POPULARITY
Featuring an interview with Dr William K Oh, including the following topics: Use of secondary hormonal agents for patients with metastatic hormone-sensitive prostate cancer (0:00) Data supporting the clinical activity of PARP inhibitors for metastatic castration-resistant prostate cancer (mCRPC) (11:10) Radiopharmaceuticals for the treatment of mCRPC (16:53) Available data on cabozantinib for mCRPC (24:38) Cabozantinib combinations for advanced renal cell carcinoma (RCC) (26:17) Subcutaneous nivolumab versus intravenous nivolumab for advanced RCC (30:00) Addition of nivolumab to tivozanib compared to tivozanib alone in advanced relapsed/refractory RCC previously treated with an immune checkpoint inhibitor (31:28) Long-term follow-up with belzutifan for relapsed/refractory advanced RCC (33:39) Major findings from the NIAGARA study of perioperative durvalumab for muscle-invasive bladder cancer (MIBC) (35:44) Data surrounding adjuvant immunotherapy for MIBC (38:07) Clinical development of TAR-200 for high-risk non-muscle-invasive bladder cancer (39:44) Updated analysis of EV-302 study of enfortumab vedotin in combination with pembrolizumab for previously untreated advanced urothelial cancer (UC) (41:06) Implementation of emerging data in the treatment landscape of UC (41:56) CME information and select publications
Welcome to another episode of the Oncology Brothers podcast! In this episode, Drs. Rohit and Rahul Gosain are joined by Dr. Aman Chauhan, a medical oncologist specializing in neuroendocrine tumors from Sylvester Comprehensive Cancer Center in Miami. As of April 2025, the oncology landscape has seen 10 new FDA approvals, including the recent approval of cabozantinib for neuroendocrine tumors based on the CABINET study. The discussion dived deep into the implications of this approval, the study design, and how cabozantinib fits into the treatment landscape for both pancreatic and extra-pancreatic neuroendocrine tumors. Key topics covered in this episode include: • The evolution of treatment options for neuroendocrine tumors • Insights into the CABINET study design and results • Sequencing treatment options for patients with neuroendocrine tumors • Side effects and management strategies for cabozantinib • The importance of personalized treatment approaches in oncology Join us as we explore the exciting advancements in neuroendocrine tumor management and what they mean for patients and oncologists alike. Don't forget to like, subscribe, and check out our other discussions on FDA approvals, toxicity management, and conference highlights! Follow us on social media: • X/Twitter: https://twitter.com/oncbrothers • Instagram: https://www.instagram.com/oncbrothers • Website: https://oncbrothers.com/ Don't forget to like, subscribe, and hit the notification bell for more updates on oncology insights!
New antibiotic has been approved for uncomplicated UTIs; Cabometyx approved for advanced neuroendocrine tumors; new rosacea treatment option; Tremfya gains Crohn disease indication; Department of HHS cuts 10,000 jobs.
Welcome to another episode of the Oncology Brothers podcast! In this episode, Drs. Rahul and Rohit Gosain are joined by Dr. Toni Choueiri, a leading GU medical oncologist from Dana-Farber Cancer Institute. Together, they dive into the highlights from the GU ASCO 2025 conference, covering key studies and updates in the world of genitourinary oncology. Episode Highlights: • TALAPRO-2: An in-depth discussion on the role of PARP inhibitors in prostate cancer, focusing on the study's design, findings, and the importance of germline and NGS testing. • NIAGARA Update: Insights into the new standard of care for resectable muscle-invasive bladder cancer and the promising results from the perioperative approach with Durvalumab. • CheckMate-9ER Update: A look at the combination of Cabozantinib and Nivolumab in first-line metastatic RCC, including the latest findings and implications for treatment beyond the first line. • TiNivo2: Exploring the role of Tivozanib in the treatment landscape of RCC and potential sequencing strategies. Join us for this informative discussion that aims to keep community oncologists up to date with the latest advancements in cancer care. If you find this episode helpful, please share it with your colleagues and leave us a review! YouTube: https://youtu.be/OzeHhyAdF9Q Follow us on social media: • X/Twitter: https://twitter.com/oncbrothers • Instagram: https://www.instagram.com/oncbrothers • Website: https://oncbrothers.com/ Don't forget to subscribe for more insights and updates from the Oncology Brothers!
Back to basics as I break down a trial
In this episode of the Oncology Brothers podcast, hosts Drs. Rohit and Rahul Gosain welcome Dr. Pamela Kunz, a world-renowned medical oncologist from the Yale Cancer Center, to discuss the complex landscape of neuroendocrine tumors (NETs). Join us as we explore: • The classification of neuroendocrine tumors based on grade, histological features, and the significance of KI-67. • The role of imaging modalities, including Gallium PET-CT and its importance in evaluating disease extent. • Treatment strategies for localized versus metastatic NETs, including the use of somatostatin analogs and the nuances of observation versus intervention. • Insights into the latest treatment options, including lutetium dotatate, Capecitabine-Temozolomide, and the anticipated approval of Cabozantinib. • The potential role of NGS testing and the challenges of combining chemotherapy with immunotherapy in high-grade neuroendocrine tumors. Whether you're a healthcare professional or someone interested in the latest advancements in oncology, this episode provides valuable insights into the management of neuroendocrine tumors. Don't forget to like, subscribe, and check out our other episodes for more discussions on current standard of care treatment options, conference highlights, and new drug approvals. We look forward to seeing you at GI ASCO in January 2025! #OncologyBrothers #NeuroendocrineTumors #CancerCare #MedicalOncology #Podcast #NETs Website: http://www.oncbrothers.com/ X/Twitter: https://twitter.com/oncbrothers Contact us at info@oncbrothers.com
In this episode, Thor R. Halfdanarson, MD, and Jonathan Strosberg, MD, discuss important topics related to gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including:The diagnosis and typical presenting symptoms of GEP-NETsFindings from recent key phase III studies including NETTER-2 and CABINETRecommendations for treatment sequencingNotable clinical pearls regarding GEP-NET therapiesCurrent guidelines for GEP-NET care and monitoringPresenters:Thor R. Halfdanarson, MDConsultant, Division of Medical OncologyProfessor of OncologyAssociate Professor of MedicineMayo Clinic Comprehensive Cancer CenterChair, Hepato-Pancreatico-Biliary Disease GroupRochester, MinnesotaJonathan StrosbergProfessor, GI OncologyChair, Neuroendocrine Tumor DivisionMoffitt Cancer Center and Research InstituteTampa, FloridaLink to full program: https://bit.ly/3Y0JWBa
Did you miss the ESMO Congress 2024? Listen here: NEJM Editor-in-Chief Eric Rubin and NEJM Evidence Associate Editor Oladapo Yeku discuss research that was presented at the 2024 European Society of Medical Oncology annual meeting. Visit NEJM.org to read the latest research.
Kevin Campbell, MD, a pediatric oncologist at Children's Mercy Kansas City and Clinical Assistant Professor of Pediatrics, University of Missouri-Kansas City School of Medicine discusses results from the Phase 1 study assessing the safety and toxicity of cabozantinib in combination with topotecan and cyclophosphamide for relapsed osteosarcoma and Ewing sarcoma.Dr. Kevin Campbell is a pediatric oncologist at Children's Mercy Kansas City and a Clinical Assistant Professor of Pediatrics at the University of Missouri-Kansas City School of Medicine. He has an interest in clinical trials relevant to children with solid tumors, with an emphasis on neuroblastoma and sarcomas. During his training at Dana-Farber Cancer Institute/Boston Children's Hospital and now extending into his career as an attending, his research focuses on clinical outcomes for patients with high-risk or advanced solid tumors and the development and implementation of early phase clinical trials with novel agents or combinations of agents to improve outcomes.His work to advance clinical trials includes experience in multiple spheres. He has completed specific training in the writing, development and management of early phase clinical trials and currently has a phase I clinical trial open which he developed. His work also involves the analysis of biomarkers that have been incorporated into national phase II and phase III clinical trials.
Dr. Andy Livingston is a clinician and researcher in Sarcoma Medical Oncology and holds a joint appointment in Pediatric Oncology, and is Co-director of the MD Anderson Adolescent and Young Adult (AYA) oncology program. His clinical and translational research is focused on developing new treatment strategies for patients with osteosarcoma and other bone sarcomas. Dr. Livingston joins us on OsteoBites to discuss the background and scientific rationale for combining immunotherapy with cabozantinib in teens and young adults with osteosarcoma and provide information about the ongoing TACOS study: Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma.Dr. Livingston is a clinician and researcher in Sarcoma Medical Oncology and holds a joint appointment in Pediatric Oncology at MD Anderson Cancer Center in Houston, Texas. After completing medical school at the University of Texas Medical Branch at Galveston, he went on to residency training at Duke University where he completed a combined residency in internal medicine and pediatrics. Dr. Livingston completed his fellowship training at MD Anderson where he served as the Chief Fellow for Hematology/Oncology Fellowship Program. Dr. Livingston has a particular interest in the care of teens and young adults with cancer and is Co-director of the MD Anderson Adolescent and Young Adult (AYA) oncology program. His clinical and translational research is focused on developing new treatment strategies for patients with osteosarcoma and other bone sarcomas. He received the MIB OutSmarting Osteosarcoma award in 2020 for his work on the immune landscape of osteosarcoma and serves as a member of the MIB Scientific Advisory Board.
Neeraj Agarwal describes the results of this positive randomised Phase 3 trial.
Nilay Shah, MD is a clinician-scientist and Associate Professor in the Division of Hematology/Oncology/BMT at Nationwide Children's Hospital. His primary clinical focus is on pediatric solid tumors, including neuroblastomas, tumors of the kidneys, and rare solid tumors of childhood. His research focuses on the molecular drivers of pediatric cancers and how new treatment approaches can be taken to better target those drivers. In this role, he works to identify new uses of currently available anticancer treatments, including drugs originally developed for use against cancers in adults. He serves as Associate Director for Liver Tumor, Kidney Tumor, Germ Cell, and Neuroblastoma Targeted Therapies, and is currently the Sponsor and Study Principal Investigator the CaboMain trial, a Phase 2 study evaluating the efficacy of the oral anticancer agent cabozantinib as a maintenance therapy for ultra-high-risk solid tumors. He also serves as co-director of the Cancer Genetics Program. This program serves to advance the use of genetic and genomic evaluations for the benefits of patients. In this role, he sees patients in the Cancer Predisposition Clinic for evaluation, surveillance, and management of patients with genetic alterations that predispose to cancer development. He also consults on patients for precision oncology, partnering with the Institute for Genomic Medicine to identify therapeutic approaches based on patient tumor and germline genomics. --- What We Do at MIB Agents: PROGRAMS: End-of-Life MISSIONS Gamer Agents Agent Writers Prayer Agents Healing Hearts - Bereaved Parent and Sibling Support Ambassador Agents - Peer Support Warrior Mail Young Adult Survivorship Support Group EDUCATION for physicians, researchers and families: OsteoBites, weekly webinar & podcast with thought leaders and innovators in Osteosarcoma MIB Book: Osteosarcoma: From our Families to Yours RESEARCH: Annual MIB FACTOR Research Conference Funding multiple $100,000 and $50,000 grants annually for OS research MIB Testing & Research Directory The Osteosarcoma Project partner with Broad Institute of MIT and Harvard ... Kids are still dying with 40+ year old treatments. Help us MakeItBetter. https://www.mibagents.org Help support MIB Agents, Donate here https://give-usa.keela.co/embed/YAipuSaWxHPJP7RCJ SUBSCRIBE for all the Osteosarcoma Intel
In this podcast, Dr Mélanie Claps and Dr Giuseppe Procopio discuss about the results of the Breakpoint Trial: a prospective, multicenter, single arm phase II trial evaluating efficacy and safety of cabozantinib for patients with metastatic renal cell carcinoma progressed after one line of treatment based on immune-checkpoints inhibitors.
