SAN DIEGO, CA USA (UroToday.com) - Interim results of a randomized clinical trial comparing robotic and open radical cystectomy were presented at a late-breaking news plenary at the 2013 AUA in San Diego, CA.
Dr. Vincent P. Laudone, the co-director for robotic surgery at Memorial Sloan-Kettering Cancer Center presented the results. The primary goal of the study was to compare complications within 90 days of surgery (as stratified by modified Clavien Classification System). Secondary aims compared operative time, estimated blood loss, hospital LOS, margin status, LN status, recurrence, and mortality. All patients were followed for a minimum of 2 years, and were maintained on the same post-operative pathway. All surgeons were dedicated, high-volume urologic oncologists, and all data was obtained from an institutionally maintained database.
Following exclusion, a total of 116 patients were randomized to robotic or open cystectomy (59 robotic, 57 open). Four patients (6.8%) randomized to robotic surgery refused, and were treated with open surgery. On analysis, those patients were randomized by intention to treat. At the time of the interim analysis, 109 patients had been followed for > 90 days. Thirty-one percent versus 46% of patients were treated with neoadjuvant chemotherapy in the robotic and open arms, respectively. The rate of continent neobladder construction was equivalent between arms (approximately 54%).
Clavien grade 2-5 complications occurred in 61% vs 62% of robotic and open cystectomy patients, while grade 3-5 complications occurred in 24% vs 22%. On average, patients undergoing robotic and open cystectomy experienced a mean 2.1 vs 1.7 complications, respectively, which was not significantly different. Among the secondary outcomes of the trial, procedure time was 2 hours longer for patients treated robotically (454 min vs 328 min), while EBL was less in the robotic cohort. pT0 disease was found in 20% vs 12% (robotic vs open). High-risk and possibly locally-advanced disease was found at similar rates between the two cohorts (pT3 20% vs 26%, robotic vs open).
The level of node dissection was left to the discretion of the surgeon, and while more patients in the robotic group underwent extended (above the aortic bifurcation) lymphadenectomy (78% vs 47%), the number of nodes harvested was not significantly different (30 vs 25). Further, there was no difference in the rate of positive LNs between robotic and open surgery (17% vs 16%). Positive soft-tissue surgical margins were comparable between groups (3% robotic vs 5% open), as was hospital length of stay (mean 8 days in both arms).
In conclusion, a randomized trial of robotic versus open cystectomy revealed no difference in the rate or severity of complications incurred within 90 days of surgery. Since the interim trial results met the pre-specified criteria for trial closure, and showed a lack of observed difference between the two arms, the study is now closed to accrual. Data collection for longer-term secondary outcomes, including cost and quality of life outcomes, will continue. This study demonstrates that “well designed randomized, controlled trials of new surgical technologies are possible and should be strongly encouraged to better answer important clinical questions.”
Presented by Vincent P. Laudone, MD at the American Urological Association (AUA) Annual Meeting - May 4 - 8, 2013 - San Diego Convention Center - San Diego, California USA
Co-Director for Robotic Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY USA
Reported for UroToday.com by Jeffrey J. Tomaszewski, MD