TY - JOUR
T1 - Improved survival with combined gemcitabine and S-1 for locally advanced pancreatic cancer
T2 - Pooled analysis of three randomized studies
AU - Yanagimoto, Hiroaki
AU - Ishii, Hiroshi
AU - Nakai, Yousuke
AU - Ozaka, Masato
AU - Ikari, Takaaki
AU - Koike, Kazuhiko
AU - Ueno, Hideki
AU - Ioka, Tatsuya
AU - Satoi, Sohei
AU - Sho, Masayuki
AU - Okusaka, Takuji
AU - Tanaka, Masao
AU - Shimokawa, Toshio
AU - Kwon, A. Hon
AU - Isayama, Hiroyuki
N1 - Publisher Copyright:
© 2014 Japanese Society of Hepato-Biliary-Pancreatic Surgery.
PY - 2014/10/1
Y1 - 2014/10/1
N2 - 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.
AB - 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.
KW - Gemcitabine with S-1
KW - Locally advanced pancreatic cancer
KW - Pooled analysis
UR - http://www.scopus.com/inward/record.url?scp=84927633457&partnerID=8YFLogxK
U2 - 10.1002/jhbp.130
DO - 10.1002/jhbp.130
M3 - Article
C2 - 24925464
AN - SCOPUS:84927633457
SN - 1868-6974
VL - 21
SP - 761
EP - 766
JO - Journal of Hepato-Biliary-Pancreatic Sciences
JF - Journal of Hepato-Biliary-Pancreatic Sciences
IS - 10
ER -