Podcasts about magee womens hospital

JCO PO author Dr. Foldi at UPMC Hillman Cancer Center and University of Pittsburgh School of Medicine shares insights into the JCO PO article, "Personalized Circulating Tumor DNA Testing for Detection of Progression and Treatment Response Monitoring in Patients With Metastatic Invasive Lobular Carcinoma of the Breast." Host Dr. Rafeh Naqash and Dr. Foldi discuss how serial ctDNA testing in patients with mILC is feasible and may enable personalized surveillance and real-time therapeutic monitoring. 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 am your host, Dr. Rafeh Naqash, podcast editor for JCO Precision Oncology and Associate Professor at the OU Health Stephenson Cancer Center at the University of Oklahoma. Today, we are thrilled to be joined by Dr. Julia Foldi, Assistant Professor of Medicine in the Division of Hematology-Oncology at University of Pittsburgh School of Medicine and the Magee-Womens Hospital of the UPMC. She is also the lead and corresponding author of the JCO Precision Oncology article entitled "Personalized Circulating Tumor DNA Testing for Detection of Progression and Treatment Response Monitoring in Patients with Metastatic Invasive Lobular Carcinoma of the Breast." At the time of this recording, our guest's disclosures will be linked in the transcript. Julia, welcome to our podcast, and thank you for joining us today. Dr. Julia Foldi: Thank you so much for having me. It is a pleasure. Dr. Rafeh Naqash: Again, your manuscript and project address a few interesting things, so we will start with the basics, since we have a broad audience that comprises trainees, community oncologists, and obviously precision medicine experts as well. So, let us start with invasive lobular breast carcinoma. I have been out of fellowship for several years now, and I do not know much about invasive lobular carcinoma. Could you tell us what it is, what some of the genomic characteristics are, why it is different, and why it is important to have a different way to understand disease biology and track disease status with this type of breast cancer? Dr. Julia Foldi: Yes, thank you for that question. It is really important to frame this study. So, lobular breast cancers, which we shorten to ILC, are the second most common histologic subtype of breast cancer after ductal breast cancers. ILC makes up about 10 to 15 percent of all breast cancers, so it is relatively rare, but in the big scheme of things, because breast cancer is so common, this represents actually over 40,000 new diagnoses a year in the US of lobular breast cancers. What is unique about ILC is it is characterized by loss of an adhesion molecule, E-cadherin. It is encoded by the CDH1 gene. What it does is these tumors tend to form discohesive, single-file patterns and infiltrate into the tumor stroma, as opposed to ductal cancers, which generally form more cohesive masses. As we generally explain to patients, ductal cancers tend to form lumps, while lobular cancers often are not palpable because they infiltrate into the stroma. This creates several challenges, particularly when it comes to imaging. In the diagnostic setting, we know that mammograms and ultrasounds have less sensitivity to detect lobular versus ductal breast cancer. When it comes to the metastatic setting, conventional imaging techniques like CT scans have less sensitivity to detect lobular lesions often. One other unique characteristic of ILC is that these tumors tend to have lower proliferation rates. Because our glucose-based PET scans depend on glucose uptake of proliferating cells, often these tumors also are not avid on conventional FDG-PET scans. It is a challenge for us to monitor these patients as they go through treatment. If you think about the metastatic setting, we start a new treatment, we image people every three to four cycles, about every three months, and we combine the imaging results with clinical assessment and tumor markers to decide if the treatment is working. But if your imaging is not reliable, sometimes even at diagnosis, to really detect these tumors, then really, how are we following these patients? This is really the unique challenge in the metastatic setting in patients with lobular breast cancer: we cannot rely on the imaging to tell if patients are responding to treatment. This is where liquid biopsies are really, really important, and as the field is growing up and we have better and better technologies, lobular breast cancer is going to be a field where they are going to play an important role. Dr. Rafeh Naqash: Thank you for that easy-to-understand background. The second aspect that I would like to have some context on, to help the audience understand why you did what you did, is ctDNA, tumor informed and non-informed. Could you tell us what these subtypes of liquid biopsies are and why you chose a tumor informed assay for your study? Dr. Julia Foldi: Yes, it is really important to understand these differences. As you mentioned, there are two main platforms for liquid biopsy assays, circulating tumor DNA assays. I think what is more commonly used in the metastatic setting are non-tumor informed assays, or agnostic assays. These are generally next-generation sequencing-based assays that a lot of companies offer, like Guardant, Tempus, Caris, and FoundationOne. These do not require tumor tissue; they just require a blood sample, a plasma sample, essentially. The next-generation sequencing is done on cell-free DNA that is extracted from the plasma, and it is looking for any cell-free DNA and essentially, figuring out what part of the cell-free DNA comes from the tumor is done through a bioinformatics approach. Most of these assays are panel tests for cancer-associated mutations that we know either have therapeutic significance or biologic significance. So, the results we receive from these tests generally read out specific mutations in oncogenic genes, or sometimes things like fusions where we have specific targeted drugs. Some of the newer assays can also read out tumor fraction; for example, the newest generation Guardant assay that is methylation-based, they can also quantify tumor fraction. But the disadvantage of the tumor agnostic approach is that it is a little bit less sensitive. Opposed to that, we have our tumor informed tests, and these require tumor tissue. Essentially, the tumor is sequenced; this can either be whole exome or whole genome