Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial
Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial
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DOI：
10.1200/jco.18.01138
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发表时间：
2019-05-20
影响因子：
45.3
通讯作者：
Fujii, Masashi
中科院分区：
文献类型：
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作者：
Yoshida, Kazuhiro;Kodera, Yasuhiro;Fujii, Masashi
S-1是亚洲II或III期胃癌患者的标准术后辅助化疗。新辅助或围手术期策略占主导地位，在西方国家，多西他赛最近表现出显着的生存益处时，结合其他标准方案在晚期癌症和围手术期settings.Patients和方法这随机III期研究的目的是证明优越性术后S-1加多西他赛超过S-1单为R 0切除病理III期胃癌。1,100例患者的样本量是必要的，以检测3年无复发生存率增加7%作为主要终点（风险比，0.78;双侧α = 0.05; β = 0.2）。分析表明，S-1加多西他赛（66%）优于S-1（50%）的3年无复发生存率（风险比，0.632; 99.99% CI，0.400 - 0.998;分层对数秩检验，P <0.001），并根据独立数据和安全性监测委员会的建议终止招募。3级或更高的不良事件，特别是中性粒细胞减少症和白细胞减少症的发生率，在S-1加多西他赛组较高，但所有事件是manageable.CONCLUSION多西他赛加S-1是有效的，在III期胃癌患者的安全性问题很少。目前的研究结果也可能适用于围手术期辅助化疗或放化疗不标准的国家。(C)2019年美国临床肿瘤学会
PURPOSE S-1 is a standard postoperative adjuvant chemotherapy for patients with stage II or III gastric cancer in Asia. Neoadjuvant or perioperative strategies dominate in Western countries, and docetaxel has recently shown significant survival benefits when combined with other standard regimens in advanced cancer and perioperative settings.PATIENTS AND METHODS This randomized phase III study was designed to prove the superiority of postoperative S-1 plus docetaxel over S-1 alone for R0 resection of pathologic stage III gastric cancer. The sample size of 1,100 patients was necessary to detect a 7% increase in 3-year relapse-free survival as the primary end point (hazard ratio, 0.78; 2-sided alpha = .05; beta = .2).RESULTS The second interim analysis was conducted when the number of events reached 216 among 915 enrolled patients (median follow-up, 12.5 months). Analysis demonstrated the superiority of S-1 plus docetaxel (66%) to S-1 (50%) for 3-year relapse-free survival (hazard ratio, 0.632; 99.99% CI, 0.400 to 0.998; stratified log-rank test, P < .001), and enrollment was terminated as recommended by the independent data and safety monitoring committee. Incidences of grade 3 or greater adverse events, particularly neutropenia and leukopenia, were higher in the S-1 plus docetaxel group, but all events were manageable.CONCLUSION Addition of docetaxel to S-1 is effective with few safety concerns in patients with stage III gastric cancer. The present findings may also be applicable in countries in which perioperative adjuvant chemotherapy or chemoradiation is not standard. (C) 2019 by American Society of Clinical Oncology