A Multicenter, Phase I Dose-Escalating Study of Docetaxel, Cisplatin and S-1 for Advanced Gastric Cancer (KDOG0601)

作者：Norisuke Nakayama, Wasaburo Koizumi, Tohru Sasaki, Katsuhiko Higuchi, Satoshi Tanabe, Ken Nishimura, Chikatoshi Katada, Kento Nakatani, Seiichi Takagi, Katsunori Saigenji · 发表于：Oncology · 年份：2008 · DOI：10.1159/000151613 · 被引用次数：33 · 研究领域：Gastric Cancer Management and Outcomes、Helicobacter pylori-related gastroenterology studies、Colorectal Cancer Treatments and Studies

OBJECTIVE: This dose-escalation study of a combination of docetaxel, cisplatin and S-1 investigated the dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), recommended dose (RD) and antitumor activity in advanced gastric cancer. PATIENTS AND METHODS: Patients received docetaxel (40 mg/m(2)), cisplatin (DIV on day 1) and S-1 (40 mg/m(2) p.o., twice daily, on days 1-14 every 28 days). The starting dose of cisplatin was 60 mg/m(2) (level 1); the dose was escalated to 70 (level 2) and 80 mg/m(2) (level 3) in a stepwise fashion. RESULTS: Fourteen patients were enrolled. The MTD of cisplatin was 80 mg/m(2) (level 3). DLT was grade 3 diarrhea, febrile neutropenia and delayed resumption of treatment. The RD of cisplatin was considered to be 70 mg/m(2) (level 2). DLT was liver dysfunction, occurring in only 1 patient at level 2. The response rate was 69.2% (9/13). CONCLUSIONS: For combined treatment with docetaxel, cisplatin and S-1 in patients with advanced gastric cancer, RD were docetaxel 40 mg/m(2), cisplatin 70 mg/m(2) and S-1 80 mg/m(2)/day. This regimen yields a high rate of tumor response and can be administered safely. Phase II studies of this regimen are under way.