Toni Choueiri describes the results of this renal cancer trial exploring rechallange with immune therapy
Drs Sumanta Pal and Rana McKay discuss the use of biomarkers in treating patients with renal cell carcinoma to identify whose disease will recur and who will respond to therapy. Relevant disclosures can be found with the episode show notes on Medscape (https://www.medscape.com/viewarticle/968743). The topics and discussions are planned, produced, and reviewed independently of advertiser. This podcast is intended only for US healthcare professionals. Resources Longitudinal Molecular Profiling of Circulating Tumor Cells in Metastatic Renal Cell Carcinoma https://ascopubs.org/doi/10.1200/JCO.22.00219 The Detection of EpCAM+ and EpCAM– Circulating Tumor Cells https://www.nature.com/articles/srep12270 Optimized Management of Nivolumab and Ipilimumab in Advanced Renal Cell Carcinoma: A Response-Based Phase II Study (OMNIVORE) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768333/ ctDNA Guiding Adjuvant Immunotherapy in Urothelial Carcinoma https://www.nature.com/articles/s41586-021-03642-9 Clinical Activity and Molecular Correlates of Response to Atezolizumab Alone or in Combination With Bevacizumab Versus Sunitinib in Renal Cell Carcinoma https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6721896/ Atezolizumab Plus Bevacizumab Versus Sunitinib in Patients With Previously Untreated Metastatic Renal Cell Carcinoma (IMmotion151): A Multicentre, Open-Label, Phase 3, Randomised Controlled Trial https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(19)30723-8 Nivolumab Plus Ipilimumab Versus Sunitinib in Advanced Renal-Cell Carcinoma https://www.nejm.org/doi/full/10.1056/nejmoa1712126 Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study https://clinicaltrials.gov/ct2/show/NCT05361720 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (COSMIC-313) https://clinicaltrials.gov/ct2/show/NCT03937219 Single-Cell RNA Sequencing of Human Kidney https://www.nature.com/articles/s41597-019-0351-8 Progressive Immune Dysfunction With Advancing Disease Stage in Renal Cell Carcinoma https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8138872/
Drs Sumanta Pal and Mehmet Asim Bilen discuss the complexities of treating patients with non–clear cell renal carcinoma, the nuances of rare subtypes, and when to use chemotherapy vs immunotherapy. Relevant disclosures can be found with the episode show notes on Medscape (https://www.medscape.com/viewarticle/968741). The topics and discussions are planned, produced, and reviewed independently of advertiser. This podcast is intended only for US healthcare professionals. Resources Renal Cell Carcinoma https://emedicine.medscape.com/article/281340-overview Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology https://pubmed.ncbi.nlm.nih.gov/34991070/ PAPMET Trial: Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed https://clinicaltrials.gov/ct2/show/NCT02761057 Phase II Trial of Cabozantinib Plus Nivolumab in Patients With Non–Clear-Cell Renal Cell Carcinoma and Genomic Correlates https://ascopubs.org/doi/10.1200/JCO.21.01944 Phase I Study of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced or Metastatic Urothelial Carcinoma and Other Genitourinary Tumors https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605393/ Cabozantinib Plus Nivolumab Phase I Expansion Study in Patients With Metastatic Urothelial Carcinoma Refractory to Immune Checkpoint Inhibitor Therapy https://aacrjournals.org/clincancerres/article/28/7/1353/682207/Cabozantinib-plus-Nivolumab-Phase-I-Expansion Cabozantinib in Combination With Atezolizumab for Advanced Renal Cell Carcinoma: Results From the COSMIC-021 Study https://ascopubs.org/doi/10.1200/JCO.21.00939 A Single-Arm, Multicenter, Phase 2 Study of Lenvatinib Plus Everolimus in Patients With Advanced Non–Clear Cell Renal Cell Carcinoma https://pubmed.ncbi.nlm.nih.gov/33867192/ ESMO 2022 https://www.esmo.org/meetings/esmo-immuno-oncology-congress-2022/abstracts Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma. The SAVOIR Phase 3 Randomized Clinical Trial https://jamanetwork.com/journals/jamaoncology/fullarticle/2766797 SAMETA: An Open-Label, Three-Arm, Multicenter, Phase III Study of Savolitinib + Durvalumab Versus Sunitinib and Durvalumab Monotherapy in Patients With MET-Driven, Unresectable, Locally Advanced/Metastatic Papillary Renal Cell Carcinoma (PRCC). https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.TPS4601 A Phase II Trial of Doxorubicin and Gemcitabine in Renal Cell Carcinoma With Sarcomatoid Features: ECOG 8802 https://pubmed.ncbi.nlm.nih.gov/21298497/ A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER) https://clinicaltrials.gov/ct2/show/NCT03141177
Drs Sumanta Pal and Brian Rini discuss front-line treatment of renal cell carcinoma. Relevant disclosures can be found with the episode show notes on Medscape (https://www.medscape.com/viewarticle/968736). The topics and discussions are planned, produced, and reviewed independently of advertiser. This podcast is intended only for US healthcare professionals. Resources Bevacizumab Plus Interferon-alpha Versus Interferon-alpha Monotherapy in Patients With Metastatic Renal Cell Carcinoma: Results of Overall Survival for CALGB 90206 https://ascopubs.org/doi/10.1200/jco.2009.27.18_suppl.lba5019 An updated table of the front-line IO combination RCC studies that have shown an OS advantage https://twitter.com/brian_rini/status/1309609380585844736/photo/1 Targeting PD-1 or PD-L1 in Metastatic Kidney Cancer: Combination Therapy in the First-Line Setting https://aacrjournals.org/clincancerres/article/26/9/2087/83102/Targeting-PD-1-or-PD-L1-in-Metastatic-Kidney Conditional Survival and Long-term Efficacy With Nivolumab Plus Ipilimumab Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.34180 International Metastatic Renal Cell Carcinoma Database Consortium Criteria https://www.uptodate.com/contents/image?imageKey=ONC%2F116130&topicKey=ONC%2F2984&source=see_link Molecular Correlates Differentiate Response to Atezolizumab (atezo) + Bevacizumab (bev) vs Sunitinib (sun): Results From a Phase III Study (IMmotion151) in Untreated Metastatic Renal Cell Carcinoma (mRCC) https://cslide.ctimeetingtech.com/esmo2018/attendee/confcal/presentation/list?q=LBA31 Nivolumab Versus Everolimus in Patients With Advanced Renal Cell Carcinoma: Updated Results With Long-term Follow-up of the Randomized, Open-Label, Phase 3 CheckMate 025 Trial https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8415096/pdf/nihms-1732721.pdf Lenvatinib Plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma https://www.nejm.org/doi/10.1056/NEJMoa2035716 The Uromigos Debate: Treatment of Favorable Risk Renal Cancer https://anchor.fm/the-uromigos/episodes/Episode-67-The-Third-Uromigos-Debate---fPD1VEGF-vs-PD1CTLA4-for-front-line-renal-cancer-emjpji Health-Related Quality-of-Life Outcomes in Patients With Advanced Renal Cell Carcinoma Treated With Lenvatinib Plus Pembrolizumab or Everolimus Versus Sunitinib (CLEAR): A Randomised, Phase 3 Study https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00212-1/fulltext Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (COSMIC-313) https://clinicaltrials.gov/ct2/show/NCT03937219 A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) https://clinicaltrials.gov/ct2/show/NCT04736706 Twitter poll questions: What magnitude of benefit is required to adopt triplets? OS https://mobile.twitter.com/brian_rini/status/1508450496104783877 What magnitude of absolute PFS benefit vs doublets is required to adopt triplets? https://mobile.twitter.com/brian_rini/status/1508450910506295305 What would be the most convincing endpoint to adopt triplets? https://mobile.twitter.com/brian_rini/status/1508451622564909057 Molecular Subsets in Renal Cancer Determine Outcome to Checkpoint and Angiogenesis Blockade https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8436590/ OPtimal Treatment by Invoking biologic Clusters in Renal Cell Carcinoma (OPTIC RCC) https://www.kcameetings.org/wp-content/uploads/2021/12/IKCSNA21_TIP8_Chen.pdf
Drs Sumanta Pal and Tian Zhang review the state of the data on adjuvant treatment with immunotherapy for patients with renal cell carcinoma, including where current clinical trials stand. Relevant disclosures can be found with the episode show notes on Medscape (https://www.medscape.com/viewarticle/968737). The topics and discussions are planned, produced, and reviewed independently of advertiser. This podcast is intended only for US healthcare professionals. Resources Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study https://clinicaltrials.gov/ct2/show/NCT03793166 The Role of Targeted Therapy in the Management of High-Risk Resected Kidney Cancer: What Have We Learned and How Will It Inform Future Adjuvant Trials https://journals.lww.com/journalppo/Abstract/2020/09000/The_Role_of_Targeted_Therapy_in_the_Management_of.3.aspx Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy https://www.nejm.org/doi/10.1056/NEJMoa1611406 Sutent (sunitinib) prescribing information https://labeling.pfizer.com/showlabeling.aspx?id=607 Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma (KEYNOTE-564) https://www.nejm.org/doi/full/10.1056/NEJMoa2106391 RAMPART: A Phase III Multi-arm Multi-stage Trial of Adjuvant Checkpoint Inhibitors in Patients With Resected Primary Renal Cell Carcinoma (RCC) at High or Intermediate Risk of Relapse https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8520913/ A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy (IMmotion010) https://clinicaltrials.gov/ct2/show/NCT03024996 A Comparison of Sunitinib with Cabozantinib, Crizotinib, and Savolitinib for Treatment of Advanced Papillary Renal Cell Carcinoma: a Randomised, Open-Label, Phase 2 Trial https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8687736/ A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney (CheckMate 914) https://clinicaltrials.gov/ct2/show/NCT03138512 PROSPER: Phase III RandOmized Study Comparing PERioperative nivolumab versus observation in patients with renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN EA8143). https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.TPS4596 Pembrolizumab as Post Nephrectomy Adjuvant Therapy for Patients With Renal Cell Carcinoma: Results From 30-Month Follow-up of KEYNOTE-564 https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.6_suppl.290 Leibovich RCC Model: Prediction of Progression After Radical Nephrectomy for patients With Clear Cell Renal Cell Carcinoma https://cancernomograms.com/nomograms/972 Effects of Adjuvant Sorafenib and Sunitinib on Cardiac Function in Renal Cell Carcinoma Patients without Overt Metastases: Results From ASSURE, ECOG 2805 https://aacrjournals.org/clincancerres/article/21/18/4048/117759/Effects-of-Adjuvant-Sorafenib-and-Sunitinib-on
Rob Jones describes cabozantinib in urothelial cancer.
In this first episode of two podcasts, Dr. Amit Singal and Dr. Mark Yarchoan discuss the latest data supporting their approach to selecting treatment regimens for patients with HCC, with topics including: the current challenges in the management of HCC, recommended initial workup strategies and the evolving treatment landscape in HCC. This activity is available for CE/CME credit. Claim your credit at pce.is/GIGU.Contributors:Amit Singal, MD, MSMark Yarchoan, MDBridget O'Brien, DNP, FNP-BC, AOCNPDr Singal: consulting fees: AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Exelixis, Genentech, Roche.Dr Yarchoan: consulting fees: AstraZeneca, Eisai, Exelixis, Genentech; other financial or material support: Bristol-Myers Squibb, Incyte.Dr O'Brien: fees for non-CME/CE services: Amgen, Novartis.
