Patients who underwent robotic-assisted radical cystectomy with intracorporeal diversion spent fewer days in the hospital and experienced fewer complications compared with those who underwent open radical cystectomy, according to data presented at the 2022 American Urological Association (AUA) Annual Meeting.1 These findings were published simultaneously in JAMA.2
Key Findings and Study Background
Results of the randomized, phase III trial of 317 patients with nonmetastatic bladder cancer showed a median of 82 vs 80 days alive and out of the hospital within 90 days of surgery for patients who underwent robotic vs open surgery (adjusted difference, 2.2 days; 95% confidence interval [CI] = 0.50–3.85, P = .01). Researchers also reported that patients undergoing robotic surgery experienced fewer complications than those in the open-surgery arm.
“This trial shows that patients who undergo robotic cystectomy have shorter times in the hospital, fewer wound complications, fewer clots in their legs and lungs, and overall patients are happier in their quality of life,” said lead study author Pramit Khetrapal, PhD, Academic Clinical Fellow in Urology at Barts Health NHS Trust in London. “Of note, there was no difference in overall cancer specific-survival.”
“Patients who underwent open radical cystectomy experienced three times as many wound-related complications and four times as many venous thromboembolism events [compared with those who underwent robot-assisted surgery].”— Pramit Khetrapal, PhD
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As Dr. Khetrapal explained, current guidelines recommend radical cystectomy with pelvic lymphadenectomy for aggressive bladder cancer. Because individuals with bladder cancer often have coexisting illnesses, however, morbidity from complications after cystectomy can be considerable. Most patients develop one or more complications, 20% require intervention after radical cystectomy, and 20% to 30% are readmitted after discharge, said Dr. Khetrapal.
Given the prevalence of coexisting illnesses, patients undergoing radical cystectomy may benefit more than others from robot-assisted surgery. According to Dr. -Khetrapal, however, the advantage of minimal-access surgery using a robotic platform to perform radical cystectomy and intracorporeal diversion is unclear in the current scientific literature, and the potential for gain such as early recovery and reduced complication rates is largely based on observational case series.
Study Methods
iROC is a phase III, multicenter, unblinded, randomized trial conducted at nine National Health Service cancer centers in the United Kingdom. Dr. Khetrapal and colleagues recruited patients undergoing radical cystectomy between March 2017 and March 2020.
Adult patients with nonmetastatic urothelial squamous, adenocarcinoma, or variant bladder cancer who were fit for radical cystectomy were eligible for enrollment. Investigators excluded patients with prior abdominal/pelvic surgery, pelvic radiotherapy, or concomitant diseases that rendered them unsuitable for either approach, patients who had synchronous upper urinary tract tumors, and patients who were pregnant or lactating. All participants were randomly assigned to either robotic or open radical cystectomy and were stratified by center and type of diversion (continent diversion/neobladder or ileal conduit).
The primary endpoint of the trial was the number of days alive and out of the hospital within 90 days after surgery. Secondary outcomes included survival, complications, physical activity, quality of life, and cancer recurrence.
Quicker Recovery and Fewer Complications With Robot-Assisted Surgery
Of the 338patients randomly assigned in the iROC trial, a total of 317 underwent cystectomy. As Dr. Khetrapal reported, most participants were male (78.9%), as bladder cancer is more commen in men than women, the average age was 69 years, and most were current or ex-smokers (71%). More than one-third of study participants (34%) received neoadjuvant chemotherapy, and most patients underwent ileal conduit reconstruction (89%).
Findings showed that patients randomly assigned to intracorporeal robot-assisted radical cystectomy spent more days out of the hospital than those undergoing open radical cystectomy within 90 days of surgery (P = .012).
“Our primary outcome favored the robotic approach by more than 2 days,” said Dr. Khetrapal. “Patients who underwent intracorporeal robotic cystectomy stayed out of the hospital for a total of 82 days out of 90, including the length of stay for surgery, whereas those who underwent open surgery stayed out for only 80 days.”
According to Dr. Khetrapal, this result reflected shorter lengths of stay with robotic vs open surgery (median 7 days vs 8 days) and fewer readmissions. Patients who underwent open radical cystectomy were readmitted more than 32% of the time, whereas those who underwent robotic surgery were readmitted 21% of the time.
Although complication rates were similar with respect to grade and type, wound-related and thromboembolic complications differed significantly between study arms. “Patients who underwent open radical cystectomy experienced three times as many wound-related complications and four times as many venous thromboembolism events,” said Dr. Khetrapal.
Health-related quality-of-life measures—including the World Health Organization Disability Assessment Schedule (WHODAS) and the European Organisation for Research and Treatment of Cancer Core Quality-of-Life instrument (EORTC QLQ-C30)—showed improved outcomes for robotic surgery vs open radical cystectomy up to 12 weeks after surgery. By 26 weeks, however, no differences in quality-of-life measurements were observed.
Investigators observed no difference in cancer recurrence or overall survival between surgical interventions.
DISCLOSURE: This study was funded by The Urology Foundation and the Champniss Foundation. Intuitive Surgical provided consumables for the robotic arm of the trial. None of these organizations had any input in the design, data collection, or analysis of the trial. Dr. Khetrapal reported no conflicts of interest.
REFERENCES
1. Khetrapal P, Catto J, Ambler G, et al: Results of the intracorporeal robotic vs open cystectomy (iROC) multi-centre randomised trial. 2022 American Urological Association Annual Meeting. Abstract PD42-02. Presented May 15, 2022.
2. Catto JWF, Khetrapal P, Ricciardi F, 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. JAMA. May 15, 2022 (early release online).
