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. 2017 Jun 6;116(12):1544-1550.
doi: 10.1038/bjc.2017.128. Epub 2017 May 4.

Efficacy and safety of gemcitabine plus S-1 in pancreatic cancer: a pooled analysis of individual patient data

Chikuma Hamada  1 , Takuji Okusaka  2 , Takaaki Ikari  3 , Hiroyuki Isayama  4 , Junji Furuse  5 , Hiroshi Ishii  6 , Yousuke Nakai  4 , Shogo Imai  1 , Shota Okamura  1
Affiliations

Efficacy and safety of gemcitabine plus S-1 in pancreatic cancer: a pooled analysis of individual patient data

Chikuma Hamada et al. Br J Cancer. .

Abstract

Background: 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.

Methods: 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).

Results: 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.

Conclusions: Gemcitabine plus S-1 is a viable treatment alternative to gemcitabine, which is one of the standard treatments in patients with LAPC.

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Conflict of interest statement

CH has received consultancies from Taiho Pharmaceutical Co., Ltd. TO has received honoraria from Taiho Pharmaceutical Co., Ltd., Eli Lilly Japan KK, consultancies and research funding from Eli Lilly Japan KK and Taiho Pharmaceutical Co., Ltd. H Isayama has received honoraria from Taiho Pharmaceutical Co., Ltd. and Eli Lilly Japan KK, and research funding from Taiho Pharmaceutical Co., Ltd. JF has received honoraria from Taiho Pharmaceutical Co., Ltd. and Eli Lilly Japan KK, consultancies from Taiho Pharmaceutical Co., Ltd., and research funding from Taiho Pharmaceutical Co., Ltd. and Eli Lilly Japan KK H Ishii, has received honoraria from Taiho Pharmaceutical Co., Ltd. and Eli Lilly Japan KK, and research funding from Taiho Pharmaceutical Co., Ltd. The remaining authors declare no conflict of interest.

Figures

Figure 1
Figure 1
CONSORT diagram.
Figure 2
Figure 2
Cox’s proportional hazards model and test for heterogeneity (OS).
Figure 3
Figure 3
The Kaplan–Meier plot for overall survival in patients with locally advanced pancreatic cancer (A) and patients with metastatic pancreatic cancer (B).
See this image and copyright information in PMC

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