Twelve-Month Results From the CISTO Study Comparing Radical Cystectomy Versus Bladder-Sparing Therapy for Recurrent High-Grade Non–Muscle-Invasive Bladder Cancer
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 Of 570 participants (mean age 71.4 years; 21% female), 371 selected BST and 199 selected RC. Physical function was significantly worse in the RC arm at 3 months; by 9 months, there was no difference between arms, and at 12 months, physical function did not differ (ATE, 0.9; 95% CI, –0.6 to 2.4; P = .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.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (71)
John L. Gore
Department of Urology, Seattle Cancer Care Alliance, University of Washington, Seattle, WA
Angela B. Smith
Erika M. Wolff
Department of Urology, University of Washington, Seattle, WA
Bryan A. Comstock
Department of Biostatistics, University of Washington, Seattle, WA
Michael G. Nash
Kristin M. Follmer
Department of Urology, University of Washington, Seattle, WA
Jenney R. Lee
Department of Urology, University of Washington, Seattle, WA
Sung Min Kim
Larry G. Kessler
Scott M. Gilbert
Department of Genitourinary Oncology, H. Lee Moffit Cancer Center and Research Institute, Tampa, FL
Sam S. Chang
Vanderbilt University Medical Center, Nashville, TN
Jonathan L. Wright
University of Washington, Seattle, WA
Max R. Kates
Department of Urology, The James Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD
Kamal S. Pohar
Department of Urology, The Ohio State University, Columbus, OH
Thomas J. Guzzo
Division of Urology, Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
Trinity J. Bivalacqua
Kenneth G. Nepple
University of Iowa and Clinic Holden Cancer Center, Iowa City, IA
Jeffrey S. Montgomery
Department of Urology, Michigan Medicine, Ann Arbor, MI
Kristen R. Scarpato
Department of Urology, Vanderbilt University Medical Center, Nashville, TN
Solomon L. Woldu
Department of Urology, UT Southwestern Medical Center, Dallas, TX
Viraj A. Master
David Y.T. Chen
Department of Urology, Fox Chase Cancer Center, Philadelphia, PA
Matthew Mossanen
Siamak Daneshmand
Department of Urology, Keck School of Medicine of University of Southern California, Norris Comprehensive Cancer Center
Brock B. O'Neil
Division of Urology, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT
Mark D. Tyson
Department of Urology, Mayo Clinic, Scottsdale, AZ
Mary E. Westerman
University of North Carolina, Chapel Hill, NC
Ashish M. Kamat
Ahmed M. Mansour
Department of Urology, University of Texas Health, San Antonio, TX
Karim Chamie
David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA
Stephen B. Riggs
Department of Urology, Levine Cancer Institute, Atrium Health, Charlotte, NC
Janet B. Kukreja
Department of Urology, University of Colorado, Denver, CO
Parth K. Modi
Section of Urology, Department of Surgery, University of Chicago, Chicago, IL
Tullika Garg
Department of Urology, Geisinger Health System, Danville, PA
Charles C. Peyton
Department of Urology, University of Alabama at Birmingham, Birmingham, AL
Jeffrey W. Nix
Department of Urology, University of Alabama, Birmingham, AL
Rian Dickstein
Chesapeake Urology, Baltimore, MD
Adam J. Gadzinski
Comprehensive Urology, Royal Oak, MI
Alex Sankin
Department of Urology, Montefiore Medical Center and Albert Einstein School of Medicine, Bronx, NY
Neal D. Shore
START Carolinas/Carolina Urologic Research Center, Myrtle Beach, SC
Brian R. Lane
Division of Urology, Corewell Health West, Grand Rapids, MI
Jeffrey C. Bassett
Department of Urologic Oncology, Hoag Memorial Presbyterian Hospital, Newport Beach, CA
Sanjay Patel
Heart Research Institute; Faculty of Medicine and Health, The University of Sydney Sydney New South Wales Australia
David S. Morris
Urology Associates, PC, Nashville, TN
Liam C. Macleod
Department of Urology and Heiman Cancer Center, Asante Rogue Regional Medical Center, Medford, OR
Eugene K. Lee
Department of Urology, University of Kansas Medical Center, Kansas City, KS
Chad R. Ritch
Desai Sethi Urology Institute, University of Miami Miller School of Medicine, Miami, FL
Stephanie Chisolm
Bladder Cancer Advocacy Network, Bethesda, MD
Douglas B. MacLean
CISTO Advocate Advisory Board, Seattle, WA
Fred Almeida
Mary Beth Ballard Murray
Nancy Lindsey
Robert Lipman
Richard M. Oliver
Lori A. Roscoe
Karen Sachse
Inova Alexandria Hospital, Alexandria, VA
Yair Lotan
Department of Urology, UT Southwestern Medical Center, Dallas, TX
Sima P. Porten
Jennifer M. Taylor
Gary D. Steinberg
Rush University Medical Center, Chicago, IL
James W.F. Catto
Division of Clinical Medicine, University of Sheffield, Sheffield, United Kingdom
Tracy M. Downs
Jennifer L. Malin
Elai Davicioni
Patricia Rios
Marielle Yano
Grace Jun
University of Washington, Seattle, WA
Casey Li
Christopher Nefcy
Anirban Basu
Patrick J. Heagerty