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

Autor: Seiichi Takagi, Tohru Sasaki, Norisuke Nakayama, Wasaburo Koizumi, Katsuhiko Higuchi, Katsunori Saigenji, Kento Nakatani, Ken Nishimura, Chikatoshi Katada, Satoshi Tanabe
Rok vydání: 2008
Předmět:
Zdroj: Oncology. 75:1-7
ISSN: 1423-0232
0030-2414
DOI: 10.1159/000151613
Popis: 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/m2), cisplatin (DIV on day 1) and S-1 (40 mg/m2 p.o., twice daily, on days 1–14 every 28 days). The starting dose of cisplatin was 60 mg/m2 (level 1); the dose was escalated to 70 (level 2) and 80 mg/m2 (level 3) in a stepwise fashion. Results: Fourteen patients were enrolled. The MTD of cisplatin was 80 mg/m2 (level 3). DLT was grade 3 diarrhea, febrile neutropenia and delayed resumption of treatment. The RD of cisplatin was considered to be 70 mg/m2 (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/m2, cisplatin 70 mg/m2 and S-1 80 mg/m2/day. This regimen yields a high rate of tumor response and can be administered safely. Phase II studies of this regimen are under way.
Databáze: OpenAIRE