A phase II prospective study of the trastuzumab combined with 5-weekly S-1 and CDDP therapy for HER2-positive advanced gastric cancer
A phase II prospective study of the trastuzumab combined with 5-weekly S-1 and CDDP therapy for HER2-positive advanced gastric cancer
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DOI：
10.1007/s00280-016-3013-y
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发表时间：
2016-03
影响因子：
3
通讯作者：
H. Kataoka;Yoshinori Mori;T. Shimura;H. Nishie;M. Natsume;Hisato Mochizuki;Yoshikazu Hirata;S. Sobue;Takashi Mizushima;H. Sano;Y. Mizuno;Makoto Nakamura;Atsuyuki Hirano;K. Tsuchida;K. Adachi;K. Seno;M. Kitagawa;T. Kawai;T. Joh
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文献类型：
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作者：
H. Kataoka;Yoshinori Mori;T. Shimura;H. Nishie;M. Natsume;Hisato Mochizuki;Yoshikazu Hirata;S. Sobue;Takashi Mizushima;H. Sano;Y. Mizuno;Makoto Nakamura;Atsuyuki Hirano;K. Tsuchida;K. Adachi;K. Seno;M. Kitagawa;T. Kawai;T. Joh
背景我们评估了每 5 周一次的 S-1 和顺铂联合曲妥珠单抗（一种抗人表皮生长因子受体 2 型 (HER2) 的单克隆抗体）治疗 HER2 阳性晚期胃癌 (AGC) 的疗效和安全性。方法此 II 期研究治疗包括第 1-21 天口服 S-1（每天 80-120 毫克），当天静脉注射顺铂（60 毫克/平方米） 8 和曲妥珠单抗（第一个周期第一天 8 毫克/公斤，随后每 3 周 6 毫克/公斤）静脉注射。主要终点是 1 年生存率。次要终点包括总生存期、无进展生存期 (PFS)、缓解率 (RR) 和安全性。 结果 共有来自 7 个中心的 22 名患者入组。在可评估分析的 20 名患者中，1 年生存率为 70%（95% 置信区间 (CI) 49.9–90.1%），中位生存时间、PFS 和 RR 分别为 15.3、7.5 个月和 41.2%。主要的 3/4 级不良事件为中性粒细胞减少 (30%)、厌食 (30%)、白细胞减少 (25%)、疲劳 (20%) 和贫血 (15%)。 结论 对于 HER2 阳性 AGC 患者，每周五次 S-1 和顺铂联合曲妥珠单抗显示有效且安全性良好。
BackgroundWe evaluated the efficacy and safety of 5-weekly S-1 and cisplatin combined with trastuzumab, a monoclonal antibody against human epidermal growth factor receptor type 2 (HER2) for HER2-positive advanced gastric cancer (AGC).MethodsThis phase II study treatment consisted of S-1 (80–120 mg per day) orally on day 1–21, cisplatin (60 mg/m2) intravenously on day 8, and trastuzumab (8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks) intravenously. The primary end point was 1-year survival rate. The secondary end points included overall survival, progression-free survival (PFS), response rate (RR), and safety.ResultsA total 22 patients from seven centers were enrolled. In the 20 patients evaluable for analysis, the 1-year survival rate was 70 % (95 % confidence interval (CI) 49.9–90.1 %), and median survival time, PFS, and RR were 15.3, 7.5 months and 41.2 %, respectively. Major grade 3/4 adverse events were neutropenia (30 %), anorexia (30 %), leukopenia (25 %), fatigue (20 %), and anemia (15 %).ConclusionsFive-weekly S-1 and cisplatin combined with trastuzumab showed effective with favorable safety profile in patients with HER2-positive AGC.