Comparative effectiveness of gemcitabine plus cisplatin versus methotrexate, vinblastine, doxorubicin, plus cisplatin as neoadjuvant therapy for muscle-invasive bladder cancer
Comparative effectiveness of gemcitabine plus cisplatin versus methotrexate, vinblastine, doxorubicin, plus cisplatin as neoadjuvant therapy for muscle-invasive bladder cancer
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DOI：
10.1002/cncr.29387
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发表时间：
2015-08-01
期刊：
影响因子：
6.2
通讯作者：
Rosenberg, Jonathan E.
中科院分区：
文献类型：
--
作者：
Galsky, Matthew D.;Pal, Sumanta K.;Rosenberg, Jonathan E.
吉西他滨加顺铂（GC）已被通过作为新辅助治疗方案的肌肉浸润性膀胱癌，尽管缺乏I级证据，在此setting. METHODS数据收集使用电子数据采集平台，从28个国际中心。符合条件的患者具有临床T分类2（cT 2）至cT 4aN 0 M0膀胱尿路上皮癌，并在接受cyclohexaminase之前接受新辅助GC或甲氨蝶呤、长春碱、多柔比星加顺铂（MVAC）。使用逻辑回归计算倾向评分，作为根据患者基线特征分配至MVAC与GC的预测概率。然后将这些倾向评分纳入新的逻辑回归模型，以估计调整后的比值比，比较接受MVAC和接受GC的患者之间获得病理完全缓解（pCR）的几率。结果，总共有212例患者（GC队列中146例患者和MVAC队列中66例患者）符合纳入分析的标准。MVAC队列中的大多数患者（77%）接受了剂量密度MVAC。患者的中位年龄为63岁，主要为男性（74%），接受了中位3个周期的新辅助化疗。MVAC队列的pCR率为29%，GC队列为31%。两种治疗方案的倾向评分校正后，pCR率无显著差异（比值比，0.91; 95%置信区间，0.48-1.72; P= 0.77）。在一项评估生存率的探索性分析中，MVAC与GC的风险比经倾向评分调整后的风险率无统计学显著性差异（风险比，0.78; 95%置信区间，0.40-1.54; P= 0.48）。结论：接受新辅助GC和MVAC的患者在当前分析中获得了相当的pCR率，为支持已成为常规做法提供了证据。Cancer 2015;121：2586-2593. (c)2015年美国癌症协会。使用新辅助顺铂为基础的化疗肌肉浸润性膀胱癌是由随机，3期研究支持。目前的分析，其中包括200多名患者，支持使用顺铂与吉西他滨作为甲氨蝶呤，长春碱，多柔比星，顺铂的替代方案。
BACKGROUNDGemcitabine plus cisplatin (GC) has been adopted as a neoadjuvant regimen for muscle-invasive bladder cancer despite the lack of Level I evidence in this setting.METHODSData were collected using an electronic data-capture platform from 28 international centers. Eligible patients had clinical T-classification 2 (cT2) through cT4aN0M0 urothelial cancer of the bladder and received neoadjuvant GC or methotrexate, vinblastine, doxorubicin, plus cisplatin (MVAC) before undergoing cystectomy. Logistic regression was used to compute propensity scores as the predicted probabilities of patients being assigned to MVAC versus GC given their baseline characteristics. These propensity scores were then included in a new logistic regression model to estimate an adjusted odds ratio comparing the odds of attaining a pathologic complete response (pCR) between patients who received MVAC and those who received GC.RESULTSIn total, 212 patients (146 patients in the GC cohort and 66 patients in the MVAC cohort) met criteria for inclusion in the analysis. The majority of patients in the MVAC cohort (77%) received dose-dense MVAC. The median age of patients was 63 years, they were predominantly men (74%), and they received a median of 3 cycles of neoadjuvant chemotherapy. The pCR rate was 29% in the MVAC cohort and 31% in the GC cohort. There was no significant difference in the pCR rate when adjusted for propensity scores between the 2 regimens (odds ratio, 0.91; 95% confidence interval, 0.48-1.72; P=.77). In an exploratory analysis evaluating survival, the hazard ratio comparing hazard rates for MVAC versus GC adjusted for propensity scores was not statistically significant (hazard ratio, 0.78; 95% confidence interval, 0.40-1.54; P=.48).CONCLUSIONSPatients who received neoadjuvant GC and MVAC achieved comparable pCR rates in the current analysis, providing evidence to support what has become routine practice. Cancer 2015;121:2586-2593. (c) 2015 American Cancer Society.The use of neoadjuvant cisplatin-based chemotherapy for muscle-invasive bladder cancer is supported by randomized, phase 3 studies. The current analysis, which includes more than 200 patients, supports the use of cisplatin with gemcitabine as an alternative regimen to methotrexate, vinblastine, doxorubicin, and cisplatin.