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Robotic Surgery Noninferior to Open Surgery in Bladder Cancer Treatment

Robotic surgery and traditional open surgery are equally effective in treating bladder cancer, according to a study published in The Lancet (online: June 23, 2018; doi:10.1016/S0140-6736(18)30996-6).

Dipen J Parekh, MD, University of Miami School and Medicine (Miami, FL), and colleagues compared progression-free survival in patients with bladder cancer treated with open cystectomy and robot-assisted cystectomy. 

The Randomized Open Versus Robotic (RAZOR) trial enrolled 350 patients between July 1, 2011 and November 18, 2014. Eligible participants were aged 18 years or older and had biopsy-proven clinical stage T1–T4, N0–N1, M0 bladder cancer, or refractory carcinoma in situ. Individuals who had previously open abdominal or pelvic surgery, or who had any pre-existing health conditions that would preclude safe initiation or maintenance of pneumoperitoneum, were excluded.

Patients were randomized (1:1) to receive robotic cystectomy or open cystectomy. Authors noted that 302 patients were included in the per-protocol analysis set. 

Authors noted the primary endpoint was 2-year progression-free survival, with non-inferiority established if the lower bound of the one-sided 97.5% CI for the treatment difference (robotic cystectomy minus open cystectomy) was greater than 15 percentage points. 

Researchers reported that 2-year progression-free survival was 72.3% in the robotic cystectomy arm and 71.6% in the open cystectomy arm. These results showed non-inferiority of robotic cystectomy, they noted. 

Additionally, researchers observed adverse events in 101 patients in the robotic cystectomy arm and 105 patients in the open cystectomy arm. The most common adverse events were urinary tract infection (35% and 26%, respectively) and postoperative ileus (22% and 35%, respectively).

“In patients with bladder cancer, robotic cystectomy was non-inferior to open cystectomy for 2-year progression-free survival,” authors of the study concluded. “Increased adoption of robotic surgery in clinical practice should lead to future randomized trials to assess the true value of this surgical approach in patients with other cancer types.”—Janelle Bradley

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