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

on behalf of the GEST group

Research output: Contribution to journalArticle

13 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1053-1059
Number of pages7
JournalJournal of Cancer Research and Clinical Oncology
Volume143
Issue number6
DOIs
Publication statusPublished - 2017 Jun 1

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gemcitabine
Pancreatic Neoplasms
Survival
Confidence Intervals
Survival Analysis

Keywords

  • Gemcitabine
  • Pancreatic cancer
  • S-1
  • Subgroup analysis
  • Updated data

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Updated results from GEST study : a randomized, three-arm phase III study for advanced pancreatic cancer. / on behalf of the GEST group.

In: Journal of Cancer Research and Clinical Oncology, Vol. 143, No. 6, 01.06.2017, p. 1053-1059.

Research output: Contribution to journalArticle

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title = "Updated results from GEST study: a randomized, three-arm phase III study for advanced pancreatic cancer",
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-na{\"i}ve 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",
author = "{on behalf of the GEST group} and Takuji Okusaka and H. Miyakawa and H. Fujii and S. Nakamori and T. Satoh and Yasuo Hamamoto and T. Ito and H. Maguchi and S. Matsumoto and H. Ueno and T. Ioka and N. Boku and S. Egawa and T. Hatori and J. Furuse and K. Mizumoto and S. Ohkawa and T. Yamaguchi and K. Yamao and A. Funakoshi and Chen, {J. S.} and Cheng, {A. L.} and A. Sato and Y. Ohashi and M. Tanaka",
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T1 - Updated results from GEST study

T2 - a randomized, three-arm phase III study for advanced pancreatic cancer

AU - on behalf of the GEST group

AU - Okusaka, Takuji

AU - Miyakawa, H.

AU - Fujii, H.

AU - Nakamori, S.

AU - Satoh, T.

AU - Hamamoto, Yasuo

AU - Ito, T.

AU - Maguchi, H.

AU - Matsumoto, S.

AU - Ueno, H.

AU - Ioka, T.

AU - Boku, N.

AU - Egawa, S.

AU - Hatori, T.

AU - Furuse, J.

AU - Mizumoto, K.

AU - Ohkawa, S.

AU - Yamaguchi, T.

AU - Yamao, K.

AU - Funakoshi, A.

AU - Chen, J. S.

AU - Cheng, A. L.

AU - Sato, A.

AU - Ohashi, Y.

AU - Tanaka, M.

PY - 2017/6/1

Y1 - 2017/6/1

N2 - 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.

AB - 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.

KW - Gemcitabine

KW - Pancreatic cancer

KW - S-1

KW - Subgroup analysis

KW - Updated data

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U2 - 10.1007/s00432-017-2349-y

DO - 10.1007/s00432-017-2349-y

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