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Clinical Trial
. 2017 Jun;143(6):1053-1059.
doi: 10.1007/s00432-017-2349-y. Epub 2017 Feb 16.

Updated results from GEST study: a randomized, three-arm phase III study for advanced pancreatic cancer

Takuji Okusaka  1 , H Miyakawa  2 , H Fujii  3 , S Nakamori  4 , T Satoh  5 , Y Hamamoto  6 , T Ito  7 , H Maguchi  8 , S Matsumoto  9 , H Ueno  10 , T Ioka  11 , N Boku  12 , S Egawa  13 , T Hatori  14 , J Furuse  15 , K Mizumoto  16 , S Ohkawa  17 , T Yamaguchi  18 , K Yamao  19 , A Funakoshi  20 , J S Chen  21 , A L Cheng  22 , A Sato  23 , Y Ohashi  24 , M Tanaka  25 ; GEST group
Affiliations
Clinical Trial

Updated results from GEST study: a randomized, three-arm phase III study for advanced pancreatic cancer

Takuji Okusaka et al. J Cancer Res Clin Oncol. 2017 Jun.

Abstract

Purpose: The GEST study showed non-inferiority of S-1 but not superiority of gemcitabine plus S-1 (GS) to gemcitabine alone for overall survival with the data by the cut-off date of 31st July in 2010 for chemo-naïve patients with advanced pancreatic cancer. We considered it important to determine whether S-1 maintains non-inferiority after a long-term follow-up in the GEST study and to obtain a firm positive conclusion. In addition, it may be an interesting challenge to explore the efficacious profile of GS in the long-term follow-up study. Using the data from the follow-up period, background and efficacy in patients from Taiwan and Japan, as well as the rates of tumor shrinkage in locally advanced and metastatic patients (Waterfall plot) were also analyzed.

Methods: The results of the primary analysis were reconfirmed, and subset analysis of overall survival and progression-free survival was performed based on the overall survival data updated by the cut-off date of 31st July in 2011.

Results: The median follow-up period was 29.8 months, and 795 deaths occurred (95.6%). The median overall survival was 8.8 months for gemcitabine, 9.7 months for S-1 (hazard ratio [HR], 0.96; 97.5% confidence interval [CI], 0.79-1.17), and 9.9 months for GS (HR 0.91; 97.5% CI 0.75-1.11). In patients with performance status (PS) 0, the median overall survival was 9.8 months for gemcitabine, 10.9 months for S-1, and 10.5 months for GS. In patients with PS 1, the median overall survival was 6.2 months for gemcitabine, 6.3 months for S-1, and 9.6 months for GS.

Conclusion: Our survey reconfirmed the non-inferiority of S-1 to gemcitabine and showed S-1 can be used as one of the standard treatment options for advanced pancreatic cancer.

Trial registration: ClinicalTrials.gov: NCT00498225.

Keywords: Gemcitabine; Pancreatic cancer; S-1; Subgroup analysis; Updated data.

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Conflict of interest statement

TO has received consulting fees, honoraria, and research funding from Taiho Pharmaceutical Co. Ltd. (Taiho) and Eli Lilly and Company (Eli Lilly). SM has received honoraria from Taiho and Eli Lilly. HU has received consulting fees and research funding from Taiho; honoraria from Taiho and Eli Lilly. TI has received consulting fees, honoraria, and research funding from Taiho. NB has received honoraria and research funding from Taiho. TH has received consulting fees and research funding from Taiho. JF has received consulting fees from Taiho; honoraria and research funding from Taiho and Eli Lilly. KM has received consulting fees and research funding from Taiho. SO has received consulting fees, honoraria and research funding from Taiho. TY has received consulting fees and research funding from Taiho. KY has received consulting fees and research funding from Taiho; honoraria from Taiho and Eli Lilly. AF has received consulting fees, honoraria, and research funding from Taiho. JSC has received consulting fees from TTY Biopharm Co. Ltd. (TTY), Eli Lilly, Novartis, and Bayer. ALC has received consultant fees from Boehringer Ingelheim, Sanofi K.K., and TTY; honoraria from Novartis, Bayer and Merck Sharp & Dohme(MSD); research funding from Sanofi K.K. AS has received consulting fees and honoraria from Taiho. YO has received consulting fees from Taiho; honoraria from Eli Lilly. All remaining authors have declared no conflicts of interest.

Figures

Fig. 1
Fig. 1
Kaplan–Meier curves for updated OS in the full analysis set. CI confidence interval, GEM gemcitabine, GS gemcitabine plus S-1, HR hazard ratio, OS overall survival
Fig. 2
Fig. 2
Forest plots of treatment effects on OS in subgroup analyses. a S-1 vs. gemcitabine. b GS vs. gemcitabine. CI confidence interval, GEM gemcitabine, GS gemcitabine plus S-1, HR hazard ratio, OS overall survival, PS performance status
Fig. 3
Fig. 3
Kaplan–Meier plots for updated OS in the subset analysis (a, PS 0; b, PS 1). CI confidence interval, GEM gemcitabine, GS gemcitabine plus S-1, HR hazard ratio, PS performance status
See this image and copyright information in PMC

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