A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study.
A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study.
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DOI：
10.1038/bjc.2012.183
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发表时间：
2012-06-05
影响因子：
8.8
通讯作者：
Koike K
中科院分区：
文献类型：
--
作者：
Nakai Y;Isayama H;Sasaki T;Sasahira N;Tsujino T;Toda N;Kogure H;Matsubara S;Ito Y;Togawa O;Arizumi T;Hirano K;Tada M;Omata M;Koike K
这项随机II期试验比较了吉西他滨单药与吉西他滨和S-1联合治疗晚期胰腺癌的疗效。患者被随机分配至吉西他滨单药治疗（第1、8和15天1000 mg m−2吉西他滨30分钟输注）或吉西他滨和S-1联合治疗（第1和15天1000 mg m−2吉西他滨30分钟输注，第1- 15天40 mg m−2 S-1口服，每日两次），为期4周。主要终点是无进展生存期（PFS）。2006年7月至2009年2月期间，入组了106例患者。吉西他滨和S-1联合治疗组的PFS显著长于吉西他滨组（5.4 vs 3.6个月），风险比为0.64（P=0.036）。吉西他滨和S-1联合治疗的总生存期（OS）长于吉西他滨单药治疗（13.5 vs 8.8个月），风险比为0.72（P=0.104）。总体而言，两组的3级或4级不良事件相似。吉西他滨和S-1联合治疗显示晚期胰腺癌的PFS更长。吉西他滨和S-1联合治疗的OS持续时间延长了4.7个月，但无统计学显著性。
This randomised phase II trial compared gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer. Patients were randomly assigned to 4-week treatment with gemcitabine alone (1000, mg m−2 gemcitabine by 30-min infusion on days 1, 8, and 15) or gemcitabine and S-1 combination therapy (1000, mg m−2 gemcitabine by 30-min infusion on days 1 and 15 and 40 mg m−2 S-1 orally twice daily on days 1–15). The primary end point was progression-free survival (PFS). Between July 2006 and February 2009, 106 patients were enrolled. The PFS in gemcitabine and S-1 combination arm was significantly longer than in gemcitabine arm (5.4 vs 3.6 months), with a hazard ratio of 0.64 (P=0.036). Overall survival (OS) for gemcitabine and S-1 combination was longer than that for gemcitabine monotherapy (13.5 vs 8.8 months), with a hazard ratio of 0.72 (P=0.104). Overall, grade 3 or 4 adverse events were similar in both arms. Gemcitabine and S-1 combination therapy demonstrated longer PFS in advanced pancreatic cancer. Improved OS duration of 4.7 months was found for gemcitabine and S-1 combination therapy, though this was not statistically significant.