Clinical Benefit With Docetaxel Plus Fluorouracil and Cisplatin Compared With Cisplatin and Fluorouracil in a Phase III Trial of Advanced Gastric or Gastroesophageal Adenocarcinoma: The V-325 Study Group

作者：Jaffer A. Ajani, Vladimir Moiseyenko, Sergei Tjulandin, Alejandro Majlis, Manuel Constenla, C. Boni, Adriano Rodrigues, M Fodor, Yee Chao, Э К Возный, Cindy Marabotti, Eric Van Cutsem · 发表于：Journal of Clinical Oncology · 年份：2007 · DOI：10.1200/jco.2006.10.4968 · 被引用次数：251 · 研究领域：Gastric Cancer Management and Outcomes、Esophageal Cancer Research and Treatment、Colorectal Cancer Treatments and Studies

PURPOSE: For patients with advanced gastric or gastroesophageal cancer (AGGEC) providing clinical benefit with improved palliation is highly desirable. However, a prospective evaluation of clinical benefit in AGGEC patients has never before been reported in a phase III setting. PATIENTS AND METHODS: In a multinational trial (V325), 445 patients were randomly assigned and treated with either docetaxel plus cisplatin and fluorouracil (DCF) or cisplatin and fluorouracil (CF). Clinical benefit was prospectively evaluated in this trial as a secondary end point. The primary measure for clinical benefit analysis was time to definitive worsening by one or more categories of Karnofsky performance status (KPS). Secondary clinical benefit end points included time to 5% definitive weight loss, time to definitive worsening of appetite by one grade, pain-free survival (defined as time to first appearance of pain), and time to first cancer pain-related opioid intake. Clinical benefit assessments were recorded at each clinic visit. RESULTS: Clinical benefit assessments were performed in more than 75% of patients throughout V325. DCF significantly prolonged time to definitive worsening of KPS compared with CF (median, 6.1 v 4.8 months; hazard ratio, 1.38; 95% CI, 1.08 to 1.76; log-rank P = .009). Although time to definitive weight loss and time to definitive worsening of appetite favored DCF, the results were not statistically significant. Pain-free survival and time to first cancer pain-rela...