Twelve-Month Results From the CISTO Study Comparing Radical Cystectomy Versus Bladder-Sparing Therapy for Recurrent High-Grade Non–Muscle-Invasive Bladder Cancer
John L. Gore, Erika M. Wolff, Michael G. Nash, Bryan A. Comstock, Scott M. Gilbert, Sam S. Chang, Stephanie Chisolm, Douglas B. MacLean, Jonathan L. Wright, Max Kates, Kamal S. Pohar, Thomas J. Guzzo, Trinity J Bivalacqua, Kenneth G. Nepple, Jeffrey S. Montgomery, Kristen R. Scarpato, Solomon L. Woldu, Viraj A. Master, David YT Chen, Matthew Mossanen, Siamak Daneshmand, Brock O’Neil, Mark D. Tyson, Mary E. Westerman, Ashish M. Kamat, Ahmed M. Mansour, Karim Chamie, Stephen B. Riggs, Janet Baack Kukreja, Parth K. Modi, Tullika Garg, Cheri L. Peyton, Jeffrey W. Nix, Rian Dickstein, Adam J. Gadzinski, Alex Sankin, Neal D. Shore, Brian R. Lane, Jeffrey C. Bassett, Sanjay Patel, David Morris, Liam C. Macleod, Eugene K. Lee, Chad R. Ritch, Kristin Follmer, Jenney R. Lee, Sung Min Kim, Larry G. Kessler, Angela B. Smith, on behalf of the CISTO Collaborative group, John L. Gore, Angela B. Smith, Erika M. Wolff, Bryan A. Comstock, Michael G. Nash, Kristin M. Follmer, Jenney R. Lee, Sung Min Kim, Larry G. Kessler, Scott M. Gilbert, Sam S. Chang, Jonathan L. Wright, Max R. Kates, Kamal S. Pohar, Thomas J. Guzzo, Trinity J. Bivalacqua, Kenneth G. Nepple, Jeffrey S. Montgomery, Kristen R. Scarpato, Solomon L. Woldu, Viraj A. Master, David Y.T. Chen, Matthew Mossanen, Siamak Daneshmand, Brock B. O'Neil, Mark D. Tyson, Mary E. Westerman, Ashish M. Kamat, Ahmed M. Mansour, Karim Chamie, Stephen B. Riggs, Janet B. Kukreja, Parth K. Modi, Tullika Garg, Charles C. Peyton, Jeffrey W. Nix, Rian Dickstein, Adam J. Gadzinski, Alex Sankin, Neal D. Shore, Brian R. Lane, Jeffrey C. Bassett, Sanjay Patel, David S. Morris, Liam C. Macleod, Eugene K. Lee, Chad R. Ritch, Stephanie Chisolm, Douglas B. MacLean, Fred Almeida
Abstract
PURPOSE: To compare patient-reported and clinical outcomes between radical cystectomy (RC) and bladder-sparing therapy (BST) in patients with recurrent high-grade non-muscle-invasive bladder cancer (NMIBC). PATIENTS AND METHODS: This pragmatic, prospective observational cohort study was designed with patients, who selected and prioritized outcomes. Eligible adults were candidates for both RC or BST, had previous induction Bacillus Calmette-Guérin (BCG), and received their last treatment within 12 months. The primary outcome was the EORTC-QLQ-C30 physical function scale at 12 months. Secondary outcomes included other EORTC-QLQ-C30 scales, depression, anxiety, bladder cancer-specific quality of life (QOL), financial burden, and cancer-specific outcomes. Targeted maximum likelihood estimation (TMLE) was used to calculate average treatment effect (ATE) estimates between arms. Inverse probability weighted risk ratios (wRR) were calculated using quasi-Poisson regression. RESULTS: = .22). RC was associated with better emotional function, generic health-related QOL, and financial burden, and lower depression and anxiety, while BST was associated with better bowel and sexual health. Cancer-specific survival was 99% for BST versus 96% for RC (wRR, 0.99; 95% CI, 0.97 to 1.01). RC was associated with a higher risk of adverse events and serious adverse events, including a 90-day mortality rate of 2.5%. CONCLUSION: Most patient-prioritized outcomes were similar or better among participants who chose RC compared with BST. These findings support the continued role of RC in managing recurrent high-grade NMIBC.