There are multiple ongoing and planned clinical trials that are evaluating novel therapies to treat patients with BCG-unresponsive high grade nonmuscle invasive bladder cancer (NMIBC). Importantly, there is considerable variation in surveillance strategies between these clinical trials, specifically with regards to the use of advanced imaging, enhanced cystoscopy, and mandatory biopsies, which could impact landmark efficacy assessments of investigational agents. To present guideline recommendations for the standardization of cystoscopic evaluation, surveillance, and efficacy assessments for patients with BCG-unresponsive NMIBC participating in clinical trials. On September 29, 2023 at the annual meeting of the International Bladder Cancer Network, a breakout session was convened, during which representatives from various disciplines discussed potential guidance statements with opportunity for discussion and comment. A set of statements regarding use of white light and enhanced cystoscopy were developed to help guide a pragmatic approach to surveillance and efficacy assessments of patients in clinical trials. The use of "for cause" and "mandatory" biopsies was also addressed. A standard approach to evaluation of patients within the context of clinical trials is necessary to accurately assess the efficacy of novel agents, especially within single arm trials that lack an appropriate comparator. Additionally, the utilization and timing of mandatory biopsies is critical, as these biopsies may impact both disease evaluations and the determination of duration of response.
Urologic oncology. 2024 Feb 01 [Epub ahead of print]
Yair Lotan, Piyush Agarwal, Peter Black, Rian Dickstein, Ashish M Kamat, Byron Lee, Vikram M Narayan, Sima Porten, Sarah P Psutka, Armine K Smith, Robert S Svatek, Stephen B Williams, Solomon Woldu
University of Texas Southwestern Medical Center, Dallas, TX. Electronic address: ., Department of Surgery-Urology, University of Chicago., Department of Urologic Sciences, University of British Columbia., Department of Surgery-Urology, University of Maryland BWMC., University of Texas MD Anderson Cancer Center, Houston, TX., Department of Urology, Glickman Urological and Kidney Institute., Department of Urology, Emory University School of Medicine., Department of Urology, University of California, San Francisco., Department of Urology, University of Washington, Fred Hutchinson Cancer Center., Johns Hopkins University, Brady Urological Institute., Department of Urology, University of Texas Health Science Center at San Antonio., Division of Urology, Department of Surgery, University of Texas, Medical Branch Health System., University of Texas Southwestern Medical Center, Dallas, TX.