Hamada Chikuma, Okusaka Takuji, Ikari Takaaki, Isayama Hiroyuki, Furuse Junji, Ishii Hiroshi, Nakai Yousuke, Imai Shogo, Okamura Shota
Department of Management Science, Tokyo University of Science, 6-3-1 Niijuku, Katsushika-ku, Tokyo 125-8585, Japan.
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
Br J Cancer. 2017 Jun 6;116(12):1544-1550. doi: 10.1038/bjc.2017.128. Epub 2017 May 4.
Three randomised trials (GEST, JACCRO PC-01, and GEMSAP) were conducted to evaluate the efficacy of gemcitabine plus S-1 (GS) vs gemcitabine alone in patients with advanced pancreatic cancer (PC). In this pooled analysis, the efficacy and safety of GS vs gemcitabine were evaluated.
Additional follow-up was conducted and survival data were updated in each study. A total of 770 patients (gemcitabine 389; GS 381) were included in the pooled analysis. The efficacy and safety data were analysed according to disease extent: locally advanced PC (LAPC) or metastatic PC (MPC).
There were 738 (95.8%) overall survival events. In patients with LAPC (n=193), the median survival was 11.83 months for gemcitabine and 16.41 months for GS (hazard ratio (HR)=0.708; 95% confidence intervals (CI), 0.527-0.951; P=0.0220). In patients with MPC (n=577), the median survival was 8.02 months for gemcitabine and 9.43 months for GS (HR=0.872; 95% CI, 0.738-1.032; P=0.1102). The rate of grade 3/4 toxicity (rash and thrombocytopenia in LAPC; rash, diarrhoea, vomiting, and neutropaenia in MPC) was significantly higher for GS than for gemcitabine.
Gemcitabine plus S-1 is a viable treatment alternative to gemcitabine, which is one of the standard treatments in patients with LAPC.
开展了三项随机试验（GEST、JACCRO PC - 01和GEMSAP），以评估吉西他滨联合S - 1（GS）对比单用吉西他滨治疗晚期胰腺癌（PC）患者的疗效。在这项汇总分析中，对GS和吉西他滨的疗效及安全性进行了评估。
在每项研究中进行了额外随访并更新了生存数据。汇总分析共纳入770例患者（吉西他滨组389例；GS组381例）。根据疾病范围（局部晚期PC（LAPC）或转移性PC（MPC））分析疗效和安全性数据。
共有738例（95.8%）总生存事件。在LAPC患者（n = 193）中，吉西他滨组的中位生存期为11.83个月，GS组为16.41个月（风险比（HR）= 0.708；95%置信区间（CI），0.527 - 0.951；P = 0.0220）。在MPC患者（n = 577）中，吉西他滨组的中位生存期为8.02个月，GS组为9.43个月（HR = 0.872；95% CI，0.738 - 1.032；P = 0.1102）。GS组3/4级毒性（LAPC中为皮疹和血小板减少；MPC中为皮疹、腹泻、呕吐和中性粒细胞减少）发生率显著高于吉西他滨组。
吉西他滨联合S - 1是吉西他滨可行的治疗替代方案，吉西他滨是LAPC患者的标准治疗方法之一。
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