Randomized Phase III Study of Gemcitabine Plus S-1, S-1 Alone, or Gemcitabine Alone in Patients With Locally Advanced and Metastatic Pancreatic Cancer in Japan and Taiwan: GEST Study
Resource
J. Clin. Oncol., 31(13), 1640-+
Journal
Journal of Clinical Oncology
Pages
1640-1648
Date Issued
2013
Date
2013
Author(s)
Ueno H.
Ioka T.
Ikeda M.
Ohkawa S.
Yanagimoto H.
Boku N.
Fukutomi A.
Sugimori K.
Baba H.
Yamao K.
Shimamura T.
Sho M.
Kitano M.
Mizumoto K.
Chen J.-S.
Furuse J.
Funakoshi A.
Hatori T.
Yamaguchi T.
Egawa S.
Sato A.
Ohashi Y.
Okusaka T.
Tanaka M.
鄭安理
Abstract
Purpose
The present phase III study was designed to investigate the noninferiority of S-1 alone and superiority of gemcitabine plus S-1 compared with gemcitabine alone with respect to overall survival.
Patients and Methods
The participants were chemotherapy-naive patients with locally advanced or metastatic pancreatic cancer. Patients were randomly assigned to receive only gemcitabine (1,000 mg/m(2) on days 1, 8, and 15 of a 28-day cycle), only S-1 (80, 100, or 120 mg/d according to body-surface area on days 1 through 28 of a 42-day cycle), or gemcitabine plus S-1 (gemcitabine 1,000 mg/m2 on days 1 and 8 plus S-1 60, 80, or 100 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle).
Results
In the total of 834 enrolled patients, median overall survival was 8.8 months in the gemcitabine group, 9.7 months in the S-1 group, and 10.1 months in the gemcitabine plus S-1 group. The noninferiority of S-1 to gemcitabine was demonstrated (hazard ratio, 0.96; 97.5% CI, 0.78 to 1.18; P < .001 for noninferiority), whereas the superiority of gemcitabine plus S-1 was not (hazard ratio, 0.88; 97.5% CI, 0.71 to 1.08; P = .15). All treatments were generally well tolerated, although hematologic and GI toxicities were more severe in the gemcitabine plus S-1 group than in the gemcitabine group.
Conclusion
Monotherapy with S-1 demonstrated noninferiority to gemcitabine in overall survival with good tolerability and presents a convenient oral alternative for locally advanced and metastatic pancreatic cancer. J Clin Oncol 31: 1640-1648. (C) 2013 by American Society of Clinical Oncology
SDGs
Other Subjects
gemcitabine; gimeracil plus oteracil potassium plus tegafur; antineoplastic agent; antineoplastic antimetabolite; deoxycytidine; drug derivative; gemcitabine; oteracil; S 1 (combination); tegafur; acute hepatitis; adult; advanced cancer; aged; anorexia; cancer chemotherapy; cancer combination chemotherapy; cancer survival; Conference Paper; controlled study; diarrhea; drug efficacy; drug safety; drug tolerability; fatigue; febrile neutropenia; female; human; infection; Japan; leukopenia; lung disease; major clinical study; male; metastatic pancreatic cancer; metastatic pancreatic cancer; monotherapy; mucosa inflammation; multiple cycle treatment; nausea; neutropenia; overall survival; pancreas cancer; phase 3 clinical trial; pneumonia; priority journal; quality adjusted life year; randomized controlled trial; rash; second line chemotherapy; sepsis; Taiwan; thrombocytopenia; treatment response; vomiting; article; controlled clinical trial; drug combination; metastasis; middle aged; multicenter study; pancreas tumor; pathology; quality of life; survival; treatment outcome; Aged; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Deoxycytidine; Drug Combinations; Female; Humans; Japan; Male; Middle Aged; Neoplasm Metastasis; Oxonic Acid; Pancreatic Neoplasms; Quality of Life; Survival Analysis; Taiwan; Tegafur; Treatment Outcome
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