吉西他滨与S-1联合治疗局部晚期胰腺癌可提高生存率：三项随机研究的汇总分析
Improved survival with combined gemcitabine and S-1 for locally advanced pancreatic cancer: pooled analysis of three randomized studies.
作者信息
Yanagimoto Hiroaki, Ishii Hiroshi, Nakai Yousuke, Ozaka Masato, Ikari Takaaki, Koike Kazuhiko, Ueno Hideki, Ioka Tatsuya, Satoi Sohei, Sho Masayuki, Okusaka Takuji, Tanaka Masao, Shimokawa Toshio, Kwon A-Hon, Isayama Hiroyuki
机构信息
Department of Surgery, Kansai Medical University, 2-5-1 Shin-machi, Hirakata, 573-1010, Japan.
出版信息
J Hepatobiliary Pancreat Sci. 2014 Oct;21(10):761-6. doi: 10.1002/jhbp.130. Epub 2014 Jun 13.
BACKGROUND
The long-term prognosis for localized pancreatic cancer (PC) remains poor. Three randomized trials (GEST phase III, JACCRO PC-01 phase II and GEMSAP phase II) evaluated gemcitabine (Gem) with or without S-1 for patients with metastatic and locally advanced PC. A pooled analysis based on published data examined whether Gem with S-1 (GS) is superior to Gem alone in overall survival (OS) in patients with locally advanced PC.
METHODS
Data were extracted on 193 patients: 31 (JACCRO), 28 (GEMSAP), and 134 (GEST). OS was used for primary endpoint and progression-free survival (PFS) was used for secondary endpoint. A general variance-based method was used to estimate the pooled HR and 95% CI between GS (n = 96) and Gem (n = 97).
RESULTS
Meta-analysis demonstrated that the overall risk of death was significantly different between the two chemotherapies (hazard ratio = 0.673, 95% confidence interval: 0.488-0.929, P = 0.016). The median PFSs for GS and GEM in the JACCRO, GEMSAP, and GEST studies were 12.0, 12.6, and 10.7 months, and 4.1, 8.1, and 6.2 months, respectively (P = 0.001). The random-effect pooled estimate for 165 patients showed the objective response rate (ORR) in the GS group (28.4%) was better in the Gem group (8.3%, P = 0.001).
CONCLUSIONS
GS improved ORR, PFS and OS in patients with locally advanced PC over Gem alone. GS could become one of the front-line chemotherapeutic agents.
背景
局部胰腺癌（PC）的长期预后仍然很差。三项随机试验（GEST III期、JACCRO PC-01 II期和GEMSAP II期）评估了吉西他滨（Gem）联合或不联合S-1用于转移性和局部晚期PC患者的疗效。一项基于已发表数据的汇总分析探讨了吉西他滨联合S-1（GS）在局部晚期PC患者的总生存期（OS）方面是否优于单用吉西他滨。
方法
提取了193例患者的数据：31例（JACCRO）、28例（GEMSAP）和134例（GEST）。OS用作主要终点，无进展生存期（PFS）用作次要终点。采用基于一般方差的方法估计GS组（n = 96）和吉西他滨组（n = 97）之间的汇总风险比（HR）和95%置信区间（CI）。
结果
荟萃分析表明，两种化疗方案的总体死亡风险存在显著差异（风险比 = 0.673，95%置信区间：0.488 - 0.929，P = 0.016）。在JACCRO、GEMSAP和GEST研究中，GS组和吉西他滨组的中位PFS分别为12.0、12.6和10.7个月，以及4.1、8.1和6.2个月（P = 0.001）。对165例患者的随机效应汇总估计显示，GS组的客观缓解率（ORR）为28.4%，优于吉西他滨组的8.3%（P = 0.001）。
结论
与单用吉西他滨相比，GS改善了局部晚期PC患者的ORR、PFS和OS。GS可能成为一线化疗药物之一。
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