NEW ORLEANS — Robot-assisted radical cystectomy with intracorporeal urinary diversion compared with open radical cystectomy among patients with non-metastatic bladder cancer resulted in a statistically significant increase in days alive and out of the hospital, according to results from the iROC trial.
Within 90 days of surgery, patients undergoing robotic surgery spent a median of 82 days alive and out of the hospital versus 80 days for open-surgery patients (adjusted difference 2.2 days, 95% CI 0.50-3.85, P=0.01), reported Pramit Khetrapal, PhD, of University College London, at the American Urological Society (AUA) annual meeting. Findings were simultaneously published in JAMA.
Khetrapal and colleagues also found that patients undergoing robotic surgery experienced fewer complications. “This trial shows that patients who undergo robotic cystectomy have shorter times in the hospital, less wound complications, less clots in their legs and lungs, and overall patients are happier in their quality of life [QoL],” Khetrapal said at an AUA press briefing.
In an accompanying JAMA editorial, Brent K. Hollenbeck, MD, of the University of Michigan in Ann Arbor, and colleagues stated that the study “is an important milestone for robotic surgery, as it is among the first to demonstrate a benefit in a multicenter clinical trial.”
But they also cautioned that “Whether the benefit in days spent outside of the hospital is clinically meaningful and sufficient to promote further diffusion is likely to be a source of debate, with rational arguments on both sides of quality and cost issues. Nonetheless, robotic surgery is here to stay.”
Khetrapal and colleagues noted that while robot-assisted radical cystectomy is being performed with increasing frequency, it is unclear whether total intracorporeal surgery improves recovery compared with open radical cystectomy for bladder cancer.
iROC was a randomized, multi-center trial conducted in the U.K. The majority of the trial patients were white and between ages 70-79 at time of surgery. Most had urothelial cell carcinoma. They were randomized 1:1 to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n=169) or open radical cystectomy (n=169). Of these patients, 317 underwent radical cystectomy. About one-third of patients (34%) received neoadjuvant chemotherapy, while 89% underwent ileal conduit reconstruction.
The median length of stay in the hospital was 7 days for robotic cystectomy and 8 days for open surgery (difference 1 day, 95% CI 0.03-1.97 days). Also, patients undergoing robotic surgery were less likely to be readmitted to the hospital after discharge (21.8% vs 32.2%, difference 10.4%, 95% CI 0.5%-20.3%, P=0.04).
Death within 90 days occurred in two participants (1.2%) in the robotic surgery group (one cardiorespiratory failure; one cancer progression) and in two participants (2.6%) in the open-surgery group (two intra-abdominal sepsis/laparotomy/organ failure; one pulmonary embolus; one cancer progression).
Following surgery, 208 participants (65.6%) had at least one complication within 12 weeks, including 63.4% in the robotic surgery group and 67.9% in the open-surgery group.
Patients receiving robotic surgery compared with open surgery were significantly less likely to have wound-related complications (5.6% vs 17.3%, difference -11.72%, 95% CI -18.59% to -4.58%), and fewer thromboembolic complications (1.9% vs 8.3%, difference -6.47%, 95% CI -11.43% to -1.38).
Khetrapal and colleagues pointed out that “Measures suggesting less disability, greater stamina, and more mobility with robotic surgery were associated with a reduction in rates of thromboembolism. Participants in both groups received thromboprophylaxis (including low-molecular-weight heparin and compression stockings).”
Postoperative blood transfusions were needed for 11 of 158 participants (7%) in the robotic surgery group and 18 of 149 participants (12%) in the open-surgery group. After discharge, there were no transfusions in the robotic surgery group, and one transfusion at 5 weeks, along with two transfusions at 12 weeks, in the open-surgery group.
There were no statistically significant differences in cancer recurrence (18% in the robotic surgery group vs 16% in the open-surgery group) and overall mortality (14.3% vs 14.7%, respectively) at a median follow-up of 18.4 months.
Those in the open-surgery group reported the following versus robotic surgery:
- Worse QoL at 5 weeks: -0.07 difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores (95% CI -0.11 to -0.03, P=0.003)
- Greater disability at 5 weeks: 0.48 difference in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 scores (95% CI 0.15-0.73, P=0.003)
- Greater disability at 12 weeks: 0.38 difference in WHODAS 2.0 scores (95% CI 0.09-0.68, P=0.01)
However, these differences were not significant after 12 weeks, according to the authors, who also noted that “Greater mobility was observed in the robotic surgery group, although the difference was less than anticipated.”
Trial limitations included the fact that it closed early, and “adherence to in-person measurement of end points was compromised” because of the pandemic, the authors stated. Also, the trial was done at high-volume hospitals so the results may not apply to low-volume centers.
AUA press briefing moderator Benjamin Davies, MD, of the University of Pittsburgh School of Medicine, said that the study provided a lot of “great” data, but “there’s a lot here for both sides.”
“I could argue vociferously that you really haven’t shown much, and you could argue there are solid differences,” Davies told Khetrapal. Davies noted that there were no QoL differences after 12 weeks and asked “What’s the impetus for change [in practice].” Khetrapal acknowledged that surgeons currently may not be “keen” to change practice, and that going forward surgical residents may want to consider developing a proficiency in both surgical methods.
And Khetrapal’s group also argued that “the [trial’s] primary outcome might be questioned; however, patients, surgeons, and purchasers value improved quality of recovery.”
The study was supported by the University College London and funded by The Urological Foundation and The Champniss Foundation.
Khetrapal disclosed funding from a Urology Foundation fellowship. Co-authors disclosed multiple relationships with industry.
Hollenbeck disclosed relationships with, and/or support from, Elsevier, the National Cancer Institute (NCI), the American Cancer Society, the Agency for Healthcare Research and Quality, and the National Institute on Aging. A co-author disclosed support from NCI and the Prostate Cancer Foundation/Pfizer.