Hospital in Georgia, USA
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Join host Dr. Nikolaos Papadantonakis as he welcomes Dr. Colin Vale from Winship Cancer Institute of Emory University and Dr. Nancy Luna Torres from Moffitt Cancer Center to discuss the fundamentals of allogeneic hematopoietic stem cell transplantation for MDS patients. Our experts break down complex medical concepts into easy-to-understand language, helping patients make informed decisions about this important treatment option.
We bring back our prior pharmacology discussion because it's so incredibly important for the conversations that are on the horizon over the next few weeks. In this continuation of our myeloma series, we begin our discussion about treatment options for multiple myeloma, focusing first on pharmacology. We are so thrilled to have a special guest, Kathryn Maples, PharmD, BCOP who is a clinical pharmacy specialist in Multiple Myeloma at the Winship Cancer Institute of Emory Healthcare in Atlanta, Georgia!Content:- What are common drugs we use in "triplet regimens"? "quadruple therapy"? - What considerations must we take into account when prescribing commonly used medications in myeloma? - How should we counsel our patients? - What about supportive care?- How and when do we make dose adjustments? - This episode is SO eye-opening about the "behind the scenes" of myeloma care that physicians do not seeWant to review the show notes for this episode and others? Check out our website: https://www.thefellowoncall.com/our-episodesLove what you hear? Tell a friend and leave a review on our podcast streaming platforms!Twitter: @TheFellowOnCallInstagram: @TheFellowOnCallListen in on: Apple Podcast, Spotify, and Google Podcast
We bring back our prior pharmacology discussion because it's so incredibly important for the conversations that are on the horizon over the next few weeks. In this continuation of our myeloma series, we begin our discussion about treatment options for multiple myeloma, focusing first on pharmacology. We are so thrilled to have a special guest, Kathryn Maples, PharmD, BCOP who is a clinical pharmacy specialist in Multiple Myeloma at the Winship Cancer Institute of Emory Healthcare in Atlanta, Georgia!Content:- What are common drugs we use in "triplet regimens"? "quadruple therapy"? - What considerations must we take into account when prescribing commonly used medications in myeloma? - How should we counsel our patients? - What about supportive care?- How and when do we make dose adjustments? - This episode is SO eye-opening about the "behind the scenes" of myeloma care that physicians do not seeWant to review the show notes for this episode and others? Check out our website: https://www.thefellowoncall.com/our-episodesLove what you hear? Tell a friend and leave a review on our podcast streaming platforms!Twitter: @TheFellowOnCallInstagram: @TheFellowOnCallListen in on: Apple Podcast, Spotify, and Google Podcast
Jean Koff, MD, MSc Non-Hodgkin lymphoma (NHL) can sound overwhelming, but what does it really mean for patients and families? In this episode, we speak to Dr. Jean Koff of Winship Cancer Institute of Emory University, who breaks down the big picture of NHL: what it is, how it's an umbrella term for multiple subtypes, and what today's treatments and tomorrow's innovations could mean for you. From understanding subtypes and staging to exploring options like watchful waiting, chemotherapy, and cutting-edge immunotherapies, we cover what matters most: knowledge, clarity, and hope. DOWNLOAD TRANSCRIPT CLICK HERE to participate in our episode survey. Mentioned on this episode: Non-Hodgkin lymphoma The Lymphoma Guide Lugano staging system Immunotherapy fact sheet CAR T-cell therapy Allogeneic stem cell transplantation Clinical Trial Support Center Online NHL Chat Additional Blood Cancer United Support Resources: Free Nutrition Consultations Information Specialists Financial support Free telephone/web patient programs Free booklets Young Adult Resources Support groups Caregiver support Caregiver Workbook Survivorship Workbook Advocacy and Public Policy Patient Community Mental Health Resources Supported by AbbVie Inc. and Genentech, A Member of the Roche Group.The post The Big Picture on Non-Hodgkin Lymphoma: Treatments, Trends, and Tomorrow first appeared on The Bloodline with Blood Cancer United Podcast.
Today we are bringing you a conversation on the evolving landscape for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) treatment. Ryan Haumschild, PharmD, MS, MBA, vice president of ambulatory pharmacy at Emory Healthcare and Winship Cancer Institute, spoke with Marilyn Glassberg, MD, the John W. Clarke Professor and Chair of medicine at Loyola University Chicago Stritch School of Medicine; Ayodeji Adegunsoye, MD, MSc, PhD, FACP, FCCP, assistant professor at the University of Chicago; and Janet Pope, MD, MPH, professor of medicine and division member of rheumatology at the University of Western Ontario in Canada. IPF and PPF are increasingly prevalent conditions that pose a growing burden on both patients and health care systems. Despite the availability of FDA-approved antifibrotic therapies, the median survival for patients with IPF and PPF remains less than 5 years after diagnosis—underscoring the critical unmet needs that persist in this field. The panelists discussed the impact these conditions have on patients' lives, evaluated emerging agents, and addressed economic considerations that affect treatment decisions and health care resource allocation.
In today's episode, we had the pleasure of speaking with Kevin Kalinsky, MD, MS, FASCO, about the evolving treatment paradigm for hormone receptor (HR)–positive breast cancer post-CDK4/6 inhibition, as well as the need for more advanced therapies to improve patient outcomes in this setting. Dr Kalinsky is a professor and director in the Division of Medical Oncology of the Department of Hematology and Medical Oncology at Emory University School of Medicine, as well as the director of the Glenn Family Breast Center and the Louisa and Rand Glenn Family Chair in Breast Cancer Research at Winship Cancer Institute in Atlanta, Georgia. In our exclusive interview, Dr Kalinsky discussed combination therapies that have shown promise for the management of HR-positive breast cancer following endocrine therapy, factors influencing treatment selection for patients who have received prior CDK4/6 inhibition, best practices for genomic testing in this population, and breast cancer research highlights from the 2025 ESMO Congress.
Today on Sauna Talk, we are joined by the dynamic duo of researcher from Emery University, Deanna Kaplan and Roman Palitsky. Deanna Kaplan Deanna Kaplan, PhD is a clinical psychologist with expertise in digital health technologies. She has more than a decade of experience using wearable and smartphone-based technologies to study the dynamics of health processes and clinical change during daily life. Her research is grounded in a whole-person (bio-psycho-social-spiritual) model of health, and much of her work focuses on investigating the dynamics of change of integrative interventions, such as psychedelic-assisted therapies and contemplative practices. Dr. Kaplan is the Director of the Human Experience and Ambulatory Technologies (HEAT) Lab, a multidisciplinary collaboration between the Department of Family and Preventive Medicine and Emory Spiritual Health. More information about the HEAT Lab is here. Dr. Kaplan is the co-creator and Scientific Director of Fabla, an unlicensed Emory-hosted app for multimodal daily diary and ecological momentary assessment (EMA) research. Fabla is an EMA app that can securely collect voice-recorded, video-recorded , and photographic responses from research participants. More information about Fabla is here. Dr. Kaplan holds an adjunct appointment in Emory's Department of Psychology and is appointed faculty for several Emory centers, including the Winship Cancer Institute, Emory Spiritual Health (ESH), the Emory Center for Psychedelics and Spirituality (ECPS), and the Advancement of Diagnostics for a Just Society (ADJUST) Center. She also holds an appointment as an adjunct Assistant Professor at Brown University in affiliation with the Center for Digital Health. Dr. Kaplan received her PhD in Clinical Psychology from the University of Arizona, completed her predoctoral clinical internship at the Alpert Medical School of Brown University, and completed a postdoctoral research fellowship at Brown University, where she received an F32 National Research Service Award (NRSA) from the National Institutes of Health (NIH). Her research is funded by the NIH, the Health Resources Services Administration (HRSA), the Georgia Clinical and Translational Science Alliance, the Tiny Blue Dot Foundation, and the Vail Health Foundation among others. She was named as a 2025 Rising Star by Genomics Press for her work in mental health assessment innovation. Roman Palitsky Roman Palitsky, MDiv, Ph.D. is Director of Research Projects for Emory Spiritual Health and a Research Psychologist for Emory University School of Medicine. His research program investigates the pathways through which culture and health interact by examining the biological, psychological, and social processes that constitute these pathways. His areas of interest include biopsychosocial determinants in cardiovascular health, chronic pain, and grief. In collaboration with Emory Spiritual Health, his research addresses cultural and existential topics in healthcare such as religion, spirituality, and the way people find meaning in suffering, as they relate to health and illness. His work has also focused on the role of religious and existential worldviews in mindfulness-based interventions, as well as implementation and cultural responsiveness of these interventions. Dr. Palitsky's academic training includes a PhD in Clinical Psychology from the University of Arizona with a concentration in Behavioral Medicine/Health Psychology, and a Master of Divinity from Harvard University. He completed clinical internship in the behavioral medicine track at Brown University Warren Alpert Medical School, where he also completed a postdoctoral fellowship. Deanna and Roman were in town attending and speaking at the 2025 SSSR Conference, Society for the Scienific Study of Religion. And as you will hear, we get deep into the spirit of sauna, a spiritual connection we allow ourselves to have, presented to us through the wonderfulness of time on the bench and chilling out in the garden, all misty wet with rain.
Kevin Kalinsky from Winship Cancer Institute of Emory University in Atlanta, Georgia, discusses recent developments with TROP2-directed antibody-drug conjugates in the management of breast cancer. CME information and select publications here.
Dr Kevin Kalinsky from the Winship Cancer Institute of Emory University in Atlanta, Georgia, discusses recent developments with TROP2-directed antibody-drug conjugates in the management of breast cancer. CME information and select publications here.
Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Jonathon B. Cohen, MD, MS As the therapeutic landscape for follicular lymphoma continues to evolve, CAR T-cell therapy is emerging as a transformative option for select patients with relapsed or high-risk disease. But it also comes with a lot of important considerations, like knowing when to refer and how to manage common adverse events. Joining Dr. Charles Turck to explore how CAR T fits into the broader treatment algorithm for follicular lymphoma is Dr. Jonathan Cohen. Not only is he a Professor in the Department of Hematology and Medical Oncology at the Emory University School of Medicine, but he's also the Co-Director of the Lymphoma Program at the Winship Cancer Institute of Emory University in Atlanta.
Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Jonathon B. Cohen, MD, MS As the therapeutic landscape for follicular lymphoma continues to evolve, CAR T-cell therapy is emerging as a transformative option for select patients with relapsed or high-risk disease. But it also comes with a lot of important considerations, like knowing when to refer and how to manage common adverse events. Joining Dr. Charles Turck to explore how CAR T fits into the broader treatment algorithm for follicular lymphoma is Dr. Jonathan Cohen. Not only is he a Professor in the Department of Hematology and Medical Oncology at the Emory University School of Medicine, but he's also the Co-Director of the Lymphoma Program at the Winship Cancer Institute of Emory University in Atlanta.
This episode features Dr. Nikolaos Papadantonakis from the Winship Cancer Institute of Emory University and Dr. Amer Zeidan from the Yale School of Medicine, discussing research on Myelodysplastic Syndromes (MDS) presented at the 2025 European Hematology Association (EHA) Congress in Milan.
In today's episode, supported by Boehringer Ingelheim, we spoke with Ticiana Leal, MD, and Misako Nagasaka, MD, PhD, about the FDA approval of zongertinib (Hernexeos) for previously treated patients with HER2 TKD–mutant advanced non–small cell lung cancer (NSCLC). Dr Leal is an associate professor and director of the Thoracic Medical Oncology Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia; as well as medical director of the Clinical Trials Office and leader of the Lung Cancer Disease Team at the Winship Cancer Institute of Emory University. Dr Nagasaka is an associate professor of medicine in the Division of Hematology and Oncology at the University of California, Irvine (UCI) School of Medicine; as well as a medical oncologist at UCI Health. In our conversation, Drs Leal and Nagasaka discussed the significance of this approval, key efficacy and safety findings from the pivotal phase 1 Beamion LUNG-1 trial (NCT04886804), and where zongertinib currently fits into the NSCLC treatment paradigm.
For this patient-focused webinar, medical oncologist Dr Neil Love is joined by Dr Natalie S Callander from the University of Wisconsin Carbone Cancer Center in Madison and Dr Sagar Lonial from the Winship Cancer Institute of Emory University in Atlanta, Georgia, to discuss the patient experience associated with the diagnosis and treatment of relapsed/refractory multiple myeloma. Educational and faculty information here.
Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Neil M. Iyengar, MD Guest: Komal Jhaveri, MD, FACP The second-line treatment of HR+/HER2-advanced breast cancer has evolved in recent years, particularly with the rise of biomarker-driven strategies targeting PI3Kα and other mutations. But given these advances, there's a lot we need to think about when selecting therapy, like the differences between selective and non-selective inhibitors, toxicity profiles, and shared decision-making. Joining Dr. Charles Turck to share their insights on those key considerations and how we can personalize care for patients with PI3Kα-mutated HR+/HER2- advanced breast cancer are Drs. Komal Jhaveri and Neil Iyengar. Dr. Jhaveri is the section head for the Endocrine Therapy Research Program in the Breast Medicine Service at Memorial Sloan Kettering Cancer Center, and Dr. Iyengar is the Co-Director of the Breast Oncology Program at the Winship Cancer Institute at Emory University.
Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Neil M. Iyengar, MD Due to their wild-type inhibition, first-generation PIK3CA inhibitors for HR+/HER2- advanced breast cancer were limited by significant toxicities, including hyperglycemia, rash, and diarrhea. But now, mutation-specific PIK3CA inhibitors could help improve tolerability and adherence as well as simplify dosing strategies—all while maintaining efficacy. To learn more about the efficacy and safety of current and emerging PIK3CA-targeted therapies, Dr. Charles Turck speaks with Dr. Neil Iyengar, Co-Director of the Breast Oncology Program and Director of Cancer Survivorship Service at Winship Cancer Institute at Emory University.
Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Neil M. Iyengar, MD Due to their wild-type inhibition, first-generation PIK3CA inhibitors for HR+/HER2- advanced breast cancer were limited by significant toxicities, including hyperglycemia, rash, and diarrhea. But now, mutation-specific PIK3CA inhibitors could help improve tolerability and adherence as well as simplify dosing strategies—all while maintaining efficacy. To learn more about the efficacy and safety of current and emerging PIK3CA-targeted therapies, Dr. Charles Turck speaks with Dr. Neil Iyengar, Co-Director of the Breast Oncology Program and Director of Cancer Survivorship Service at Winship Cancer Institute at Emory University.
Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Neil M. Iyengar, MD Guest: Komal Jhaveri, MD, FACP The second-line treatment of HR+/HER2-advanced breast cancer has evolved in recent years, particularly with the rise of biomarker-driven strategies targeting PI3Kα and other mutations. But given these advances, there's a lot we need to think about when selecting therapy, like the differences between selective and non-selective inhibitors, toxicity profiles, and shared decision-making. Joining Dr. Charles Turck to share their insights on those key considerations and how we can personalize care for patients with PI3Kα-mutated HR+/HER2- advanced breast cancer are Drs. Komal Jhaveri and Neil Iyengar. Dr. Jhaveri is the section head for the Endocrine Therapy Research Program in the Breast Medicine Service at Memorial Sloan Kettering Cancer Center, and Dr. Iyengar is the Co-Director of the Breast Oncology Program at the Winship Cancer Institute at Emory University.
Dr Ajay K Nooka from Winship Cancer Institute of Emory University in Atlanta, Georgia, and Dr Paul G Richardson from Dana-Farber Cancer Institute in Boston, Massachusetts, discuss recent updates on available and novel treatment strategies for multiple myeloma. CME information and select publications here.
What if the key to better cancer outcomes lies not just in surgery or chemotherapy, but also in mindfulness, movement, and diet? In this episode of the BackTable Tumor Board, host Dr. Aditya Bagrodia interviews urologic oncologist Dr. Viraj Master, Professor of Urology at Emory University, about his role in developing the integrative oncology and survivorship service line at Winship Cancer Institute. --- This podcast is supported by: Ferring Pharmaceuticals https://ad.doubleclick.net/ddm/trackclk/N2165306.5658203BACKTABLE/B33008413.420220578;dc_trk_aid=612466359;dc_trk_cid=234162109;dc_lat=;dc_rdid=;tag_for_child_directed_treatment=;tfua=;gdpr=${GDPR};gdpr_consent=${GDPR_CONSENT_755};gpp=${GPP_STRING_755};gpp_sid=${GPP_SID};ltd=;dc_tdv=1 --- SYNPOSIS They discuss the evidence-based use of complementary therapies alongside conventional cancer treatments, touching on various integrative methods including diet, exercise, mindfulness, acupuncture, yoga, and supplements. Dr. Master emphasizes the importance of physicians being open to these practices and understanding their potential benefits for improving patient outcomes and quality of life, even in highly acute cases like muscle-invasive bladder cancer. The conversation covers the importance of honesty and understanding across patient journeys–from initial diagnosis to survivorship–highlighting the value of holistic approaches in cancer care. ---TIMESTAMPS00:00 - Integrative Oncology: Definitions and Basics06:28 - Exercise and Its Impact on Cancer Treatment08:12 - Physician Perspectives on Complementary Medicine20:58 - Acupuncture and Acupressure in Cancer Care25:28 - Practical Implementation of Integrative Approaches31:30 - Supplements and Immuno Nutrition36:25 - Cannabis, CBD, and Ayurveda in Cancer Care44:39 - Conclusion and Final Thoughts --- RESOURCES Society of Urologic Oncologyhttps://suonet.org/home.aspx
Podcast 286 – Empowering Patients During Cancer Treatment with myFriendMD – Dr. Sarah Friend Dunwoody's Dr. Sarah Friend is bringing something new to cancer care. Through her virtual service myFriendMD, she gives breast cancer patients and their families what the medical system often cannot. Time, clarity, and emotional support. With over a decade of experience including years at Emory's Winship Cancer Institute she now helps patients slow down, ask better questions, and take control of their treatment journey. Her coaching model is built for the space between appointments. The part where fear sets in, questions build, and Google becomes your worst enemy. Dr. Friend steps in when patients need more than facts. They need perspective. They need to feel heard. You get to ask questions one through four during your doctor visit. She helps with questions five through twenty. The ones that matter just as much, but rarely get answered. Know someone facing breast cancer or walking beside someone who is? Visit myFriendMD.com https://whatsupdunwoody.com/podcast-286-empowering-patients-during-cancer-treatment-with-myfriendmd-dr-sarah-friend/ What's Up Dunwoody Links:
Dr. Ko Un “Clara” Park and Dr. Mylin Torres present the latest evidence-based changes to the SLNB in early-stage breast cancer guideline. They discuss the practice-changing trials that led to the updated recommendations and topics such as when SLNB can be omitted, when ALND is indicated, radiation and systemic treatment decisions after SLNB omission, and the role of SLNB in special circumstances. We discuss the importance of shared decision-making and other ongoing and future de-escalation trials that will expand knowledge in this space. Read the full guideline update, “Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer: ASCO Guideline Update” at www.asco.org/breast-cancer-guidelines. TRANSCRIPT This guideline, clinical tools, and resources are available at http://www.asco.org/breast-cancer-guidelines. Read the full text of the guideline and review authors' disclosures of potential conflicts of interest in the Journal of Clinical Oncology, https://ascopubs.org/doi/10.1200/JCO-25-00099 Brittany Harvey: Hello and welcome to the ASCO Guidelines podcast, one of ASCO's podcasts delivering timely information to keep you up to date on the latest changes, challenges and advances in oncology. You can find all the shows, including this one at asco.org/podcasts. My name is Brittany Harvey and today I'm interviewing Dr. Ko Un "Clara" Park from Brigham and Women's Hospital, Dana-Farber Cancer Institute, and Dr. Mylin Torres from Glenn Family Breast Center at Winship Cancer Institute of Emory University, co-chairs on “Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer: ASCO Guideline Update.” Thank you for being here today, Dr. Park and Dr. Torres. Dr. Mylin Torres: Thank you, it's a pleasure to be here. Brittany Harvey: And before we discuss this guideline, I'd like to note that ASCO takes great care in the development of its guidelines and ensuring that the ASCO Conflict of Interest Policy is followed for each guideline. The disclosures of potential conflicts of interest for the guideline panel, including Dr. Torres and Dr. Park, who have joined us here today, are available online with the publication of the guideline in the Journal of Clinical Oncology, which is linked in the show notes. To start us off, Dr. Torres, what is the scope and purpose of this guideline update on the use of sentinel lymph node biopsy in early-stage breast cancer? Dr. Mylin Torres: The update includes recommendations incorporating findings from trials released since our last published guideline in 2017. It includes data from nine randomized trials comparing sentinel lymph node biopsy alone versus sentinel lymph node biopsy with a completion axillary lymph node dissection. And notably, and probably the primary reason for motivating this update, are two trials comparing sentinel lymph node biopsy with no axillary surgery, all of which were published from 2016 to 2024. We believe these latter two trials are practice changing and are important for our community to know about so that it can be implemented and essentially represent a change in treatment paradigms. Brittany Harvey: It's great to hear about these