Randomized study of orally administered fluorinated pyrimidines (capecitabine versus S-1) in women with metastatic or recurrent breast cancer: Japan Breast Cancer Research Network 05 Trial
Randomized study of orally administered fluorinated pyrimidines (capecitabine versus S-1) in women with metastatic or recurrent breast cancer: Japan Breast Cancer Research Network 05 Trial
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DOI：
10.1007/s00280-015-2738-3
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发表时间：
2015-06-01
影响因子：
3
通讯作者：
Yamaguchi, T.
中科院分区：
文献类型：
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作者：
Yamamoto, D.;Iwase, S.;Yamaguchi, T.
卡培他滨和S-1是口服氟化嘧啶类药物，具有高水平的抗转移性乳腺癌活性。本研究采用随机、多中心、II期临床研究方法，对乳腺癌患者口服卡培他滨和S-1的疗效和安全性进行比较。乳腺癌患者随机分为两组，卡培他滨825g/m(2)，每日2次，第1~21天，每4周1次；S-140~60 mg，每日2次，第1~28天，每6周1次。研究的主要终点是无进展生存(PFS)。共有14 2名患者入选，随机分为卡培他滨(N=73)和S-1(N=69)。卡培他滨和S-1的中位无进展生存期分别为1.2年和1.3年，风险比(S-1/卡培他滨)为0.85(95%可信区间为0.52~1.38)(按对数排序P=0.48)。卡培他滨组客观有效率为24.0%，S-1组为23.1%(P=0.938)。最常见的与治疗相关的不良事件是强度1-2级。血小板减少(S-1：9.2%，卡培他滨：1.4%；P=0.040)和恶心(S-1：26.2%，卡培他滨：14.1%；P=0.079)和手足综合征发生率在S-1组较多(S-1：10.8%，卡培他滨：25.4%；P=0.029)。它们都是方便的口服药物，使它们在门诊治疗中具有吸引力。
Capecitabine and S-1 are orally administered fluorinated pyrimidines with high-level activity against metastatic breast cancer (MBC). This randomized, multicenter, phase II study compared the activities and safeties of the oral fluoropyrimidines, capecitabine and S-1, in breast cancer patients.Patients with MBC were randomly assigned to receive capecitabine 825 g/m(2) twice daily on days 1-21 every 4 weeks or S-1 40-60 mg twice daily, according to body surface area, on days 1-28 every 6 weeks. The primary endpoint was progression-free survival (PFS).A total of 142 patients were enrolled and randomized to either capecitabine (N = 73) or S-1 (N = 69). Median PFS (progression-free survival) was 1.2 years for capecitabine and 1.3 years for S-1, with a hazard ratio (S-1/capecitabine) of 0.85 (95 % confidence interval [CI] 0.52-1.38) (P = 0.48 by log-rank). The confirmed objective response rates were 24.0 % for capecitabine and 23.1 % for S-1 (P = 0.938). The most common treatment-related adverse events were grade 1-2 in intensity. Thrombocytopenia (S-1: 9.2 %, capecitabine: 1.4 %; P = 0.040) and nausea (S-1: 26.2 %, capecitabine: 14.1 %; P = 0.079) were more frequent in the S-1 group, while hand-foot syndrome occurred more often in the capecitabine group (S-1: 10.8 %, capecitabine: 25.4 %; P = 0.029).The results of the current study demonstrate that both S-1 and capecitabine are effective and well-tolerated treatments in patients with MBC, while their adverse events were different. They are both convenient, orally administered drugs, making them attractive agents for use in outpatient treatment.