期刊
CANCER SCIENCE
卷 104, 期 9, 页码 1211-1216出版社
WILEY-BLACKWELL
DOI: 10.1111/cas.12218
关键词
-
类别
资金
- National Cancer Center Research and Development Fund [23-A-16, 23-A-22]
- Ministry of Health, Labour and Welfare of Japan [20S-3, 20S-6, 19-022, 22-013]
The oral fluoropyrimidine, S-1, combined with or without gemcitabine is considered to be a promising agent for treating advanced biliary tract cancer; gemcitabine plus cisplatin is the current standard regimen. This randomized phase II trial was designed to evaluate the safety and efficacy of two regimens: gemcitabine plus S-1 (GS) (gemcitabine: 1000mg/m(2), day 1 and day 8; S-1: 60mg/m(2), twice daily on days 1-14, repeated every 3weeks); and S-1 (80mg/m(2), days 1-28, given orally twice daily for 4weeks, followed by a 2-week rest, repeated every 6weeks). The regimen with a higher 1-year survival would be selected for a subsequent phase III trial. Between February 2009 and April 2010, 101 patients were randomized. For the GS (n=51) and S-1 (n=50) arms, the 1-year survival was 52.9% (95% confidence interval, 38.5-65.5) and 40.0% (95% confidence interval, 26.5-53.1), and the median survival times were 12.5 and 9.0months, respectively. Grade 3/4 hematological toxicities were more frequent in the GS arm (leucocytes 29.4%, neutrophils 60.8%, hemoglobin 11.8%, platelets 11.8%) than in the S-1 arm (leucocytes 2.0%, neutrophils 4.0%, hemoglobin 4.0%, platelets 4.0%). Although two treatment-related deaths occurred in the GS arm, all other grade 3/4 non-hematological toxicities were reversible. In conclusion, GS was considered to be more promising and was selected as the test regimen for a subsequent phase III trial comparing GS with gemcitabine plus cisplatin combination therapy. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001685 (http://www.umin.ac.jp/ctr/index.htm).
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据