Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: A report of the V325 study group
Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: A report of the V325 study group
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DOI：
10.1200/jco.2006.06.8429
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发表时间：
2006-11-01
影响因子：
45.3
通讯作者：
Ajani, Jaffer A.
中科院分区：
文献类型：
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作者：
Van Cutsem, Eric;Moiseyenko, Vladimir M.;Ajani, Jaffer A.
在对未经治疗的进展期胃癌患者进行的随机多国II/III期试验(V325)中，II期部分选择了多西紫杉醇、顺铂和氟尿嘧啶(DCF)，而不是多西他赛和顺铂(CF；晚期胃癌患者随机分为两组，多西紫杉醇75 mg/m(2)，顺铂75 mg/m(2)，第1天，联合氟尿嘧啶750 mg/m(2)/d，第1~5天；顺铂100 mg/m(2)(第1天)，联合氟尿嘧啶1000 mg/m(2)/d，每4周1次。结果在445名随机分配和治疗的患者中(DCF=221；CF=224)，DCF组和CF组的TTP较长(风险降低32%；对数等级P
PurposeIn the randomized, multinational phase II/III trial (V325) of untreated advanced gastric cancer patients, the phase II part selected docetaxel, cisplatin, and fluorouracil (DCF) over docetaxel and cisplatin for comparison against cisplatin and fluorouracil (CF; reference regimen) in the phase III part.Patients and MethodsAdvanced gastric cancer patients were randomly assigned to docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2) (day 1) plus fluorouracil 750 mg/m(2)/ d ( days 1 to 5) every 3 weeks or cisplatin 100 mg/m(2) ( day 1) plus fluorouracil 1,000 mg/m(2)/ d (days 1 to 5) every 4 weeks. The primary end point was time-to-progression (TTP).ResultsIn 445 randomly assigned and treated patients ( DCF = 221; CF = 224), TTP was longer with DCF versus CF (32% risk reduction; log-rank P