曲妥珠单抗联合S-1加顺铂治疗HER2阳性胃癌的II期研究（HERBIS-1）
Phase II study of trastuzumab in combination with S-1 plus cisplatin in HER2-positive gastric cancer (HERBIS-1).
作者信息
Kurokawa Y, Sugimoto N, Miwa H, Tsuda M, Nishina S, Okuda H, Imamura H, Gamoh M, Sakai D, Shimokawa T, Komatsu Y, Doki Y, Tsujinaka T, Furukawa H
机构信息
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2-E2, Yamadaoka, Suita 565-0871, Japan.
Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 3-3-1, Nakamichi, Osaka 537-8511, Japan.
出版信息
Br J Cancer. 2014 Mar 4;110(5):1163-8. doi: 10.1038/bjc.2014.18. Epub 2014 Jan 28.
BACKGROUND
S-1, an oral fluoropyrimidine, plus cisplatin (SP) is a standard regimen for advanced gastric cancer (AGC) in East Asia. To date, no studies have evaluated the efficacy and safety of trastuzumab combined with SP in patients with human epidermal growth factor receptor type 2 (HER2)-positive AGC.
METHODS
Patients with HER2-positive AGC received S-1 (80-120 mg per day) orally on days 1-14, cisplatin (60 mg m(-2)) intravenously on day 1, and trastuzumab (course 1, 8 mg kg(-1); course 2 onward, 6 mg kg(-1)) intravenously on day 1 of a 21-day cycle. The primary end point was response rate (RR); secondary end points included overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), and adverse events.
RESULTS
A total of 56 patients were enrolled. In the full analysis set of 53 patients, the confirmed RR was 68% (95% confidence interval (CI)=54-80%), and the disease control rate was 94% (95% CI=84-99%). Median OS, PFS, and TTF were estimated as 16.0, 7.8, and 5.7 months, respectively. Major grade 3 or 4 adverse events included neutropaenia (36%), anorexia (23%), and anaemia (15%).
CONCLUSIONS
Trastuzumab in combination with SP showed promising antitumour activity and manageable toxic effects in patients with HER2-positive AGC.
背景
S-1是一种口服氟尿嘧啶，联合顺铂（SP）是东亚晚期胃癌（AGC）的标准治疗方案。迄今为止，尚无研究评估曲妥珠单抗联合SP治疗人表皮生长因子受体2（HER2）阳性AGC患者的疗效和安全性。
方法
HER2阳性AGC患者在21天周期的第1天口服S-1（每天80-120mg），第1天静脉注射顺铂（60mg/m²），第1天静脉注射曲妥珠单抗（第1疗程，8mg/kg；第2疗程及以后，6mg/kg）。主要终点为缓解率（RR）；次要终点包括总生存期（OS）、无进展生存期（PFS）、治疗失败时间（TTF）和不良事件。
结果
共纳入56例患者。在53例患者的全分析集中，确认的RR为68%（95%置信区间（CI）=54-80%），疾病控制率为94%（95%CI=84-99%）。OS、PFS和TTF的中位数分别估计为16.0、7.8和5.7个月。主要的3级或4级不良事件包括中性粒细胞减少（36%）、厌食（23%）和贫血（15%）。
结论
曲妥珠单抗联合SP在HER2阳性AGC患者中显示出有前景的抗肿瘤活性和可管理的毒性作用。
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