In a randomized controlled trial published by the group in Memorial Sloan Kettering, open cystectomy was compared to robotic cystectomy.1 Included in the trial were 118 bladder cancer patients with Ta-3N0-3 disease. The primary endpoint was 90-day clavien 2-5 adverse effects, and the secondary endpoints included recurrence-free survival, cancer-specific survival, and overall survival. This was a negative study demonstrating no difference between the two arms. Importantly the robotic cystectomy in this trial was done with extra-corporeal urinary diversion. The robotic procedure did not reduce the adverse events rates within 90 days of surgery, and surgery length and hospital stay were the same in both arms. No difference was observed in cancer control or overall survival.
The other important randomized controlled trial was the RAZOR study, which was a phase 3 non-inferiority open-label randomized controlled trial comparing open and robotic cystectomy.2 The included 350 patients had T1-4N0-1M0 disease. The primary endpoint was 2-year progression free survival. The results demonstrated that the 2-year progression free survival was 72.3% in the RARC group and 71.6% in the open cystectomy group, indicating non-inferiority of robotic radical cystectomy. In this trial, robotic cystectomy with extracorporeal urinary diversion was associated with a lower perioperative blood transfusion rate and decreased length of hospital stay. However, no difference was seen in the adverse events between both arms.
Dr. Fairey summarized his talk, concluding that the best evidence to date suggests that open radical cystectomy is the standard of care surgical treatment for muscle-invasive bladder cancer. Multiple open radical cystectomy series have shown excellent perioperative and survival outcomes in this modality. Lastly, robotic radical cystectomy should not be recommended as a surgical treatment modality, outside of a clinical trial in 2019 in Canada. The data from these two randomized controlled data are quite convincing according to Dr. Fairey and represent solid level one evidence. Until further level one evidence comes along, open radical cystectomy should be the only possible option offered to patients with muscle-invasive bladder cancer.
Presented by: Adrian Fairey, MD, MS, Urologic Surgeon, Assistant Professor, Division of Urology, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada
Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre, Twitter: @GoldbergHanan at the CUOS – Canadian Uro-Oncology Summit 2019, #CUOS19 January 10-12, 2019 Westin Harbour Castle, Toronto, Ontario, Canada
1. Bochner BH. Et al. Eur Urol 2018
2. Parekh DJ et al. Lancet 2018
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Robotic Radical Cystectomy, Controversial Topics in Urothelial Carcinoma