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首页> 外文期刊>Gastric cancer: official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association >Multicenter phase II study of trastuzumab with S-1 plus oxaliplatin for chemotherapy-naive, HER2-positive advanced gastric cancer
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Multicenter phase II study of trastuzumab with S-1 plus oxaliplatin for chemotherapy-naive, HER2-positive advanced gastric cancer

机译：曲妥珠单抗与S-1加上奥沙拉铂研究化疗 - 幼稚，海绵体幼虫，HER2阳性晚期胃癌

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Background Trastuzumab with cisplatin and fluoropyrimidines improves overall survival (OS) in patients with HER2-positive advanced gastric cancer (AGC). S-1 plus oxaliplatin (SOX) is one of the standard regimens for HER2-negative AGC in Japan. However, few studies have evaluated trastuzumab combined with SOX in patients with HER2-positive AGC. Methods This was a multicenter, phase II study conducted at 10 institutions in Japan. Patients with HER2-positive AGC received S-1 twice a day on days 1-14 and oxaliplatin and trastuzumab on day 1 of a 21-day cycle. The primary endpoint was the confirmed overall response rate (ORR), and the secondary endpoints were OS, progression-free survival (PFS), and safety. The sample size was 75 to have 90% power with an alpha error of 0.1 (one-sided), expecting an ORR of 65% and threshold of 50%. Results From June 2015 to January 2018, 75 patients were enrolled. The ORR was 70.7% [95% confidence interval (CI) 59.0-80.6]. The median OS and PFS were estimated as 18.1 months (95% CI 15.6-26.5) and 8.8 months (95% CI 7.4-12.2), respectively. The major grade 3 or 4 adverse events were sensory neuropathy (16.0%) and neutropenia (10.7%). Conclusions Trastuzumab with SOX had promising activity with well-tolerated toxicities for patients with HER2-positive AGC.
机译：背景技术曲妥珠单抗与顺铂和氟嘧啶，改善了Her2阳性晚期胃癌（AGC）患者的整体存活率（OS）。 S-1加上oxaliplatin（Sox）是日本海洋2级AGC的标准方案之一。然而，很少有研究评估了HER2阳性AGC患者中的曲妥珠单抗与SOX相结合。方法这是在日本10个机构进行的一项多中心的研究。 Her2阳性AGC的患者在21天循环的第1天的第1-14天和Oxaliplatin和Trastuzumab上每天接受S-1两次。主要终点是确诊的总反应率（ORR），次级终点是OS，无进展的存活率（PFS）和安全性。样品尺寸为75，具有90％的功率，α误差为0.1（单侧），期望ORR为65％和阈值50％。结果2015年6月至2018年1月，75名患者注册。 ORR为70.7％[95％置信区间（CI）59.0-80.6]。中位OS和PFS分别估计为18.1个月（95％CI 15.6-26.5）和8.8个月（95％CI 7.4-12.2）。主要3或4级不良事件是感觉神经病变（16.0％）和中性粒细胞病（10.7％）。结论Trastuzumab具有SOX的令人兴奋的活动，对HER2阳性AGC的患者具有良好耐受性的毒性。

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