunotherapies in this post-operative setting, however, those are all pending. And we're hoping that immunotherapy used earlier in the disease course will allow us to see a benefit overall. Now, nivolumab, the immunotherapy that's studied in the PROSPER trial, is approved for metastatic kidney cancer. And therefore, we know nivolumab is effective at extending overall survival for these patients. And so the question is if we can use this active immunotherapy agent earlier in the disease course if we can to try to prevent disease recurrence. Dr. Pal: That makes a lot of sense. Now, what is this particular study attempting to demonstrate? What are we trying to prove here with this trial? Dr. Zhang: Right. So the primary outcome of PROSPER is the time to disease recurrence or spread to other sites, what we call recurrence free-survival. There are secondary outcomes. So trying to get patients to live longer, overall survival, toxicity of giving nivolumab up front for these patients. As well as, specifically in patients who have clear cell kidney cancer, the time to disease recurrence for those patients, as well. So there are patients who are on the control cohort of surgery alone, and we'll be able to study that tissue in conjunction and compare those with patients who have received immunotherapy or nivolumab prior to their surgeries. So they have a number of biomarkers planned for the tissue that's being collected from the study. Dr. Pal: Very interesting. Well, I can't wait to see the results, ultimately, of this trial. But in the meantime, Petros had outline some of the risks associated with immunotherapy in the context of the study he discussed. Anything to add to that, in terms of the risks that might be entailed in this trial? Dr. Zhang: Right. So it is certainly a randomized trial, as Petros mentioned, so there are patients who are randomized to surgery alone versus patients who are randomized to the immunotherapy up front. So one dose of nivolumab followed by surgery and then maintenance treatment with nivolumab. And I fully agreed with the toxicity profile that Petros outlined very nicely. And when we get patients started on these immunotherapies treatments in clinic, I often talk about, we're activating your immune system, and therefore, toxicities can occur where the immune system is very active. So on the skin it can cause a rash, in the GI tract it can cause diarrhea or colitis, in a very small proportion of patients it can cause inflammation in the lungs or liver, and then, finally, it can affect their endocrine organs: the pituitary, thyroid, adrenal glands, and pancreas. And one more note about treatment with these immune checkpoint inhibitors of nivolumab, and other agents like nivolumab, is that these are really not for patients who have active autoimmune disease. We think that those patients who have active autoimmune disease requiring prednisone or other disease-modifying agents, those patients are probably going to have worsening of their baseline autoimmune disorder. So patients who do have that need to have a very close discussion with their providers before going on any of these trials. Dr. Pal: Well, that's an excellent overview of toxicity, and again, just as I mentioned earlier, I certainly leave it in the hands of the patient and their respective clinicians to go through a very thorough discussion of toxicity, but I think that was a fantastic primer on it, Tian. Thank you for that. Before we close, I wanted to go to Petros for any additional comments on this concept of the PROSPER study. Petros, any additional thoughts? Dr. Grivas: I think that Tian did a wonderful job summarizing all the key points. I think one of the key characteristics of this trial is, again, their rationale. The reasoning behind it, which as Tian mentioned, is we have the immunotherapy up front in the beginning of the treatment while the tumor is still present and the proteins, the antigens of the tumor, are still present, and that might be relevant in the recognition of those elements by the immune system when you give the immunotherapy. And then you have surgery, and then you have continuation of postoperative treatment, as Tian mentioned, and maybe that combination approach may be relevant. We have to see, of course, but I think it's a very, very compelling design that makes sense, at least scientifically speaking. The other point, I think, is as [inaudible] already mentioned, this very [inaudible] teamwork, team effort from multiple investigators across the country. And that speaks volumes of the very nice design, as well as the collaborative in spirit, which I think is important for that patient to know, that people do work together to come up with these clinical trials. We all hope that this trial will keep accruing well and will end up with accrual target in order to answer this important question which is, as Tian mentioned, whether immunotherapy before and after surgery prolongs life and improves the times of cancer remission, which is important and clinically relevant question. And of course, it's a key point to have discussions about sometimes uncommon but significant immune-related reaction and go through the different nuances carefully with the providers when a patient's considering clinical trial. But clinical trials, as you mentioned Monty, is the way to develop new therapies and are very important part of a discussion in the routine patient care. Dr. Pal: Excellent, Petros. Well, on behalf of Dr. Petros Grivas, Dr. Neeraj Agarwal, and Dr. Tian Zhang, I really want to thank you for joining our very first podcast from Cancer.Net. There's so many different clinical trials out there enrolling patients with genitourinary cancers, and we've only had time here to discuss 3 of them. If you have interest in participating in clinical trials, please do get in touch with your healthcare team. And of course, Cancer.Net serves as an excellent resource to communicate with experts in the field and learn more about respective genitourinary types of cancer. Thank you again for joining. ASCO: Thank you, Drs. Pal, Agarwal, Grivas, and Zhang. Visit www.cancer.net/clinicaltrials to learn more about participating in clinical trials. All treatments have side effects—please talk to your health care team about possible side effects to watch out for. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play. This Cancer.Net podcast is part of the ASCO Podcast Network. This collection of 9 programs offers insight into the world of cancer care, covering a range of educational, inspirational, and scientific content. You can find all 9 shows, including this one, at podcast.asco.org.  Cancer.Net is supported by Conquer Cancer, the ASCO 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/donate.