practice changing trials and how that will impact these recommendation updates. So Dr. Park, I'd like to start by reviewing the key recommendations across all of these six overarching clinical questions that the guideline addressed. So first, are there patients where sentinel lymph node biopsy can be omitted? Dr. Ko Un "Clara" Park: Yes. The key change in the current management of early-stage breast cancer is the inclusion of omission of sentinel lymph node biopsy in patients with small, less than 2 cm breast cancer and a negative finding on preoperative axillary ultrasound. The patients who are eligible for omission of sentinel lymph node biopsy according to the SOUND and INSEMA trial are patients with invasive ductal carcinoma that is size smaller than 2 cm, Nottingham grades 1 and 2, hormone receptor-positive, HER2-negative in patients intending to receive adjuvant endocrine therapy, and no suspicious lymph nodes on axillary ultrasound or if they have only one suspicious lymph node, then the biopsy of that lymph node is benign and concordant according to the axillary ultrasound findings. The patients who are eligible for sentinel lymph node biopsy omission according to the SOUND and INSEMA trials were patients who are undergoing lumpectomy followed by whole breast radiation, especially in patients who are younger than 65 years of age. For patients who are 65 years or older, they also qualify for omission of sentinel lymph node biopsy in addition to consideration for radiation therapy omission according to the PRIME II and CALGB 9343 clinical trials. And so in those patients, a more shared decision-making approach with the radiation oncologist is encouraged. Brittany Harvey: Understood. I appreciate you outlining that criteria for when sentinel lymph node biopsy can be omitted and when shared decision making is appropriate as well. So then, Dr. Torres, in those patients where sentinel lymph node biopsy is omitted, how are radiation and systemic treatment decisions impacted? Dr. Mylin Torres: Thank you for that question. I think there will be a lot of consternation brought up as far as sentinel lymph node biopsy and the value it could provide in terms of knowing whether that lymph node is involved or not. But as stated, sentinel lymph node biopsy actually can be safely omitted in patients with low risk disease and therefore the reason we state this is that in both SOUND and INSEMA trial, 85% of patients who had a preoperative axillary ultrasound that did not show any signs of a suspicious lymph node also had no lymph nodes involved at the time of sentinel node biopsy. So 85% of the time the preoperative ultrasound is correct. So given the number of patients where preoperative ultrasound predicts for no sentinel node involvement, we have stated within the guideline that radiation and systemic treatment decisions should not be altered in the select patients with low risk disease where sentinel lymph node biopsy can be omitted. Those are the patients who are postmenopausal and age 50 or older who have negative findings on preoperative ultrasound with grade 1 or 2 disease, small tumors less than or equal to 2 cm, hormone receptor-positive, HER2-negative breast cancer who undergo breast conserving therapy. Now, it's important to note in both the INSEMA and SOUND trials, the vast majority of patients received whole breast radiation. In fact, within the INSEMA trial, partial breast irradiation was not allowed. The SOUND trial did allow partial breast irradiation, but in that study, 80% of patients still received whole breast treatment. Therefore, the preponderance of data does support whole breast irradiation when you go strictly by the way the SOUND and INSEMA trials were conducted. Notably, however, most of the patients in these studies had node-negative disease and had low risk features to their primary tumors and would have been eligible for partial breast irradiation by the ASTRO Guidelines for partial breast treatment. So, given the fact that 85% of patients will have node-negative disease after a preoperative ultrasound, essentially what we're saying is that partial breast irradiation may be offered in these patients where omission of sentinel node biopsy is felt to be safe, which is in these low risk patients. Additionally, regional nodal irradiation is something that is not indicated in the vast majority of patients where omission of sentinel lymph node biopsy is prescribed and recommended, and that is because very few of these patients will actually end up having pathologic N2 disease, which is four or more positive lymph nodes. If you look at the numbers from both the INSEMA and the SOUND trial, the number of patients with pathologic N2 disease who did have their axilla surgically staged, it was less than 1% in both trials. So, in these patients, regional nodal irradiation, there would be no clear indication for that more aggressive and more extensive radiation treatment. The same principles apply to systemic therapy. As the vast majority of these patients are going to have node-negative disease with a low risk primary tumor, we know that postmenopausal women, even if they're found to have one to three positive lymph nodes, a lot of the systemic cytotoxic chemotherapy decisions are driven by genomic assay score which is taken from the primary tumor. And therefore nodal information in patients who have N1 disease may not be gained in patients where omission of sentinel lymph node biopsy is indicated in these low risk patients. 14% of patients have 1 to 3 positive lymph nodes in the SOUND trial and that number is about 15% in the INSEMA trial. Really only the clinically actionable information to be gained is if a patient has four or more lymph nodes or N2 disease in this low risk patient population. So, essentially when that occurs it's less than 1% of the time in these patients with very favorable primary tumors. And therefore we thought it was acceptable to stand by a recommendation of not altering systemic therapy or radiation recommendations based on omission of sentinel nodes because the likelihood of having four more lymph nodes is so low. Dr. Ko Un "Clara" Park: I think one thing to add is the use of CDK4/6 inhibitors to that and when we look at the NATALEE criteria for ribociclib in particular, where node-negative patients were included, the bulk majority of the patients who were actually represented in the NATALEE study were stage III disease. And for stage I disease to upstage into anatomic stage III, that patient would need to have pathologic N2 disease. And as Dr. Torres stated, the rate of having pathologic N2 disease in both SOUND and INSEMA studies were less than 1%. And therefore it would be highly unlikely that these patients would be eligible just based on tumor size and characteristics for ribociclib. So we think that it is still safe to omit sentinel lymph node biopsy and they would not miss out, if you will, on the opportunity for CDK4/6 inhibitors. Brittany Harvey: Absolutely. I appreciate you describing those recommendations and then also the nuances of the evidence that's underpinning those recommendations, I think that's important for listeners. So Dr. Park, the next clinical question addresses patients with clinically node negative early stage breast cancer who have 1 or 2 sentinel lymph node metastases and who will receive breast conserving surgery with whole breast radiation therapy. For these patients, is axillary lymph node dissection needed? Dr. Ko Un "Clara" Park: No. And this is confirmed based on the ACOSOG Z0011 study that demonstrated in patients with 1 to 3 positive sentinel lymph node biopsy when the study compared completion axillary lymph node dissection to no completion axillary lymph node dissection, there was no difference. And actually, the 10-year overall survival as reported out in 2017 and at a median follow up of 9.3 years, the overall survival again for patients treated with sentinel lymph node biopsy alone versus those who were treated with axillary lymph node dissection was no different. It was 86.3% in sentinel lymph node biopsy versus 83.6% and the p-value was non-inferior at 0.02. And so we believe that it is safe for the select patients who are early stage with 1 to 2 positive lymph nodes on sentinel lymph node biopsy, undergoing whole breast radiation therapy to omit completion of axillary lymph node dissection. Brittany Harvey: Great, I appreciate you detailing what's recommended there as well. So then, to continue our discussion of axillary lymph node dissection, Dr. Torres, for patients with nodal metastases who will undergo mastectomy, is axillary lymph node dissection indicated? Dr. Mylin Torres: It's actually not and this is confirmed by two trials, the AMAROS study as well as the SENOMAC trial. And in both studies, they compared a full lymph node dissection versus sentinel lymph node biopsy alone in patients who are found to have 1 to 2 positive lymph nodes and confirmed that there was no difference in axillary recurrence rates, overall survival or disease-free survival. What was shown is that with more aggressive surgery completion axillary lymph node dissection, there were higher rates of morbidity including lymphedema, shoulder pain and paresthesias and arm numbness, decreased functioning of the arm and so there was only downside to doing a full lymph node dissection. Importantly, in both trials, if a full lymph node dissection was not done in the arm that where sentinel lymph node biopsy was done alone, all patients were prescribed post mastectomy radiation and regional nodal treatment and therefore both studies currently support the use of post mastectomy radiation and regional nodal treatment when a full lymph node dissection is not performed in these patients who are found to have N1 disease after a sentinel node biopsy. Brittany Harvey: Thank you. And then Dr. Park, for patients with early-stage breast cancer who do not have nodal metastases, can completion axillary lymph node dissection be omitted? Dr. Ko Un "Clara" Park: Yes, and this is an unchanged recommendation from the earlier ASCO Guidelines from 2017 as well as the 2021 joint guideline with Ontario Health, wherein patients with clinically node-negative early stage breast cancer, the staging of the axilla can be performed through sentinel lymph nodal biopsy and not completion axillary lymph node dissection. Brittany Harvey: Understood. So then, to wrap us up on the clinical questions here, Dr. Park, what is recommended regarding sentinel lymph node biopsy in special circumstances in populations? Dr. Ko Un "Clara" Park: One key highlight of the special populations is the use of sentinel lymph node biopsy for evaluation of the axilla in clinically node negative multicentric tumors. While there are no randomized clinical trials evaluating specifically the role of sentinel lymph nodal biopsy in multicentric tumors, in the guideline, we highlight this as one of the safe options for staging of the axilla and also for pregnant patients, these special circumstances, it is safe to perform sentinel lymph node biopsy in pregnant patients with the use of technetium - blue dye should be avoided in this population. In particular, I want to highlight where sentinel lymph node biopsy should not be used for staging of the axilla and that is in the population with inflammatory breast cancer. There are currently no studies demonstrating that sentinel lymph node biopsy is oncologically safe or accurate in patients with inflammatory breast cancer. And so, unfortunately, in this population, even after neoadjuvant systemic therapy, if they have a great response, the current guideline recommends mastectomy with axillary lymph node dissection. Brittany Harvey: Absolutely. I appreciate your viewing both where sentinel lymph node can be offered in these special circumstances in populations and where it really should not be used. So then, Dr. Torres, you talked at the beginning about how there's been these new practice changing trials that really impacted these recommendations. So in your view, what is the importance of this guideline update and how does it impact both clinicians and patients? Dr. Mylin Torres: Thank you for that question. This update and these trials that inform the update represent a significant shift in the treatment