IBCN 2017: Trial design for BCG unresponsive Non-Muscle Invasive Bladder Cancer

Lisbon, Portugal (UroToday.com) Ashish M. Kamat from MD Anderson, Houston, TX discussed clinical trial designs for BCG unresponsive non-muscle invasive bladder cancer (NMIBC). Clinical trial designs have been plagued by confusion of interpretation of findings not only by clinicians, researchers but also by the FDA and other regulatory agencies. Furthermore, recent European Association of Urology (EAU) and American Urological Association (AUA) revised guidelines have risk stratification which do not necessarily match and careful consideration of which organization and risk stratification is needed. Definition of BCG failure should be adequate BCG therapy (induction plus 1 course maintenance) with failure within 6mo. Decision timing is important as additional immune response needed as 64% failures are salvaged by 3 week maintenance of BCG. It is critical to not call a BCG failure sooner than above to ensure adequate treatments and clinical trial design.

Speaker(s): Randy Sweis, The University of Chicago; John Rodriguez-Faba, Mount Sinai, New York, New York; Colin PN Dinney, MD Anderson, Houston, TX

Written by: Stephen B. Williams, M.D., Associate Professor, Division of Urology, The University of Texas Medical Branch, Galveston, TX. and Ashish M. Kamat, M.D. Professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX., at the International Bladder Cancer Network - October 21, 2017- Lisbon, Portugal

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