Thomas LeBlanc, MD, of Duke Cancer Institute in Durham, N.C., joins host David H. Henry, MD, of Pennsylvania Hospital, Philadelphia, to discuss the evolution of the palliative care field and some of the underrecognized ways that it can improve care for hematology-oncology patients. Plus, in Clinical Correlation, Ilana Yurkiewicz, MD, of Stanford (Calif.) University, shares the story of a patient who put aside her own desire for hospice because of family pressure to pursue curative treatment. *  *  * Palliative medicine has evolved tremendously over the past decade; it used to be synonymous with hospice and dying. It is now a sophisticated medical subspecialty with growing and large evidence base.  Palliative treatments are aimed at maximizing patient's quality of life and can be provided alongside other curative treatments.  Physicians, physician assistants, and nurse practitioners form an interdisciplinary team along with patients and their families.  Palliative care specialists can work alongside oncologists to optimize symptom management in patients with multiple or refractory/severe symptoms, including chemotherapy-induced nausea and pain neuropathy.  Palliative care specialists also can help provide a safe space and an extra layer of support to patients having difficulty coping with illness.  The American Society of Clinical Oncology (ASCO) has developed a guideline that all patients with advanced cancer should be receiving dedicated palliative care services concurrent with active treatment.  Workforce shortages in palliative care are limiting access for patients with cancer. Resource: Integration of palliative care into standard oncology care: ASCO Practice Guideline update (2017) Show notes by Debika Biswal Shinohara, MD, PhD, resident in the department of internal medicine, University of Pennsylvania, Philadelphia. *  *  * 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

Dr. Daniel George is Professor of Medicine and Surgery, Director of GU Oncology for the Duke Cancer Institute, and Co-Chair of the DCI Center for Prostate and Urologic Cancers. Dr George’s primary areas of interest are in drug development and optimizing care for patients with GU cancers, particularly prostate and kidney cancers. In this episode, Dr. George reviews disparities in prostate care. The ASCO eLearning Weekly Podcast is an educational series focused on helping learners identify knowledge gaps and stay up-to-date with the latest in new drug developments, cancer treatments and patient care approaches. If you enjoyed this podcast, make sure to subscribe for more weekly education content from ASCO eLearning. Subscribe to the podcast through a mobile device by clicking the Apple Podcasts link (iOS devices) or the Google Play Music link (Android devices). We truly value your feedback and suggestions, so please take a minute to leave a review. If you are an oncology professional and interested in contributing to the ASCO eLearning Weekly Podcast, email elearning@asco.org for more information.

