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.ANN-LII CHENGSato A.Ohashi Y.Tanaka M.on behalf of the GEST group2021-08-312021-08-3120170171-5216https://www.scopus.com/inward/record.uri?eid=2-s2.0-85013123660&doi=10.1007%2fs00432-017-2349-y&partnerID=40&md5=6d79b133766f591347630889ec633ae3https://scholars.lib.ntu.edu.tw/handle/123456789/580097Purpose: 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).Gemcitabine; Pancreatic cancer; S-1; Subgroup analysis; Updated data[SDGs]SDG3gemcitabine; 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; Tegafurjournal article10.1007/s00432-017-2349-y282108432-s2.0-85013123660