sequencing. The newer generation assays are now using whole genome sequencing of the tumor tissue, and a personalized, patient-specific panel of alterations is essentially barcoded on that tumor tissue. This can be either structural variants or it can be mutations, but generally, these are not driver mutations, but sort of things that are present in the tumor tissue that tend to stay unchanged over time. For each particular patient, a personalized assay, if you want to call it a fingerprint or barcode, is created, and then that is what then is used to test the plasma sample. Essentially, you are looking for that specific cancer in the blood, that barcode or fingerprint in the blood. Because of this, this is a much more sensitive way of looking for ctDNA, and obviously, this detects only that particular tumor that was sequenced originally. So, it is much more sensitive and specific to that tumor that was sequenced. You can argue for both approaches in different settings. We use them in different settings because they give us different information. The tumor agnostic approach gives us mutations, which can be used to determine what the next best therapy to use is, while the tumor informed assay is more sensitive, but it is not going to give us information on therapeutic targets. However, it is quantified, and we can follow it over time to see how it changes. We think that it is going to tell us how patients respond to treatment because we see our circulating tumor DNA levels rise and fall as the cancer burden increases or decreases. We decided to use the tumor informed approach in this particular study because we were really interested in how to determine if patients are having response to treatment versus if they are going to progress on their treatment, more so than looking for specific mutations. Dr. Rafeh Naqash: When you think about these tumor informed assays and you think about barcoding the mutations on the original tumor that you try to track or follow in subsequent blood samples, plasma samples, in your experience, if you have done it in non-lobular cancers, do you think shedding from the tumor has something to do with what you capture or how much you capture? Dr. Julia Foldi: Absolutely. I think there are multiple factors that go into whether someone has detectable ctDNA or not, and that has to do with the type of cancer, the location, right, where is the metastatic site? This is something that we do not fully understand yet: what are tumors that shed more versus not? There is also clearance of ctDNA, and so how fast that clearance occurs is also something that will affect what you can detect in the blood. ctDNA is very short-lived, only has a half-life of hours, and so you can imagine that if there is little shedding and a lot of excretion, then you are not going to be detecting a lot of it. In general, in the metastatic setting, we see that we can detect ctDNA in a lot of cases, especially when patients are progressing on treatment, because we imagine their tumor burden is higher at that point. Even with the non-tumor informed assays, we detect a lot of ctDNA. Part of this study was to actually assess: what is the proportion of patients where we can have this information? Because if we are only going to be able to detect ctDNA in less than 50 percent of patients, then it is not going to be a useful method to follow them with. Because this field is new and we have not been using a lot of tumor informed assays in the metastatic setting, we did not really know what to expect when we set out to look at this. We did not know what was going to be the baseline detection rate in this patient population, so that was one of the first things that we wanted to answer. Dr. Rafeh Naqash: Excellent. Now going to this manuscript in particular, what was the research question, what was the patient population, and what was the strategy that you used to investigate some of these questions? Dr. Julia Foldi: So, we partnered with Natera, and the reason was that their Signatera tumor-informed assay was the first personalized, tumor-informed, really an MRD assay, minimal residual disease detection assay. It has been around the longest and has been pretty widely used commercially already, even though some of our data is still lacking. but we know that people are using this in the real world. We wanted to gather some real-world data specifically in lobular patients. So, we asked Natera to look at their database of commercial Signatera testing and look for patients with stage 4 lobular breast cancer. The information all comes from the submitting physicians sending in pathologic reports and clinical notes, and so they have that information from the requisitions essentially that are sent in by the ordering physician. We found 66 patients who were on first-line or close to first-line endocrine-based therapies for their metastatic lobular breast cancer and had serial collections of Signatera tests. The way we defined baseline was that the first Signatera had to be sent within three months of starting treatment. So, it is not truly baseline, but again, this is a limitation of looking at real-world data is that you are not always going to get the best time point that you need. We had over 350 samples from those 66 patients, again longitudinal ctDNA samples, and our first question was what is the baseline detection rate using this tumor informed assay? Then, most importantly, what is the concordance between changes in ctDNA and clinical response to treatment? That is defined by essentially radiologic response to treatment. Dr. Rafeh Naqash: Interesting. So, what were some of your observations in terms of ctDNA dynamics, whether baseline levels made a difference, whether subsequent levels at different time points made a difference, or subsequent levels at, let us say, cycle three made a difference? Were there any specific trends that you saw? Dr. Julia Foldi: So, first, at baseline, 95 percent of patients had detectable ctDNA, which is, I think, a really important data point because it tells us that this can be a really useful test. If we can detect it in almost all patients before they start treatment, we are going to be able to follow this longitudinally. And again, these were not true baseline samples. So, I think if we look really at baseline before starting treatment, almost all patients will have detectable ctDNA in the metastatic setting. The second important thing we