Updated results from GEST study: a randomized, three-arm phase III study for advanced pancreatic cancer
Journal
Journal of Cancer Research and Clinical Oncology
Journal Volume
143
Journal Issue
6
Pages
1053-1059
Date Issued
2017
Author(s)
Okusaka T.
Miyakawa H.
Fujii H.
Nakamori S.
Satoh T.
Hamamoto Y.
Ito T.
Maguchi H.
Matsumoto S.
Ueno H.
Ioka T.
Boku N.
Egawa S.
Hatori T.
Furuse J.
Mizumoto K.
Ohkawa S.
Yamaguchi T.
Yamao K.
Funakoshi A.
Chen J.S.
Sato A.
Ohashi Y.
Tanaka M.
on behalf of the GEST group
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?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. ? 2017, The Author(s).
Subjects
Gemcitabine; Pancreatic cancer; S-1; Subgroup analysis; Updated data
SDGs
Other Subjects
gemcitabine; gimeracil plus oteracil potassium plus tegafur; antineoplastic agent; deoxycytidine; drug combination; gemcitabine; oteracil; S 1 (combination); tegafur; advanced cancer; aged; Article; cancer combination chemotherapy; cancer mortality; cancer patient; cancer survival; controlled study; drug efficacy; female; follow up; human; Japan; local metastasis; long term survival; major clinical study; male; median survival time; monotherapy; multicenter study; multiple cycle treatment; open study; overall survival; pancreas cancer; phase 3 clinical trial; priority journal; progression free survival; randomized controlled trial; response evaluation criteria in solid tumors; survival rate; Taiwan; adenocarcinoma; adult; analogs and derivatives; clinical trial; disease course; drug combination; middle aged; mortality; neoadjuvant therapy; Pancreatic Neoplasms; pathology; very elderly; Adenocarcinoma; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Deoxycytidine; Disease Progression; Drug Combinations; Female; Follow-Up Studies; Humans; Male; Middle Aged; Neoadjuvant Therapy; Oxonic Acid; Pancreatic Neoplasms; Tegafur
Publisher
Springer Verlag
Type
journal article