Dr. Daniel George is Professor of Medicine and Surgery, Director of GU Oncology for the Duke Cancer Institute, and Co-Chair of the DCI Center for Prostate and Urologic Cancers. Dr George’s primary areas of interest are in drug development and optimizing care for patients with GU cancers, particularly prostate and kidney cancers. In this week's episode, Dr. George presents two contrasting cases with nephrectomy as a possible treatment path. Can you determine the best course of treatment for each patient? If you enjoyed this podcast, make sure to subscribe for more weekly education content from ASCO University. We truly value your feedback and suggestions, so please take a minute to leave a review. If you are an oncology professional and interested in contributing to the ASCO University Weekly Podcast, email ascou@asco.org for more information. TRANSCRIPT Welcome to the ASCO University Weekly Podcast. My name is Dr. Daniel George. And I'm a professor of medicine and surgery at Duke University. I'm also the director of GU oncology at the Duke Cancer Institute and co-chair of the DCI Center for Prostate and Neurologic Cancers. Today we'll discuss two similar cases of patients presenting with metastatic renal cell carcinoma in our multidisciplinary management options. Without any standard screening procedures, 20% to 30% of kidney cancer patients today present with metastatic disease. Historically, debulking nephrectomy has been our standard of care. And this has been based on old trials from the interferon era of treatments. Since then, many drugs have been approved for the management of patients with metastatic renal cell carcinoma, many of which have improved the progression free survival and overall survival of patients with metastatic disease, which may have had an impact on the landscape and role for debulking nephrectomy. Furthermore, metastatic kidney cancer patients can be risk stratified. There's a number of criteria used. But historically the most commonly used criteria has been the Memorial Sloan Kettering Cancer Center criteria. Which included five factors, including KPS score less than 70, a calcium score greater than 10, A serum hemoglobin of less than the lower limit of normal, and LDH greater than 1.5 times the upper limit of normal, or having their primary tumor in place, meaning no prior nephrectomy. If patients had zero of these factors they were considered good risk with the best survival. Patients with one or two of these factors are considered intermediate risk. And patients with three or more of these factors historically have been very poor risk, with median survivals of six months or less. The Carmena Study was a prospective, multi-center, randomized, non inferiority trial comparing upfront nephrectomy followed by sunitinib therapy, compared to upfront sunitinib therapy alone in patients with metastatic renal cell carcinoma amenable to cytoreductive nephrectomy. We'll get to these results in a moment. But the study population included, importantly, patients with e cog performance status zero or one. And 40% plus of these patients were considered poor risk, with the average sum of metastatic tumor burden being greater than five centimeters. So now, let's get to some modern cases. The first case we'll discuss is George. He's an 83-year-old man who presented with gross hematuria and a hemoglobin of 13.8 in the normal range. A CT scan revealed an eight centimeter right renal mass and multiple pulmonary mets, up to two centimeters in size. His e cog performance status is zero. And his calcium was 8.4, and LDH was normal as well. Our second case, for comparison, is Philip, a 76-year-old man who was found to have a 16 centimeter left renal mass incidentally on a spine MRI. This was confirmed by CT scan, along with some pulmonary nodules measuring up to 1.8 centimeters, as well as enlarged mediastinal lymph nodes up to two centimeters, and an eight millimeter liver lesion. His calcium score was 10.4. And his hemoglobin was 12.5, which was below the limit of normal. He had a normal LDH and an absolutely zero performance status. So for these two cases, we have four choices. The first choice is for both cases a nephrectomy followed by systemic treatment, our historical approach. The second is systemic therapy first, with plus or minus a subsequent nephrectomy for both cases. Our third choice would be to treat case number one with a nephrectomy, followed by systemic therapy, and case number two with systemic therapy first. And our fourth option would be systemic therapy first for case one and a nephrectomy first for case two. Now, to me, when I look at these cases, the correct answer is three. Nephrectomy first for case one, and systemic therapy first for case two. Let me explain. Even though these cases are fairly similar in age, gender, performance status, and had the presence of a large primary tumor, for case one this is an intermediate risk patient. This patient has lung only disease that's relatively low volume, a good performance status, and normal labs. In addition, he's symptomatic with gross hematuria. For these reasons, a debulking nephrectomy is really indicated. And because of his good performance status, he's very likely to recover well from the surgery, despite the fact that he's 83 years old. Case two is subtly different. This is actually a poor risk patient. Even though his e cog performance status is zero, he has an elevated calcium, a decreased hemoglobin, and he's got his primary tumor still in place. That puts him into a poor risk category. And some of these patients never recover from surgery well enough to get systemic therapy. He also has multi organ involvement, involving his lungs and nodes, and possibly even his liver. This is a patient that really mirrors the patient population of Carmena. Based upon this, I think systemic therapy first is a reasonable treatment option for this patient. If we actually look at the results of Carmena, the study confirmed that sunitinib therapy alone, systemic therapy, was non inferior, and actually trended towards improved survival compared to cytoreductive nephrectomy followed by sunitinib. The results suggest that for poor risk or for high volume metastatic patients, that systemic therapy first should be the standard of care. But, importantly, not included in a Carmena study were patients that had low volume metastatic disease and intermediate risk features, or good prognosis. These patients not included in the Carmena study might still benefit first from a debulking or cytoreductive nephrectomy. So thank you for listening to this week's episode of the ASCO University Weekly Podcast. For more information on the role of cytoreductive nephrectomy, including additional patient cases and opportunities for self-evaluation, visit the Comprehensive eLearning Center at university.asco.org. 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.