saw was that disease progression correlated very well with increase in ctDNA. So, in most patients who had disease progression by imaging, we saw increase in ctDNA. Conversely, in most patients who had clinical benefit from their treatment, so they had a response or stable disease, we saw decrease in ctDNA levels. It seems that what we call molecular response based on ctDNA is tracking very nicely along with the radiographic response. So, those were really the two main observations. Again, this is a small cohort, limited by its real-world nature and the time points that ctDNA assay was sent was obviously not mandated. This is a real-world data set, and so we could not really look at specific time points like you asked about, let us say, cycle three of therapy, right? We did not have all of the right time points for all of the patients. But what we were able to do was to graph out some specific patient scenarios to illustrate how changes in ctDNA correlate with imaging response. I can talk a little bit about that. Dr. Rafeh Naqash: That was going to be my question. Did you see patients who had serial monitoring using the tumor informed ctDNA assay where the assay became positive a few months before the imaging? Did you have any of those kinds of observations? Dr. Julia Foldi: Yes, so I think this is where the field is going: are we able to use this technology to maybe detect progression before it becomes clinically apparent? Of course, there are lots of questions about: does that really matter? But it seems like, based on some of the patient scenarios that we present in the paper, that this testing can do that. So, we had a specific scenario, and this is illustrated in a figure in the paper, really showing the treatment as well as the changes in ctDNA, tumor markers, and also radiographic response. So, this particular patient was on first-line endocrine therapy and CDK4/6 inhibitor with palbociclib. Initially, she had a low-level detectable ctDNA. It became undetectable during treatment, and the patient had a couple of serial ctDNA assays that were negative, so undetectable. And then we started, after about seven months on this combination therapy, the ctDNA levels started rising. She actually had three serial ctDNA assays with increasing level of ctDNA before she even had any imaging tests. And then around the time that the ctDNA peaked, this patient had radiographic evidence of progression. There was also an NGS-based assay sent to look for specific mutations at that point. The patient was found to have an ESR1 mutation, which is very common in this patient population. She was switched to a novel oral SERD, elacestrant, and the ctDNA fell again to undetectable within the first couple months of being on elacestrant. And then a very similar thing happened: while she was on this second-line therapy, she had three serial negative ctDNA assays, and then the fourth one was positive. This was two months before the patient had a scan that showed progression again. Dr. Rafeh Naqash: And Julia, like you mentioned, this is a small sample size, limited number of patients, in this case, one patient case scenario, but provides insights into other important aspects around escalation or de-escalation of therapy where perhaps ctDNA could be used as an integral biomarker rather than an exploratory biomarker. What are some of your thoughts around that and how is the breast cancer space? I know like in GI and bladder cancer, there has been a significant uptrend in MRD assessments for therapeutic decision making. What is happening in the breast cancer space? Dr. Julia Foldi: So, super interesting. I think this is where a lot of our different fields are going. In the breast cancer space, so far, I have seen a lot of escalation attempts. It is not even necessarily in this particular setting where we are looking at dynamics of ctDNA, but in the breast cancer world, of course, we have a lot of data on resistance mutations. I mentioned ESR1 mutation in a particular patient in our study. ESR1 mutations are very common in patients with ER-positive breast cancer who are on long-term endocrine therapy, and ESR1 mutations confer resistance to aromatase inhibitors. So, that is an area that there has been a lot of interest in trying to detect ESR1 mutations earlier and switching therapy early. So, this was the basis of the SERENA-6 trial, which was presented last year at ASCO and created a lot of excitement. This was a trial where patients had non-tumor-informed NGS-based Guardant assay sent every three to six months while they were on first-line endocrine therapy with a CDK4/6 inhibitor. If they had an ESR1 mutation detected, they were randomized to either continue the same endocrine therapy or switch to an oral SERD. The trial showed that the population of patients who switched to the oral SERD did better in terms of progression-free survival than those who stayed on their original endocrine therapy. There are a lot of questions about how to use this in routine practice. Of course, it is not trivial to be sending a ctDNA assay every three to six months. The rate of detection of these mutations was relatively low in that study; again, the incidence increases in later lines of therapy. So, there are a lot of questions about whether we should be doing this in all of our first-line patients. The other question is, even the patients who stayed on their original endocrine therapy were able to stay on that for another nine months. So, there is this question of: are we switching patients too early to a new line of therapy by having this escalation approach? So, there are a lot of questions about this. As far as I know, at least in our practice, we are not using this approach just yet to escalate therapy. Time will tell how this all pans out. But I think what is even more interesting is the de-escalation question, and I think that is where tumor informed assays like Signatera and the data that our study generated can be applied. Actually, our plan is to generate some prospective data in the lobular breast cancer population, and I have an ongoing study to do that, to really be able to tease out the early ctDNA dynamics as patients first start on endocrine therapy. So, this is patients who are newly diagnosed, they are just starting on their first-line endocrine therapy, and measure, with sensitive assays, measure ctDNA dynamics in the first few months of therapy. In those patients who have