In this second episode of two podcasts, Dr. Amit Singal and Dr. Mark Yarchoan discuss how to identify, prevent and mitigate treatment-related adverse events, and review cases with careful considerations for patient-specific factors guiding treatment selection, followed by a question-and-answer session on the management of patients with HCC. This activity is available for CE/CME credit. Claim your credit at pce.is/GIGU.Contributors:Amit Singal, MD, MSMark Yarchoan, MDBridget O'Brien, DNP, FNP-BC, AOCNPDr Singal: consulting fees: AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Exelixis, Genentech, Roche.Dr Yarchoan: consulting fees: AstraZeneca, Eisai, Exelixis, Genentech; other financial or material support: Bristol-Myers Squibb, Incyte.Dr O'Brien: fees for non-CME/CE services: Amgen, Novartis.
In this podcast episode from Clinical Care Options (CCO), Josep M. Llovet, MD, PhD, and Markus Peck-Radosavljevic, MD, MBA, discuss second line treatment of patients with advanced hepatocellular carcinoma. Topics include:Available agents for the management of advanced hepatocellular carcinoma in the second lineThe current role of tyrosine kinase inhibitors in second-line treatment of advanced hepatocellular carcinomaOngoing clinical trials in the second-line settingPresenters: Josep M. Llovet, MD, PhD, FAASLDProfessor of MedicineDirector, Mount Sinai Liver Cancer ProgramDivision of Liver DiseasesMount Sinai School of MedicineNew York, New YorkProfessor of ResearchLiver Unit, IDIBAPSHospital Clinic BarcelonaBarcelona, SpainUniv. Prof. Markus Peck-Radosavljevic, MD, MBAProfessor of MedicineMedical University of ViennaVienna, AustriaDepartment Chair, Innere Medizin und GastroenterologieKlinikum Klagenfurt am WörtherseeKlagenfurt am Wörthersee, AustriaLink to full program, including accompanying downloadable slidesets:https://bit.ly/2ZL9bxq
In this interview, Dr. Thomas Abrams of Harvard Medical School discusses the role that cabozantinib/atezolizumab may play for patients with metastatic colorectal cancer, particularly those with RAS wild-type disease, in the coming years.
In this podcast episode from Clinical Care Options (CCO), Josep M. Llovet, MD, PhD, and Markus Peck-Radosavljevic, MD, MBA, discuss first-line treatment of patients with advanced hepatocellular carcinoma. Topics include:Atezolizumab plus bevacizumab as the current standard of careContraindications to atezolizumab plus bevacizumabThe current role of tyrosine kinase inhibitors in first-line treatment of advanced hepatocellular carcinomaOngoing clinical trials in the first-line settingPresenters: Josep M. Llovet, MD, PhD, FAASLDProfessor of MedicineDirector, Mount Sinai Liver Cancer ProgramDivision of Liver DiseasesMount Sinai School of MedicineNew York, NYProfessor of ResearchLiver Unit, IDIBAPSHospital Clinic BarcelonaBarcelona, SpainUniv. Prof. Markus Peck-Radosavljevic, MD, MBAProfessor of Medicine, Medical University of ViennaVienna, AustriaDepartment Chair, Innere Medizin and GastroenterologieKlinikum Klagenfurt am WörtherseeKlagenfurt am Wörthersee, AustriaLink to full program, including accompanying downloadable slidesets:https://bit.ly/2ZL9bxq
FDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
Listen to a soundcast of the September 17, 2021 FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancer.
Neeraj Agarwal describes the study and the R3.
In this episode, Scott R. Plotkin, MD, PhD, and Brian D. Weiss, MD, answer questions from a healthcare professional audience on topics related to NF1 and plexiform neurofibromas including: Whole exome sequencing for diagnosisWhen to treat asymptomatic tumorsGenetic testing of family membersChoosing a MEK inhibitorSupportive care for acneiform rashOther RAS pathway inhibitorsPresenters:Scott R. Plotkin, MD, PhDExecutive DirectorPappas Center for Neuro-OncologyProfessor of NeurologyHarvard Medical SchoolBoston, MassachusettsBrian D. Weiss, MDClinical Professor of PediatricsCancer and Blood Diseases Institute Division of Oncology Medical DirectorSolid Tumor ProgramCincinnati Children's Hospital Medical CenterCincinnati, OhioLink to full program, including downloadable slidesets, expert commentaries, and on-demand webcast:https://bit.ly/3AXckHQ
FDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
Enhertu (fam-trastuzumab deruxtecan-nxki) for locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma and received a prior trastuzumab-based regimen. Combination of Opdivo (nivolumab) + Cabometyx (cabozantinib) as first-line treatment for advanced renal cell carcinoma
Monty Pal discusses his randomised phase 2 study in papillary renal cancer.
FDA 批准首个用于治疗晚期尿路上皮癌的FGFR激酶抑制剂Nature Medicine 免疫检查点抑制剂PD-L1联合CTLA-4单抗治疗高危尿路上皮癌前沿医学 多功能天然高分子纳米颗粒作为抗纤维化基因载体用于治疗CKD厄达替尼(erdafitinib)我们的节目曾在《消化科星期三 Episode 3》中介绍过培米加替尼,治疗成纤维细胞生长因子受体编码基因(FGFR)基因融合或重排的局部晚期胆管癌,胆管癌中约有20%的患者存在这种基因突变。研究人员发现FGFR突变在尿路上皮癌中也很常见,并且可能与对免疫干预的敏感性降低相关。厄达替尼(erdafitinib)是一种FGFR1-4的酪氨酸激酶抑制剂,2019年4月,FDA已经批准厄达替尼(erdafitinib)用于治疗局部晚期或转移性尿路上皮癌。《BLC2001研究:厄达替尼治疗局部晚期或转移性尿路上皮细胞癌的2期临床研究》New England Journal of Medicine,2019年8月 (1) 在这项开放标签的2期研究中,纳入了FGFR基因突变的、局部晚期和不可切除或转移性尿路上皮细胞癌的患者99人,所有患者既往均接受过化疗,并在化疗12个月内发生疾病进展。最初将患者随机分组,随后根据中期分析,将连续用药方案的起始剂量设定为8mg/d,并可在药效学指导下,将剂量增加至9mg/d。经过平均5个周期的厄达替尼治疗后,缓解率为40%(3%完全缓解,37%部分缓解)。在既往接受过免疫治疗患者中,缓解率为59%。中位无进展生存期为5.5个月,中位总生存期为13.8个月。结论:在既往接受过治疗的、有FGFR基因突变的、且患局部晚期和不可切除或转移性的尿路上皮细胞癌的患者中,厄达替尼治疗后肿瘤客观缓解率达40%。膀胱尿路上皮癌膀胱癌是最常见的泌尿系统恶性肿瘤,其中尿路上皮癌(也称移行细胞癌)是主要的组织学类型,占所有膀胱癌的90%。膀胱尿路上皮癌可表现为非肌肉浸润癌、肌肉浸润癌和转移癌,病变的程度可以反映自然病程,并决定了治疗和预后。膀胱癌通常表现为肉眼血尿或镜下血尿,刺激性或梗阻性排尿困难也可以 是首发症状。非肌肉浸润性膀胱癌的治疗对于非肌肉浸润性膀胱癌的患者,采用经尿道膀胱肿瘤切除术(TURBT),并联合膀胱内辅助治疗等保守治疗方式有可能保留膀胱功能。膀胱内辅助治疗主要包括卡介苗(牛结合分支杆菌的减毒活疫苗)和丝裂霉素C、表柔比星、吉西他滨等化疗药物。《系统回顾:膀胱治疗非肌肉浸润性膀胱癌的疗效》European Urology,2020年9月 (2)研究的目的是评价在卡介苗治疗后,保留膀胱功能的患者的疾病完全缓解率和无复发率。研究系统地回顾了42项研究,包括24种治疗方案、2254名患者。包含原位癌在内的肿瘤治疗中位完全缓解率,6个月时为26%,12个月时为17%,24个月时为8%。相比,乳头状癌的平均无进展率,6个月时为67%,12个月时为44%,24个月时为10%。特别是在卡介苗无效的、接受草分枝杆菌细胞壁-核酸复合物的患者中,6个月和12个月的完全缓解率分别为45%和27%;6、12、24个月中位不带病生存率分别为43%、35%和18%。总的中位无进展率为91%,原位癌的研究中为95%,乳头状癌的研究中为89%。膀胱内给药的不良反应少,且轻微。结论:卡介苗治疗后的、保留膀胱疗法,在非肌肉浸润性膀胱癌患者中取得了适度的疗效。《NIMBUS研究:卡介苗标准剂量和数量灌注治疗重度非肌肉浸润性膀胱癌的3期临床研究》European Urology,2020年11月 (3)膀胱内灌注卡介苗治疗是一种被广泛接受的预防非肌肉浸润性膀胱癌复发的策略,但是具有显著的毒性。研究的目的是评估了降低标准剂量卡介苗灌注的次数是否可以达到同样的疗效。研究纳入了345名非肌肉浸润性膀胱癌的患者,分别接受标准治疗(诱导6周,在第3、6和12个月时各治疗3周,共15次灌注),或低频率治疗(第1、2和6周诱导,在第3、6和12个月时各治疗2周,共9次灌注)。中位随访12个月后,标准治疗组复发率12%,低频率治疗组复发率27%。安全性分析达到了预先定义的、无效停止标准。结论:在预防膀胱癌复发方面,标准治疗方案更好,目前研究已经停止对参与者的招募。《国家质量指标项目:提高非肌肉浸润性膀胱癌经尿道膀胱肿瘤切除术的质量和有效性》European Urology,2020年8月 (4)非肌肉浸润性膀胱癌的临床预后部分取决于初始干预。为了改善和标准化癌症治疗,苏格兰实施了一项针对膀胱癌的国家质量指标项目。研究中纳入了2689例患者,标准干预包括:(1)使用膀胱图;(2)经尿道膀胱肿瘤切除术后单次膀胱内灌注丝裂霉素C一次;(3)逼尿肌活检;(4)高危膀胱癌患者中,早期行二次手术。研究中,67%患者接受了术后一次膀胱灌注;复发率、残余癌比例和继发肿瘤的比例分别为13%、33%和2.9%。术后一次膀胱灌注复发率降低相关;逼尿肌活检则癌症残留的可能性减半。结论:在苏格兰实施国家质量指标计划似乎有助于向患者提供高质量的经尿道膀胱肿瘤切除术,且降低了术后的复发率、肿瘤分期更准确。《DaBlaCa-13研究:短期强化化疗与标准辅助膀胱内灌注治疗非肌肉浸润性膀胱癌》European Urology,2020年8月 (5)膀胱灌注治疗非肌肉浸润性膀胱癌可减少复发。术前灌注化疗副作用更少,甚至一些患者在治疗后都无需接受肿瘤切除术了。研究旨在比较术前丝裂霉素C短期强化化疗治疗复发性非肌肉浸润性膀胱癌的效果。研究纳入120例患者,短期强化化疗组,膀胱灌注化疗每周3次,共2周;对照组先行经尿道膀胱肿瘤切除术,术后6周每周进行一次膀胱灌注辅助治疗。在短期强化化疗组中,有33名参与者(57%)出现了肿瘤完全缓解,且不良事件少。结论:术前短期强化化疗使一半以上的患者避免肿瘤切除术,但长期疗效仍需随访观察。肌肉浸润性膀胱癌的治疗对于肌肉浸润性膀胱癌,需行根治性膀胱切除术+尿流改道术,以及辅助化疗、免疫治疗。化疗方案中的MVAC方案(甲氨蝶呤、长春碱、多柔比星、顺铂)被认为是一线化疗方案,临床实践中多在这个方案上增减。目前已有几个免疫检查点抑制剂被获批用于膀胱尿路上皮癌的治疗:阿替利珠单抗(atezolizumab),帕博利珠单抗(pembrolizumab),纳武利尤单抗(nivolumab),阿伟鲁单抗(avelumab),德瓦鲁单抗(durvalumab)。《回顾性综述:FGFR3的水平变化与膀胱癌对铂化疗的敏感性有关》European Urology,2020年8月(6)大约15%的膀胱癌存在成纤维细胞生长因子受体3 (FGFR3)基因突变。研究人员回顾性的比较和综述三个队列的患者:(1)新辅助化疗治疗肌肉侵袭性膀胱癌患者的数据;(2)一线铂类化疗治疗转移性尿路上皮癌患者的数据;(3)来自癌症基因组图谱中的肌肉侵袭性膀胱癌患者的数据。队列一:72例新辅助化疗的肌肉侵袭性膀胱炎癌患者中有13%具有FGFR3突变,均没有达到病理完全缓解,且无复发生存期短。队列三:来自癌症基因组图谱中的肌肉侵袭性膀胱癌的患者,接受辅助化疗、且伴有FGFR3突变的无复发生存期也更短。相反,在未接受化疗的患者中,FGFR3突变与无复发生存期更长、总生存率更高。队列二:转移性尿路上皮癌的患者中,FGFR3突变虽然药物反应低,但不影响无进展生存率和总生存率。结论:肌肉浸润性膀胱癌中,FGFR3突变可能与围手术期铂类药物化疗反应差、易复发有关。《IMvigor130研究:化疗联合阿替利珠单抗治疗转移性尿路上皮癌的3期临床研究》Lancet,2020年5月 (7)这个多中心、3期、随机研究的目的是,比较阿替利珠单抗与安慰剂加铂类化疗在一线转移性尿路上皮癌的疗效。研究纳入未经治疗的、≥18岁的、局部晚期或转移性尿路上皮细胞癌患者共1213人。随机接受阿替利珠单抗+铂类化疗,或阿替利珠单抗单药治疗,或安慰剂+铂类化疗,随访11.8个月。中位无进展生存期,在阿替利珠单抗联合化疗组为8·2个月,在安慰剂联合化疗组为6.3个月(p = 0·007)。中位生存期,在阿替利珠单抗联合化疗组为16·0个月,安慰剂联合化疗组为13·4个月(p = 0·027)。阿替利珠单抗单药治疗组中位总生存期为15·7个月,与安慰剂联合化疗组无差异。结论:阿替利珠单抗联合铂类化疗延长了转移性尿路上皮癌患者的无进展生存,研究支持使用阿替利珠单抗联合铂类化疗作为转移性尿路上皮癌的潜在的、一线治疗选择。《JAVELIN Bladder200研究:PD-L1单抗阿伟鲁单抗维持治疗局部晚期、或转移性尿路上皮癌》New England Journal of Medicine,2020年9月 (8)这项3期临床试验中,研究人员纳入无法手术的局部晚期、或转移性尿路上皮癌患者共700人,在接受一线化疗后,随机给予阿伟鲁单抗维持治疗、或仅给予支持治疗。阿伟鲁单抗维持治疗能显著延长了患者的总生存期。阿伟鲁单抗组和对照组的,1年总生存率分别为71.3%和58.4%,中位总生存期分别为21.4个月和14.3个月(死亡风险比 0.69,P = 0.001)。阿伟鲁单抗也显著延长了PD-L1阳性的患者的总生存率,两组分别为79.1%和60.4%(风险比 0.56,P < 0.001)。在总体人群中,阿伟鲁单抗组的中位无进展生存期为3.7个月,对照组为2.0个月(疾病进展或死亡的风险比为0.62);在PD-L1阳性的人群中,阿伟鲁单抗组的中位无进展生存期为5.7个月,对照组为2.1个月(风险比 0.56)。结论:一线化疗+阿伟鲁单抗维持治疗,能进一步延长了患者的总生存期。《随机对照研究:卡博替尼和纳武利尤单抗联合或不联合伊匹木单抗治疗转移性尿路上皮癌的1期临床研究》Journal of Clinical Oncology,2020年10月 (9)卡博替尼(cabozantinib)是一种酪氨酸激酶受体抑制剂 ,纳武利尤单抗(nivolumab)是一种PD-1单抗,伊匹木单抗(ipilimumab)是一种CTLA-4单抗。研究的目的是评估了卡博替尼联合纳武利尤单抗的CaboNivo方案,以及CaboNivo联合伊匹木单抗的CaboNivoIpi方案在转移性尿路上皮癌和其他泌尿生殖系统恶性肿瘤患者中的安全性和有效性,共入组54人。平均随访时间为44.6个月,转移性尿路上皮癌的客观缓解率为38.5%,平均缓解持续时间尚未达到,中位无进展生存期达12.8个月,中位总生存期为25.4个月。CaboNivo和CaboNivoIpi治疗组中,严重不良事件发生率分别为75%和87%,主要包括疲劳、腹泻、高血压、肝炎、结肠炎。II期临床研究推荐剂量为卡博替尼40 mg/d、纳武利尤单抗3 mg/kg,伊匹木单抗1 mg/kg。结论:CaboNivo方案(卡博替尼+纳武利尤单抗)和CaboNivoIpi(卡博替尼+纳武利尤单抗+伊匹木单抗)方案均显示了良好的耐受性和持久的疗效,多项II期和III期临床研究正在进行中。《随机对照临床研究:新辅助PD-L1加CTLA-4阻滞治疗顺铂化疗无法耐受的、可手术切除的、高危、尿路上皮癌的1期临床研究》Nature Medicine,2020年10月 (10)这是首个抗PD-L1单抗(德瓦鲁单抗,durvalumab)联合抗CTLA-4单抗(曲美木单抗,tremelimumab)。研究纳入在顺铂化疗无法耐受的、具有高危特征的、尿路上皮癌患者共28人(高危特征为肿块大、组织学变异、淋巴血管侵犯、肾盂积水和/或高度上尿路疾病)。在完成手术的患者中,病理完全缓解为37.5%,58%的患者达到无残余侵袭性占位。