Multicenter Phase II Trial of S-1 Plus Cisplatin in Patients With Untreated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

作者：Jaffer A. Ajani, Fa-Chyi Lee, Deepti A. Singh, Daniel G. Haller, Heinz‐Josef Lenz, Al B. Benson, Ronald H. Yanagihara, Alexandria T. Phan, James C. Yao, Dirk Strumberg · 发表于：Journal of Clinical Oncology · 年份：2006 · DOI：10.1200/jco.2005.04.2994 · 被引用次数：92 · 研究领域：Gastric Cancer Management and Outcomes、Esophageal Cancer Research and Treatment、Helicobacter pylori-related gastroenterology studies

PURPOSE: S-1 plus cisplatin is considered highly active in Japanese gastric cancer patients. We conducted a phase II multi-institutional trial, in the West, in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma to evaluate activity and safety of this combination. METHODS: Patients received cisplatin intravenously at 75 mg/m2 on day 1 and S-1 orally at 25 mg/m2/dose bid (50 mg/m2/d) on days 1 to 21, repeated every 28 days. Patients with histologic proof of gastric or gastroesophageal junction adenocarcinoma with a Karnofsky performance status (KPS) of > or = 70% and near-normal organ function were eligible. All patients provided a written informed consent. To observe a 45% confirmed overall response rate (ORR), 41 assessable patients were needed. RESULTS: All 47 patients were assessed for safety and survival, and 41 patients were assessed for ORR. The median age was 56 years and median KPS was 80%. The median number of chemotherapy cycles was four. The confirmed ORR was 51% (95% CI, 35% to 67%) and it was 49% by an independent review. At the 6-month interval, 71% of patients were alive, with a median survival time of 10.9 months. Frequent grade 3 or 4 toxicities included fatigue (26%), neutropenia (26%), vomiting (17%), diarrhea (15%), and nausea (15%); however, stomatitis (2%) and febrile neutropenia (2%) were uncommon. There was one (2%) treatment-related death. CONCLUSION: S-1 plus cisplatin is active against gastric cancer and has a favora...