a really robust response, that is where I think we can really think about de-escalation. In the patients whose ctDNA goes to undetectable after just a few weeks of therapy with just an endocrine agent, they might not even need a CDK4/6 inhibitor in their first-line treatment. So, that is an area where we are very interested in our group, and I know that other groups are looking at this too, to try to de-escalate therapy in patients who clear their ctDNA early on. Dr. Rafeh Naqash: Thank you so much. Well, lots of questions, but at the same time, progress comes through questions asked, and your project is one of those which is asking an interesting question in a rarer cancer and perhaps will lead to subsequent improvement in how we monitor these individuals and how we escalate or de-escalate therapy. Hopefully, we will get to see more of what you are working on in subsequent submissions to JCO Precision Oncology and perhaps talk more about it in a couple of years and see how the space and field is moving. Thanks again for sharing your insights. I do want to take one to two quick minutes talking about you as an investigator, Julia. If you could speak to your career pathway, your journey, the pathway to mentorship, the pathway to being a mentor, and how things have shaped for you in your personal professional growth. Dr. Julia Foldi: Sure, yeah, that is great. Thank you. So, I had a little bit of an unconventional path to clinical medicine. I actually thought I was going to be a basic scientist when I first started out. I got a PhD in Immunology right out of college and was studying not even anything cancer-related. I was studying macrophage signaling in inflammatory diseases, but I was in New York City. This was right around the time that the first checkpoint inhibitors were approved. Actually, some of my friends from my PhD program worked in Jim Allison's lab, who was the basic scientist responsible for ipilimumab. So, I got to kind of first-hand experience the excitement around bringing something from the lab into the clinic that actually changed really the course of oncology. And so, I got very excited about oncology and clinical medicine. So, I decided to kind of switch gears from there and I went back to medical school after finishing my PhD and got my MD at NYU. I knew I wanted to do oncology, so I did a research track residency and fellowship combined at Yale. I started working early on with the breast cancer team there. At the time, Lajos Pusztai was the head of translational research there at Yale, and I started working with him early in my residency and then through my fellowship. I worked on several trials with him, including a neoadjuvant checkpoint inhibitor trial in triple-negative breast cancer patients. During my last year in fellowship, I received a Conquer Cancer Young Investigator Award to study estrogen receptor heterogeneity using spatial transcriptomics in this subset of breast cancers that have intermediate estrogen receptor expression. From there, I joined the faculty at the University of Pittsburgh in 2022. So, I have been there about almost four years at this point. My interests really shifted slowly from triple-negative breast cancers towards ER-positive breast cancers. When I arrived in Pittsburgh, I started working very closely with some basic and translational researchers here who are very interested in estrogen signaling and mechanisms of resistance to endocrine therapy, and there is a large group here interested in lobular breast cancers. During my training, I was not super aware even that lobular breast cancer was a unique subtype of breast cancers, and that is, I think, changing a little bit. There is a lot more awareness in the breast cancer clinical and research community about ILC being a unique subtype, but it is not even really part of our training in fellowship, which we are trying to change. But I have become a lot more aware of this because of the research team here and through that, I have become really interested also on the clinical side. And so, we do have a Lobular Breast Cancer Research Center of Excellence here at the University of Pittsburgh and UPMC, and I am the leader on the clinical side. We have a really great team of basic and translational researchers looking at different aspects of lobular breast cancers, and some of the work that I am doing is related to this particular manuscript we discussed and the next steps, as I mentioned, a prospective study of early ctDNA dynamics in lobular patients. I also did some more clinical research work in collaboration with the NSABP looking at long-term outcomes of patients with lobular versus ductal breast cancers in some of their older trials. And so, that is, in a nutshell, a little bit about how I got here and how I became interested in ILC. Dr. Rafeh Naqash: Well, thank you for sharing those personal insights and personal journey. I am sure it will inspire other trainees, fellows, and perhaps junior faculty in trying to find their niche. The path, as you mentioned, is not always straight; it often tends to be convoluted. And then finding an area that you are interested in, taking things forward, and being persistent is often what matters. Dr. Julia Foldi: Thank you so much for having me. It was great. Dr. Rafeh Naqash: It was great chatting with you. And 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/podcasts. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, 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.  

Soul Pitt Media Health & Business Report Episode #105 | Interview with Bonita B. Pannell, MSW, MBA | Director, Women's Outreach at UPMC Magee-Womens HospitalJoin Craig as he discusses with Bonita:1) Bonita, can you talk to our listeners about Safe Sleep Deaths among infants?2) How does the use of baby cribs help deal with this issue?3) Bonita, you have an upcoming event to educate our community on this topic. Can you talk to our listeners about your event?Additionally, make sure you listen to our Community Calendar (brought to you by Pittsburgh Regional Transit, PRT) with Debbie Norrell at the end of each of our interviews so you can keep up with what's going on in our Pittsburgh region.Soul Pitt Media's Health & Business Report is sponsored by UPMC, Pittsburgh Regional Transit (PRT), Duquesne Light Co., Allegheny County Health Department, Pennsylvania's Children's Health Insurance Program (CHIP), and Central Outreach Wellness Center.