paradigm and standard of care for breast cancer patients with early-stage breast cancer. When you think about it, it seems almost counterintuitive that physicians and patients would not want to know if a lymph node is involved with cancer or not through sentinel lymph node biopsy procedure. But what these studies show is that preoperative axillary ultrasound, 85% of the time when it's negative, will correctly predict whether a sentinel lymph node is involved with cancer or not and will also be negative. So if you have imaging that's negative, your surgery is likely going to be negative. Some people might ask, what's the harm in doing a sentinel lymph node biopsy? It's important to recognize that upwards of 10% of patients, even after sentinel lymph node biopsy will develop lymphedema, chronic arm pain, shoulder immobility and arm immobility. And these can have a profound impact on quality of life. And if there is not a significant benefit to assessing lymph nodes, particularly in someone who has a preoperative axillary ultrasound that's negative, then why put a patient at risk for these morbidities that can impact them lifelong? Ideally, the adoption of omission of sentinel lymph node biopsy will lead to more multidisciplinary discussion and collaboration in the preoperative setting especially with our diagnostic physicians, radiology to assure that these patients are getting an axillary ultrasound and determine how omission of sentinel lymph node biopsy may impact the downstream treatments after surgery, particularly radiation and systemic therapy decisions, and will be adopted in real world patients, and how clinically we can develop a workflow where together we can make the best decisions for our patients in collaboration with them through shared decision making. Brittany Harvey: Absolutely. It's great to have these evidence-based updates for clinicians and patients to review and refer back to. So then finally, Dr. Park, looking to the future, what are the outstanding questions and ongoing trials regarding sentinel lymph node biopsy in early-stage breast cancer? Dr. Ko Un "Clara" Park: I think to toggle on Dr. Torres's comment about shared decision making, the emphasis on that I think will become even more evident in the future as we incorporate different types of de-escalation clinical studies. In particular, because as you saw in the SOUND and INSEMA studies, when we de-escalate one modality of the multimodality therapy, i.e., surgery, the other modalities such as radiation therapy and systemic therapy were “controlled” where we were not de-escalating multiple different modalities. However, as the audience may be familiar with, there are other types of de-escalation studies in particular radiation therapy, partial breast irradiation or omission of radiation therapy, and in those studies, the surgery is now controlled where oftentimes the patients are undergoing surgical axillary staging. And conversely when we're looking at endocrine therapy versus radiation therapy clinical trials, in those studies also the majority of the patients are undergoing surgical axillary staging. And so now as those studies demonstrate the oncologic safety of omission of a particular therapy, we will be in a position of more balancing of the data of trying to select which patients are the safe patients for omission of certain types of modality, and how do we balance whether it's surgery, radiation therapy, systemic therapy, endocrine therapy. And that's where as Dr. Torres stated, the shared decision making will become critically important. I'm a surgeon and so as a surgeon, I get to see the patients oftentimes first, especially when they have early-stage breast cancer. And so I could I guess be “selfish” and just do whatever I think is correct. But whatever the surgeon does, the decision does have consequences in the downstream decision making. And so the field really needs to, as Dr. Torres stated earlier, rethink the workflow of how early-stage breast cancer patients are brought forth and managed as a multidisciplinary team. I also think in future studies the expansion of the data to larger tumors, T3, in particular,reater than 5 cm and also how do we incorporate omission in that population will become more evident as we learn more about the oncologic safety of omitting sentinel lymph node biopsy. Dr. Mylin Torres: In addition, there are other outstanding ongoing clinical trials that are accruing patients right now. They include the BOOG 2013-08 study, SOAPET, NAUTILUS and the VENUS trials, all looking at patients with clinical T1, T2N0 disease and whether omission of sentinel lymph node biopsy is safe with various endpoints including regional recurrence, invasive disease-free survival and distant disease-free survival. I expect in addition to these studies there will be more studies ongoing even looking at the omission of sentinel lymph node biopsy in the post-neoadjuvant chemotherapy setting. And as our imaging improves in the future, there will be more studies improving other imaging modalities, probably in addition to axillary ultrasound in an attempt to accurately characterize whether lymph nodes within axilla contain cancer or not, and in that context whether omission of sentinel lymph node biopsy even in patients with larger tumors post-neoadjuvant chemotherapy may be done safely and could eventually become another shift in our treatment paradigm. Brittany Harvey: Yes. The shared decision making is key as we think about these updates to improve quality of life and we'll await data from these ongoing trials to inform future updates to this guideline. So I want to thank you both so much for your extensive work to update this guideline and thank you for your time today. Dr. Park and Dr. Torres. Dr. Mylin Torres: Thank you. Dr. Ko Un "Clara" Park: Thank you. Brittany Harvey: And thank you to all of our listeners for tuning in to the ASCO Guidelines podcast. To read the full guideline, go to www.asco.org/breast-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app available in the Apple App Store or the Google Play Store. If you have enjoyed what you've heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode. 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.
In this episode of The Scope of Things, host Deborah Borfitz covers the latest news, including setting expectations for Phase II cancer trials, key learnings about dementia from the Nun Study, links between cardiovascular disease and mild cognitive impairment, using aspirin to prevent cancer spread, a clinical trial map to improve study access, and a naturally occurring molecule that rivals Ozempic in its weight loss potential. Deborah also speaks with Ravi Parikh, medical director of data and technology applications shared resource at Winship Cancer Institute of Emory University, about a novel AI platform he helped develop to translate clinical trial results to real world populations. News Roundup Phase 2 cancer drug trials Study in the Journal of the National Cancer Institute Nun Study insights Review article in Alzheimer's & Dementia DORIAN GRAY project Press release by the European Society of Cardiology Aspirin for preventing cancer spread Study in Nature New clinical trial map News announcement on the EMA website Molecule rivaling Ozempic Study in NatureThe Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider's look at clinical research today.
Welcome to the Oncology Brothers podcast! In this episode, Drs. Rahul and Rohit Gosain are joined by Dr. Kevin Kalinsky, a leading breast medical oncologist and director of the breast cancer program at the Winship Cancer Institute of Emory University. Join us as we dive deep into the complexities of hormone receptor-positive breast cancer treatment. We discuss the latest advancements in treatment algorithms, including the use of OncotypeDX in premenopausal versus postmenopausal women, the role of ovarian function suppression, and the implications of new approvals like Inavolisib and CDK4-6 inhibitors. Key topics covered in this episode: • The significance of recurrence scores in dictating adjuvant chemotherapy • The ongoing OFSET trial and its potential impact on treatment decisions • Insights into the use of genomic assays like MammaPrint and RS-Clin • The evolving landscape of treatment options for locally advanced and metastatic breast cancer • The latest on PARP inhibitors, T-DXd, and other novel therapies Whether you're a medical professional or someone interested in the latest in oncology, this episode is packed with valuable insights and clinical pearls. Don't forget to subscribe for more discussions on cancer treatment, FDA approvals, and conference highlights! YouTube: https://youtu.be/_icBN3J3Bc0 Follow us on social media: • X/Twitter: https://twitter.com/oncbrothers • Instagram: https://www.instagram.com/oncbrothers #OncologyBrothers #HR+ #breastcancer #HormoneReceptorPositiveCancer #oncbrothers #Podcast
Ilana Graetz, PhD, is an Associate Professor at Emory University's Rollins School of Public Health and leader of the Cancer Prevention and Control Research Program at the Winship Cancer Institute. Dr. Graetz's research centers on leveraging health information technology to transform care delivery and improve patient outcomes. As the principal investigator and co-investigator on numerous federally and institutionally funded studies, her work encompasses a wide range of topics, including data analytics, the use of electronic health records and patient portals to enhance care quality and coordination, telehealth innovations, remote monitoring, and patient-reported outcomes. She also leads efforts to design and evaluate mobile health interventions that strengthen patient-provider communication, support treatment adherence, and improve health outcomes.
Dr Erika Hamilton from the Sarah Cannon Research Institute in Nashville, Tennessee, Dr Kevin Kalinsky from the Winship Cancer Institute of Emory University in Atlanta, Georgia, Dr Ian E Krop from the Yale Cancer Center in New Haven, Connecticut, Dr Joyce O'Shaughnessy from the Sarah Cannon Research Institute in Dallas, Texas, and Dr Sara M Tolaney from the Dana-Farber Cancer Institute in Boston, Massachusetts, discuss available and novel treatment strategies for metastatic breast cancer, moderated by Dr Neil Love. Produced by Research To Practice. CME information and select publications here (https://www.researchtopractice.com/SABCS2024/mBC).
Dr Erika Hamilton from the Sarah Cannon Research Institute in Nashville, Tennessee, Dr Kevin Kalinsky from the Winship Cancer Institute of Emory University in Atlanta, Georgia, Dr Ian E Krop from the Yale Cancer Center in New Haven, Connecticut, Dr Joyce O'Shaughnessy from the Sarah Cannon Research Institute in Dallas, Texas, and Dr Sara M Tolaney from the Dana-Farber Cancer Institute in Boston, Massachusetts, discuss available and novel treatment strategies for metastatic breast cancer.
Today we are bringing you a conversation on treatment with Bruton tyrosine kinase inhibitors for patients with treatment-naïve chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Ryan Haumschild, PharmD, MS, MBA, CPEL, vice president of ambulatory pharmacy at Emory Healthcare and Winship Cancer Institute, spoke with 3 experts: Tara Graff, DO, medical oncologist, Mission Cancer and Blood; Jacqueline Barrientos, MD, MS, chief, Hematologic Malignancies, and director, Oncology Research at Mount Sinai Comprehensive Cancer Center; and Matthew Davids, MD, MMSc, director of Clinical Research, Division of Lymphoma, Dana-Farber Cancer Institute, and associate professor of medicine, Harvard Medical School. They covered a wide range of topics including the data on treatment regimens for both CLL and MCL, the cost of treatment, patient-specific considerations during treatment decision making, and the future of treatment.
Prof Philippe Moreau of University Hospital – CHU de Nantes in France, Dr Robert Z Orlowski of The University of Texas MD Anderson Cancer Center in Houston, Dr Noopur Raje of Massachusetts General Hospital Cancer Center in Boston, Dr Paul G Richardson of Dana-Farber Cancer Institute in Boston, and Dr Sagar Lonial of Winship Cancer Institute of Emory University in Atlanta, Georgia, discuss current questions and controversies in the management of multiple myeloma.
