一项关于顺铂/S-1 治疗不明原发灶癌患者的 II 期研究。
A phase II study of cisplatin /S-1 in patients with carcinomas of unknown primary site.
机构信息
Division of thoracic Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan,
出版信息
Invest New Drugs. 2013 Dec;31(6):1568-72. doi: 10.1007/s10637-013-0014-0. Epub 2013 Aug 24.
BACKGROUND
Carcinomas of unknown primary site (CUPs) are heterogeneous tumors associated with a poor prognosis. This phase II trial was designed to evaluate the efficacy and safety of a novel combination chemotherapy of S-1 and cisplatin (CDDP) in patients with CUP.
PATIENTS AND METHODS
Patients with previously untreated CUPs were eligible for this trial. The treatment schedule consisted of oral S-1 (40 mg/m(2)) twice a day on days 1-21, and intravenous CDDP (60 mg/m(2)) on day 8. This schedule was repeated every 5 weeks.
RESULTS
A total of 46 patients were enrolled. The overall response rate and the disease control rate were 41.3% and 80.4%, respectively. The median overall survival time was 17.4 months. Grade 3/4 neutropenia, thrombocytopenia, and febrile neutropenia occurred in 28.3%, 13.0%, and 2.2% of the patients, respectively.
CONCLUSION
CDDP plus S-1 combination chemotherapy is well tolerated and active first-line empiric therapies for patients with CUP.
背景
不明原发灶肿瘤（CUPs）是一组异质性肿瘤，预后较差。本 II 期临床试验旨在评估 S-1 联合顺铂（CDDP）方案治疗 CUP 患者的疗效和安全性。
患者和方法
本试验入组未经治疗的 CUP 患者。治疗方案为：S-1（40 mg/m2）口服，每日 2 次，第 1-21 天；顺铂（60 mg/m2）静脉滴注，第 8 天。每 5 周重复。
结果
共入组 46 例患者。总缓解率和疾病控制率分别为 41.3%和 80.4%。中位总生存时间为 17.4 个月。患者发生 3/4 级中性粒细胞减少、血小板减少和发热性中性粒细胞减少的比例分别为 28.3%、13.0%和 2.2%。
结论
CDDP 联合 S-1 方案化疗耐受性良好，是治疗 CUP 患者的有效一线经验性治疗方案。
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