When children go through treatment for cancer, there's a risk it could affect their fertility. Pittsburgh is on the cutting edge of something that could help: a process called pediatric fertility treatment. But how does it work for kids who haven't gone through puberty yet? And what's it like to broach this subject with families who've just received a life-altering diagnosis? Amy Jutca, the fertility preservation program navigator at Children's Hospital of Pittsburgh, joins us to talk about helping kids and families with their options. Check here for more about fertility preservation programs at Children's Hospital and Magee-Womens Hospital. Our newsletter is fresh daily at 6 a.m. Sign up here. We're also on Twitter @citycastpgh & Instagram @CityCastPgh! Learn more about your ad choices. Visit megaphone.fm/adchoices

Join Craig as he discusses with LaJuana: Breast Cancer is the #1 leading cause of cancer death of African American Women. Why getting a Mammogram is so important to African American Women? How UPMC is targeting outreach to the African American community to help battle Breast Cancer. Additionally, make sure you listen to our Community Calendar (brought to you by Port Authority Transit Employment) with Debbie Norrell at the end of each of our interviews so you can keep up with what's going on in our Pittsburgh region. Soul Pitt Media's Health & Business Report is sponsored by UPMC, Port Authority Transit, Duquesne Light Co., ThermoFisher Scientific, Pennsylvania's Children's Health Insurance Program (CHIP), and PA Unites Against COVID.

Dr. Richard Beigi, President of UPMC Magee Womens Hospital explains the hospital's new protocols to keep you safe while delivering world-class care.

Dr. Richard Beigi, President of UPMC Magee Womens Hospital explains the hospital’s new protocols to keep you safe while delivering world class care.

Regenerative Medicine Today welcomes Dr. Stephen Emery.  Dr. Emery is an Associate Professor, Department of Obstetrics, Gynecology, & Reproductive Sciences, Maternal Fetal Medicine, at Magee-Womens Hospital of UPMC.  He is also the Director of the Center for Innovative Fetal Intervention at Magee-Womens Hospital of UPMC.   Dr. Emery discusses his research in prenatal treatments. For more [...]

Welcome to the ASCO Daily News podcast. I'm Lauren Davis. And joining me today is Dr. Priya Rastogi, who specializes in the diagnosis, treatment, and prevention of breast cancer at the Magee-Womens Hospital of the University of Pittsburgh Medical Center. And she's also the senior associate medical director for the NSABP Foundation. Today, we're discussing the topic of recurrence among patients with HER2 positive breast cancer, progress and providing more aggressive therapies in early breast cancer for those patients whose cancer is more likely to recur. Namely those with residual invasive disease following taxane and trastuzumab based treatment given before surgery is our area of focus. Dr. Rastogi, welcome to the podcast. Hi, Lauren, happy to discuss the exciting results from the KATHERINE study. We're glad you're here. So as an investigator of the KATHERINE study, I'd like to hear a little bit about some of the findings. So I understand that the study showed that T-DM1 reduced the risk of disease recurring by half compared with trastuzumab in HER2 positive early breast cancer. Yes. So in terms of background information, patients with HER2 positive early breast cancer receiving neoadjuvant treatment had favorable outcomes if they achieve a pathological complete response. But patients with residual breast cancer in the surgical specimen have a higher risk of recurrence. And so that's some of the rationale of how the KATHERINE study was set up. The KATHERINE trial was an open label study with 1,486 patients with HER2 positive early stage breast cancer who received neoadjuvant chemotherapy plus HER2 targeted therapy that included a taxane and trastuzumab followed by surgery. And then all these patients had residual invasive disease in the breast and/or actually in lymph nodes. So within 12 weeks of surgery, patients were assigned to either T-DM1 or to trastuzumab. And as you mentioned, the primary endpoint was IDFS. And so in the KATHERINE study, T-DM1 significantly reduced the risk of developing an invasive disease free survival event by three years by 50%. And this corresponds to an absolute improvement in three year invasive disease free survival of 11 percentage points. So this is really exciting. So the invasive disease free survival rate was 77% with trastuzumab, and it increased to 88.3% with T-DM1. So the KATHERINE trial demonstrates that neoadjuvant therapy can be used to identify patients at increased risk for recurrence based on less than optimal response to standard neoadjuvant therapies who can then benefit by switching to T-DM1. The overall survival analysis has not yet matured. We had a total of 98 deaths, 56 deaths with trastuzumab and 42 with T-DM1 for a hazard rate of 0.7. So clearly, this study will need more follow up. So the FDA approved T-DM1 as adjuvant treatment for this patient population. Do patients have immediate access? Yes, so this is also exciting news that the US FDA approved T-DM1 for the adjuvant treatment in patients with HER2 positive early stage breast cancer with residual invasive disease after neoadjuvant taxane trastuzumab based therapy. The results and approval form the foundation of a new standard of care in patients in this setting. And this should lead to access and availability for patients. Patients should discuss with their physicians and their insurance providers. That's exciting. So one of the things we always think about are side effects. What should specialists tell their patients? Yeah, so as you mentioned, side effects are very important. So the safety profile of T-DM1 is as expected from what has been seen in the metastatic setting in the use of T-DM1. The main adverse events in our study was a decrease in platelet counts, an increase in sensory neuropathy and liver enzymes compared to trastuzumab. Although, these side effects are mostly mild. Fatigue and nausea were also greater. But they were manageable and reversible. So the side effect profile is similar to what had been seen in the metastatic setting and the efficacy is fantastic for this drug. Oh, that's great. Were there any surprises in the results? So the analysis by the subgroups demonstrated that there was a benefit across all the key subgroups. So for example, patients with operable or inoperable cancers at presentation, hormone receptor positive or hormone receptor negative, post neoadjuvant positive or negative nodes, and even patients with very small residual disease all had a tremendous benefit from T-DM1. So this is also very exciting that all the subgroups benefited. So what do you think is on the horizon for breast cancer studies? That is also a very important question. So immunotherapy is a type of cancer treatment which also helps the immune system fight cancer. And immunotherapy has been approved in other cancers. One type of these drugs is atezolizumab, which belongs to a class of drugs known as the checkpoint inhibitors. By inhibiting the checkpoint proteins such as PD-L1 and PD-1, these drugs enhance the ability for the immune cells to attack cancer cells. So recently, the FDA approved atezolizumab in combination with chemotherapy for the initial treatment of women for advanced triple negative breast cancer with PD-L1 positive tumors. So the NSABP Foundation in collaboration with the German Breast Group is conducting a phase III study, it's NSABP B59 [INAUDIBLE], for patients with early stage high risk triple negative breast cancer. And so this trial is evaluating neoadjuvant chemotherapy with atezolizumab or a placebo followed by surgery. Patients then receive an additional six months of either atezo or placebo after surgery. And the co-primary end points are pathological complete response and event free survival. And this study will address if neoadjuvant atezolizumab in combination with neoadjuvant chemotherapy followed by adjuvant atezolizumab will improve outcomes in this high risk patient population. That's fantastic. It sounds like there's a lot of things to look forward to. Again, today, my guest has been Dr. Rastogi. Thank you so much for being on our podcast today. It has been a privilege. And thank you for inviting me to talk about the KATHERINE study. And to our listeners, thank you for tuning in to the ASCO Daily News podcast. If you're enjoying the content, we encourage you to rate us and review us on Apple Podcast.

