Vivek Venkatramani1, Isildinha M Reis2, Erik P Castle3, Mark L Gonzalgo1,4, Michael E Woods5, Robert S Svatek6, Alon Z Weizer7, Badrinath R Konety8, Mathew Tollefson3, Tracey L Krupski9, Norm D Smith10, Ahmad Shabsigh11, Daniel A Barocas12, Marcus L Quek13, Atreya Dash14, Adam S Kibel15,16, Raj S Pruthi5, Jeffrey Scott Montgomery7, Christopher J Weight8, David S Sharp11, Sam S Chang12, Michael S Cookson17, Gopal N Gupta13, Alex Gorbonos13, Edward M Uchio18, Eila Skinner19, Nachiketh Soodana-Prakash1, Maria F Becerra1, Sanjaya Swain1, Kerri Kendrick6, Joseph A Smith12, Ian M Thompson20, Dipen J Parekh1,4. 1. Department of Urology, University of Miami, Miami, Florida. 2. Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida. 3. Department of Urology, Mayo Clinic, Phoenix, Arizona. 4. Sylvester Comprehensive Cancer Center, Miami, Florida. 5. Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. 6. Division of Urologic Oncology, Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. 7. Department of Urology, University of Michigan, Ann Arbor,Michigan. 8. Department of Urology, University of Minnesota, Minneapolis, Minnesota. 9. Department of Urology, University of Virginia Health Science Center, Charlottesville, Virginia. 10. Department of Urology, University of Chicago, Chicago, Illinois. 11. Department of Urology, Ohio State University, Columbus, Ohio. 12. Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee. 13. Department of Urology, Loyola University Medical Center, Maywood, Illinois. 14. Department of Urology, University of Washington, Seattle, Washington. 15. Harvard Medical School, Boston, Massachusetts. 16. Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts. 17. Department of Urology, Oklahoma University of Oklahoma, Norman, Oklahoma. 18. Department of Urology,University of California at Irvine, Irvine, California. 19. Department of Urology, Stanford University, Stanford, California. 20. CHRISTUS Santa Rosa Medical Center Hospital, San Antonio, Texas.
Abstract
PURPOSE: The RAZOR (Randomized Open versus Robotic Cystectomy) trial revealed noninferior 2-year progression-free survival for robotic radical cystectomy. This update was performed with extended followup for 3 years to determine potential differences between the approaches. We also report 3-year overall survival and sought to identify factors predicting recurrence, and progression-free and overall survival. MATERIALS AND METHODS: We analyzed the per protocol population of 302 patients from the RAZOR study. Cumulative recurrence was estimated using nonbladder cancer death as the competing risk event and the Gray test was applied to assess significance in differences. Progression-free survival and overall survival were estimated by the Kaplan-Meier method and compared with the log rank test. Predictors of outcomes were determined by Cox proportional hazard analysis. RESULTS:Estimated progression-free survival 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). At 36 months overall survival was 73.9% (95% CI 65.5-80.5) and 68.5% (95% CI 59.8-75.7) in the robotic and open groups, respectively (p=0.334). There was no significant difference in the cumulative incidence rates of recurrence (p=0.802). Patient age greater than 70 years, poor performance status and major complications were significant predictors of 36-month progression-free survival. Stage and positive margins were significant predictors of recurrence, and progression-free and overall survival. Surgical approach was not a significant predictor of any outcome. CONCLUSIONS: This analysis showed no difference in recurrence, 3-year progression-free survival or 3-year overall survival for robotic vs open radical cystectomy. It provides important prospective data on the oncologic efficacy of robotic radical cystectomy and high level data for patient counseling.
RCT Entities:
PURPOSE: The RAZOR (Randomized Open versus Robotic Cystectomy) trial revealed noninferior 2-year progression-free survival for robotic radical cystectomy. This update was performed with extended followup for 3 years to determine potential differences between the approaches. We also report 3-year overall survival and sought to identify factors predicting recurrence, and progression-free and overall survival. MATERIALS AND METHODS: We analyzed the per protocol population of 302 patients from the RAZOR study. Cumulative recurrence was estimated using nonbladder cancer death as the competing risk event and the Gray test was applied to assess significance in differences. Progression-free survival and overall survival were estimated by the Kaplan-Meier method and compared with the log rank test. Predictors of outcomes were determined by Cox proportional hazard analysis. RESULTS: Estimated progression-free survival 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). At 36 months overall survival was 73.9% (95% CI 65.5-80.5) and 68.5% (95% CI 59.8-75.7) in the robotic and open groups, respectively (p=0.334). There was no significant difference in the cumulative incidence rates of recurrence (p=0.802). Patient age greater than 70 years, poor performance status and major complications were significant predictors of 36-month progression-free survival. Stage and positive margins were significant predictors of recurrence, and progression-free and overall survival. Surgical approach was not a significant predictor of any outcome. CONCLUSIONS: This analysis showed no difference in recurrence, 3-year progression-free survival or 3-year overall survival for robotic vs open radical cystectomy. It provides important prospective data on the oncologic efficacy of robotic radical cystectomy and high level data for patient counseling.
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