As reported in JAMA by Catto et al, the phase III iROC trial showed that robot-assisted radical cystectomy with intracorporeal urinary diversion resulted in better 90-day outcomes compared with open radical cystectomy in patients with bladder cancer.
Study Details
In the multicenter trial, 338 patients were randomly assigned between March 2017 and March 2020 to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169). The primary outcome measure was the number of days alive and out of hospital within 90 days of surgery. A total of 156 vs 149 patients who underwent assigned surgery were included in the primary analysis. Final follow-up was in September 2021.
Key Findings
The median number of days alive and out of hospital within 90 days of surgery was 82 (interquartile range [IQR] = 76–84 days) in the robotic surgery group vs 80 days (IQR = 72–83 days) in the open surgery group (adjusted difference = 2.2 days, 95% confidence interval [CI] = 0.50–3.85, P = .01).
Death within 90 days occurred in two patients (1.2%) in the robotic surgery group (due to cardiorespiratory failure in one and cancer progression in one) and four patients (2.6%) in the open surgery group (due to intra-abdominal sepsis/laparotomy/organ failure in two, pulmonary embolus in one, and cancer progression in one).
Thromboembolic complications occurred in 1.9% vs 8.3% of patients (difference = –6.5%, 95% CI = –11.4% to –1.4%) and wound complications occurred in 5.6% vs 16.0% (difference = –11.7%, 95% CI = –18.6% to –4.6%).
Patients in the open surgery group had worse quality of life at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores = –0.07, 95% CI = –0.11 to –0.03, P = .003) and greater rates of disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores = 0.48, 95% CI = 0.15–0.73, P = .003) and 12 weeks (difference = 0.38, 95% CI = 0.09–0.68, P = .01). No significant differences in these measures were observed after 12 weeks.
At a median follow-up of 18.4 months (IQR = 12.8–21.1 months), disease recurrence was observed in 18% vs 16% of patients (hazard ratio [HR] = 0.9, 95% CI = 0.53–1.54, P = .70); recurrence within 90 days of surgery was observed in two (1.2%) vs four (2.6%) patients. Death from any cause occurred in 14.3% vs 14.7% of patients (HR = 1.06, 95% CI = 0.60–1.90, P = .80).
The investigators concluded, “Among patients with nonmetastatic bladder cancer undergoing radical cystectomy, treatment with robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy resulted in a statistically significant increase in days alive and out of the hospital over 90 days. However, the clinical importance of these findings remains uncertain.”
James W.F. Catto, PhD, of The Medical School, University of Sheffield, is the corresponding author for the JAMA article.
Disclosure: The study was funded by The Urological Foundation and The Champniss Foundation. For full disclosures of the study authors, visit jamanetwork.com.