Our guest today is a healthcare evangelist and international healthcare industry expert. Tanya Abreu pioneered the planning of the first network of freestanding breast health centers in the greater Pittsburgh area and the establishment of more than 75 model women’s health education and primary care clinics around the world. As a healthcare marketing innovator, Tanya is also a successful speaker, author and workshop leader. Tanya’s Background Tanya began her career in education as a business communications professor in the Graduate School of Industrial Management at Carnegie Mellon University. She went to Russia to teach American English at Moscow State University. While there, Tanya got excited about being able to change a healthcare system with terrifying technology into something more humane. She came back to the U.S. to partner with Magee-Womens Hospital in Pittsburgh, where she took part in the transformation of women’s health through branding and outreach. The CEO at Magee, Irma Goertzen, believed women feared coming to the hospital in the inner city for a breast image knowing there was a possibility that she might have cancer. Goertzen believed the hospital’s responsibility was to care for women.  She spent millions setting up freestanding breast care clinics within the communities where the women lived. The clinics eventually expanded to provide pelvic health and heart disease prevention. When Tanya left Magee, she started her own company called Spirit of Women. In this role, Tanya worked with C-suite executives to help them reevaluate how they presented healthcare to women. She is now involved in the Lipstick Alliance movement and is the national director of the Women’s Choice Award. Creating Successful Healthcare Brands for Women According to Tanya, there are distinct differences between men and women when it comes to healthcare. Men are more action-driven. They want to know what they have and what to do. Women often shun wellness care because it takes them away from their families’ needs. It’s not that women fear the disease, they just don’t want to have it now because they must stop what they are doing. Women make more than 85 percent of all healthcare decisions for their family. Tanya says for hospitals and health groups to grow its brand with women, they need to capture the “heart” share of women before the money. The biggest mistakes that healthcare providers make is trying to fix women. Women don’t want to be fixed. They want to be listened to and encouraged. They want to know about the experiences and quality of life other women have had. Taking a grassroots approach to healthcare marketing is paramount. Patient testimonials, community events and social media are more important to women than advertisements and billboards. It’s all about patient and community experience communications. With 30 years in this industry, Tanya has always believed hospitals that support and encourage women are the ones that will have their loyalty and generate revenue. After her own experience with cancer, she realized there was more. She realized that much of what she had been doing was lip service to women wanted to hear. She didn’t want to be controlled, she wanted to be encouraged. She wanted hope, not more medication. The Lipstick Alliance These days, Tanya is working with hospitals to form the Lipstick Alliance. Statistics show that 83 percent of women put on lipstick daily to make them feel good. The Lipstick Alliance is about wellness every day for women. Tanya wants it to be a movement that gets women thinking about doing something healthy every time they put on lipstick, lip gloss or chapstick. She hopes that one day the lipstick icon will be as recognizable as the red dress is for heart health and the pink ribbon is for breast cancer awareness. The Lipstick Alliance is about wellness every day for women. The national program is market exclusive, so there can only be one hospital per market in the U.S. Hospitals don’t have to apply, but they must be focused on wellness. They must also agree to use the organization’s 1-4-12 strategy which includes templates, education materials, content and a national awards program for organizations that build relationships with women that result in increased revenues. Tanya says they are reducing the fee for the first 20 hospitals and that the program is typically less than $3,000/month. The Patient Experience Two things are pivotal in healthcare branding for women. She must feel she is being listened to and heard, and not just filling out a bunch of paperwork. She also needs to feel more encouraged when she leaves the hospital or clinic than when she came in. And the experience must be positive. As an example, Tanya says heart disease is the number one killer of women, yet one in five women in their 50s have had a baseline heart evaluation.  Why?  She says it is because women fear the results. Healthcare groups and hospitals need to find ways to educate and motivate women in a fun way.  Among her many ideas, Tanya says to invite women to a heart day event at a hospital where women can get a free echo-cardiogram. If the hospital is part of the Lipstick Alliance, they can hand out free lipstick when they are done. Wellness Care is in Vogue Hospitals can’t continue to be acute-care facilities. Tanya says they need to start focusing on wellness, incentivizing doctors and providing telemedicine, but only if it is part of a total wellness experience. People have a tendency not to tell everything to a healthcare provider online. Without complete records of the patient, diagnosis can be risky and often incorrect. Women’s Choice Awards Tanya’s newest role is as the national director of the Women’s Choice Awards. The award is third-party verified and 100 percent objective about a company or hospital’s quality measures in patient care and service lines. The seal says the organization has been approved by women and has the objective standards of quality and healthcare capabilities for patient satisfaction. Connect with Tanya Phone: 561-358-5230 Email: tanya@optimisticmedicinegroup.com LinkendIn: @tanyaabreu Facebook: Lipstick Alliance Website: www.womenschoiceaward.com    

