Phase III, Randomized Study of Gemcitabine and Oxaliplatin Versus Gemcitabine (fixed-dose rate infusion) Compared With Gemcitabine (30-minute infusion) in Patients With Pancreatic Carcinoma E6201: A Trial of the Eastern Cooperative Oncology Group
Phase III, Randomized Study of Gemcitabine and Oxaliplatin Versus Gemcitabine (fixed-dose rate infusion) Compared With Gemcitabine (30-minute infusion) in Patients With Pancreatic Carcinoma E6201: A Trial of the Eastern Cooperative Oncology Group
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DOI：
10.1200/jco.2008.20.9007
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发表时间：
2009-08-10
影响因子：
45.3
通讯作者：
Benson, Al Bowen, III
中科院分区：
文献类型：
--
作者：
Poplin, Elizabeth;Feng, Yang;Benson, Al Bowen, III
目的单药吉西他滨(GEM)是治疗转移性胰腺癌的标准方案。固定剂量率(FDR)GEM和GEM+奥沙利铂在早期临床试验中显示出良好的前景。E6201用于比较标准每周GEM 1,000 mg/m(2)/30分钟与GEM FDR 1,500 mg/m(2)/150分钟或GEM 1,000 mg/m(2)/100分钟/天1加奥沙利铂100 mg/m(2)/d 2每14天(GEMOX)治疗的总生存率(OS)。方法本试验包括转移性或局部晚期胰腺癌、器官功能正常、功能状态为0至2的患者。该研究旨在检测中位生存期(风险比[HR])的33%差异
PurposeSingle-agent gemcitabine (GEM) is standard treatment of metastatic pancreatic cancer. Fixed-dose rate (FDR) GEM and GEM plus oxaliplatin have shown promise in early clinical trials. E6201 was designed to compare overall survival (OS) of standard weekly GEM 1,000 mg/m(2)/30 minutes versus GEM FDR 1,500 mg/m(2)/150 minutes or GEM 1,000 mg/m(2)/100 minutes/day 1 plus oxaliplatin 100 mg/m(2)/day 2 every 14 days (GEMOX).MethodsThis trial included patients with metastatic or locally advanced pancreatic cancer, normal organ function, and performance status of 0 to 2. The study was designed to detect a 33% difference in median survival (hazard ratio [HR]