The evolving treatment landscape of muscle-invasive bladder cancer (MIBC) increasingly warrants novel trial design to evaluate perioperative strategies aimed at bladder preservation. To establish standardized outcome measures for evaluating organ preservation strategies in MIBC, the International Bladder Cancer Group (IBCG) and the Global Society of Rare Genitourinary Tumors (GSRGT) assembled an international, multidisciplinary consensus panel.
The IBCG and GSRGT gathered global bladder cancer experts and patient advocates to establish a framework for risk-adapted bladder-sparing treatment approaches for MIBC. Working groups reviewed the literature and developed draft recommendations, which were discussed at a live meeting in December 2024 in Milan. This was followed by voting by the members using a modified Delphi process. Recommendations achieving ≥75% agreement during the meeting were further refined and presented.
Clinical complete response (cCR) definition should encompass the absence of high-grade malignancy on pathology and malignant cells on urine cytology and no evidence of local or metastatic disease on cross-sectional imaging. Although cCR remains immature as a primary or coprimary end point in registrational trials, it could serve as a suitable end point in early-phase studies and risk-adapted investigations. Event-free survival (EFS) remains the preferred primary end point as it could reliably capture the durability of clinically meaningful benefit after omittance of surgical consolidation or chemoradiation. Given the composite nature of EFS, events should be prespecified, evaluated in an intention-to-treat approach, and meticulously collected. Continuous assessment of individual patient preferences should begin at the outset of perioperative therapy discussions, with informed decision making prioritized throughout.
The consensus definition of cCR and the framework presented in this study can serve as a foundation for thorough testing of risk-adapted bladder-sparing treatment paradigms for MIBC.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2025 Sep 11 [Epub ahead of print]
Andrea Necchi, Matthew D Galsky, Nazli Dizman, David H Aggen, Neeraj Agarwal, Hikmat Al-Ahmadie, Andrea B Apolo, Leslie Ballas, Rick Bangs, Peter C Black, Maurizio Brausi, Giorgio Brembilla, Liang Cheng, Arturo Chiti, Alessia Cimadamore, Maurizio Colecchia, Siamak Daneshmand, Savino Di Stasi, Jason A Efstathiou, Alex Filicevas, Daniel M Geynisman, Petros Grivas, Shilpa Gupta, Alexia Iasonos, Nick D James, Seth P Lerner, Yohann Loriot, Lydia E Makaroff, Fernando Maluf, Marco Moschini, Irina Ostrovnaya, Sumanta K Pal, Elizabeth R Plimack, Gagan Prakash, Sarah P Psutka, Jonathan E Rosenberg, Sarmad Sadeghi, Bogdana Schmidt, Lawrence H Schwartz, Guru P Sonpavde, Marie-Pier St Laurent, Dingwei Ye, Philippe E Spiess, Ashish M Kamat
Vita-Salute San Raffaele University, Milan, Italy., Icahn School of Medicine at Mount Sinai, New York, NY., The University of Texas MD Anderson Cancer Center, Houston, TX., Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY., Huntsman Cancer Institute (NCI-CCC), University of Utah, Salt Lake City, UT., Department of Pathology, Memorial Sloan-Kettering Cancer Center (MSKCC), New York, NY., Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD., Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA., Bladder Cancer Advocacy Network, Bethesda, MD., Department of Urologic Sciences, Vancouver Prostate Centre, University of British Columbia, Vancouver, BC, Canada., Department of Urology, Hesperia Hospital, Modena, Italy., Department of Radiology, IRCCS San Raffaele Hospital, Milan, Italy., Department of Surgery (Urology), Brown University Warren Alpert Medical School, Providence, RI., Department of Medicine, Institute of Pathological Anatomy, University of Udine, Udine, Italy., Department of Urology, USC/Norris Comprehensive Cancer Center, Los Angeles, CA., Catholic University "Our Lady of Good Counsel", Tirana, Albania., Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA., World Bladder Cancer Patient Coalition, Brussels, Belgium., Fox Chase Cancer Center-Temple University Health System, Philadelphia, PA., University of Washington, Fred Hutchinson Cancer Center, Seattle, WA., Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, OH., Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY., Institute of Cancer Research, London, United Kingdom., Baylor College of Medicine, Houston, TX., Early Drug Development Department, Gustave Roussy, Villejuif, France., Hospital Israelita Albert Einstein, São Paulo, Brazil., Department of Urology, IRCCS San Raffaele Hospital, Milan, Italy., Division of Medical Oncology, City of Hope Cancer Center, Duarte, CA., Department of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India., Department of Urology, University of Washington, Fred Hutchinson Cancer Center, Seattle, WA., Department of Medicine, USC/Norris Comprehensive Cancer Center, Los Angeles, CA., University of Utah, Salt Lake City, UT., Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY., AdventHealth Cancer Institute, Orlando, FL., Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, PR China., Department of GU Oncology, Moffitt Cancer Center, Tampa, FL., Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.