Date: May 3, 2012 Featuring: Maureen Bisognano, President and CEO, Institute for Healthcare Improvement, Co-author, Pursuing the Triple Aim Charles Kenney, Writer and Journalist, Co-author, Pursuing the Triple Aim Alide Chase, Senior Vice President, Medicare Clinical Operations and Population Care, Kaiser Foundation Health Plan, Inc., and Kaiser Foundation Hospitals Anthony M. DiGioia, MD, Renaissance Orthopaedics; Medical Director, Bone and Joint Center, Magee-Womens Hospital and PFCC Partners – Innovation Center of UPMC George E. Kerwin, FACHE, President and Chief Executive Officer, Bellin Health Patricia A. McDonald, Vice President, Technology and Manufacturing Group and Director of Product Health Enhancement Organization, Intel Corporation Diane K. Miller, MBA, Vice President, Virginia Mason Medical Center, Executive Director, Virginia Mason Institute Rebecca Ramsay, RN, MPH, Director, Care Support Manager, CareOregon Brian H. Rank, MD, Medical Director, HealthPartners Medical Group, HealthPartners, Inc. Marci Sindell, Chief External Affairs Officer, Atrius Health and Harvard Vanguard It isn’t always easy to tell the story of improving health care in the US. An awful lot of the answers and promising solutions fly under the radar screen and get drowned out by politics and policy debates. That’s why Maureen Bisognano and Charlie Kenney decided to move about the country this past year and capture just a small sample of the innovation underway that promises to move health reform forward… even as national debates rage on. What the organizations featured in Maureen and Charlie’s new book, Pursuing the Triple Aim: Seven Innovators Show the Way to Better Care, Better Health, and Lower Costs, share in common is this clear-eyed view that the status quo is not sustainable and that new models to simultaneously improve health, improve health care, and reduce per capita costs aren’t just needed, they’re needed urgently. The organizations whose stories you can read about in the new book and that you’ll hear about on WIHI are currently in the trenches and represent a leading spear of change, tackling some of the hardest issues ever for health care. All the people associated with the work are eager to share whatever they can with as many as they can. WIHI host Madge Kaplan pulls together the program’s first ever audio “book party” with enough time to hear from all the contributors and also ask questions and engage in discussion. A special note to improvers in other countries and around the globe: many of you have been part of IHI’s Triple Aim prototyping initiative for the past several years or have crafted initiatives of your own. Work outside the US is also critical and vital to everyone’s learning and everyone is encouraged to participate in this WIHI discussion.

Date: September 8, 2011 Featuring: Lucile O. Hanscom, Executive Director, Picker Institute Dale Shaller, MPA, Principal, Shaller Consulting Group Martha Hayward, Lead for Public-Patient Engagement, Institute for Healthcare Improvement Gaye Smith, Chief Patient Experience and Service Officer, Vanderbilt University Medical Center Anthony M. DiGioia, MD, Founder, The Orthopaedic Program and Innovation Center, Magee-Womens Hospital of UPMC Most of us are familiar with the National Quality Forum’s list of Serious Reportable Events in health care — often referred to as “Never Events.” There’s a wide consensus that everything from performing surgery on the wrong patient or wrong site, to a medication error-induced death, to a physical assault aren’t only tragic and harmful, they are not supposed to happen. Period. It’s a strong statement about patient safety and what the system as a whole should not be willing to tolerate. And, by extension, it’s a call to action to do better and to take care of patients differently so that terrible things do not occur.  There are, of course, many ways to draw a line in the sand or to envision the health care system patients deserve and that providers want to work in. One of the most innovative in the last few years has been the Picker Institute’s development of a concept they’ve dubbed “Always Events®.” First conceived in 2009, Always Events®are activities and processes that should routinely be part of patient care and the patient and family experience, to ensure optimal communication, discharge, handoffs, transitions, health literacy, and more.WIHI welcomes the Picker Institute’s Executive Director, Lucile Hanscom; consultant Dale Shaller, who has an extensive history developing benchmarks and measurement systems for patient-centered care; Martha Hayward, who has been working with IHI to help shape public and patient engagement, drawing on her own history as a patient and as a strong and effective leader in Massachusetts; and dynamic leaders from two organizations that have received Always Events Challenge Grants: Gaye Smith of Vanderbilt University Medical Center and Tony DiGioia of the University of Pittsburgh Medical Center (UPMC).Dr. DiGioia’s groundbreaking improvements at UPMC are anchored in a first of its kind patient- and family-centered methodology. Picker’s support is helping to integrate these processes into the hospital’s transplant program. The grant-funded work at Vanderbilt, under Gaye Smith, is targeting better communication and collaboration between patients, family members, and providers to prevent patient falls during hospital stays.