21%的患者出现免疫相关不良事件,包括无症状实验室异常、肝炎和结肠炎结论:研究提供了抗PD-L1单抗联合抗CTLA-4单抗新辅助治疗的初步安全性、有效性和生物标志物数据,这对于局限性尿路上皮癌患者,特别是具有高危特征且目前没有建立标准护理新辅助治疗的顺铂不合格患者,值得进一步发展。《NABUCCO研究:术前CTLA-4联合PD-1抑制剂治疗局部晚期尿路上皮癌的1期临床研究》Nature Medicine,2020年10月 (11)伊匹木单抗(ipilimumab)是一种CTLA-4单抗,纳武利尤单抗(nivolumab)是一种PD-1单抗,在NABUCCO研究中,纳入了24名III期、尿路上皮癌患者,术前接受两次伊匹木单抗联合纳武利尤单抗治疗后,然后在12周内接受手术切除。研究中46%的患者达到病理学完全缓解,58%达到无残余侵袭性占位。与单独使用PD-1/PD-L1抑制剂的研究相比,伊匹木单抗联合纳武利尤单抗的疗效与基线时CD8+ T细胞活性无关。3-4级免疫相关不良事件发生率分别为55%和41%。结论:在局部晚期尿路上皮癌患者中,CTLA-4联合PD-1阻断可能提供一个有效的术前治疗策略,而不用考虑先前的CD8+ T细胞的活性。纳米颗粒作为抗纤维化基因载体治疗CKD《基础研究:多功能天然高分子纳米颗粒作为抗纤维化基因载体用于治疗慢性肾脏病》J American Society of Nephrology,2020年8月 (12)预防或逆转促纤维化的细胞的基因表型是治疗慢性肾脏病的一个方向,来自南开大学的研究人员开发了一种纳米颗粒,作为抗纤维化的基因的载体,为损伤组织和常驻细胞提供抗纤维化治疗,以限制促纤维化表型的表现。研究人员将表达骨形态发生蛋白7(BMP7)或肝细胞生长因子(HGF)-NK1(HGF/NK1)的质粒DNA包裹在有一层透明质酸壳的聚糖纳米颗粒内,安全地将含有质粒DNA的多功能纳米粒导入肾脏,用于抗纤维化因子的局部和持续表达。在小鼠模型中,静脉注射后,这些纳米颗粒约有10-45%的基因被肾脏摄取,减轻了纤维化的发展,并挽救了肾功能。BMP7基因逆转了纤维化进展、促进肾小管再生;HGF/NK1基因减少胶原纤维沉积。结论:纳米颗粒作为BMP7基因和HGF-NK1基因的载体,提供了今后靶向基因治疗慢性肾脏病的基础。参考文献1.Loriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, et al. 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Enhanced Quality and Effectiveness of Transurethral Resection of Bladder Tumour in Non-muscle-invasive Bladder Cancer: A Multicentre Real-world Experience from Scotland's Quality Performance Indicators Programme. Eur Urol. 2020.5.Lindgren MS, Bue P, Azawi N, Blichert-Refsgaard L, Sundelin MO, Dyrskjøt L, et al. The DaBlaCa-13 Study: Short-term, Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in Non-muscle-invasive Bladder Cancer-A Randomised Controlled Trial. Eur Urol. 2020.6.Teo MY, Mota JM, Whiting KA, Li HA, Funt SA, Lee CH, et al. Fibroblast Growth Factor Receptor 3 Alteration Status is Associated with Differential Sensitivity to Platinum-based Chemotherapy in Locally Advanced and Metastatic Urothelial Carcinoma. Eur Urol. 2020.7.Galsky MD, Arija JÁ A, Bamias A, Davis ID, De Santis M, Kikuchi E, et al. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. 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FDA 批准首个用于治疗晚期尿路上皮癌的FGFR激酶抑制剂Nature Medicine 免疫检查点抑制剂PD-L1联合CTLA-4单抗治疗高危尿路上皮癌前沿医学 多功能天然高分子纳米颗粒作为抗纤维化基因载体用于治疗CKD厄达替尼(erdafitinib)我们的节目曾在《消化科星期三 Episode 3》中介绍过培米加替尼,治疗成纤维细胞生长因子受体编码基因(FGFR)基因融合或重排的局部晚期胆管癌,胆管癌中约有20%的患者存在这种基因突变。研究人员发现FGFR突变在尿路上皮癌中也很常见,并且可能与对免疫干预的敏感性降低相关。厄达替尼(erdafitinib)是一种FGFR1-4的酪氨酸激酶抑制剂,2019年4月,FDA已经批准厄达替尼(erdafitinib)用于治疗局部晚期或转移性尿路上皮癌。《BLC2001研究:厄达替尼治疗局部晚期或转移性尿路上皮细胞癌的2期临床研究》New England Journal of Medicine,2019年8月 (1) 在这项开放标签的2期研究中,纳入了FGFR基因突变的、局部晚期和不可切除或转移性尿路上皮细胞癌的患者99人,所有患者既往均接受过化疗,并在化疗12个月内发生疾病进展。最初将患者随机分组,随后根据中期分析,将连续用药方案的起始剂量设定为8mg/d,并可在药效学指导下,将剂量增加至9mg/d。经过平均5个周期的厄达替尼治疗后,缓解率为40%(3%完全缓解,37%部分缓解)。在既往接受过免疫治疗患者中,缓解率为59%。中位无进展生存期为5.5个月,中位总生存期为13.8个月。结论:在既往接受过治疗的、有FGFR基因突变的、且患局部晚期和不可切除或转移性的尿路上皮细胞癌的患者中,厄达替尼治疗后肿瘤客观缓解率达40%。膀胱尿路上皮癌膀胱癌是最常见的泌尿系统恶性肿瘤,其中尿路上皮癌(也称移行细胞癌)是主要的组织学类型,占所有膀胱癌的90%。膀胱尿路上皮癌可表现为非肌肉浸润癌、肌肉浸润癌和转移癌,病变的程度可以反映自然病程,并决定了治疗和预后。膀胱癌通常表现为肉眼血尿或镜下血尿,刺激性或梗阻性排尿困难也可以 是首发症状。非肌肉浸润性膀胱癌的治疗对于非肌肉浸润性膀胱癌的患者,采用经尿道膀胱肿瘤切除术(TURBT),并联合膀胱内辅助治疗等保守治疗方式有可能保留膀胱功能。膀胱内辅助治疗主要包括卡介苗(牛结合分支杆菌的减毒活疫苗)和丝裂霉素C、表柔比星、吉西他滨等化疗药物。《系统回顾:膀胱治疗非肌肉浸润性膀胱癌的疗效》European Urology,2020年9月 (2)研究的目的是评价在卡介苗治疗后,保留膀胱功能的患者的疾病完全缓解率和无复发率。研究系统地回顾了42项研究,包括24种治疗方案、2254名患者。包含原位癌在内的肿瘤治疗中位完全缓解率,6个月时为26%,12个月时为17%,24个月时为8%。相比,乳头状癌的平均无进展率,6个月时为67%,12个月时为44%,24个月时为10%。特别是在卡介苗无效的、接受草分枝杆菌细胞壁-核酸复合物的患者中,6个月和12个月的完全缓解率分别为45%和27%;6、12、24个月中位不带病生存率分别为43%、35%和18%。总的中位无进展率为91%,原位癌的研究中为95%,乳头状癌的研究中为89%。膀胱内给药的不良反应少,且轻微。结论:卡介苗治疗后的、保留膀胱疗法,在非肌肉浸润性膀胱癌患者中取得了适度的疗效。《NIMBUS研究:卡介苗标准剂量和数量灌注治疗重度非肌肉浸润性膀胱癌的3期临床研究》European Urology,2020年11月 (3)膀胱内灌注卡介苗治疗是一种被广泛接受的预防非肌肉浸润性膀胱癌复发的策略,但是具有显著的毒性。研究的目的是评估了降低标准剂量卡介苗灌注的次数是否可以达到同样的疗效。研究纳入了345名非肌肉浸润性膀胱癌的患者,分别接受标准治疗(诱导6周,在第3、6和12个月时各治疗3周,共15次灌注),或低频率治疗(第1、2和6周诱导,在第3、6和12个月时各治疗2周,共9次灌注)。中位随访12个月后,标准治疗组复发率12%,低频率治疗组复发率27%。安全性分析达到了预先定义的、无效停止标准。结论:在预防膀胱癌复发方面,标准治疗方案更好,目前研究已经停止对参与者的招募。《国家质量指标项目:提高非肌肉浸润性膀胱癌经尿道膀胱肿瘤切除术的质量和有效性》European Urology,2020年8月 (4)非肌肉浸润性膀胱癌的临床预后部分取决于初始干预。为了改善和标准化癌症治疗,苏格兰实施了一项针对膀胱癌的国家质量指标项目。研究中纳入了2689例患者,标准干预包括:(1)使用膀胱图;(2)经尿道膀胱肿瘤切除术后单次膀胱内灌注丝裂霉素C一次;(3)逼尿肌活检;(4)高危膀胱癌患者中,早期行二次手术。研究中,67%患者接受了术后一次膀胱灌注;复发率、残余癌比例和继发肿瘤的比例分别为13%、33%和2.9%。术后一次膀胱灌注复发率降低相关;逼尿肌活检则癌症残留的可能性减半。结论:在苏格兰实施国家质量指标计划似乎有助于向患者提供高质量的经尿道膀胱肿瘤切除术,且降低了术后的复发率、肿瘤分期更准确。《DaBlaCa-13研究:短期强化化疗与标准辅助膀胱内灌注治疗非肌肉浸润性膀胱癌》European Urology,2020年8月 (5)膀胱灌注治疗非肌肉浸润性膀胱癌可减少复发。术前灌注化疗副作用更少,甚至一些患者在治疗后都无需接受肿瘤切除术了。研究旨在比较术前丝裂霉素C短期强化化疗治疗复发性非肌肉浸润性膀胱癌的效果。研究纳入120例患者,短期强化化疗组,膀胱灌注化疗每周3次,共2周;对照组先行经尿道膀胱肿瘤切除术,术后6周每周进行一次膀胱灌注辅助治疗。在短期强化化疗组中,有33名参与者(57%)出现了肿瘤完全缓解,且不良事件少。结论:术前短期强化化疗使一半以上的患者避免肿瘤切除术,但长期疗效仍需随访观察。肌肉浸润性膀胱癌的治疗对于肌肉浸润性膀胱癌,需行根治性膀胱切除术+尿流改道术,以及辅助化疗、免疫治疗。化疗方案中的MVAC方案(甲氨蝶呤、长春碱、多柔比星、顺铂)被认为是一线化疗方案,临床实践中多在这个方案上增减。目前已有几个免疫检查点抑制剂被获批用于膀胱尿路上皮癌的治疗:阿替利珠单抗(atezolizumab),帕博利珠单抗(pembrolizumab),纳武利尤单抗(nivolumab),阿伟鲁单抗(avelumab),德瓦鲁单抗(durvalumab)。《回顾性综述:FGFR3的水平变化与膀胱癌对铂化疗的敏感性有关》European Urology,2020年8月(6)大约15%的膀胱癌存在成纤维细胞生长因子受体3 (FGFR3)基因突变。研究人员回顾性的比较和综述三个队列的患者:(1)新辅助化疗治疗肌肉侵袭性膀胱癌患者的数据;(2)一线铂类化疗治疗转移性尿路上皮癌患者的数据;(3)来自癌症基因组图谱中的肌肉侵袭性膀胱癌患者的数据。队列一:72例新辅助化疗的肌肉侵袭性膀胱炎癌患者中有13%具有FGFR3突变,均没有达到病理完全缓解,且无复发生存期短。队列三:来自癌症基因组图谱中的肌肉侵袭性膀胱癌的患者,接受辅助化疗、且伴有FGFR3突变的无复发生存期也更短。相反,在未接受化疗的患者中,FGFR3突变与无复发生存期更长、总生存率更高。队列二:转移性尿路上皮癌的患者中,FGFR3突变虽然药物反应低,但不影响无进展生存率和总生存率。结论:肌肉浸润性膀胱癌中,FGFR3突变可能与围手术期铂类药物化疗反应差、易复发有关。《IMvigor130研究:化疗联合阿替利珠单抗治疗转移性尿路上皮癌的3期临床研究》Lancet,2020年5月 (7)这个多中心、3期、随机研究的目的是,比较阿替利珠单抗与安慰剂加铂类化疗在一线转移性尿路上皮癌的疗效。研究纳入未经治疗的、≥18岁的、局部晚期或转移性尿路上皮细胞癌患者共1213人。随机接受阿替利珠单抗+铂类化疗,或阿替利珠单抗单药治疗,或安慰剂+铂类化疗,随访11.8个月。中位无进展生存期,在阿替利珠单抗联合化疗组为8·2个月,在安慰剂联合化疗组为6.3个月(p = 0·007)。中位生存期,在阿替利珠单抗联合化疗组为16·0个月,安慰剂联合化疗组为13·4个月(p = 0·027)。阿替利珠单抗单药治疗组中位总生存期为15·7个月,与安慰剂联合化疗组无差异。结论:阿替利珠单抗联合铂类化疗延长了转移性尿路上皮癌患者的无进展生存,研究支持使用阿替利珠单抗联合铂类化疗作为转移性尿路上皮癌的潜在的、一线治疗选择。《JAVELIN Bladder200研究:PD-L1单抗阿伟鲁单抗维持治疗局部晚期、或转移性尿路上皮癌》New England Journal of Medicine,2020年9月 (8)这项3期临床试验中,研究人员纳入无法手术的局部晚期、或转移性尿路上皮癌患者共700人,在接受一线化疗后,随机给予阿伟鲁单抗维持治疗、或仅给予支持治疗。阿伟鲁单抗维持治疗能显著延长了患者的总生存期。阿伟鲁单抗组和对照组的,1年总生存率分别为71.3%和58.4%,中位总生存期分别为21.4个月和14.3个月(死亡风险比 0.69,P = 0.001)。阿伟鲁单抗也显著延长了PD-L1阳性的患者的总生存率,两组分别为79.1%和60.4%(风险比 0.56,P < 0.001)。在总体人群中,阿伟鲁单抗组的中位无进展生存期为3.7个月,对照组为2.0个月(疾病进展或死亡的风险比为0.62);在PD-L1阳性的人群中,阿伟鲁单抗组的中位无进展生存期为5.7个月,对照组为2.1个月(风险比 0.56)。结论:一线化疗+阿伟鲁单抗维持治疗,能进一步延长了患者的总生存期。《随机对照研究:卡博替尼和纳武利尤单抗联合或不联合伊匹木单抗治疗转移性尿路上皮癌的1期临床研究》Journal of Clinical Oncology,2020年10月 (9)卡博替尼(cabozantinib)是一种酪氨酸激酶受体抑制剂 ,纳武利尤单抗(nivolumab)是一种PD-1单抗,伊匹木单抗(ipilimumab)是一种CTLA-4单抗。研究的目的是评估了卡博替尼联合纳武利尤单抗的CaboNivo方案,以及CaboNivo联合伊匹木单抗的CaboNivoIpi方案在转移性尿路上皮癌和其他泌尿生殖系统恶性肿瘤患者中的安全性和有效性,共入组54人。平均随访时间为44.6个月,转移性尿路上皮癌的客观缓解率为38.5%,平均缓解持续时间尚未达到,中位无进展生存期达12.8个月,中位总生存期为25.4个月。CaboNivo和CaboNivoIpi治疗组中,严重不良事件发生率分别为75%和87%,主要包括疲劳、腹泻、高血压、肝炎、结肠炎。II期临床研究推荐剂量为卡博替尼40 mg/d、纳武利尤单抗3 mg/kg,伊匹木单抗1 mg/kg。结论:CaboNivo方案(卡博替尼+纳武利尤单抗)和CaboNivoIpi(卡博替尼+纳武利尤单抗+伊匹木单抗)方案均显示了良好的耐受性和持久的疗效,多项II期和III期临床研究正在进行中。《随机对照临床研究:新辅助PD-L1加CTLA-4阻滞治疗顺铂化疗无法耐受的、可手术切除的、高危、尿路上皮癌的1期临床研究》Nature Medicine,2020年10月 (10)这是首个抗PD-L1单抗(德瓦鲁单抗,durvalumab)联合抗CTLA-4单抗(曲美木单抗,tremelimumab)。研究纳入在顺铂化疗无法耐受的、具有高危特征的、尿路上皮癌患者共28人(高危特征为肿块大、组织学变异、淋巴血管侵犯、肾盂积水和/或高度上尿路疾病)。在完成手术的患者中,病理完全缓解为37.5%,58%的患者达到无残余侵袭性占位。21%的患者出现免疫相关不良事件,包括无症状实验室异常、肝炎和结肠炎结论:研究提供了抗PD-L1单抗联合抗CTLA-4单抗新辅助治疗的初步安全性、有效性和生物标志物数据,这对于局限性尿路上皮癌患者,特别是具有高危特征且目前没有建立标准护理新辅助治疗的顺铂不合格患者,值得进一步发展。《NABUCCO研究:术前CTLA-4联合PD-1抑制剂治疗局部晚期尿路上皮癌的1期临床研究》Nature Medicine,2020年10月 (11)伊匹木单抗(ipilimumab)是一种CTLA-4单抗,纳武利尤单抗(nivolumab)是一种PD-1单抗,在NABUCCO研究中,纳入了24名III期、尿路上皮癌患者,术前接受两次伊匹木单抗联合纳武利尤单抗治疗后,然后在12周内接受手术切除。研究中46%的患者达到病理学完全缓解,58%达到无残余侵袭性占位。与单独使用PD-1/PD-L1抑制剂的研究相比,伊匹木单抗联合纳武利尤单抗的疗效与基线时CD8+ T细胞活性无关。3-4级免疫相关不良事件发生率分别为55%和41%。结论:在局部晚期尿路上皮癌患者中,CTLA-4联合PD-1阻断可能提供一个有效的术前治疗策略,而不用考虑先前的CD8+ T细胞的活性。纳米颗粒作为抗纤维化基因载体治疗CKD《基础研究:多功能天然高分子纳米颗粒作为抗纤维化基因载体用于治疗慢性肾脏病》J American Society of Nephrology,2020年8月 (12)预防或逆转促纤维化的细胞的基因表型是治疗慢性肾脏病的一个方向,来自南开大学的研究人员开发了一种纳米颗粒,作为抗纤维化的基因的载体,为损伤组织和常驻细胞提供抗纤维化治疗,以限制促纤维化表型的表现。研究人员将表达骨形态发生蛋白7(BMP7)或肝细胞生长因子(HGF)-NK1(HGF/NK1)的质粒DNA包裹在有一层透明质酸壳的聚糖纳米颗粒内,安全地将含有质粒DNA的多功能纳米粒导入肾脏,用于抗纤维化因子的局部和持续表达。在小鼠模型中,静脉注射后,这些纳米颗粒约有10-45%的基因被肾脏摄取,减轻了纤维化的发展,并挽救了肾功能。BMP7基因逆转了纤维化进展、促进肾小管再生;HGF/NK1基因减少胶原纤维沉积。结论:纳米颗粒作为BMP7基因和HGF-NK1基因的载体,提供了今后靶向基因治疗慢性肾脏病的基础。参考文献1.Loriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, et al. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. New England Journal of Medicine. 2019;381(4):338-48.2.Li R, Sundi D, Zhang J, Kim Y, Sylvester RJ, Spiess PE, et al. Systematic Review of the Therapeutic Efficacy of Bladder-preserving Treatments for Non-muscle-invasive Bladder Cancer Following Intravesical Bacillus Calmette-Guerin. Eur Urol. 2020;78(3):387-99.3.Grimm MO, van der Heijden AG, Colombel M, Muilwijk T, Martinez-Pineiro L, Babjuk MM, et al. Treatment of High-grade Non-muscle-invasive Bladder Carcinoma by Standard Number and Dose of BCG Instillations Versus Reduced Number and Standard Dose of BCG Instillations: Results of the European Association of Urology Research Foundation Randomised Phase III Clinical Trial "NIMBUS". Eur Urol. 2020;78(5):690-8.4.Mariappan P, Johnston A, Padovani L, Clark E, Trail M, Hamid S, et al. Enhanced Quality and Effectiveness of Transurethral Resection of Bladder Tumour in Non-muscle-invasive Bladder Cancer: A Multicentre Real-world Experience from Scotland's Quality Performance Indicators Programme. Eur Urol. 2020.5.Lindgren MS, Bue P, Azawi N, Blichert-Refsgaard L, Sundelin MO, Dyrskjøt L, et al. The DaBlaCa-13 Study: Short-term, Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in Non-muscle-invasive Bladder Cancer-A Randomised Controlled Trial. Eur Urol. 2020.6.Teo MY, Mota JM, Whiting KA, Li HA, Funt SA, Lee CH, et al. Fibroblast Growth Factor Receptor 3 Alteration Status is Associated with Differential Sensitivity to Platinum-based Chemotherapy in Locally Advanced and Metastatic Urothelial Carcinoma. Eur Urol. 2020.7.Galsky MD, Arija JÁ A, Bamias A, Davis ID, De Santis M, Kikuchi E, et al. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10236):1547-57.8.Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020;383(13):1218-30.9.Apolo AB, Nadal R, Girardi DM, Niglio SA, Ley L, Cordes LM, et al. Phase I Study of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced or Metastatic Urothelial Carcinoma and Other Genitourinary Tumors. J Clin Oncol. 2020;38(31):3672-84.10.Gao J, Navai N, Alhalabi O, Siefker-Radtke A, Campbell MT, Tidwell RS, et al. Neoadjuvant PD-L1 plus CTLA-4 blockade in patients with cisplatin-ineligible operable high-risk urothelial carcinoma. Nat Med. 2020.11.van Dijk N, Gil-Jimenez A, Silina K, Hendricksen K, Smit LA, de Feijter JM, et al. Preoperative ipilimumab plus nivolumab in locoregionally advanced urothelial cancer: the NABUCCO trial. Nat Med. 2020.12.Midgley AC, Wei Y, Zhu D, Gao F, Yan H, Khalique A, et al. Multifunctional Natural Polymer Nanoparticles as Antifibrotic Gene Carriers for CKD Therapy. J Am Soc Nephrol. 2020.
