Lymph node yield was used as a surrogate marker for an oncologically sound operation, and the trial also found decreased blood loss in the robotic arm at the expense of increased operative time.1 Parekh and colleagues at the University of Texas San Antonio conducted a single-center trial randomizing 47 patients, with the intent of evaluating perioperative outcomes and oncologic efficacy. Findings from this trial were consistent with the Nix study, with the robotic approach offering decreasing blood loss but no major differences in complications, although all urinary diversions were performed open.2 A much larger RCT was conducted and published by Bochner et al from Memorial Sloan Kettering Cancer in 2015, with endpoints focused on the comparison of complications, including estimated blood loss, operative time, pathologic outcomes, quality of life outcomes, and operative room and inpatient costs.3 The trial did not identify an advantage for the robot-assisted cystectomy with respect to complications, although the urinary diversions were again performed openly in both groups. A follow-up study published in 2018 looked at secondary outcomes from the trial, specifically recurrence-free, cancer-specific, and overall survival, noting that there were no differences between the groups although there seemed to be a different pattern of the recurrences that did occur; specifically, patients in the robotic group who experienced recurrences had a greater number of local/abdominal recurrences. However, the overall recurrence rate was not different.4
Another RCT in this space was reported by Khan et al in 2016; this trial differs from the others in that it also compared open radical cystectomy with pure laparoscopic (rather than robot-assisted) radical cystectomy. Though a small trial, with only 20 patients randomized to each arm, key findings were that there were no differences between the groups at 90 days, confirming previous studies published on the topic.5
The largest and most definitive published RCT to date is the RAZOR trial, which was a multi-institutional effort and randomized 350 patients to either open or robot-assisted cystectomy. Key findings were that 2-year progression-free survival was non-inferior between the groups.2 All diversions were performed open.
Finally, Dr. Navai noted that a recently published systematic review and meta-analysis including 540 participants from the 5 key studies concluded that the surgical approach does not impact oncological safety or quality of life outcomes; the primary benefits conferred by the robotic approach are a reduced need for blood transfusion and shorter length of stay.6
Presented by: Neema Navai, MD, Assistant Professor, Urology, University of Texas MD Anderson Cancer Center, Houston, Texas
Written by Dr. Vikram M. Narayan (@VikramNarayan), Urologic Oncology Fellow and Ashish M. Kamat, MD (@UroDocAsh), Professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX at the 13th Update on the Management of Genitourinary Malignancies, The University of Texas (MDACC - MD Anderson Cancer Center) November 9-10, 2018, Dan L. Duncan Building, Houston, TX
1. Nix J, Smith A, Kurpad R, Nielsen ME, Wallen EM, Pruthi RS. Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: perioperative and pathologic results. Eur Urol [Internet]. 2010 Feb;57(2):196–201.
2. Parekh DJ, Messer J, Fitzgerald J, Ercole B, Svatek R. Perioperative outcomes and oncologic efficacy from a pilot prospective randomized clinical trial of open versus robotic-assisted radical cystectomy. J Urol [Internet]. 2013 Feb;189(2):474–9.
3. Bochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, et al. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol [Internet]. 2015 Jun;67(6):1042–50.
4. Bochner BH, Dalbagni G, Marzouk KH, Sjoberg DD, Lee J, Donat SM, et al. Randomized Trial Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: Oncologic Outcomes. Eur Urol [Internet]. 2018 Oct;74(4):465–71.
5. Khan MS, Gan C, Ahmed K, Ismail AF, Watkins J, Summers JA, et al. A Single-centre Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL). Eur Urol [Internet]. 2016 Apr;69(4):613–21.
6. Sathianathen NJ, Kalapara A, Frydenberg M, Lawrentschuk N, Weight CJ, Parekh D, et al. Robotic-assisted radical cystectomy vs open radical cystectomy: systematic review and meta-analysis. J Urol [Internet]. 2018 Oct 12