Nawar Hanna1, Jeffrey J Leow1, Maxine Sun1, David F Friedlander1, Thomas Seisen1, Firas Abdollah2, Stuart R Lipsitz1, Mani Menon2, Adam S Kibel1, Joaquim Bellmunt3, Toni K Choueiri3, Quoc-Dien Trinh4. 1. Division of Urological Surgery and Center for Surgery and Public Health, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA. 2. Henry Ford Hospital, Vattikuti Institute of Urology, Center for Outcomes Research, Analytics and Evaluation, Detroit, MI. 3. Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Brigham and Women's Hospital, Boston, MA. 4. Division of Urological Surgery and Center for Surgery and Public Health, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA. Electronic address: qtrinh@bwh.harvard.edu.
Abstract
OBJECTIVES: Over the past decade, robot-assisted radical cystectomy (RARC) has gained traction as an alternative to the conventional open approach open radical cystectomy (ORC). However, the benefits of RARC over ORC remain unclear. Our objective was to conduct a comparative effectiveness analysis between RARC and ORC using data from the National Cancer Data Base. MATERIALS AND METHODS: Within the National Cancer Data Base, we identified patients with localized muscle-invasive bladder cancer who underwent RC between 2010 and 2013. Patients were stratified according to surgical approach: ORC vs. RARC. Intraoperative endpoints included: the presence of positive surgical margins, the performance of a pelvic lymph node dissection, and number of lymph nodes (LN) removed. Postoperative endpoints included: length of stay (LOS), 30- and 90-day postoperative mortality (POM) rates, 30-day readmission rate, and overall survival (OS). To minimize selection bias, observed differences in baseline characteristics between RARC vs. ORC patients were controlled for using weighted propensity scores. Binary endpoints and OS were assessed using propensity score-adjusted logistic and Cox regression analyses, respectively. POM was assessed using propensity score weighted Kaplan-Meier survival estimates at 30 and 90 days after RC. RESULTS: Of 9,561 patients who underwent RC, 2,048 (21.4%) and 7,513 (78.6%) underwent RARC and ORC, respectively. The use of RARC increased over time, from 16.7% in 2010 to 25.3% in 2013. With regard to intraoperative outcomes, RARC was associated with equivalent rates of positive surgical margins (9.3% vs. 10.7%, odds ratio [OR] = 0.86, 95% CI: 0.72-1.03; P = 0.10), higher rates of pelvic lymph node dissection (96.4% vs. 92.0%, OR = 2.30, 95% CI: 1.67-3.16; P<0.001), higher median LN count (17 vs. 12, P<0.001), higher rates of LN count above the median (56.8% vs. 40.4%, OR = 1.94, 95% CI: 1.55-2.42, P<0.001). With regard to postoperative outcomes, receipt of RARC was associated with a shorter median LOS (7 vs. 8, P<0.001), and lower rates of pLOS (45.0% vs. 54.8%, OR = 0.68, 95% CI: 0.58-0.79; P<0.001). The 30- and 90-day POM rates were 2.8%, 6.7% for ORC, and 1.4%, 4.8% for RARC, respectively (hazard ratio [HR] = 0.48, 95% CI: 0.29-0.80, P = 0.005 and HR = 0.71, 95% CI: 0.54-0.93; P = 0.014). Finally, with a mean follow-up of 26.9 months, on IPTW-adjusted Cox regression analysis, RARC vs. ORC was associated with a benefit in OS (HR = 0.79, 95% CI: 0.71-0.88; P<0.001). CONCLUSIONS: Our large contemporary study found an increased adoption of RARC between 2010 and 2013, with more than 1 out of 4 patients undergoing RARC by the end of the study period. We found that RARC was associated with higher LN counts, shorter LOS, and lower POM. Our results allude to potential benefits of RARC while we wait for more definitive answers from randomized trials.
OBJECTIVES: Over the past decade, robot-assisted radical cystectomy (RARC) has gained traction as an alternative to the conventional open approach open radical cystectomy (ORC). However, the benefits of RARC over ORC remain unclear. Our objective was to conduct a comparative effectiveness analysis between RARC and ORC using data from the National Cancer Data Base. MATERIALS AND METHODS: Within the National Cancer Data Base, we identified patients with localized muscle-invasive bladder cancer who underwent RC between 2010 and 2013. Patients were stratified according to surgical approach: ORC vs. RARC. Intraoperative endpoints included: the presence of positive surgical margins, the performance of a pelvic lymph node dissection, and number of lymph nodes (LN) removed. Postoperative endpoints included: length of stay (LOS), 30- and 90-day postoperative mortality (POM) rates, 30-day readmission rate, and overall survival (OS). To minimize selection bias, observed differences in baseline characteristics between RARC vs. ORC patients were controlled for using weighted propensity scores. Binary endpoints and OS were assessed using propensity score-adjusted logistic and Cox regression analyses, respectively. POM was assessed using propensity score weighted Kaplan-Meier survival estimates at 30 and 90 days after RC. RESULTS: Of 9,561 patients who underwent RC, 2,048 (21.4%) and 7,513 (78.6%) underwent RARC and ORC, respectively. The use of RARC increased over time, from 16.7% in 2010 to 25.3% in 2013. With regard to intraoperative outcomes, RARC was associated with equivalent rates of positive surgical margins (9.3% vs. 10.7%, odds ratio [OR] = 0.86, 95% CI: 0.72-1.03; P = 0.10), higher rates of pelvic lymph node dissection (96.4% vs. 92.0%, OR = 2.30, 95% CI: 1.67-3.16; P<0.001), higher median LN count (17 vs. 12, P<0.001), higher rates of LN count above the median (56.8% vs. 40.4%, OR = 1.94, 95% CI: 1.55-2.42, P<0.001). With regard to postoperative outcomes, receipt of RARC was associated with a shorter median LOS (7 vs. 8, P<0.001), and lower rates of pLOS (45.0% vs. 54.8%, OR = 0.68, 95% CI: 0.58-0.79; P<0.001). The 30- and 90-day POM rates were 2.8%, 6.7% for ORC, and 1.4%, 4.8% for RARC, respectively (hazard ratio [HR] = 0.48, 95% CI: 0.29-0.80, P = 0.005 and HR = 0.71, 95% CI: 0.54-0.93; P = 0.014). Finally, with a mean follow-up of 26.9 months, on IPTW-adjusted Cox regression analysis, RARC vs. ORC was associated with a benefit in OS (HR = 0.79, 95% CI: 0.71-0.88; P<0.001). CONCLUSIONS: Our large contemporary study found an increased adoption of RARC between 2010 and 2013, with more than 1 out of 4 patients undergoing RARC by the end of the study period. We found that RARC was associated with higher LN counts, shorter LOS, and lower POM. Our results allude to potential benefits of RARC while we wait for more definitive answers from randomized trials.
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