In this episode, an expert medical oncology panel led by Elizabeth R. Plimack, MD, MS, with Brian A. Costello, MD, and Martin H. Voss, MD, discusses clinical pearls for the management of patients with metastatic renal cell carcinoma (RCC). Topics include:Treating beyond progression with immunotherapyManagement of patients with less common histologic subtypes of RCCPotential biomarkers for RCCAdverse event managementPresenters:Elizabeth R. Plimack, MD, MSChief, Division of Genitourinary Medical Oncology Director, Genitourinary Clinical Research Professor, Department of Hematology/Oncology Fox Chase Cancer Center Temple Health Philadelphia, PennsylvaniaBrian A. Costello, MDAssociate Professor of Oncology and UrologyDivision of Medical OncologyMayo ClinicRochester, MinnesotaMartin H. Voss, MDClinical Director, Genitourinary Medical Oncology ServiceMemorial Sloan Kettering Cancer CenterAssistant Professor Weill Cornell Medical CollegeNew York, New YorkContent based on an online CME program supported by educational grants from Eisai, Exelixis, and Pfizer and EMD Serono.Link to full program:https://bit.ly/32IS9gx
In this episode, an expert medical oncology panel, led by Elizabeth R. Plimack, MD, with Brian A. Costello, MD, and Martin H. Voss, MD, discusses current best practices for the second-line treatment and beyond of patients with metastatic renal cell carcinoma (RCC). Topics include:• Treatment sequencing with IO and TKI therapies• Optimizing dose for patients with preexisting toxicities• Considerations for local control of metastatic sites • Ongoing clinical trials Presenters:Elizabeth R. Plimack, MD, MSChief, Division of Genitourinary Medical Oncology Director, Genitourinary Clinical Research Professor, Department of Hematology/Oncology Fox Chase Cancer Center Temple Health Philadelphia, PennsylvaniaBrian A. Costello, MDAssociate Professor of Oncology and UrologyDivision of Medical OncologyMayo ClinicRochester, MinnesotaMartin H. Voss, MDClinical Director, Genitourinary Medical Oncology ServiceMemorial Sloan Kettering Cancer CenterAssistant Professor Weill Cornell Medical CollegeNew York, New YorkContent based on an online CME program supported by an educational grant from Eisai, Exelixis, and Pfizer and EMD Serono.Link to full program:https://bit.ly/32IS9gx
Andrea talks about her phase 2 trial which shows activity for Cabozantinib in urothelial cancer.
This week, we'll discuss phase II results on cabozantinib in patients with advanced bladder cancer. Then, we'll review a study on behaviors related to COVID-19 prevention among cancer survivors. Lastly, we'll hear a discussion about the keynote lecture presented at the First International Summit on Interventional Pharmacoeconomics. Coverage of stories discussed this week on ascopost.com:Cabozantinib in Platinum-Refractory Metastatic Urothelial CarcinomaCancer Survivors Are Adhering to COVID-19–Related Preventive Behaviors, but Continuity of Care May Be Impacted
Oncotarget - Hyperprogression To Immune Blockade Followed By A Response With Cabozantinib by Oncotarget Podcast
ASCO: You’re listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the world’s leading professional organization for doctors who care for people with cancer. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Cancer research discussed in this podcast is ongoing, so clinical trials described here may no longer be enrolling patients, and final results are not yet available. Before any new cancer treatment can be approved for general use, it must be studied in a clinical trial in order to prove it is safe and effective. In today’s podcast, members of the Cancer.Net Editorial Board discuss 3 clinical trials that are exploring new treatment options across prostate, bladder, and kidney cancer. This podcast will be led by Dr. Timothy Gilligan, Dr. Sumanta (Monty) Pal, Dr. Petros Grivas, and Dr. Tian Zhang. Dr. Gilligan is an Associate Professor and Medical Oncologist at the Cleveland Clinic Taussig Cancer Center. He has no relevant relationships to disclose. Dr. Pal is co-director of City of Hope's Kidney Cancer Program and is the head of the kidney and bladder cancer disease team at the institution. He has served in a consulting or advisory role for Astellas Pharma, Exelixis, and Pfizer. Dr. Grivas is the clinical director of the Genitourinary Cancers Program at University of Washington Medicine. He is also an associate member of the clinical research division at the Fred Hutchinson Cancer Research Center. He has served in a consulting or advisory role for Exelixis, Merck, and Pfizer. Dr. Zhang is an assistant professor of medicine at Duke University School of Medicine and is a medical oncologist at Duke Cancer Institute. She has served in a consulting or advisory role for Exelixis, Merck, and Pfizer. View full disclosures for Dr. Gilligan, Dr. Pal, Dr. Grivas, and Dr. Zhang at Cancer.Net. Dr. Gilligan: Hi. I'm Dr. Timothy Gilligan from the Cleveland Clinic. I'm joined today by Dr. Monty Pal from the City of Hope Cancer Center, Dr. Petros Grivas from the Fred Hutchinson Cancer Research Center and University of Washington, and Dr. Tian Zhang from Duke Cancer Institute. Today, we're going to discuss three ongoing clinical trials in prostate, bladder, and kidney cancer. As you may know, clinical trials are the main way the doctors are able to find better treatment for cancer and other diseases. Patient participation is vital for clinical trials. By participating in a clinical trial, you can directly help researchers develop better treatment, reduce side effects, or even reduce the risk of cancer all together. The three trials we'll discuss today were chosen by members of the Cancer.Net Editorial Board Genitourinary Cancers Panel from the trials and progress abstracts that were presented at ASCO's 2020 Genitourinary Cancers Symposium. Because these are ongoing clinical trials, final results from these studies are not available yet. I'd like to note that none of us have any direct involvement with any of these trials. To view our full disclosures, please visit the show notes for this episode on Cancer.Net. So to get started, the first study we'll discuss is the TALAPRO-2 trial for prostate cancer, [Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC (TALAPRO-2)] and Dr. Pal is going to discuss this. So if we could get started, just to begin with, who is the study designed for? Dr. Pal: Thanks a lot, Dr. Gilligan. Well, this study addresses a unique disease population. It's patients with prostate cancer that's metastatic, and that implies that the cancer has migrated out of the prostate to other organs. But beyond that, it also implies that these patients have also developed some resistance to first line hormone treatment. So patients in this study [have] so-called hormone resistant or castration resistant [prostate cancer]. Dr. Gilligan: So if a patient was in this situation, and they weren't going on this trial, what would be the standard treatment for them at this time? Dr. Pal: There are several options for these patients. Hormone therapies like abiraterone and enzalutamide could be considered. Chemotherapy is also a consideration. Dr. Gilligan: And can you say a little bit more about what the patients would receive if they went on it? The subjects of the study, what they'll get? Dr. Pal: Some patients with prostate cancer may have [a deficiency in their cancer’s ability to repair damage to DNA]. This is something that we've seen in other tumor types, breast cancer perhaps being the most notable example. Pancreatic cancer being another one. In this particular trial, [the researchers] try to exploit that by using a class of drugs called PARP inhibitors. In this case, a drug called talazoparib. So patients in this study receive a standard hormone therapy called enzalutamide. And they receive that with or without this drug, talazoparib. Dr. Gilligan: So they will get either-- what you described before is the standard of care—hormonal therapy, or that combined with this new drug. Dr. Pal: That's exactly right, Dr. Gilligan. Dr. Gilligan: I wanted to make that clear because this is a trial that has placebo, and sometimes research [participants] have concern about, "Do I want to be on a trial that has a placebo?" Do you want to say anything about that? Dr. Pal: It's very important to bear in mind that every patient that enrolls in this study is going to get the