吉西他滨联合 S-1 方案对比吉西他滨治疗不可切除胰腺癌的随机对照研究。
Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer.
机构信息
Department of Gastroenterology, Chiba Cancer Center, 666-2 Nitona-cho, Chuo-ku, Chiba, 260-8717, Japan,
出版信息
Cancer Chemother Pharmacol. 2014 Feb;73(2):389-96. doi: 10.1007/s00280-013-2368-6. Epub 2013 Dec 10.
PURPOSE
The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 (GS) combination chemotherapy in patients with unresectable pancreatic cancer.
METHODS
Patients were randomly assigned to receive GS (oral S-1 60 mg/m(2) daily on days 1-15 every 3 weeks and gemcitabine 1,000 mg/m(2) on days 8 and 15) or gemcitabine (1,000 mg/m(2) on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS).
RESULTS
One hundred and one patients were randomly assigned. PFS was significantly longer in the GS arm with an estimated hazard ratio (HR) of 0.65 (95 % CI 0.43-0.98; P = 0.039; median 5.3 vs 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P = 0.048). Median survival was 8.6 months for GS and 8.6 months for GEM (HR 0.93; 95 % CI 0.61-1.41; P = 0.714). Grade 3-4 neutropenia (44 vs 19.6 %, P = 0.011) and thrombocytopenia (26 vs 8.7 %, P = 0.051) were more frequent in the GS arm.
CONCLUSIONS
GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.
目的
本研究旨在评估吉西他滨联合替吉奥（GS）联合化疗治疗不可切除胰腺癌患者的疗效和安全性。
方法
患者被随机分配接受 GS（替吉奥 60mg/m2，每日 1 次，第 1-15 天，每 3 周；吉西他滨 1000mg/m2，第 8 和 15 天）或吉西他滨（1000mg/m2，第 1、8 和 15 天，每 4 周）治疗。主要终点是无进展生存期（PFS）。
结果
共有 101 例患者被随机分配。GS 组的 PFS 显著延长，估计风险比（HR）为 0.65（95%可信区间 0.43-0.98；P=0.039；中位数 5.3 与 3.8 个月）。GS 组客观缓解率（ORR）也更好（21.6%与 6%，P=0.048）。GS 组和 GEM 组的中位总生存期分别为 8.6 个月和 8.6 个月（HR 0.93；95%可信区间 0.61-1.41；P=0.714）。GS 组 3-4 级中性粒细胞减少症（44%与 19.6%，P=0.011）和血小板减少症（26%与 8.7%，P=0.051）更为常见。
结论
GS 治疗可改善不可切除胰腺癌患者的 PFS 和 ORR，且毒性谱可接受。
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