Cindy Kennedy is joined by Dr. Neil Spector M.D., to discuss his experience with debilitating Lyme Disease symptoms and how to manage them. Neil is the Sandra Coates Associate Professor of Medicine, an Associate Professor of Cancer Biology and Pharmacology and the Associate Director of Developmental Therapeutics for the Duke Cancer Institute.

Health literacy in the United States is low to begin with, and health financial literacy is even lower. The changing health insurance system is partly to blame. A few decades ago, health insurance covered everything. Now, patients have a lot more financial responsibility, and they don’t always understand it. In cancer, health financial literacy is particularly important since treatment can be so costly. This episode of Managed Care Cast includes conversations with a few experts in the field: Yousuf Zafar, MD, MHS, of the Duke Cancer Institute; Clara Lambert, BBA, OPN-CG, chair of the Association of Community Cancer Centers Financial Advocacy Network Advisory Committee; Todd Yezefski, MD, senior fellow in the Clinical Research Division at the Fred Hutchinson Cancer Research Center and Division of Medical Oncology at the University of Washington; and Michele McCourt, senior director of the CancerCare Co-Payment Assistance Foundation. Read more: A Descriptive Study of Patients Receiving Foundational Financial Assistance Through Local Specialty Pharmacies: www.ajmc.com/journals/supplement/2018/the-patient-assistance-safety-net-how-many-need-help-how-many-are-helped/a-descriptive-study-of-patients-receiving-foundational-financial-assistance-through-local-specialty-pharmacies Impact of Trained Oncology Financial Navigators on Patient Out-of-Pocket Spending: www.ajmc.com/journals/supplement/2018/the-patient-assistance-safety-net-how-many-need-help-how-many-are-helped/impact-of-trained-oncology-financial-navigators-on-patient-outofpocket-spending Policy Improvement Areas to Reduce Financial Hardship: www.ajmc.com/conferences/pan-2018/policy-improvement-areas-to-reduce-financial-hardship Addressing Financial Concerns at the Outset to Improve Patient Outcomes: www.ajmc.com/conferences/pan-2018/addressing-financial-concerns-at-the-outset-to-improve-patient-outcomes

