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Clinical Trial
. 2020 Mar;203(3):522-529.
doi: 10.1097/JU.0000000000000565. Epub 2019 Sep 24.

Predictors of Recurrence, and Progression-Free and Overall Survival following Open versus Robotic Radical Cystectomy: Analysis from the RAZOR Trial with a 3-Year Followup

Vivek Venkatramani  1 , Isildinha M Reis  2 , Erik P Castle  3 , Mark L Gonzalgo  1   4 , Michael E Woods  5 , Robert S Svatek  6 , Alon Z Weizer  7 , Badrinath R Konety  8 , Mathew Tollefson  3 , Tracey L Krupski  9 , Norm D Smith  10 , Ahmad Shabsigh  11 , Daniel A Barocas  12 , Marcus L Quek  13 , Atreya Dash  14 , Adam S Kibel  15   16 , Raj S Pruthi  5 , Jeffrey Scott Montgomery  7 , Christopher J Weight  8 , David S Sharp  11 , Sam S Chang  12 , Michael S Cookson  17 , Gopal N Gupta  13 , Alex Gorbonos  13 , Edward M Uchio  18 , Eila Skinner  19 , Nachiketh Soodana-Prakash  1 , Maria F Becerra  1 , Sanjaya Swain  1 , Kerri Kendrick  6 , Joseph A Smith Jr  12 , Ian M Thompson  20 , Dipen J Parekh  1   4
Affiliations
Clinical Trial

Predictors of Recurrence, and Progression-Free and Overall Survival following Open versus Robotic Radical Cystectomy: Analysis from the RAZOR Trial with a 3-Year Followup

Vivek Venkatramani et al. J Urol. 2020 Mar.

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.

Keywords: bladder neoplasms; cystectomy; mortality; neoplasm recurrence; robotic surgical procedures.

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Conflict of interest statement

Financial interest and/or other relationship with UNC Urology.

Figures

Figure 1.
Figure 1.. Progression-free survival (A) and overall survival (B) by surgical groups.
| Tick marker for censored observations.
Figure 2.
Figure 2.. Cumulative incidence of recurrence, taking into account non-cancer death as a competing risk, by surgical group (A), pathological stage (B) and surgical margin (C).
| Tick marker for censored observations.
See this image and copyright information in PMC

References

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    1. Gray RJ: A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1988; 16: 1141.

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