https://scholars.lib.ntu.edu.tw/handle/123456789/190377
標題: | 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 | 作者: | 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. ANN-LII CHENG 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 |
公開日期: | 2013 | 起(迄)頁: | 1640-1648 | 來源出版物: | Journal of Clinical Oncology | 摘要: | 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 |
URI: | http://ntur.lib.ntu.edu.tw//handle/246246/259260 | DOI: | 10.1200/JCO.2012.43.3680 | SDG/關鍵字: | 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 |
顯示於: | 醫學系 |
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