The randomised phase 3 iROC trial (NCT03049410) was designed to compare robotically assisted radical cystectomy with open radical cystectomy in patients with urothelial cell carcinoma (n=338; mean age 69 years). During the opening session of EAU 2022, Prof. James Catto (University of Sheffield, UK) presented the results of the trial. The number of days alive and out of hospital within 90 days of surgery (DAOH90) was the primary outcome of this study, including both the length of stay and readmissions.
The DAOH90 was significantly lower in the robotic surgery arm than in the open surgery arm (median 82 vs 80 days; P=0.01). Prof. Catto added that both the length of stay (median 7 vs 8 days; P=0.045) and the readmission rates (21.8% vs 32.2%; P=0.04) contributed to the favourable DAOH90 outcomes for patients in the robotic surgery arm.
Several quality-of-life measures indicated an improved quality of life 5 to 12 days after surgery for patients in the robotic surgery arm. However, 26 days after surgery, the quality-of-life outcomes were comparable for those who underwent robotic surgery and those who received open surgery.
Wound infections (5.6% vs 17.3%) and thromboembolic events (1.9% vs 8.3%) were more common in patients who underwent open surgery. There were no substantial differences in mortality rates (14.3% vs 14.7%; P=0.8) or cancer recurrence rates (18% vs 16%) between the 2 study arms.
Prof. Catto concluded that the iROC trial showed that robotic surgery may offer benefits over open surgery in patients with urothelial carcinoma, but that the clinical importance of the observed differences remains uncertain.
1. Catto J, et al. Effect of robot-assisted radical cystectomy with intracorporeal urinary diversion vs. open radical cystectomy on 90-day morbidity and mortality among patients with bladder cancer: a randomized clinical trial. Game-Changing Session 1, EAU 2022, 01–04 July.