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
Department of Surgery, Kansai Medical University, 2-5-1 Shin-machi, Hirakata, 573-1010, Japan.
J Hepatobiliary Pancreat Sci. 2014 Oct;21(10):761-6. doi: 10.1002/jhbp.130. Epub 2014 Jun 13.
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.
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).
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).
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.
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。
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）。
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）。
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。
