Hanna Nawar, Leow Jeffrey J, Sun Maxine, Friedlander David F, Seisen Thomas, Abdollah Firas, Lipsitz Stuart R, Menon Mani, Kibel Adam S, Bellmunt Joaquim, Choueiri Toni K, Trinh Quoc-Dien
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.
Henry Ford Hospital, Vattikuti Institute of Urology, Center for Outcomes Research, Analytics and Evaluation, Detroit, MI.
Urol Oncol. 2018 Mar;36(3):88.e1-88.e9. doi: 10.1016/j.urolonc.2017.09.018. Epub 2017 Dec 23.
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.
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.
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).
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.
在过去十年中,机器人辅助根治性膀胱切除术(RARC)作为传统开放性根治性膀胱切除术(ORC)的替代方法逐渐受到关注。然而,RARC相对于ORC的优势仍不明确。我们的目的是利用国家癌症数据库的数据对RARC和ORC进行比较有效性分析。
在国家癌症数据库中,我们确定了2010年至2013年间接受根治性膀胱切除术的局限性肌层浸润性膀胱癌患者。患者根据手术方式分层:ORC与RARC。术中终点包括:手术切缘阳性情况、盆腔淋巴结清扫情况以及切除的淋巴结数量。术后终点包括:住院时间(LOS)、术后30天和90天死亡率(POM)、30天再入院率以及总生存期(OS)。为尽量减少选择偏倚,使用加权倾向评分控制RARC与ORC患者基线特征的观察差异。分别使用倾向评分调整的逻辑回归和Cox回归分析评估二元终点和OS。使用倾向评分加权的Kaplan-Meier生存估计评估根治性膀胱切除术后30天和90天的POM。
在9561例接受根治性膀胱切除术的患者中,分别有2048例(21.4%)和7513例(78.6%)接受了RARC和ORC。RARC的使用随时间增加,从2010年的16.7%增至2013年的25.3%。关于术中结果,RARC的手术切缘阳性率相当(9.3%对10.7%,优势比[OR]=0.86,95%可信区间:0.72 - 1.03;P = 0.10),盆腔淋巴结清扫率更高(96.4%对92.0%,OR = 2.30,95%可信区间:1.67 - 3.16;P<0.001),中位淋巴结计数更高(17对12,P<0.001),淋巴结计数高于中位数的比例更高(56.8%对40.4%,OR = 1.94,95%可信区间:1.55 - 2.42,P<0.001)。关于术后结果,接受RARC与较短的中位LOS相关(7对8,P<0.001),pLOS率较低(45.0%对54.8%,OR = 0.68,95%可信区间:0.58 - 0.79;P<0.001)。ORC的30天和90天POM率分别为2.8%、6.7%,RARC分别为1.4%、4.8%(风险比[HR]=0.48,95%可信区间:0.29 - 0.80,P = 0.005;HR = 0.71,95%可信区间:0.54 - 0.93;P = 0.014)。最后,平均随访26.9个月,经逆概率加权倾向评分调整的Cox回归分析显示,RARC与ORC相比在OS方面有优势(HR = 0.79,95%可信区间:0.71 - 0.88;P<0.001)。
我们的大型当代研究发现,2010年至2013年间RARC的采用率有所增加,到研究期结束时,超过四分之一的患者接受了RARC。我们发现RARC与更高的淋巴结计数、更短的住院时间和更低的术后死亡率相关。在等待随机试验给出更明确答案的同时,我们的结果暗示了RARC的潜在益处。