Department of Urology, University of Miami, Miami, Florida.
Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.
J Urol. 2020 Mar;203(3):522-529. doi: 10.1097/JU.0000000000000565. Epub 2019 Sep 24.
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.
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.
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.
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.
RAZOR（随机开放与机器人根治性膀胱切除术）试验显示，机器人根治性膀胱切除术在 2 年内无进展生存率无差异。本研究进行了扩展随访 3 年，以确定两种方法之间的潜在差异。我们还报告了 3 年总生存率，并试图确定预测复发、无进展生存率和总生存率的因素。
我们分析了 RAZOR 研究中 302 名患者的方案人群。使用非膀胱癌死亡作为竞争风险事件来估计累积复发率，并应用 Gray 检验评估差异的显著性。无进展生存率和总生存率采用 Kaplan-Meier 法估计，并采用对数秩检验进行比较。采用 Cox 比例风险分析确定结局的预测因素。
36 个月时，机器人组和开放组的无进展生存率分别为 68.4%（95%CI 60.1-75.3）和 65.4%（95%CI 56.8-72.7）（p=0.600）。36 个月时，机器人组和开放组的总生存率分别为 73.9%（95%CI 65.5-80.5）和 68.5%（95%CI 59.8-75.7）（p=0.334）。两组累积复发率无显著差异（p=0.802）。患者年龄大于 70 岁、一般状况差和主要并发症是 36 个月无进展生存率的显著预测因素。分期和阳性切缘是复发、无进展生存率和总生存率的显著预测因素。手术方式不是任何结局的显著预测因素。
本分析显示，机器人与开放根治性膀胱切除术在复发、3 年无进展生存率或 3 年总生存率方面无差异。它提供了机器人根治性膀胱切除术在肿瘤学疗效方面的重要前瞻性数据，并为患者咨询提供了高级别的数据。