Prof Philippe Moreau of University Hospital – CHU de Nantes in France, Dr Robert Z Orlowski of The University of Texas MD Anderson Cancer Center in Houston, Dr Noopur Raje of Massachusetts General Hospital Cancer Center in Boston, Dr Paul G Richardson of Dana-Farber Cancer Institute in Boston, and Dr Sagar Lonial of Winship Cancer Institute of Emory University in Atlanta, Georgia, discuss current questions and controversies in the management of multiple myeloma. Produced by Research To Practice. CME information and select publications here (https://www.researchtopractice.com/ASHMM24).
Bispecific antibodies (BsAbs) have transformative potential in cancer treatment and can be successfully integrated into community oncology practices. To support this integration, ACCC is committed to providing educational initiatives and support for cancer care teams to optimize care coordination. In this episode, CANCER BUZZ speaks with Jean Louise Koff, MD, MSc, associate professor of hematology and medical oncology at Winship Cancer Institute of Emory University, to discuss the impact of bispecific antibodies on cancer treatment outcomes, and the challenges and opportunities of integrating this innovative approach into community oncology practices. Dr. Koff sheds light on the opportunities for future partnerships with academic centers and community oncology sites to ensure there is proper infrastructure and training to safely administer bispecific antibodies. “We're only at the beginning here; I think that as new bispecific agents are developed, there may be other indications in which they can be used, so it will be a broader population of patients who may end up being eligible to receive these drugs.” -Jean Louise Koff Jean Louise Koff, MD, MSc Associate Professor, Hematology and Medical Oncology Winship Cancer Institute of Emory University Atlanta, GA This podcast was developed in connection with APSHO and LRF and made possible with support by Genentech and Johnson & Johnson. Resources: ASCO Use of BsAbs in Community AJMC Obstacles to Optimal Transition Between Academic and Community Centers
Lung Cancer Considered host Dr. Narjust Florez and Dr. Suresh Ramalingam discuss the recent FDA approval of osimertinib after chemo-radiation in EGFR positive NSCLC. The approval was based, in part, on the results of the LAURA trial, which was presented at the 2024 ASCO Annual Meeting. Guest: Dr. Suresh Ramalingam is the Executive Director, Winship Cancer Institute of Emory University, the Roberto C. Goizueta Distinguished Chair for Cancer Research, and a professor of medicine at Emory University School of Medicine. He is also the editor in chief for the Cancer Journal.
Prof Francois-Clement Bidard from Institut Curie in Paris and Dr Kevin Kalinsky from Winship Cancer Institute of Emory University in Atlanta discuss improving the outcomes of first-line endocrine-based therapy for patients with HR-positive, HER2-negative metastatic breast cancer, moderated by Dr Neil Love. Produced by Research To Practice. CME information and select publications here (https://www.researchtopractice.com/FirstLineTherapymBC24).
Prof Francois-Clement Bidard from Institut Curie in Paris and Dr Kevin Kalinsky from Winship Cancer Institute of Emory University in Atlanta discuss improving the outcomes of first-line endocrine-based therapy for patients with HR-positive, HER2-negative metastatic breast cancer.
The race to develop an effective COVID-19 vaccine showed the world just how powerful the immune system can be to prevent serious illness. Rafi Ahmed discusses how understanding the immune system is key to developing lifesaving vaccines. Ahmed, the Charles Howard Candler Professor of Microbiology and Immunology at Emory School of Medicine, directs the Emory Vaccine Center and is co-leader of the Cancer Immunology Research Program at Emory's Winship Cancer Institute. Hosted on Acast. See acast.com/privacy for more information.
Dr Melissa Johnson from Sarah Cannon Research Institute in Nashville, Tennessee, Dr Ticiana Leal from Winship Cancer Institute of Emory University in Atlanta, Georgia, and Dr Manish Patel from Florida Cancer Specialists & Research Institute in Sarasota, Florida, summarize recently presented advancements, including novel strategies, in the treatment of lung cancer.
Dr Melissa Johnson from Sarah Cannon Research Institute in Nashville, Tennessee, Dr Ticiana Leal from Winship Cancer Institute of Emory University in Atlanta, Georgia, and Dr Manish Patel from Florida Cancer Specialists & Research Institute in Sarasota, Florida, summarize recently presented advancements, including novel strategies, in the treatment of lung cancer, moderated by Dr Neil Love. Produced by Research To Practice. CME information and select publications here (https://www.researchtopractice.com/OncologyToday24/NovelLung).
In this episode of JCO Article Insights, Rohit Singh interviews Dr. Ticiana Leal on the editorial, "Back to the Drawing Board: Overcoming Resistance to PD-1 Blockade." TRANSCRIPT The guests' disclosures can be found in the transcript. Dr. Rohit Singh: Hello and welcome to JCO's Article Insights. I am your host Rohit Singh and today we will be discussing the JCO article, “Back to the Drawing Board: Overcoming Resistance to PD-1 Blockade.” And we are joined by the senior author of the article, Dr. Ticiana Leal. Dr. Leal is an Associate Professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine, and she serves as director of Thoracic Medical Thoracic Oncology Medical Program and Multidisciplinary Thoracic Oncology Leader at the Winship Cancer Institute. She also served as a member of the Board of Directors at the Georgia Society of Clinical Oncology. Dr. Leal, welcome to our podcast and thank you for joining us. Dr. Ticiana Leal: Thank you, Rohit. Thank you for this interesting opportunity to discuss our editorial. My co-authors and I are very glad to be here today. So, Dr. Jennifer Carlisle and Dr. Liu were co-authors with me on this editorial. Dr. Rohit Singh: It's a really good article. And just for our audiences, the article again, titled “Back to the Drawing Board: Overcoming Resistance to PD-1 Blockade,” it discusses the challenges and the potential strategies for overcoming resistance to immune checkbox inhibitors in patients with non-small cell lung cancer. In this article, Dr. Leal and colleagues talk about the second line of drug when the patient developed disease progression while immunotherapy and they develop resistance and their definitions and what to do. So, to Dr. Leal, can you please explain the mechanisms of primary and acquired resistance to immune check prohibitors in non-small cell lung cancer? I also saw in your article you proposed the definition of immunotherapy resistance in solid tumors, distinguishing between primary resistance and acquired resistance. So, if you can please share your thoughts and explain their mechanism. Dr. Ticiana Leal: So primary resistance and acquired resistance are related to tumor intrinsic and tumor extrinsic factors. And this is mainly clinically defined as of now according to previous response patterns and timing of occurrence, and these definitions can be heterogeneous, and we certainly think that biologically they can be very different. And it can be different according to prior therapy, whether patients got immunotherapy as PD-1, PD-L1 inhibitor alone or combination strategy with CTLA-4, or the combination with chemotherapy. But the patterns of resistance can be very different and can be based on defects and antigen presentation. It can also be due to tumor microenvironment immunosuppressive effects, and there are also additional inhibitory checkpoints that can be involved. The definition in terms of when to call it primary or acquired resistance at this point has really been based on consensus guidelines by SITC, by Esmo, as well as our group Lung-MAP has developed clinical trials in this space. Specifically, through Lung-MAP, we've defined and incorporated the definition of acquired resistance as patients who have had prior exposure of 84 days or greater and then have had progression of their disease. Dr. Rohit Singh: I can see why it is so challenging to come up with a standard definition for immune checkpoint resistance and I think incorporating these definitions and predictive biomarkers for clinical trial design is going to be more important going forward. Your article talks about CONTACT-01 study, so can you please discuss the CONTACT-01 study and how the shifting treatment paradigm in the first-time study impacted it and at the same time also discuss the potential implication of the differential outcome observed between the men and women in the CONTACT-01 study. Dr. Ticiana Leal: CONTACT-01 was a much-awaited study. The authors, Dr. Neal et al, looked at a very important question in the area of immunotherapy resistance. So, CONTACT-01 was a randomized phase three global study that investigated the combination of cabozantinib plus atezolizumab versus docetaxel in patients previously treated with chemotherapy and immunotherapy. And as background, cabozantinib is an inhibitor of multiple receptor tyrosine kinases including VEGFR-2, MET, RET and TAM family kinases. Preclinically, cabozantinib could lead to immuno permissive tumor microenvironment and so it was rational to combine it with a PD-1 inhibitor. In early results of a phase 1B expanded cohort of COSMIC-021 showed really promising results of this combination which led to the rationale of CONTACT-01. In this study, however, patients that were included had different prior treatment sequences. They could have had prior immunotherapy alone followed by chemo or the opposite, or they could have had prior immunotherapy and then upon progression gotten a combination of immunotherapy plus chemotherapy. That to say that immunotherapy rechallenge is something that people are doing in clinical practice given the unmet need and the desire to overcome immunotherapy resistance. But perhaps that also includes a more resistant population of patients, and these patients certainly could have had heterogeneous mechanisms of resistance which could have impacted these results. The study did not meet the primary endpoint of overall survival. We saw a median overall survival of 10.7 months with the combination of atezo plus cabo and 10.5 months with docetaxel alone. In terms of the differences between sex that we saw in the CONTACT-01 study, just to go back in terms of the preclinical studies that have been done, there have been some preclinical studies that demonstrated that perhaps there may be some biological differences in models of different genders in mice. However, in the clinical setting, there have been, I think, contradicting results. A meta-analysis showed that perhaps women derive less benefit than men. Other studies have shown that perhaps women have more adverse events to immunotherapy. In this study specifically, only about 20% of the patients enrolled were women and the majority actually had non squamous histology. And we saw here less benefit for immunotherapy in women. But again, I think the numbers here are quite small. This is an exploratory analysis and I do think it highlights though the importance of making sure that we include populations and have higher rates of accrual, not only in women, but in other representative populations. In this study, only about 1% of the patients were black. Dr. Rohit Singh: Yeah. Thank you so much for highlighting those disparities. I think it's very important to make sure that we have proper representation of all the groups in our trials. I think based on just coming off the VEGF inhibitors, I think the Lung-MAP trial S1800A, showed a significant improvement in median OS with the combination of pembrolizumab and ramucirumab compared to standard of care. Do you envision any future commission therapies targeting the VEGF pathway with immune prohibitors in non-small cell lung cancer? Dr. Ticiana Leal: I definitely think that targeting VEGF with multikinase TKIs based on the studies that we have seen, several now randomized phase 3 studies showing that this strategy is ineffective. So, this has been quite disappointing. But