123: As co-author of “The New York Times” best-selling book “In an Instant: A Family’s Journey of Love and Healing”, Lee Woodruff garnered critical acclaim for the compelling and humorous chronicle of her family’s journey to recovery following her husband’s, journalist Bob Woodruff, roadside bomb injury in Iraq. Appearing on national television and as keynote speakers since the February, 2007 publication of their book, the couple has helped put a face on the serious issue of traumatic brain injury among returning Iraq war veterans as well as the millions of Americans who live with this often invisible, but life-changing affliction. - Fertility help for military families - Helping our wounded warriors start a family - Providing fertility support for our wounded warriors - Reintegrating our wounded warriors into their community  They have founded the non-profit Bob Woodruff Foundation to assist injured service members and their families in healing from the wounds of war, having raised $27 million and investing in grassroots organizations and programs around the country that are helping veterans successfully reintegrate into their communities and receive critical long-term care.  Lee is a contributing editor for “Working Mother” magazine and a contributing national television network reporter and runs a media training/speaker presentation business for clients who want to polish their performance. Her best-selling book “Perfectly Imperfect - A Life in Progress” was followed by her first novel “Those We Love Most” which became a “New York Times” best-seller and won the Washington Irving Book Award for fiction.  A freelance writer, Leef has penned numerous personal articles about her family and parenting that have run in magazines such as “Ladies Home Journal”, “Real Simple”, “MORE”, “Good Housekeeping”, and Parade. A trustee and alumnus of Colgate University and an avid lover of the Adirondack region, Lee lives  in Westchester County, New York, with her husband and four children.  For much more information on Lee Woodruff, please visit http://www.leewoodruff.com/about-me.  For much more information on Bob Woodruff, please visit http://www.bobwoodrufffoundation.org.  BIOGRAPHICAL INFORMATION on nationally-renowned fertility specialist Dr. Gilbert Mottla Dr. Gilbert L. Mottla, M.D., is board-certified in obstetrics and gynecology as well as reproductive endocrinology and infertility. He treats many U.S. veterans in his Annapolis, Maryland practice and is a member of the American Society for Reproductive Medicine.  Having received his medical degree from Boston University School of Medicine, Dr. Mottla completed his internship and residency in obstetrics and gynecology at Magee-Womens Hospital, University of Pittsburg and completed a two-year fellowship in reproductive endocrinology and infertility at The George Washington University School of Medicine. Dr. Mottla is currently a clinical assistant professor of obstetrics and gynecology at Georgetown University.  Recently recognized by “Washingtonian” magazine and “What’s Up Annapolis” magazine in the top doctor’s edition for reproductive endocrinology and infertility, Dr. Mottla sees and consults with patients who need care in all areas of both infertility and reproductive endocrinology. His particular area of interest is in the evaluation and care of couples utilizing gestational surrogacy and egg donation.  For much more information on Dr. Mottla, please visit http://www.shadygrovefertility.com/doctors/mottla. When you're planning to leave the military visit USAA's separations tools and advice for information on readiness and making a successful transition. http://www.veteranonthemove.com/leavingthemilitary The Veteran On the Move podcast has published over 100 episodes giving listeners the opportunity to hear in-depth interviews conducted by host Joe Crane featuring the people, programs and resources to assist veterans in their transition to entrepreneurship:  Marine Corps,

Host: Prathima Setty, MD Guest: Draion M. "Dr. Drai" Burch, DO Female sexual dysfunction (FSD) occurs in about 20 - 60% of patients. FSD is common problem but how comfortable are clinicians in disussing this with their patients? Host Dr. Prathima Setty welcomes Dr. Draion "Dr. Drai" Burch, obstetrician-gynecologist and teaching faculty member at Magee-Womens Hospital of The University of Pittsburgh Medical Center. Dr. Drai reviews the symptoms and causes of FSD and how he counsels patients on FSD. Dr. Drai is also Clinical Assistant Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of Pittsburgh School of Medicine.

Host: Prathima Setty, MD Guest: Draion M. "Dr. Drai" Burch, DO What does transgender mean? What are common health issues found in transgender patients? Host Dr. Prathima Setty welcomes Dr. Draion M. Burch, also known as "Dr Drai". Dr. Drai will address these questions, as well as, information on screening, hormone therapy, and resources available for clinicians, specifically on how to make their offices transgender-friendly. Dr. Burch is a practicing physician and teaching faculty member at Magee-Womens Hospital of The University of Pittsburgh Medical Center. Dr. Drai is the Founder and Chief Medical Advisor of DrDrai.com, where he discusses actionable ideas and real-world strategies to help women take control of their health.