There is a significant unmet need for new and efficacious therapies in urothelial cancer (UC). To provide recommendations on appropriate clinical trial designs across disease settings in UC, the Society for Immunotherapy of Cancer (SITC) and the International Bladder Cancer Group (IBCG) convened a multidisciplinary, international consensus panel.
Through open communication and scientific debate in small- and whole-group settings, surveying, and responses to clinical questionnaires, the consensus panel developed recommendations on optimal definitions of the disease state, end points, trial design, evaluations, sample size calculations, and pathology considerations for definitive studies in low- and intermediate-risk nonmuscle-invasive bladder cancer (NMIBC), high-risk NMIBC, muscle-invasive bladder cancer in the neoadjuvant and adjuvant settings, and metastatic UC. The expert panel also solicited input on the recommendations through presentations and public discussion during an open session at the 2021 Bladder Cancer Advocacy Network (BCAN) Think Tank (held virtually).
The consensus panel developed a set of stage-specific bladder cancer clinical trial design recommendations, which are summarized in the table that accompanies this text.
These recommendations developed by the SITC-IBCG Bladder Cancer Clinical Trial Design consensus panel will encourage uniformity among studies and facilitate drug development in this disease.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2023 Oct 04 [Epub ahead of print]
Ashish M Kamat, Andrea B Apolo, Marek Babjuk, Trinity J Bivalacqua, Peter C Black, Roger Buckley, Matthew T Campbell, Eva Compérat, Jason A Efstathiou, Petros Grivas, Shilpa Gupta, Neil J Kurtz, Donald Lamm, Seth P Lerner, Roger Li, David J McConkey, Joan Palou Redorta, Thomas Powles, Sarah P Psutka, Neal Shore, Gary D Steinberg, Richard Sylvester, J Alfred Witjes, Matthew D Galsky
Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX., Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD., Department of Urology, Teaching Hospital Motol, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic., Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada., Division of Urology, Department of Surgery, University of Pennsylvania, Philadelphia, PA., Department of Urology, North York General Hospital, Toronto, Ontario, Canada., Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX., Department of Pathology, Medical University of Vienna, Vienna, Austria., Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA., Department of Medicine, Division of Oncology, University of Washington; Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA., Department of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH., Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY., Patient Advocate, Bladder Cancer Advocacy Network (BCAN), Bethesda, MD., BCG Oncology, Phoenix, AZ., Scott Department of Urology, Dan L Duncan Cancer Center, Baylor College of Medicine, Houston, TX., Department of Genitourinary Oncology, H Lee Moffitt Cancer Center, Tampa, FL., Johns Hopkins Greenberg Bladder Cancer Institute, Johns Hopkins University, Baltimore, MD., Department of Urology, Fundació Puigvert, Universitat Autònoma de Barcelona, Barcelona, Spain., Queen Mary University of London, London, United Kingdom., Department of Urology, University of Washington, Fred Hutchinson Cancer Center, Seattle, WA., Carolina Urologic Research Center, Myrtle Beach, SC., Department of Urology, Rush University Medical Center, Chicago, IL., EAU NMIBC Guidelines Panel, Arnhem, the Netherlands., Radboud University Medical Center, Nijmegen, the Netherlands.