we've now seen the results of CONTACT-01, that we're just discussing here, but also other studies, including SAPPHIRE, which was also a randomized phase 3 that investigated nivolumab plus another VEGF multikinase TKI, sitravatinib. And then we also saw LEAP-008, which was a negative study investigating lenvatinib plus pembrolizumab. There still is a question though, whether you can target the VEGF pathway inhibition with a monoclonal antibody, so that's ramucirumab targeting VEGFR-2 plus ICI, and whether that can actually be an effective strategy. In our Lung-MAP trial, the S1800A, this study was a randomized phase 2. Here we used the definition of acquired resistance of patients receiving prior immune checkpoint inhibitor for a minimum of 84 days, and they were randomized to the combination of pembrolizumab plus ramucirumab versus investigator's choice of standard of care, which did include docetaxel, ramucirumab, docetaxel gemcitabine and methotrexate. This was a positive study. It led to significant improvement in median overall survival and there weren't any significant safety signals here. And we're waiting for another confirmatory study called the Pragmatica-Lung study. Dr. Rohit Singh: Yeah, I did have one patient who raced through pembro, and I utilized this combination and was able to get some responses. You mentioned Pragmatica-Lung trial. Can you provide more information about the ongoing Pragmatica-Lung trial and its potential impact on the treatment paradigm? Dr. Ticiana Leal: Yeah, the Pragmatica-Lung trial is an ongoing study, S2302. This is an effort that is ongoing. Dr. Karen Reckamp is the chair of this study. And this is a study that actually has a very, I think, modern study design. The term Pragmatica, this is an effort that is supported by the NCI to really propose a clinical trial design that is pragmatic to promote diversity and inclusion in clinical trials. The aim of this trial specifically is to validate what we saw in terms of overall survival in S1800A. So, in this study, patients with previously treated advanced non-small cell lung cancer are randomized 1:1 to the combination of pembrolizumab plus ramucirumab versus standard of care for patients previously treated with immunotherapy and chemotherapy for stage 4 recurrent non-small cell lung cancer. Primary endpoint here is overall survival. And I think this kind of highlights what we were talking about in terms of empowering investigators to treat patients in a clinical trial more so like a real-world setting. And I think this can be paradigm changing and decrease barriers to enrollment and also include now the real-world population that we see in clinical practice. Dr. Rohit Singh: Yeah, changing gears a little bit. I think your article also mentioned other agents that have been tested in ICI resistance settings, like lenvatinib-sitra. However, those trials results have been disappointing. What are the possible reasons behind those dose point results with multikinase inhibitors? Dr. Ticiana Leal: We saw some really interesting, promising overall survival results with these combinations in phase two setting. In the phase 1B expansion with CONTACT-01, we saw prolonged overall survival that we thought would be promising enough to investigate in a phase 3. Ultimately, I don't know because there weren't any biomarkers that we could really tease out what was going on. Again, to highlight that both in LEAP-008 as well as CONTACT-01, there was no definition of immunotherapy resistance, which could have impacted, and we did choose the definition for SAPPHIRE, that patients had to have acquired resistance and immunotherapy had to be the most recent prior therapy. Ultimately, one potential reason for why these are not effective could be that this targeting with a multikinase TKI with multiple targets is ineffective, and you really have to target VEGF more precisely, which is the case here of ramucirumab, which targets VEGFR-2, and whether there are differences between a TKI and a monoclonal antibody may also impact the outcomes here. Dr. Rohit Singh: You mentioned biomarkers. Do you think, are there any other potential biomarkers beyond PDL-1 or human mutation burden expression that can help us predict the response image checkpoint, especially in non-small cell lung cancer? Dr. Ticiana Leal: I think that's a great question. I definitely think that more effort needs to be dedicated, and of course, there are multiple efforts in this direction. One of the challenges, obviously, has been to obtain tissue to do this biomarker testing in clinical trials. When you look at CONTACT-01, they did PDL-1 expression, but this was all based on archival tissue and it was all based on standard of care, local testing. So, a lot of heterogeneity there, and certainly using PDL-1 at baseline from initial diagnosis for a second line trial may have significant flaws there. Ultimately, right now, for clinical practice, there isn't anything that's ready for prime time. But certainly, it sounds like, based on what we're seeing, that combining biomarkers is more likely to improve the accuracy. And I think a single biomarker alone is probably going to have insufficient predictive capacity. It'd be great to be able to better comprehensively characterize an individual's tumor, to individualize immunotherapy strategies in this relapse setting. Dr. Rohit Singh: Yeah, definitely. We need more, better biomarkers. Coming to your point of heterogeneity, PD-L1. I myself had a patient, when we got PDL expressions from one site, they gave us one to 49%. However, for the testing, I sent the patient to a further lab at outset and PDL turned out to be 80%. But that was from a different site because of the bio sets only. Yeah, to your point, it's very heterogeneous and definitely we need to be more cautious interpreting those. In that trial, in CONTACT-01, we have, through the patient who have oncogenetic lung cancer. Are there any plans to explore the role of immune checkpoint in oncogenetic lung cancer, especially like non-EGFR, non ALK? I know those are the ones that we have seen in multiple studies that don't respond but are other oncogenetic lung cancer is getting more and more target treatments coming out for non-small lung cancer? Dr. Ticiana Leal: Yeah. So, for patients with driver mutations, the paradigm has been well established that if there is a driver mutation, the patient should receive the appropriate targeted therapy. Immunotherapy as monotherapy has been ineffective in a lot of the patients with driver mutations beyond EGFR and ALK, certainly RET and HER2, ROS1, or other driver mutations that we believe that immunotherapy alone is ineffective. However, we are seeing some interesting ongoing clinical trials, or completed clinical trials investigating immunotherapy in patients with driver mutations. Going back to the EGFR population, we recently saw the results of HARMONi-A, which investigated ivonescimab, which is a bispecific antibody hitting PD-1, and VEGF, that in combination with chemotherapy, improved progression free survival in patients with EGFR mutated, non-squamous, non-small cell lung cancer with progression on prior TKI treatment. So, I think it is still an area of active investigation, and I do think that ongoing trials, perhaps with different PD-1, PD-L1 combination strategies such as bispecifics may be interesting but does require investigation. Dr. Rohit Singh: Yeah, definitely. It looks like combination therapy is going to be the most likely answer coming forward with more research, we're able to figure out the best possible treatment in this subgroup of patients. Considering the current challenges and ongoing research efforts, how do you see the field of non-small cell treatment evolving in coming years? Dr. Ticiana Leal: This is an interesting and important question. I think it's been really exciting to be working in thoracic oncology research. We have seen that these research efforts have led to advancement in the field. I think we need to continue to partner and collaborate with institutions, partner with industry, and also with patients and patient advocates to design clinical trials that are really going to focus on the needs of our patients in clinical trials. The gap in the second line and beyond after immunotherapy failure is a significant one. So, I do think that the challenges are to continue to develop biomarkers, to really understand who will benefit from immunotherapy strategies, who benefits from combinations, and most importantly, who does nothing. I think biomarkers are going to be something that we need to continue to incorporate in clinical trials, and I do think that there's a lot of room for hope and promise in the field. We've seen some interesting results with antibody drug conjugates and the combinations there may also be of interest. And then other important strategies, we're looking at T Cell engagers and different drugs with different mechanism of actions, including CAR T and vaccines. So beyond immune checkpoint inhibitors, I think we have different classes of drugs that may lead to different treatment strategies for patients in second line and beyond. Dr. Rohit Singh: Yeah, certainly we have seen such extensive development in lung cancer. However, there's still a lot to be done as you just mentioned. Thank you so much Dr. Leal for your time and great insights discussing your article with us. Dr. Ticiana Leal: Thank you. Dr. Rohit Singh: Thank you for listening to JCO Article Insights. Don't forget to give us a rating or review and be sure to subscribe so you never miss an episode. You'll find all ASCO shows at asco.org/podcast. 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. Dr. Leal Disclosures Consulting or Advisory Role Company name: Novocure Company name: Amgen Company name: Roche Company name: AstraZeneca Company name: Regeneron Company name: Novocure Company name: Takeda Company name: Jazz Pharmaceuticals Company name: Catalyst Pharmaceuticals Company name: Pfizer Company name: Janssen Company name: Genentech Company name: Novartis Company name: Sanofi Company name: BMS GmbH & Co. KG Company name: Abbvie Company name: OncoC4 Research Funding Company name: Pfizer Company name: Daiichi Sankyo/Astra Zeneca Travel, Accommodations, Expenses Company name: Regeneron Company name: Sanofi
Today we are bringing you a conversation between 3 experts on paroxysmal nocturnal hemoglobinuria (PNH). Ryan Haumschild, PharmD, MS, MBA, vice president of Pharmacy at Emory Healthcare and Winship Cancer Institute, spoke with Jamie Koprivnikar, MD, of John Theurer Cancer Center; David Dingli, MD, PhD, of Mayo Clinic; and Brian P. Mulherin, MD, of American Oncology Network. The topics of conversation for today's podcast include the pathophysiology of PNH, complement inhibitors, treatment strategies, and the challenges of managing this rare, life-threatening disorder.
Dr Kevin Kalinsky from Winship Cancer Institute of Emory University in Atlanta, Georgia, and Dr Heather McArthur from UT Southwestern Medical Center in Dallas, Texas, summarize the evolution of biomarker-driven treatment approaches for triple-negative breast cancer.
Dr Kevin Kalinsky from Winship Cancer Institute of Emory University in Atlanta, Georgia, and Dr Heather McArthur from UT Southwestern Medical Center in Dallas, Texas, summarize the evolution of biomarker-driven treatment approaches for triple-negative breast cancer, moderated by Dr Neil Love. Produced by Research To Practice. CME information and select publications here (https://www.researchtopractice.com/WCWtK2024/TNBC).
New data from the Phase III LAURA study, reported in Chicago at the ASCO 2024 Annual Meeting Plenary Session, suggest that the tyrosine kinase inhibitor osimertinib could become standard of care for treating patients whose unresectable locally advanced lung cancers test positive for mutated epidermal growth factor receptor (EGFR) and have no progression after definitive chemoradiotherapy. In Chicago, Oncology Times reporter Peter Goodwin met up with lead author of the LAURA study, Suresh S. Ramalingam MD, Executive Director of the Winship Cancer Institute at Emory University School of Medicine in Atlanta.
