Perioperative Chemotherapy Compared With Surgery Alone for Resectable Gastroesophageal Adenocarcinoma: An FNCLCC and FFCD Multicenter Phase III Trial
Perioperative Chemotherapy Compared With Surgery Alone for Resectable Gastroesophageal Adenocarcinoma: An FNCLCC and FFCD Multicenter Phase III Trial
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DOI：
10.1200/jco.2010.33.0597
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发表时间：
2011-05-01
影响因子：
45.3
通讯作者：
Rougier, Philippe
中科院分区：
文献类型：
--
作者：
Ychou, Marc;Boige, Valerie;Rougier, Philippe
目的胃食管腺癌根治性切除后预后差。本III期临床试验旨在评价围手术期氟尿嘧啶联合顺铂治疗可切除胃食管腺癌的总生存期（OS）的获益。患者和方法：224例可切除食管下段、胃食管交界处（GEJ）或胃腺癌患者随机分为围手术期化疗组和手术组。（CS组; n = 113）或单纯手术（S组; n = 111）。化疗包括术前顺铂（100 mg/m2，第1天）静脉滴注2 ~ 3个周期，氟尿嘧啶（800 mg/m2，第1 ~ 5天）连续静脉滴注5天，每28天1次，术后3 ~ 4个周期。结果与S组相比，CS组有更好的OS（5年率38%vs24%;死亡风险比[HR]：0.69; 95%CI：0.5
Purpose After curative resection, the prognosis of gastroesophageal adenocarcinoma is poor. This phase III trial was designed to evaluate the benefit in overall survival (OS) of perioperative fluorouracil plus cisplatin in resectable gastroesophageal adenocarcinoma.Patients and Methods Overall, 224 patients with resectable adenocarcinoma of the lower esophagus, gastroesophageal junction (GEJ), or stomach were randomly assigned to either perioperative chemotherapy and surgery (CS group; n = 113) or surgery alone (S group; n = 111). Chemotherapy consisted of two or three preoperative cycles of intravenous cisplatin (100 mg/m(2)) on day 1, and a continuous intravenous infusion of fluorouracil (800 mg/m(2)/d) for 5 consecutive days (days 1 to 5) every 28 days and three or four postoperative cycles of the same regimen. The primary end point was OS.Results Compared with the S group, the CS group had a better OS (5-year rate 38% v 24%; hazard ratio [HR] for death: 0.69; 95% CI, 0.5