Chen Felix V, Koru-Sengul Tulay, Miao Feng, Jue Joshua S, Alameddine Mahmoud, Dave Devina J, Punnen Sanoj, Parekh Dipen J, Ritch Chad R, Gonzalgo Mark L
Department of Urology, University of Miami Miller School of Medicine, Miami, FL.
Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL; Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL.
Urol Oncol. 2019 Dec;37(12):877-885. doi: 10.1016/j.urolonc.2019.06.022. Epub 2019 Aug 14.
Contemporary randomized controlled trials exploring adjuvant chemotherapy (AC) for bladder cancer (BCa) have yielded inconsistent results due to premature termination and/or poor patient accrual.
To compare efficacy of AC vs. observation after radical cystectomy stratified by disease stage in a propensity-matched cohort.
DESIGN, SETTING, AND PARTICIPANTS: We performed a retrospective study that included patients who underwent radical cystectomy for any pT, N0-1, M0 BCa from the National Cancer Data Base (2004-2014). Patients who underwent AC were 1:1 propensity matched with patients who received observation only.
Overall survival was assessed with multivariable Cox regression models where adjusted hazard ratios (aHR) and 95% confidence intervals (95% CI) were calculated.
After coarsened exact 1:1 propensity matching, 3,066 patients (AC 1,533; observation 1,533) were included in the analysis. There were no significant differences in patient-, facility-, or tumor-level characteristics among cohorts. Compared with patients who underwent observation, recipients of AC had improved overall survival (aHR 0.67; 95% CI 0.61-0.74). Patients with pT2-4, pN1 disease significantly benefited from AC. Among the pN0 cohort, improved survival from AC was observed only in stages pT3 (aHR 0.67; 95% CI 0.55-0.83) and pT4 (aHR 0.70; 95% CI 0.50-0.98).
AC was associated with improved survival in locally advanced (pT3-4, pN0) and regionally advanced (pT2-4, pN1) chemotherapy-naive BCa.
当代探索膀胱癌辅助化疗（AC）的随机对照试验因提前终止和/或患者入组不佳而产生了不一致的结果。
在倾向匹配队列中，比较根治性膀胱切除术后AC与观察的疗效，并按疾病分期分层。
设计、设置和参与者：我们进行了一项回顾性研究，纳入了来自国家癌症数据库（2004 - 2014年）中因任何pT、N0 - 1、M0期膀胱癌接受根治性膀胱切除术的患者。接受AC治疗的患者与仅接受观察的患者进行1:1倾向匹配。
采用多变量Cox回归模型评估总生存期，计算调整后的风险比（aHR）和95%置信区间（95%CI）。
经过精确的1:1倾向匹配后，3066例患者（AC组1533例；观察组1533例）纳入分析。各队列在患者、机构或肿瘤水平特征方面无显著差异。与接受观察的患者相比，接受AC治疗的患者总生存期有所改善（aHR 0.67；95%CI 0.61 - 0.74）。pT2 - 4、pN1期疾病的患者从AC治疗中显著获益。在pN0队列中，仅在pT3期（aHR 0.67；95%CI 0.55 - 0.83）和pT4期（aHR 0.70；95%CI 0.50 - 0.98）观察到AC治疗使生存期改善。
AC与局部晚期（pT3 - 4，pN0）和区域晚期（pT2 - 4，pN1）初治膀胱癌患者生存期改善相关。