standard treatment in this setting. As I've mentioned before, enzalutamide represents one of those options. And, of course, in this trial above and beyond that, they have the possibility of getting talazoparib or a placebo. So certainly patients won't be receiving placebo alone in this trial. Dr. Gilligan: Do you want to say anything more about what's kind of interesting about this new approach to treating prostate cancer? Dr. Pal: What I think is quite inventive about this study is that talazoparib, the PARP inhibitor, is being combined with hormone therapy. And I think that's the real difference in what this protocol offers versus the treatment strategies that now represent a standard option for patients. Dr. Gilligan: Right. And my understanding is that the hope is that by using this combination, we'll be able to make treatment more effective. Dr. Pal: Absolutely. When we talk about PARP inhibitors and prostate cancer currently, we're typically restricting it to patients who have these so-called DNA damage repair mutations. And that's certainly a finite group of individuals. In this particular trial, we're actually going to look not just at those patients, but all patients within this disease state. So we go beyond the 25 to 30 percent of patients who are estimated to have alterations in DNA damage repair. Dr. Gilligan: Right. I think that's an important point: to get on this trial, patients don't have to have a particular genetic profile. So how will success be evaluated? How will we know if it's working? Dr. Pal: In this case, we're going to be looking at the delay in cancer growth as the primary outcome measure. We're certainly hoping that the combination of enzalutamide with talazoparib is going to slow growth relative to enzalutamide plus placebo. The innovative endpoint that's explored in this study is also diving deeper and looking at those patients who have these DNA damage repair mutations that's going to also reflect one of the primary outcome measures in this study. And that's something quite important to bear in mind. Dr. Gilligan: So we have some experience with PARP inhibitors. Can you say something about what we know about the side effects? Dr. Pal: Fatigue is a relatively common side effect. Decreases in blood counts is another potential side effect. And in particular in my clinical experience, I've seen drops in the white blood cell counts. That of course makes patients more susceptible to infection. Diarrhea may also be one of the consequences within this class of drugs. And certainly, I would refer patients to a more comprehensive discussion of these side effects with their clinicians before entering into the study. Dr. Gilligan: Is the trial still accruing patients? And do we know when we might expect results? Dr. Pal: I think that there are many trials within this particular space. This one is ambitious in that it hopes to accrue over a thousand patients. I don't have a good finger on the pulse of when results will report. But I'm sure that'll be the subject of future podcasts for us. Dr. Gilligan: Well, thank you very much Dr. Pal. It's a very exciting study and exciting new area of research in prostate cancer. Dr. Pal: Definitely. Dr. Gilligan: We're going to move on now to the second study we want to talk about, which is the KEYNOTE-905 study. [Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)] And Dr. Grivas is going to talk to us about that. Can you orient us, Dr. Grivas, to what this study is, for which group of patients, and what it's looking at? Dr. Grivas: This clinical trial is applicable to patients with localized, meaning not spread, bladder cancer. And when the bladder cancer has invaded the muscle layer of the bladder, we call this muscle invasive bladder cancer. And these patients usually go for cystectomy, the removal of the bladder. And ideally, they get chemotherapy before, but some patients may not be fit enough for chemotherapy. So those patients go straight to cystectomy, the removal of the bladder. So this clinical trial is trying to evaluate whether immunotherapy with this drug, called pembrolizumab, helps these patients before they get the cystectomy. Dr. Gilligan: Can you tell us a little bit more about pembrolizumab and what we know about it? Where it's used currently in bladder cancer? Dr. Grivas: Pembrolizumab has three different indications for patients with bladder cancer. The first one is in an earlier stage, what we call non-muscle invasive bladder cancer, which is a very superficial cancer, when the cancer is not invading through the muscle layer. And there's a specific indication for those patients who get therapy with BCG, which is a form of immunotherapy given inside the bladder. And if the cancer is not responding well to this BCG, usually, they go for removal of the bladder. But some of them may not be able to do that or do not want that. And pembrolizumab has a track record in those specific scenarios of BCG-unresponsive tumors as we call them for those patients who cannot get cystectomy or don't want to have it. The other two indications are for patients who have metastatic, [meaning bladder cancer that has spread to other organs.] And there are two specific indications of pembrolizumab immunotherapy in that particular setting. So this trial is trying to expand upon the role of pembrolizumab in bladder cancer. Dr. Gilligan: So it's been shown to be a benefit when the disease is more advanced and now we want to see if it's helpful earlier on in the period of time around surgery. Dr. Grivas: Right. And it's interesting in a particular setting we're looking at this trial, because we have indications literally before and after in an earlier states, the non-muscle invasive disease setting. And also as you mentioned, Dr. Gilligan, in the more advanced setting. So we're trying now to see whether this middle setting of muscle invasive bladder cancer, whether there's a role of pembrolizumab by itself before removing the bladder. Dr. Gilligan: Are patients who are eligible to get chemotherapy prior to cystectomy able to go on this trial or is it only for patients who are not [well enough] to get chemotherapy? Dr. Grivas: This is for patients who are not in good condition to undergo chemotherapy. So if someone is in good condition to undergo chemotherapy, then the trial does not apply to them. This is only in those who cannot safely receive chemotherapy before the cystectomy. Dr. Gilligan: Thank you for clarifying that. What data do we have that makes us think that it may be a good idea to give immunotherapy prior to cystectomy? Because this has been looked at a little bit already, and I think it's why this trial is being done. Can you say a little bit about that? Dr. Grivas: Sure. I would like to underline that as you alluded before, the standard of care therapy for patients who undergo cystectomy, the removal of the bladder, is to undergo chemotherapy with a drug called cisplatin before cystectomy. But as we discussed before, this is the standard of care with a high evidence. However, many patients, maybe 50, maybe 55 percent of patients may not have enough condition to undergo this chemotherapy safely. And that is the population we would try to capture. And to answer your question, there have been so far, four clinical trials looking at immunotherapy before cystectomy. And all of those four clinical trials look very promising in that regard. So based on this promising information, this new trial the KEYNOTE-905 is a phase III trial trying to confirm the promising data from the previous phase II trials and help us make a final decision whether this should be the standard of care or not in patients who cannot undergo safely chemotherapy in that setting. Dr. Gilligan: What are the known side effects and risks of immunotherapy? Dr. Grivas: Immunotherapy overall is much better tolerated than chemotherapy. However, it can still cause significant side effects, especially in a small proportion of patients. So the main thing we need to keep an eye on is if the immune system gets too overstimulated, it can cause what we call immunotherapy-related adverse events or side effects. And any organ of the body could in theory be attacked by an overstimulated, overactive, immune system. So they are different forms of “-itis.” For example, if you have inflammation in the lungs, it's pneumonitis. In the liver, hepatitis. So we have to be careful and educate our patients, educate our medical providers and the teams, follow the patients and then report any new symptoms for changes in order to be able to recognize early and manage properly these side effects. As I mentioned, it's not common to have a severe reaction, but it can happen. So education helps, and I recommend to the patients to discuss with a medical provider the potential of those immunotherapy-related adverse events that usually, if they occur, can be managed with proper treatment to try to suppress, “cool down,” the immune system. So education is important. Dr. Gilligan: So just to summarize then, this is a trial for patients who would normally be treated with surgery alone, and we're looking at whether adding immunotherapy before and after surgery can improve those outcomes. Dr. Grivas: That's exactly right. Especially for those patients who cannot safely undergo chemotherapy before the surgery. Dr. Gilligan: And how are we going to measure whether it's successful? Whether that immunotherapy has improved outcomes or