Available On: iTunes  | Google Play  | Stitcher  | Spotify Kristen MacDermott is a consultant and performance coach who has created resilience training programs for some of the highest performing people on the planet, including Naval Special Warfare Command (Navy SEALs) and the Los Angeles Police Department. Kristin’s programs have also been used in more than 20 hospitals across the country, in the Duke Cancer Institute, and in the National Institutes of Health among others. Kristin brings a unique skill set to her executive coaching, leadership training, and corporate consulting work. The resilience training curriculum she created has been validated in four studies with researchers from the Duke Clinical Research Institute, published in peer-reviewed journals and shown to promote clinically significant improvement in key wellness and resilience measures. The cornerstone of Kristin’s resilience training curriculum is emotional intelligence, which is why her expertise lends itself so well to the corporate world. Study after study shows that “the single biggest predictor of professional success is not education, skill set, experience or IQ. It is emotional intelligence.” Kristin’s own research shows that emotional intelligence and resilience can be taught, and these skills improve performance and satisfaction with the workplace, which engenders loyalty to the organization. From Andy: One of the coolest parts of this interview for me was when we talked about how you can hear the same information from two different people – and one will trigger you into anger and upset while the other has no impact at all. In unraveling that, we got to the reason… that on some level, you believe that the person that triggered you is right – you believe them, and that causes you to judge yourself. So the upset is really about self-judgment… and THAT, you can do something about. There’s that… and so much more in this conversation. Check it out – you’ll be glad you did! Enjoy! FORWARD TO A FRIEND - If you enjoy the podcast, please help us spread the word by sharing it. LEAVE A REVIEW - Your written reviews in iTunes go a long way in helping us get the word out. Here's a link to make it easy - bit.ly/breakingordinary. Thanks in advance for your help and support! Connect with Kristin Instagram: kristinmacdermott Website: www.kristinmacdermott.com Facebook: Kristin MacDermott DMFT Blog: Practical Resilience   Twitter: Kristin MacDermott Questions? Feedback? Email - podcast@wholelifechallenge.com Instagram - @andypetranek Facebook - @andypetranek Twitter - @andypetranek REVIEW THE PODCAST ON iTUNES - bit.ly/breakingordinary If you liked this episode, try these: 76: Scott McGee — On Grit, Resilience and Having an Unconquerable Soul 107: Dr. Christopher Neck — The Surprising Benefits of Setbacks  

Dr. Thomas LeBlanc joins us for a comprehensive conversation about Chronic Lymphocytic Leukemia- a cancer that poses unique challenges. Dr. LeBlanc is a medical oncologist, palliative care physician, and patient experience researcher at Duke University School of Medicine's Duke Cancer Institute.

This is an in depth discussion about the connection between flame retardants and plastics, and thyroid cancer.  These chemicals, also known as endocrine disruptors, have a clear connection to thyroid cancer occurrence. The research is presented by Julie Ann Sosa, MD MA FACS is Chief of Endocrine Surgery at Duke University and leader of the endocrine neoplasia diseases group in the Duke Cancer Institute and the Duke Clinical Research Institute. She is Professor of Surgery and Medicine. Her clinical interest is in endocrine surgery, with a focus in thyroid cancer. She is widely published in outcomes analysis, as well as cost-effectiveness analysis, meta-analysis, and survey-based research, and she is director of health services research.  NOTES: Study Associates Flame Retardants with Papillary Thyroid Cancer Flame retardants used in furniture may increase thyroid cancer risk Trends in Thyroid Cancer Incidence and Mortality in the United States, 1974-2013 How to Buy a Sofa without Toxic Flame Retardants Julie Ann Sosa, MD

Nicole, Cooper, and Jason invite Shebra Hughes of the Duke Cancer Institute (www.dukecancerinstitute.org) on the program to talk about dealing with a cancer diagnosis. They also discuss resources available to patients and caregivers as well. Upcoming events are also mentioned, including Caregivers Summit. You can find more information about it here: http://caregiverssummit.org/

Nicole, Cooper, and Jason invite Shebra Hughes of the Duke Cancer Institute (www.dukecancerinstitute.org) on the program to talk about dealing with a cancer diagnosis. They also discuss resources available to patients and caregivers as well. Upcoming events are also mentioned, including Caregivers Summit. You can find more information about it here: http://caregiverssummit.org/