EVERYTHING YOU EVER WANTED TO KNOW ABOUT BRAIN TUMORS! We try to keep it simple here on YDF, but today it IS brain surgery! We are rounding out Brain Tumor Awareness Month! Building on our conversation last week with Alyx Porter, MD, re: how to know if you could have a tumor, this episode focuses on the other side of the conversation. Let's explore treatment! More specifically, answering the question, "I have a brain tumor, can you remove it?" Cue our UNBELIEVABLE guest, Neurosurgical Oncologist, Edjah Nduom, MD, FAANS! Dr. Nduom is the Daniel Louis Barrow Endowed Chair and Associate Professor in the Department of Neurosurgery at Emory University School of Medicine. He serves as Leader of the Brain Tumors Disease Group for Winship Cancer Institute. He has held numerous national and international roles in the neurosurgical and brain tumor community, including Founder and Diasporan Board Member for the Society for Neuro-Oncology Sub-Saharan Africa, Scientific Program Chair for the Congress of Neurological Surgeons Annual Meeting and Chair of the Board of Directors of the National Brain Tumor Society. He is also accomplished in basic, translational, and clinical research, developing new immune therapy treatments for malignant brain tumors. Dr. Nduom's clinical specialty is the surgical management of brain and spinal cord tumors. Topics covered in today's episode: What are common types of brain tumors and their treatment options? What kind of specialist should you see if you are diagnosed with a brain tumor? Should you get a second opinion? Which tumors should be surgically removed? Should people get routine brain or body scans to look for brain tumors? What are common surgical techniques for removing brain tumors? Are brain tumor surgeries done while the patient is awake? Does brain tumor DNA typing help to guide treatment? And much, much more! Thanks for tuning in, folks! Please sign up for our "PULSE CHECK" monthly newsletter! Signup is easy, right on our website page, and we PROMISE we will not spam you! We just want to send you cool articles, videos and thoughts :) For more episodes, limited edition merch, or to become a Friend of Your Doctor Friends (and more), follow this link! Find us at: Website: yourdoctorfriendspodcast.com Email: yourdoctorfriendspodcast@gmail.com Connect with us: @your_doctor_friends (IG) Send/DM us a voice memo/question and we might play it on the show! @yourdoctorfriendspodcast1013 (YouTube) @JeremyAllandMD (IG, FB, Twitter) @JuliaBrueneMD (IG) @HealthPodNet (IG)
In this episode, Dr. Papadantonakis from Winship Cancer Institute of Emory University, Atlanta, US, and Dr. Mittelman, chairman of the MDS Foundation scientific board, discuss the range of treatment options for patients with MDS.
Dr. Shannon Westin and her guest, Dr. Reshma Jagsi, discuss the paper "Omission of Radiotherapy After Breast-Conserving Surgery for Women With Breast Cancer With Low Clinical and Genomic Risk: 5-Year Outcomes of IDEA" recently published in the JCO. TRANSCRIPT The guest on this podcast episode has no disclosures to declare. Shannon Westin: Hello, everyone, and welcome to another episode of JCO After Hours, the podcast where we get in depth with manuscripts that were published in the Journal of Clinical Oncology. I am your host, Shannon Westin, GYN Oncologist and Social Media Editor for the JCO. It is my pleasure to speak with Dr. Reshma Jagsi. Hello, Dr. Jagsi. Dr. Reshma Jagsi: Hello. Thanks for having me. Shannon Westin: I am so excited that you're here. Dr. Jagsi is the Lawrence W. Davis Professor and Chair of the Department of Radiation Oncology at Emory University School of Medicine, Winship Cancer Institute. She is going to be talking about her incredible work, "The Omission of Radiotherapy After Breast Conserving Surgery for Women with Breast Cancer with Low Clinical and Genomic Risk: Five-year Outcomes of IDEA," which was published in JCO in February 2024. All right, let's get right to it. First, I want to levelset. Can you run us through some brief facts and figures about breast cancer just to make sure that all the listeners are on the same page? Dr. Reshma Jagsi: Breast cancer is the most common cancer in the world. It's 12.5% of all new annual cancer cases worldwide and is the most commonly diagnosed cancer among US women. About a third of all newly diagnosed cancers in women are breast cancer, and about 13% of US women develop invasive breast cancer over their lifetime. In 2023, there were nearly 300,000 new cases of invasive breast cancer. The median age of breast cancer diagnosis is 62, meaning an awful lot of people are getting diagnosed with breast cancer in the population that we specifically chose to study. Shannon Westin: Wow, you're really good at this. That's like the perfect transition to move to the next piece. So, first, I think I'd love to hear about the standard of care for the population that you were studying and how we got to this point. Dr. Reshma Jagsi: We offer women who are diagnosed with early-stage invasive breast cancer the option of breast conservation, and we encourage breast conservation because, of course, it is a better-tolerated surgery than mastectomy. Many women are eligible for breast-conserving therapy. And years ago, we as radiation oncologists encouraged our surgical colleagues to refer to breast-conserving therapy as lumpectomy plus radiation, just as one set. Because the studies that have been done in the 1970s and 1980s to establish that breast conversation was equally safe and effective in treating breast cancer relied on radiation therapy to minimize in-breast tumor recurrence rate, which one of those trials independently showed that there was no difference in survival. But the ones that compared lumpectomy surgery alone to lumpectomy followed by radiation therapy did show a pretty substantial improvement in local control with the addition of radiation treatment. And so radiation treatment became a part of a parcel of breast conservation in the early 1990s when consensus statements came out favoring breast conservation as a treatment approach. And so the net analysis has combined all of these studies together and showed that overall, without radiation treatment, a patient treatment with a lumpectomy had a 30% risk of in-breast tumor occurrence in those historical studies. And it was reduced by about two thirds to about 10% when that lumpectomy was followed by radiation in those historical randomized trials. But of course, we've made many advances in our understanding since that time, and so that's what this study is seeking to build on. Shannon Westin: It makes sense. We all know that radiotherapy can lead to other issues, acute and chronic morbidities, as well as cost and having to do the treatment itself. So we're all interested in de-escalation of therapy. Tell me, prior to your study, what data were out there potentially supporting the de-escalation and avoiding radiotherapy in that specific population? Dr. Reshma Jagsi: In the ‘90s, after those landmark foundational historical trials have been completed, there was a lot of interest in seeing if we could identify a population of patients in whom the risk of local recurrence was sufficiently low that they might safely choose to omit radiation therapy. All of these randomized trials have shown very consistently that there is a relative risk reduction. Whatever your risk is without radiation, radiation reduces that risk. The overall disease recurrence risk is cut in half with the addition of radiation treatment. But, if I told you that your overall risk was 1%, and I could cut that in half with radiation, you might say, “I might be willing to tolerate the 1%.” At least some women might be willing to tolerate that. So can we find a population in whom the risk is low enough that at least some of those women say, "Look, I want to go without radiation." And of course, the balance of where that number should be changes as we get better and better at delivering radiation. So you mentioned, radiation comes with toxicity, comes with burden and yet, there have been some tremendous advances, and particularly in recent years, to shorten the course of radiation. We have evidence that we can treat partial breast radiation safely in five treatment fractions. We have five-year data that we can treat the whole breast in five-treatment fraction. We certainly have long term evidence that we can the whole breast with 15 fractions from many patients diagnosed with breast cancer. So the burden has decreased. We've also found that with hypo fractionated shorter courses of radiation, the toxicities are much lower, patients tend to tolerate radiation treatment both in terms of acute side effects and long term side effects extremely well. So that balance of what is low enough is changing with time. But the trials that were started in the 1990s included the CALGB 9343 trial, a landmark trial published in the New England Journal of Medicine, with its five-year results showing only a 4% risk of recurrence at five years in patients who were 70 or older with clinical stage one disease that was hormone receptor-positive if they received a lumpectomy and tamoxifen alone, not receiving radiation - that risk, if we added radiation in this randomized trial, was only 1%. So there was still a substantial relative risk reduction with radiation treatment. This was published in 2004 in the New England Journal of Medicine. At the same time, there was a Canadian trial that was published, and in that trial that included women who were 50 years of age and older, there were more concerning results with, even in a very favorable prespecified subgroup of patients who had node-negative breast cancer and T1 hormone receptor-positive tumors, the risk of ipsilateral breast tumor recurrence was 15% at eight years. So that started to feel excessive for women 50 and older. Meanwhile, we went on to get the update of the CALGB trial, and the 10 -year results showed that the risk was, in the women 70 and older, was only about 10% without radiation. It was 2% with radiation. So again, there was a benefit from radiation, and it's up to each individual woman to decide whether they'd prefer to proceed and minimize their risk, or would be willing to tolerate something like a 10% risk. More recently, just this past year in the New England Journal, the PRIME 2 study from the United Kingdom, looking at women 65 and older, again, early-stage node-negative hormone receptor-positive tumors, and very similar results - 10% versus 1% local control at 10 years. So you get an improvement with radiation. But there are some women who are 65 or 70 and older who say, I'm willing to tolerate the 10% risk. And so the question was, could we identify some patients who are younger than 65 to 70, but still postmenopausal, like in that Canadian trial, who might actually have similar outcomes - low risks at five and ten years - such that they might want to entertain the option of omitting radiation therapy, which right now is not standard or in any guidelines? So we have some promising information from some retrospective analysis of that Canadian trial that suggested that looking at biology might help. And in fact, the LUMINA trial, published just this year from Canada, did a prospective cohort study selecting patients based on immunohistochemistry, and suggested very low risks, five years in patients who were somewhat younger, although it ended up that the median age of the patients in that study was 67. So we still sort of had this question of what about the younger postmenopausal patients? And that's what took us to IDEA. Shannon Westin: And just for my education and for the education of the listeners, when you have an in-breast recurrence, how likely are you to be able to cure that? Is that tough to cure, or can you usually get control again? Dr. Reshma Jagsi: It's an excellent question. And so often these recurrences are caught early and are still completely curable with additional intervention. Now, there can be an impact, of course. You can talk to any survivor about the devastating impact of being diagnosed with breast cancer recurrence, and no one wants to go through that. And so there are reasons that people will want to reduce that, and there are implications for breast conservation because it may be that the remaining breast tissue is insufficient to allow a second breast conserving surgical procedure. It may also be that when one experiences recurrence, one decides, "I'm done with this. I'm having a mastectomy at this point." So, in-breast recurrences are very meaningful to patients and something that we should not take lightly. Shannon Westin: It seems, though, the majority of the studies that you were talking about, aside from the LUMINA study, were predominantly based on those clinical features like stage and things like that. So, can you talk a little bit about the role of