not? Dr. Grivas: The two measures that we're are looking at in this particular trial are the following. Number one, we tried to see how many patients--what is the proportion of patients from everybody who gets in the trial—who has no residual cancer cells at the time of the removal of the bladder, at the cystectomy. When the pathologist looks at the cystectomy sample in the lab after the bladder is removed from the body, what is the proportion of patients with no cancer inside the bladder after the immunotherapy compared to no immunotherapy at all? So we're going to compare these. We call this “complete response,” meaning no cancer is found in the bladder after its been removed, after the immunotherapy. And we're going to compare this complete response in the two groups. The other metric we use is to see how many patients have no recurrence regardless, meaning the cancer came back after the treatment. After the cystectomy, how many of those patients either had the cancer come back later or died from another cause. So we use these metrics and we compare the two metrics in the two populations in the trial with and without immunotherapy before the surgery. Dr. Gilligan: And currently, the relapse rate's roughly 50 percent, so we're hoping for a lower number than that. Dr. Grivas: Correct. We try to look for a lower number, and we try to see to compare these two populations with and without immunotherapy and see if immunotherapy adds value in that particular setting. Dr. Gilligan: Is this trial still open and do you know when we might see results from it? Dr. Grivas: The trial is open. It started recently, so I will strongly encourage the patients to discuss with their providers and look at particular locations where this trial is open. So definitely, there is room to go. And I think the trial will take a few years to complete and then report the results. So definitely an ongoing trial options for the patients. Dr. Gilligan: Great. Well, thank you very much. So an exciting trial for patients with localized bladder cancer going through surgery to see if we can improve outcomes, increase the cure rate, by adding this interesting new immunotherapy. Thank you, Dr. Grivas. Dr. Grivas: Thank you so much. Dr. Gilligan: So now we're going to move on and talk about the COSMIC-313 trial with Dr. Zhang from the Duke Cancer Institute. [Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (COSMIC-313)] Can you tell us who this trial is designed for, or which group of patients? Dr. Zhang: Absolutely. We know that for patients with kidney cancer with a clear cell component and intermediate or poor risk by IMDC criteria, that both immunotherapy combinations with ipilimumab and nivolumab as well as the targeted therapy blocking blood vessel formation, called cabozantinib, have both demonstrated significant benefit for these patients. And these are approved treatments. So this particular trial is attempting to combine these starting as a triplet of ipilimumab, nivolumab, cabozantinib for four cycles and then maintenance nivolumab with cabozantinib. And this triplet treatment is compared to a placebo-controlled regimen of the same immunotherapies without the targeted therapy. Dr. Gilligan: So if a patient weren't going to go on this trial, what's the current standard of care? Dr. Zhang: Both the immunotherapy combination as well as having the cabozantinib by itself, are our standard of care therapies for these patients in these categories. Dr. Gilligan: Is this restricted to any particular group of kidney cancer patients? Dr. Zhang: These patients must have at least one of the IMDC criterion. So these are markers of inflammation, like high neutrophil count, low hemoglobin, or high platelet levels, high calcium levels, as well as poor performance status in less than one year from diagnosis to needing these type of treatments. Patients have to have kidney cancer that spread to other sites of their body or locally advanced disease which is not surgically resectable. And as a note, other treatments that are approved in patients who have intermediate poor risk disease include combinations of immunotherapies with targeted therapies like pembrolizumab with axitinib or avelumab with axitinib. Dr. Gilligan: So then just to be clear, these are drugs that are already being used, have already been shown to work, and we're trying to see if we combine them do we get a better result than using them by themselves. Dr. Zhang: That's right. And I think that's a main point. If two agents work on their own, can they be combined to work better? It is important to note that we must follow these patients for their side effects to make sure that the benefit of the triplet therapy would be worth the potential added toxicity of this combination. Dr. Gilligan: So as you mentioned, there's already a standard treatment that includes targeted therapies, immunotherapies, axitinib and pembrolizumab. What do you think is the interesting or different about the approach in this study? Dr. Zhang: The main difference of this triplet combination is the addition of ipilimumab which is a CTLA 4 inhibitor. This is even a bit of a stronger immunotherapy, which targets the dendritic cell interaction with cells to activate the immune cells even more. And so we know that ipilimumab in kidney cancer does drive increase the ability for us to achieve a complete response, meaning that this combination is a really active immunotherapy combination for metastatic kidney cancer. So if we can add the ipilimumab effect with a very strong targeted effect of the cabozantinib the thought is that this triplet might be even more effective than the current standard of care, pembrolizumab-axitinib or avelumab-axitinib combinations. Dr. Gilligan: Thank you for clarifying that. Just to make sure our listeners are clear on this. They're two doublets that are already approved—two kinds of immunotherapy or immunotherapy combined with targeted therapy. This will be the first triplet, if I understand correctly, that if this is shown to be more effective, it would be the first triplet therapy where we're using three different agents, our strongest immunotherapy combined with targeted therapy. Is that a fair summary? Dr. Zhang: Absolutely. I think that's a great summary. Dr. Gilligan: So how will success be evaluated? What are the endpoints for this? Dr. Zhang: Success for this particular study will be evaluated by improving time until tumor growth and the safety of the triplet combination so the primary outcome of this particular study is improving progression free survival. But one of the key secondary endpoints, of course, is to make sure that the benefit of this triplet is worth the potential combined side effects. And then also to follow patients and see if it also improves survival to make patients live longer. Dr. Gilligan: Do we have any sense of how long it'll be before we see outcomes from this? Or results? Dr. Zhang: This is an ongoing international trial enrolling in the US but also spanning Europe, Asia, South America, Australia, and New Zealand sites. It will enroll up to 676 patients, and it's open currently. And patients should discuss it with their oncologist and see if it's open in a site close to them. Dr. Gilligan: Dr. Grivas earlier told us about some of the side effects or risks with immunotherapy. This is combining immunotherapy with targeted therapy. Can you say a little bit about what we're gonna be watching for in terms of side effects or what we might expect? Dr. Zhang: Sure. I think all of the immunotherapy side effects that Dr. Grivas told us about pertain to this study as well. The rashes, the diarrhea, inflammation of the lungs or liver, and affected endocrine dysfunction. But the targeted therapies can also have high blood pressure, rashes on the hand and feet, so called hand foot syndrome, also diarrhea, and elevation of liver enzymes, as well as the loss of protein in the urine. I think the one overlapping toxicity of cabozantinib with a combination of ipilimumab and nivolumab, the immunotherapy combination, is the diarrhea. So patients who start on this trial should be careful to report any diarrhea early on so that their oncologist and their investigators on the study can get an early handle and manage their diarrhea well. Dr. Gilligan: Thank you. That's very helpful. One last question, I want to get back to that issue of eligibility. Sometimes when cancer patients want to go on a trial and they find that they are told they're not eligible to go on, this trial looking at intermediate risk patients specifically so a good risk patient might want to go on it and couldn't. Can you say a little bit about how those decisions are made and what the rationale for selecting groups of patients for trials is? Dr. Zhang: Sure. We know that the IMDC criteria were really made in the setting of targeted therapies, and they were a set of prognostic markers and markers of inflammation, for example, and of time from initial diagnosis to treatment. But now they've been used often as stratification markers in our treatment trials and as selection now for eligibility. In particular for this patient population, ipilimumab, nivolumab seem to have more benefit in this intermediate and poor risk population. And so that's why, for this particular study, they're selecting specifically those patients with intermediate poor-risk disease. Dr. Gilligan: So we want to focus on the patients who are most likely to benefit, it sounds like you're saying. Dr. Zhang: That's right. So the favorable risk patient population do have a better prognosis in general, but those patients may not have as much benefit from the immunotherapy doublet. Dr. Gilligan: All right. Thank you. Well, that brings us to the end of this podcast. Thanks for listening. There are many different clinical trials currently enrolling people with genitourinary cancers. If you're wondering whether participating in a clinical trial might be right for you, please talk to your health care team. This is Timothy Gilligan. Thank you very much. ASCO: Thank you, Drs. Gilligan, Pal, Grivas, and Zhang. Visit www.cancer.net/clinicaltrials to learn more about participating in clinical trials. All treatments have side effects—please talk to your health care team about possible side effects to watch out for. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play. This Cancer.Net podcast is part of the ASCO Podcast Network. This collection of 9 programs offers insight into the world of cancer care, covering a range of educational, inspirational, and scientific content. You can find all 9 shows, including this one, at podcast.asco.org. Cancer.Net is supported by Conquer Cancer, the ASCO Foundation, which funds breakthrough research for every type of cancer, helping patients everywhere. To help fund Cancer.Net and programs like it, donate at conquer.org/donate.
FDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
FDA D.I.S.C.O.: FDA approval of cabozantinib for hepatocellular carcinoma FDA medical oncologists discuss the January 14, 2019, approval of cabozantinib for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
BARCELONA—Oral cabozantinib “significantly improved” overall survival (OS) and progression free survival (PFS) compared to placebo in patients with advanced hepatocellular carcinoma(HCC) whose disease had progressed despite sorafenib therapy in the phase 3 CELESTIAL trial reported to the 2018 ESMO World …Pilippe Marle AJO PRODUCTION MASTER
Prof Stephane Oudard (Georges Pompidou Hospital, Paris, France) and Prof Noel Clarke (The Christie Hospital, Manchester, UK) discuss the implications of negative trial results with ecancertv at ASCO GU 2015 with special focus on the following abstracts: COMET-1: Cabozantinib versus prednisone in metastatic castration-resistant prostate cancer patients previously treated with docetaxel and abiraterone and/or enzalutamide. COMET-2 Final analysis of COMET-2: Cabozantinib versus mitoxantrone/prednisone in metastatic castration-resistant prostate cancer patients with moderate to severe pain who were previously treated with docetaxel and abiraterone and/or enzalutamide. Androgen deprivation therapy plus docetaxel versus ADT alone for hormone-naïve metastatic prostate cancer: Long-term analysis of the GETUG-AFU 15 phase III trial.
Dr Choueiri speaks with ecancertv at ESMO 2016 to discuss results from two trials for novel therapies against metastatic renal cell carcinoma (mRCC). First, he discusses the comparative trial CABOSUN, investigating cabozantinib versus sunitinib, and then a phase 1b dose escalation of checkpoint inhibitor therapy in combination with axitinib. Considering the results of these trials, Dr Choueiri describes his hopes for the future of mRCC care.
Dr Choueiri presents, at a press conference at ESMO 2016, results of the CABOSUN comparitive trial, which assessed outcomes of patients with metastatic rencal cell carcinoma receiving cabozantinib versus sunitnib. Both drugs are tyrosine kinase inhibitors (TKIs) targeting VEGFR, however cabozantinib has additional actions in inhibition of MET and AXL. He describes the results, which demonstrate improved progression free survival in the cabozantinib arm, and considers its progression towards wider adoption and approval.
MILAN, Italy—The first choice of therapy for patients with metastatic kidney cancer who have failed VEGF therapy has changed according to experts at the 2016 European Multidisciplinary Meeting on Urological Cancers (EMUC) who assessed phase 3 study data on …Thomas Powles 1 EMUC PRODUCTION Master
Dr Choueiri speaks with ecancertv at ASCO 2016 about results from METEOR, a randomised phase III trial of cabozantinib for patients with advanced renal cell carcinoma (RCC), compared to everolimus. Cabozantinib displayed a significant impact on previously treated patients, improving median overall survival from 16.5 months in the everolimus arm to 21.4 months for cabozantinib, and a 33% reduction in the rate of death He also highlights the scale of the trial, from the international team gathering data to the impact on standard of care in RCC.
Dr Escudier talks to ecancertv at ASCO GU 2016 about how patients with advanced kidney cancer live for nearly twice as long without their disease progressing if they are treated with cabozantinib, a small molecule tyrosine kinase inhibitor (TKI) that targets c-MET, VEGFR2 and AXL. In the interview he discusses the results of the open-label METEOR trial, which compared the TKI against everolimus, a standard of care in mRCC. The METEOR trial met its primary endpoint of improved progression free survival, and subgroup analyses of the endpoints progression free survival and overall response rate generally favoured cabozantinib over everolimus in patients with advanced RCC.
Prof Toni Choueiri - Dana-Farber Cancer Institute, Boston, USA Prof Choueiri talks to ecancertv at ECC 2015 about how patients with advanced kidney cancer live for nearly twice as long without their disease progressing if they are treated with cabozantinib, a small molecule tyrosine kinase inhibitor (TKI) that targets c-MET, VEGFR2 and AXL.. In the interview he discussed the results of the open-label METEOR trial, which compared the TKI against everolimus, a standard of care in mRCC.
Prof Peter Naredi - University of Gothenburg, Gothenburg, Sweden Dr Naredi, Scientific Chair of the ECC 2015 meeting, gives his highlights. Including comment on: Cabozantinib improves survival in patients with advanced kidney cancer: results from the METEOR trial Nivolumab improves overall survival in patients with advanced kidney cancer: results from the CheckMate 025 trial Rare cancer responds unusually well to new treatment: results from the NETTER-1 trial Everolimus for non-functional neuroendocrine tumours Dabrafenib and trametinib combo shows significant survival benefit in melanoma
A trial studying Cometriq (cabozantinib) for RET rearrangements showed a promising response rate, which led the doctors to discuss if they think RET is going to be the next actionable target in lung cancer.
A trial studying Cometriq (cabozantinib) for RET rearrangements showed a promising response rate, which led the doctors to discuss if they think RET is going to be the next actionable target in lung cancer.
A trial studying Cometriq (cabozantinib) for RET rearrangements showed a promising response rate, which led the doctors to discuss if they think RET is going to be the next actionable target in lung cancer.
A trial comparing Tarceva (erlotinib) to Cometriq (cabozantinib) showed modest benefit for EGFR wild type patients, but the challenging side effect profile should lead us to question if we can identify only patients most likely to benefit from Cometriq.
A trial comparing Tarceva (erlotinib) to Cometriq (cabozantinib) showed modest benefit for EGFR wild type patients, but the challenging side effect profile should lead us to question if we can identify only patients most likely to benefit from Cometriq.
A trial comparing Tarceva (erlotinib) to Cometriq (cabozantinib) showed modest benefit for EGFR wild type patients, but the challenging side effect profile should lead us to question if we can identify only patients most likely to benefit from Cometriq.
This podcast discusses a phase 2 trial of cabozantinib in men with advanced bone-metastatic prostate cancer, using a novel method to assess bone scan response.
Today in FirstWord:
Cometriq (cabozantinib) is already approved for thyroid cancer and is showing promise for late stage kidney cancer.
Cometriq (cabozantinib) is already approved for thyroid cancer and is showing promise for late stage kidney cancer.
Cometriq (cabozantinib) is already approved for thyroid cancer and is showing promise for late stage kidney cancer.
Dr. Heather Wakelee of Stanford University Medical Center discusses whether or not cabozantinib - a drug already approved for thyroid cancer - can help patients with lung cancer. February 2014.
Dr. Heather Wakelee of Stanford University Medical Center discusses whether or not cabozantinib - a drug already approved for thyroid cancer - can help patients with lung cancer. February 2014.
Dr. Heather Wakelee of Stanford University Medical Center discusses whether or not cabozantinib - a drug already approved for thyroid cancer - can help patients with lung cancer. February 2014.
Listen to our next show with Dr. Sergio Giralt of the Memorial Sloan-Kettering Cancer Center to hear about his deep expertise in transplantation and his latest trials including the use of a vaccine in combination with transplant and a gene-targeted approach using cabozantinib.
Listen to our next show with Dr. Sergio Giralt of the Memorial Sloan-Kettering Cancer Center to hear about his deep expertise in transplantation and his latest trials including the use of a vaccine in combination with transplant and a gene-targeted approach using cabozantinib.