Allogeneic stem cell transplant is rarely used in multiple myeloma treatment, but for younger patients with high-risk myeloma, it could be a highly effective strategy with durable outcomes. Dr. Cristina Gasparetto from Duke University shares the rationale of this approach for a subset of myeloma patients and how improvements in reducing allo side effects (like graft vs. host disease) are making this type of transplant easier.  Thanks to our episode sponsor, Takeda Oncology

Host: Alicia A. Sutton Host Alicia Sutton welcomes Dr. Arif Kamal, Director of Quality and Outcomes at the Duke Cancer Institute, to talk about ways in which clinicians can become more involved or even take the reins of leadership in quality improvement initiatives within their health systems. The discussion pays close attention to the burgeoning field of Big Data, and how its rapid entry into healthcare impacts quality improvement efforts.

Guest: Dr. Yousuf Zafar, gastrointestinal medical oncologist and health services researcher at the Duke Cancer Institute, and co-author of "Full Disclosure — Out-of-Pocket Costs as Side Effects". His research explores ways to improve care delivery for patients with cancer. His primary area of interest is in the cost of cancer care. He has conducted institutional and national studies on how treatment-related costs impact cancer patients' experience. His current work focuses on how the cost of care can drive medical decision-making and impact the physician-patient relationship. (For a copy of this interview go to www.w4tsr.com, click on Joni Aldrich, episode 12/9/13) Listen to Joni live M-F at 2:00 p.m. ET on www.W4CS.com. To learn more about Joni, go to www.JoniAldrich.com

Thomas W. Leblanc, MD, MA, Duke Cancer Institute, discusses the ethics of health information technology in oncology.

Andrew J. Armstrong, MD, Associate Professor of Medicine and Surgery, Duke Cancer Institute and Medical Center, highlights existing and potential biomarkers in castration-resistant prostate cancer. His podcast is based on his article, “Prognostic, Predictive, and Surrogate Factors for Individualizing Treatment for Men with Castration-Resistant Prostate Cancer.”

Kristin MacDermott is the founder and President of the MacDermott Method, which provides resilience-based resources for individuals and organizations. Kristin's evidence-based method has been validated in four studies (including two randomized-controlled trials) with researchers from the Duke Clinical Research Institute, published in peer-reviewed journals, and proven to improve key resilience and mental health benchmarks, including anxiety, depression, distress, PTSD, and self-efficacy. She has designed resilience training programs for some of the highest performing people on the planet, including Naval Special Warfare Command (Navy SEALs) and the Los Angeles Police Department; more than 20 hospitals across the country, including Duke Cancer Institute and the National Institutes of Health; numerous mentoring programs for at-risk kids in South Central LA; as well as for CEOs, corporate executives, parents, divorcing couples, and teens and young adults with anxiety. Kristin is the author of the book It Takes Two Minutes to Shift Your Mindset and Build Resilience, which contains bite-size resilience skills you can read in two minutes and apply to your life immediately (now available on Amazon). Kristin is a Licensed Marriage and Family Therapist (CA) and a Licensed Professional Counselor (CO). She holds a bachelor of arts from Duke University and a master's in clinical psychology from Antioch University. She has also completed advanced training in Mind-Body Medicine at the Center for Mind-Body Medicine in Washington, D.C. and at the Benson-Henry Institute for Mind-Body Medicine at Massachusetts General Hospital. Kristin is the co-founder of Pathfinders, an Aspen-based nonprofit dedicated to improving the lives of people living with cancer as well as those experiencing grief. She also helped start Zero Hour Expeditions, a nonprofit that helps combat veterans reintegrate into civilian life and overcome the effects of PTSD by experiencing 30- day wilderness trips. She lives between Los Angeles and Palm Beach with her husband of 28 years and her three children ages 22, 18, and 14. Check out this special offer for listners here: https://www.macdermottmethod.com/davepamah Website: https://www.kristinmacdermott.com Support this podcast at — https://redcircle.com/the-dave-pamah-show/donations