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
作者： Eric Van Cutsem , Vladimir M. Moiseyenko , Sergei Tjulandin , Alejandro Majlis , Manuel Constenla
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摘要: Purpose In the randomized, multinational phase II/III trial (V325) of untreated advanced gastric cancer patients, II part selected docetaxel, cisplatin, and fluorouracil (DCF) over docetaxel cisplatin for comparison against (CF; reference regimen) in III part. Patients Methods Advanced patients were randomly assigned to 75 mg/m2 (day 1) plus 750 mg/m2/d (days 1 5) every 3 weeks or 100 1,000 4 weeks. The primary end point was time-to-progression (TTP). Results 445 treated (DCF = 221; CF 224), TTP longer with DCF versus (32% risk reduction; log-rank P < .001). Overall survival (23% .02). Two-year rate 18% 9% CF. response higher (χ2 .01). Grade treatment-r...
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