The randomized open versus robotic cystectomy (RAZOR) trial reported non-inferior 2-year progression-free survival (PFS) for robotic radical cystectomy (RARC). This update was performed with extended follow-up for 3 years to demonstrate potential differences between the approaches.
We also report 3-year overall survival (OS) and aim to identify factors predicting recurrence, PFS and OS.
The per-protocol population of 302 patients from RAZOR study was analyzed. Cumulative recurrences were estimated using non-bladder cancer death as the competing risk event and Gray's test was used to assess significance in differences. PFS and OS were estimated by Kaplan-Meier method and compared using the log rank test. Predictors of outcomes were determined by Cox proportional hazard analysis.
Estimated PFS at 36 months was 68.4% (95% CI 60.1-75.3%) and 65.4% (95% CI 56.8-72.7%) in the robotic and open groups respectively (p=0.600). OS at 36 months was 73.9% (95% CI 65.5-80.5%) and 68.5% (95% CI 59.8-75.7%) for the robotic and open group respectively (p=0.334). There was no significant difference in the cumulative incidence rates of recurrence (p=0.802). Age >70 years, poor performance status and major complications were significant predictors of PFS and OS. Stage and positive margins were significant predictors of recurrence, PFS and OS. Surgical approach was not a significant predictor of any outcome.
This analysis shows no difference in recurrence, 3-year PFS and 3-year OS between RARC and ORC. It provides important prospective data on the oncologic efficacy of RARC and high-level data for patient counseling.
The Journal of urology. 2019 Sep 24 [Epub ahead of print]
Vivek Venkatramani, Isildinha M Reis, Erik P Castle, Mark L Gonzalgo, Michael E Woods, Robert S Svatek, Alon Z Weizer, Badrinath R Konety, Mathew Tollefson, Tracey L Krupski, Norm D Smith, Ahmad Shabsigh, Daniel A Barocas, Marcus L Quek, Atreya Dash, Adam S Kibel, Raj S Pruthi, Jeffrey Scott Montgomery, Christopher J Weight, David S Sharp, Sam S Chang, Michael S Cookson, Gopal N Gupta, Alex Gorbonos, Edward M Uchio, Eila Skinner, Nachiketh Soodana-Prakash, Maria F Becerra, Sanjaya Swain, Kerri Kendrick, Joseph A Smith, Ian M Thompson, Dipen J Parekh
Department of Urology, University of Miami Miller School, Miami, Florida., Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida., Department of Urology, Mayo Clinic, Phoenix, Arizona., Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina., Division of Urologic Oncology, Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, Texas., Department of Urology, University of Michigan, Ann Arbor, Michigan., Department of Urology, University of Minnesota, Minneapolis, Minnesota., Department of Urology, University of Virginia Health Science Center, Charlottesville, Virginia., Department of Urology, University of Chicago, Chicago, Illinois., Department of Urology, Ohio State University, Columbus, Ohio., Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee., Department of Urology, Loyola University Medical Center, Maywood, Illinois., Department of Urology, University of Washington, Seattle, Washington., Harvard Medical School, Boston, Massachusetts., Department of Urology, Oklahoma University of Oklahoma, Norman, Oklahoma., Department of Urology, University of California at Irvine, Irvine, California., Department of Urology, Stanford University, Stanford, California., CHRISTUS Santa Rosa Medical Center Hospital, San Antonio, Texas.