molecular features, genomic testing, things like that, to select patients? Dr. Reshma Jagsi: Yeah. So, we have seen a tremendous change in the way we think about breast cancer in recent years, with a real focus on tumor biology, rather than classic clinical pathologic features alone to help us make decisions about systemic therapy. And so, there is a body of work that suggests that genomic assays, including the 21-gene recurrence score, that's commonly used for treatment decision making already ordered in many of these patients and available to us, that it may be useful in understanding patients' risk of local recurrence, both when they are treated with radiation and when they are treated without radiation. So, Terry Mamounas did some wonderful work looking at NSABP data where you know that the mastectomy patients at the time of the studies that were included were not receiving radiation treatment. And it did appear that the 21-gene recurrence score was helping to discriminate for local regional recurrence risk, suggesting it might be useful to use that to select patients who might be at lower risk. Shannon Westin: All right, perfect. So, that leads us to your study. So, let's talk a little bit about the design and the population and kind of how you put it together. Dr. Reshma Jagsi: This was really a true collaboration, a partnership across multiple 13 collaborating sites, where my colleagues, the lead investigators at each site, were extremely committed to this question. And we sought to do a preliminary cohort trial, really involving 200 patients. And over the course of three years, we enrolled those 200 patients who were aged 50 to 69 years old and had unicentric invasive breast cancer and lumpectomy surgery that led to negative margins of 2 mm or greater. And their disease needed to be PR positive, HER2 negative, it needed to be node negative, pathologically node negative, and the Oncotype DX 21-gene recurrence score needed to be less than or equal to 18. And then these patients were offered the opportunity to consent and register on a trial to receive five years of endocrine therapy as standard of care alone, and 10 years of surveillance on study, or to proceed with the standard of care treatment off trial, which would have been a recommendation to receive radiation treatment. And so, we ended up with patients with a mean age of 62 years, which, as I said, that's really more mapping the overall population of patients in the country. And we were able to report our results at the San Antonio Breast Cancer Symposium and with simultaneous publication in JCO, with a median follow up of 5.2 years. Shannon Westin: Okay, and let's talk about a little bit about your major findings. Tell us what your good work demonstrated. Dr. Reshma Jagsi: So, the overall and breast cancer-specific survival rates at five years were both 100%, and the five-year freedom from any recurrence was 99%, with a 95% confidence interval that went from 96% to 100%. But I want to emphasize that these are five-year data in a younger postmenopausal population, where five-year data are not typically sufficient to guide decision making. So, I really want to emphasize that these are very early results. But really, what happened here was we only had a couple of patients who had recurrences before five years, two patients, and that was one isolated ipsilateral axillary recurrence, and one ipsilateral breast event. But we also did see six additional patients who recurred later than five years after breast conserving surgery. And because we don't have much long-term follow-up, it makes it incredibly important for us to continue to follow this cohort over time before people make any Monday morning practice implications of offering this cohort of patients, or patients like this cohort of patients, omission off trial. The good news is that there are ongoing trials that are building on this work, including NRG-BR007, the DEBRA ,that includes a population of patients really similar to those enrolled on IDEA and randomizes them to radiation or no radiation, which is actually incredibly important. Because what we want to understand is also the quality of life effects of omitting radiation therapy because what we don't want is to inadvertently cause an increase in worry about recurrence. Or, you could imagine that patients who omit radiation treatment then feel really stuck with their endocrine therapy. Now, endocrine therapy is the standard of care, but if they're experiencing terrible endocrine therapy side effects and they didn't get radiation treatment, are they more likely to persist with that endocrine therapy and to be miserable because they omitted a treatment that, as I mentioned earlier, can be administered now in five days or less? And one of the questions that keeps coming up from older patients that I treat, where we already offer the option of omitting radiation, those CALGB and PRIME II patients, those patients will often say to me, "I've got to say, Doc, that whole experience of radiation that you described for five days, and the toxicity, and that doesn't sound so bad to me. What sounds bad to me is multiple years of endocrine therapy." And so, there are also ongoing trials in Europe, and I hope one day in the United States, also looking at older women and offering them a de-escalation of a different sort. Now that we have made so many advances in radiation treatment, maybe the optimal monotherapy for an older adult is actually, for many patients, given their values and preferences, going to involve omission of endocrine therapy. And we need to find out if that's safe. And again, Europa in Europe is investigating that question, and I hope that the American cooperative groups take up something similar. Shannon Westin: That's awesome! And what else is going on in this space? Any other trials? That was like, such a great review of ongoing trials, and I'm sure our listeners would love to have your expertise. Anything else that you're looking forward to that might impact the treatment landscape here? Dr. Reshma Jagsi: Absolutely, and if there are listeners in other parts of the world, there are trials going on also looking at this. There is PRIMETIME, which is a cohort study designed, but with a much larger cohort that's going on in the United Kingdom. There's the EXPERT trial that is randomizing patients to radiation treatment or not in Australia and New Zealand. So, there are many trials that are ongoing, again, looking at de-escalation of radiation therapy. And I want us all, regardless of our specialty, to think about ways that we can de-escalate and optimize the options that are offered to our patients. And I think there's a tendency for patients to be very scared of radiation, sometimes, for our colleagues to be very scared of radiation. I mean, we are the only specialty that has a special “danger radiation sign” that comes to mind when you hear the word radiation therapy. So, it can be this very frightening thing that we often leap to efforts to avoid. And what I don't want to be the conclusion of this is, “Isn't it great? Radiation oncologists themselves recognize that radiation is terrible and that you should avoid it.” That's not the case. What I hope people will say is, “Isn't it great that radiation therapists are trying to offer as many options to patients as possible?” Because it means a lot to a patient who's had the sense of power and control and autonomy ripped away from them by a breast cancer diagnosis, to be given many options to articulate their values and their preferences and to decide what treatment makes most sense for them. I think, for a lot of patients, that involves radiation treatment. And I think what we need to do as physicians is think about what other things are our patients really concerned about. Our medical oncology colleagues have done tremendous work to de-escalate systemic therapy in the form of chemotherapy. Our colleagues in surgery have, again, de-escalated mastectomies, axillary dissection. So, there are these ongoing efforts, and I do honestly believe that the next frontier is endocrine therapy and optimization of endocrine therapy. It is so powerful. It is why we have such wonderful outcomes. We know that we should have a healthy respect for ER-positive cancer, which can recur in the long term. We don't want to throw out the baby with the bathwater, but baby steps towards understanding what happens if we peel back our treatments is our obligation. Shannon Westin: I think this is a perfect place to end/ I agree - less is more is really becoming a resonant statement across all of our different subtypes. We're certainly seeing it in GYN oncology, and just like you said, systemically or even surgically. So I agree. I think we have a call to action to really assess what we've always done and make sure that we're not over-treating patients for whom it's inappropriate. So I think this is great. And I just want to commend you again on your work. These types of multicenter trials are really hard to do, and getting it done in such a short period of time and really getting the data out to patients is so important. And I appreciate what you're saying about needing more follow-up, but it is certainly very reassuring and very in line with what we've seen. So congratulations on your work. Dr. Reshma Jagsi: Thank you. And I just again want to thank all the patients who enrolled, the Coleman Foundation for their support, the University of Michigan for doing the multi-site coordination and the biostatistic support, and all of the collaborating investigators. I mean, this was a labor of love for everyone involved. Shannon Westin: Yeah, these types of trials definitely take a village. Well, great work. Thank you for taking the time. I know how busy you are. So again, we are so honored and so excited to talk about "The Omission of Radiotherapy After Breast Conserving Surgery for Women with Breast Cancer with Low Clinical and Genomic Risk: Five-year Outcomes of IDEA,” just published in print, February 2024 in the JCO. Definitely check it out. And please check out our other episodes of JCO After Hours. We'd love to have your feedback. Take care. 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. Dr. Jagsi: Stock and Other Ownership Interests Company name: Equity Quotient Research Funding Company name: Genentech"
Rev. Caroline Peacock is the director of spiritual health at Winship Cancer Institute of Emory University. Listen to Caroline talk about spiritual distress in cancer patients, mystical experiences and the role of spiritual care practitioners in providing psychedelic-assisted therapy.
Today we are bringing you part 2 of a 2-part podcast series on opportunities for biosimilars, specifically adalimumab biosimilars, in dermatology, gastroenterology, and rheumatology. The discussion was moderated by Ryan Haumschild, PharmD, director of Pharmacy Services at Emory Healthcare and Winship Cancer Institute. The topics of conversation for today's podcast include implementation of biosimilars in patients with no history of reference biologic use, insights on switching patients from the reference to the biosimilar, auto-substitution, impact of biosimilar utilization on payers and pharmacy benefit managers, and more.
Today we are bringing you part 1 of a 2-part podcast series on opportunities for biosimilars, specifically adalimumab biosimilars, in dermatology, gastroenterology, and rheumatology. The discussion was moderated by Ryan Haumschild, PharmD, director of Pharmacy Services at Emory Healthcare and Winship Cancer Institute. The topics of conversation for today's podcast include the provider and payer considerations for transitioning patients to biosimliars, challenges associated with biosimilars, approaches to prescribing biosimilars over reference products, and more.
At this year's European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, Dr. Kevin Kalinsky, Director of the Glenn Family Breast Center at Winship Cancer Institute of Emory University, presented the results of real-world use patterns, effectiveness, and tolerability of sacituzumab govitecan for second-line or later treatment of metastatic triple-negative breast cancer (TNBC). In this interview, he gives us further insight to the results he shared and what these results could mean for the future of the TNBC treatment landscape.
Caris Precision Oncology Alliance™ Chairman, Dr. Chadi Nabhan, sits down with Dr. R. Donald Harvey, Professor Department of Hematology and Medical Oncology at Emory University School of Medicine and Director of Winship Cancer Institute's Phase I Clinical Trials Unit. Together they discuss the role of the pharmacist in pharmacovigilance and pharmacoadherence, and how we can ensure that patients are being properly educated and compliant with the new products being approved each day. For more information, please visit: www.CarisLifeSciences.com