Robot-assisted radical cystectomy (RC) for invasive bladder cancer is associated with short-term oncologic outcomes comparable to that achieved with open RC, according to a new study.
In the randomized phase 3 RAZOR (Randomised Open versus Robotic Cystectomy) trial, patients who underwent robot-assisted RC and open RC had similar 2-year progression-free survival rates (72.3% and 71.6%, respectively), a team led by Dipen J. Parekh, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, reported in The Lancet (2018;391:2525-2536).
Robotic surgery was associated with significantly less median estimated blood loss than open surgery (300 vs 700 mL). A significantly smaller proportion of patients in the robot-assisted RC group than open RC group required intraoperative blood transfusion (13% vs 34%) and post-operative blood transfusion (25% vs 40%). The robot-assisted RC group had a significantly shorter median hospital length of stay (6 vs 7 days) and a significantly larger proportion of patients who had a hospital stay of 5 or fewer days (29% vs 18%).
Robot-assisted RC required a significantly longer median operative time than open surgery (428 vs 361 minutes). The robot-assisted and open surgery groups had similar rates of adverse events (67% vs 69%) and similar patient-reported quality-of-life (QoL) outcomes.
The trial provides the first multicenter randomized evidence of the oncologic efficacy of robotic cystectomy, according to Dr Parekh and his colleagues. “In the setting of previous studies, robotic cystectomy did not compromise oncological outcomes compared with open cystectomy,” they wrote. “Our results showed that robotic cystectomy is associated with an improvement in perioperative parameters, such as blood loss and length of stay, without significant differences in complication rates and patient-reported QoL outcomes.”
The RAZOR trial involved patients recruited at 15 centers in the United States. The investigators included in their analysis 302 patients with invasive bladder cancer (biopsy-proven clinical stage T1–T4, N0–N1, M0) or refractory carcinoma in situ. Of these, 150 patients underwent robotic RC and 152 had open RC. The robotic and open surgery groups had a median age of 70 and 67 years, respectively. In both groups, 84% of patients were men.
With regard to study limitations, the authors noted that participating centers were academic medical centers, and surgeons were either fellowship-trained or had a dedicated uro-oncology practice. In addition, not all institutions contributed equally to the trial, and the patients recruited represented only a percentage of all patients with bladder cancer treated at those institutions during the study period. Another limitation was that only surgeons with substantial experience were involved in the trial. Participating surgeons were required to have performed at least 10 robotic or open cystectomies in the year before the study.
In an editorial accompanying the report by Dr Parekh’s team, Roland Seiler, MD, and George N. Thalmann, MD, of the University of Bern in Bern, Switzerland, said “the authors should be congratulated for their effort and for showing that although robot-assisted radical cystectomy is probably more expensive than open cystectomy, when done by experienced surgeons and in selected cases, the approach is comparable to open radical cystectomy in terms of perioperative morbidity, quality of life, and short-term oncological outcomes.”
As for whether robot-assisted RC should be recommended in daily clinical practice on the basis of the current findings, Drs Seiler and Thalmann pointed out that most cystectomies are performed in low-volume centers where the necessary expertise is not available.
Parekh DJ, Reis IM, Castle EP, et al. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomized, phase 3 non-inferiority trial. Lancet. 2018;391:2525-2536.
Seiler R, Thalmann GN. Robot-assisted versus open cystectomy. Lancet. 2018;391:2479-2480.