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 language | English |
|---|---|
| Pages (from-to) | 1053-1059 |
| Number of pages | 7 |
| Journal | Journal of Cancer Research and Clinical Oncology |
| Volume | 143 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 2017 Jun 1 |
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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 journal › Article
}
TY - JOUR
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
UR - http://www.scopus.com/inward/record.url?scp=85013123660&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85013123660&partnerID=8YFLogxK
U2 - 10.1007/s00432-017-2349-y
DO - 10.1007/s00432-017-2349-y
M3 - Article
C2 - 28210843
AN - SCOPUS:85013123660
VL - 143
SP - 1053
EP - 1059
JO - Journal of Cancer Research and Clinical Oncology
JF - Journal of Cancer Research and Clinical Oncology
SN - 0171-5216
IS - 6
ER -