Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial
Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial
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DOI：
10.21873/anticanres.15680
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发表时间：
2022-04-01
影响因子：
2
通讯作者：
Ishioka, Chikashi
中科院分区：
文献类型：
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作者：
Yoshioka, Takashi;Takahashi, Masanobu;Ishioka, Chikashi
背景/目的：这项II期研究评估了卡培他滨联合顺铂治疗辅助治疗S-1难治性晚期胃癌患者的疗效。患者和方法：这项单臂、开放标签、多中心、II期研究由日本东北临床肿瘤学研究和教育学会（T-CORE）进行。入组年龄≥ 20岁的S-1难治性晚期HER 2阴性胃癌患者。患者接受80 mg/m2顺铂静脉滴注，第1天，卡培他滨1，000 mg/m2，每日2次，第1天至第14天，3周为1个周期。主要终点是无进展生存期（PFS）。总缓解率（ORR）阈值估计为15%。次要终点为总生存期（OS）、至治疗失败时间、ORR和毒性。结果：共有21例患者从7家医院入组。患者年龄中位数为63岁。19例患者接受了方案治疗。中位PFS为3.7个月[90%置信区间（CI）=2.7-5.6个月]，未达到预定阈值4.0个月。ORR为5.9%（95%CI=0.0-17.1%）。中位OS为11.9个月（95% CI 63-19.4个月）。在5.3%的患者中观察到发热性中性粒细胞减少。最常见的3级非血液学毒性为恶心（15.8%）和低钠血症（15.8%）。结论：铂类药物辅助治疗后加用氟嘧啶不适用于胃癌。
Background/Aim: This phase II study assessed the efficacy of capecitabine plus cisplatin in patients with advanced gastric cancer refractory to adjuvant S-1. Patients and Methods: This single-arm, open-label, multicenter, phase II study was conducted by Tohoku Clinical Oncology Research and Education Society (T-CORE) in Japan. Patients aged >= 20 years with advanced HER2-negative gastric cancer that was refractory to S-1 were enrolled. Patients received 80 mg/m(2) cisplatin on day 1 intravenously and 1,000 mg/m(2) capecitabine twice daily from day 1 to day 14, in 3-week cycles. The primary endpoint was progression-free survival (PFS). The threshold overall response rate (ORR) was estimated to be 15%. The secondary endpoints were overall survival (OS), time to treatment failure, ORR, and toxicities. Results: In total, 21 patients were enrolled from seven hospitals. The median patient age was 63 years. Nineteen patients received the protocol treatment. Median PFS was 3.7 months [90% confidence interval (CI)=2.7-5.6 months], which did not reach the predefined threshold of 4.0 months. ORR was 5.9% (95%CI=0.0-17.1%). Median OS was 11.9 months (95% CI 63-19.4 months). Febrile neutropenia was observed in 5.3% of patients. The most frequently observed grade 3 non-hematologic toxicities were nausea (15.8%) and hyponatremia (15.8%). Conclusion: The addition of a fluoropyrimidine to a platinum agent after adjuvant therapy is not suitable for gastric cancer.