S-1联合奥沙利铂对比S-1治疗吉西他滨难治性胰腺癌患者的随机II期试验

Randomised phase II trial of S-1 plus oxaliplatin vs S-1 in patients with gemcitabine-refractory pancreatic cancer.

作者信息

Ohkawa S, Okusaka T, Isayama H, Fukutomi A, Yamaguchi K, Ikeda M, Funakoshi A, Nagase M, Hamamoto Y, Nakamori S, Tsuchiya Y, Baba H, Ishii H, Omuro Y, Sho M, Matsumoto S, Yamada N, Yanagimoto H, Unno M, Ichikawa Y, Takahashi S, Watanabe G, Wakabayashi G, Egawa N, Tsuda M, Hosotani R, Hamada C, Hyodo I

机构信息

Department of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, 2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan.

Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.

出版信息

Br J Cancer. 2015 Apr 28;112(9):1428-34. doi: 10.1038/bjc.2015.103. Epub 2015 Apr 16.

BACKGROUND

This randomised, open-label, multicenter phase II study compared progression-free survival (PFS) of S-1 plus oxaliplatin (SOX) with that of S-1 alone in patients with gemcitabine-refractory pancreatic cancer.

METHODS

Patients with confirmed progressive disease following the first-line treatment with a gemcitabine-based regimen were randomised to receive either S-1 (80/100/120 mg day(-1) based on body surface area (BSA), orally, days 1-28, every 6 weeks) or SOX (S-1 80/100/120 mg day(-1) based on BSA, orally, days 1-14, plus oxaliplatin 100 mg m(-2), intravenously, day 1, every 3 weeks). The primary end point was PFS.

RESULTS

Between January 2009 and July 2010, 271 patients were randomly allocated to either S-1 (n=135) or SOX (n=136). Median PFS for S-1 and SOX were 2.8 and 3.0 months, respectively (hazard ratio (HR)=0.84; 95% confidence interval (CI), 0.65-1.08; stratified log-rank test P=0.18). Median overall survival (OS) was 6.9 vs 7.4 months (HR=1.03; 95% CI, 0.79-1.34; stratified log-rank test P=0.82). The response rate (RR) was 11.5% vs 20.9% (P=0.04). The major grade 3/4 toxicities (S-1 and SOX) were neutropenia (11.4% and 8.1%), thrombocytopenia (4.5% and 10.3%) and anorexia (12.9% and 14.7%).

CONCLUSIONS

Although SOX showed an advantage in RR, it provided no significant improvement in PFS or OS compared with S-1 alone.

背景

这项随机、开放标签、多中心II期研究比较了S-1联合奥沙利铂（SOX）与单用S-1治疗吉西他滨难治性胰腺癌患者的无进展生存期（PFS）。

方法

一线接受基于吉西他滨方案治疗后确诊疾病进展的患者被随机分为两组，分别接受S-1（根据体表面积（BSA），80/100/120mg/天，口服，第1 - 28天，每6周重复）或SOX（S-1根据BSA，80/100/120mg/天，口服，第1 - 14天，加奥沙利铂100mg/m²，静脉注射，第1天，每3周重复）。主要终点为PFS。

结果

2009年1月至2010年7月期间，271例患者被随机分配至S-1组（n = 135）或SOX组（n = 136）。S-1组和SOX组的中位PFS分别为2.8个月和3.0个月（风险比（HR）= 0.84；95%置信区间（CI），0.65 - 1.08；分层对数秩检验P = 0.18）。中位总生存期（OS）分别为6.9个月和7.4个月（HR = 1.03；95% CI，0.79 - 1.34；分层对数秩检验P = 0.82）。缓解率（RR）分别为11.5%和20.9%（P = 0.04）。主要的3/4级毒性反应（S-1组和SOX组）为中性粒细胞减少（11.4%和8.1%）、血小板减少（4.5%和10.3%）和厌食（12.9%和14.7%）。