Phase Ⅰ trial of combination chemotherapy with gemcitabine, cisplatin, and S-1 in patients with advanced biliary tract cancer

被引：1

作者：

Akinori Watanabe ^{[1
]}

Mitsuhiro Kida ^{[1
]}

Shiro Miyazawa ^{[1
]}

Tomohisa Iwai ^{[1
]}

Kosuke Okuwaki ^{[1
]}

Toru Kaneko ^{[1
]}

Hiroshi Yamauchi ^{[1
]}

Miyoko Takezawa ^{[1
]}

Hiroshi Imaizumi ^{[1
]}

Wasaburo Koizumi ^{[1
]}

机构：

[1] Department of Gastroenterology, Kitasato University School of Medicine

来源：

World Journal of Gastroenterology | 2015年 / 19期

关键词：

Gemcitabine; Cisplatin; S-1; Advanced biliary tract cancer;

D O I：

暂无

中图分类号：

R735.8 [胆囊、胆道肿瘤];

学科分类号：

100214 ;

摘要：

AIM: To evaluate the dose-limiting toxicities(DLTs)and determine the maximum-tolerated dose(MTD) and recommended dose(RD) of combination chemotherapy with gemcitabine, cisplatin and S-1 which is an oral fluoropyrimidine pro-drug in patients with advanced biliary tract cancer.METHODS: Patients with histologically or cytologically confirmed unresectable or recurrent biliary tract cancer were enrolled. The planned dose levels of gemcitabine(mg/m2), cisplatin(mg/m2), and S-1(mg/m2 per day) were as follows: level-1, 800/20/60;level 0, 800/25/60; level 1, 1000/25/60; and level 2,1000/25/80. In each cycle, gemcitabine and cisplatin were administered intravenously on days 1 and 15,and S-1 was administered orally twice daily on days 1to 7 and days 15 to 21, every 4 wk.RESULTS: Twelve patients were enrolled, and level0 was chosen as the starting dose. None of the first three patients had DLTs at level 0, and the dose was escalated to level 1. One of six patients had DLTs(grade 4 febrile neutropenia, leucopenia, and neutropenia; grade 3 thrombocytopenia) at level 1.We then proceeded to level 2. None of three patients had DLTs during the first cycle. Although the MTD was not determined, level 2 was designated at the RD for a subsequent phase Ⅱ study.CONCLUSION: The RD was defined as gemcitabine1000 mg/m2(days 1, 15), cisplatin 25 mg/m2(days1, 15), and S-1 80 mg/m2 per day(days 1-7, 15-21),every 4 weeks. A phase Ⅱ study is planned to evaluate the effectiveness of combination chemotherapy withgemcitabine, cisplatin, and S-1 in advanced biliary tract cancer.

引用

页码：5979 / 5984

页数：6

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