Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial
Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial
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DOI：
10.1200/jco.18.02122
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发表时间：
2019-07-10
影响因子：
45.3
通讯作者：
Zhao, Kuaile
中科院分区：
文献类型：
--
作者：
Chen, Yun;Ye, Jinjun;Zhao, Kuaile
目的评价紫杉醇联合氟尿嘧啶方案与顺铂联合氟尿嘧啶方案同步放化疗治疗局部晚期食管鳞癌的疗效和安全性。紫杉醇联合氟尿嘧啶组先用紫杉醇、氟尿嘧啶dCRT治疗，每周1周期，共5个周期，再用紫杉醇、氟尿嘧啶每月1周期巩固化疗，共2个周期。顺铂+5-氟尿嘧啶组用顺铂和氟尿嘧啶每月1周期，dCRT治疗2个周期，然后巩固化疗2个周期。放疗剂量为61.2Gy34次。结果从2012年4月至2015年7月，6个中心的436名食管癌患者以1：1的比例入选。存活患者的中位随访期为48.7个月(四分位数范围为42.6-60.9)。紫杉醇联合氟尿嘧啶治疗组和顺铂联合氟尿嘧啶治疗组的3年生存率分别为55.4%和51.8%(风险比，0.905[95%CI，0.698~1.172]；P=.448)。紫杉醇联合氟尿嘧啶治疗组和顺铂联合氟尿嘧啶治疗组的3年无进展生存率分别为43.7%和45.5%，风险比为0.973[95%CI，0.762~1.243]；P=.828。紫杉醇联合氟尿嘧啶组急性3级及以上贫血、血小板减少、食欲减退、恶心、呕吐、乏力的发生率明显低于顺铂+氟尿嘧啶组(P
PURPOSE This trial aimed to assess the efficacy and safety of the paclitaxel plus fluorouracil regimen versus the cisplatin plus fluorouracil regimen in definitive concurrent chemoradiotherapy (dCRT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC).PATIENTS AND METHODS Patients with locally advanced ESCC were enrolled and randomly assigned to either the paclitaxel plus fluorouracil group or the cisplatin plus fluorouracil group. The patients in the paclitaxel plus fluorouracil group were treated with paclitaxel and fluorouracil one cycle per week in dCRT for five cycles followed by paclitaxel and fluorouracil one cycle per month in consolidation chemotherapy for two cycles. The patients in the cisplatin/5-fluorouracil group were treated with cisplatin and fluorouracil one cycle per month in dCRT for two cycles followed by two cycles in consolidation chemotherapy. The radiotherapy dose was 61.2 Gy delivered in 34 fractions. The primary end point was 3-year overall survival (OS).RESULTS Four hundred thirty-six patients with ESCC in six centers were recruited at a 1:1 ratio between April 2012 and July 2015. The median follow-up of the surviving patients was 48.7 months (interquartile range, 42.6-60.9). The 3-year OS was 55.4% in the paclitaxel plus fluorouracil group and 51.8% in the cisplatin plus fluorouracil group (hazard ratio, 0.905 [95% CI, 0.698 to 1.172]; P=.448). The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7% v 45.5%, respectively; hazard ratio, 0.973 [95% CI, 0.762 to 1.243]; P=.828). Compared with the cisplatin plus fluorouracil group, the paclitaxel plus fluorouracil group had significantly lower incidences of acute grade 3 or higher anemia, thrombocytopenia, anorexia, nausea, vomiting, and fatigue (P