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
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
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DOI：
10.1200/jco.2012.43.3680
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发表时间：
2013-05-01
影响因子：
45.3
通讯作者：
Tanaka, Masao
中科院分区：
文献类型：
--
作者：
Ueno, Hideki;Ioka, Tatsuya;Tanaka, Masao
目前的III期研究旨在探讨S-1单用的非劣势以及吉西他滨加S-1与单用吉西他滨相比在总生存率方面的优势。患者和方法受试者为局部晚期或转移性胰腺癌化疗初期患者。患者被随机分配到单用吉西他滨(1,000 mg/m~2，28天为一周期)，S-1(42天周期的第1天至28天的体表面积为80,100或120 mg/d)，或吉西他滨加S-1(吉西他滨1,000 mg/m2，21天的周期第1天和第8天，加S-1 60，80或100 mg/d，根据21天周期的体表面积，60，80或100 mg/d)。中位总生存期吉西他滨组为8.8月，S-1组为9.7个月，吉西他滨+S-1组为10.1个月。S-1与吉西他滨具有非劣势(危险比0.96；97.5%CI，0.78~1.18；P<；非劣势.001)，而吉西他滨与S-1联用则无明显优势(危险比0.88；97.5%CI，0.71~1.08；P=.15)。所有治疗方案的耐受性良好，但吉西他滨联合S-1组的血液学和胃肠道反应比吉西他滨组严重。结论S-1单药治疗胰腺癌的总生存率不低于吉西他滨，耐受性好，是治疗局部晚期和转移性胰腺癌的一种方便的口服药物。J Clin Oncol31：1640-1648。(C)美国临床肿瘤学会2013年
PurposeThe 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 MethodsThe 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).ResultsIn 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.ConclusionMonotherapy 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