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一项贝洛替康(新型喜树碱类似物)治疗未经治疗的广泛期小细胞肺癌患者的多中心 II 期研究。

A multicenter phase II study of belotecan, new camptothecin analogue, in patients with previously untreated extensive stage disease small cell lung cancer.

机构信息

Division of Pulmonology, Department of Internal Medicine, Kangnam St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.

出版信息

Lung Cancer. 2010 Jun;68(3):446-9. doi: 10.1016/j.lungcan.2009.07.002. Epub 2009 Aug 14.

DOI:10.1016/j.lungcan.2009.07.002
PMID:19683359
Abstract

Belotecan (Camtobell, CKD602) is a new camptothecin derivative antitumor agent that belongs to the topoisomerase inhibitors. The aim of this phase II study was to evaluate the efficacy and safety of single agent belotecan in patients with small cell lung cancer (SCLC). Patients with previously untreated extensive stage disease (ED) SCLC were entered into the study. Belotecan was given by daily intravenous infusion at 0.5mg/m(2)/day for 5 consecutive days, every 3 weeks. 62 patients were enrolled in this study. The overall response rate to chemotherapy on an intention-to-treat basis was 53.2%. The median overall survival was 10.4 months, the median time to progression 4.6 months, and the 1-year survival rate 49.9%. The most common toxicity was hematologic. Grade 3/4 neutropenia occurred in 71.0% of patients and grade 3/4 thrombocytopenia 12.9%. Non-hematologic toxicity of grade 3 or 4 was low. The results suggest that belotecan is relatively active and well tolerable as single agent in patients with ED SCLC. Further investigations with platinum or other active agents are needed.

摘要

贝洛替康(Camtobell,CKD602)是一种新型喜树碱衍生物抗肿瘤药物,属于拓扑异构酶抑制剂。本 II 期研究旨在评估单药贝洛替康治疗广泛期小细胞肺癌(SCLC)患者的疗效和安全性。既往未经治疗的广泛期 SCLC 患者入组本研究。贝洛替康以 0.5mg/m²/天的剂量静脉滴注,连续 5 天,每 3 周 1 次。本研究共纳入 62 例患者。基于意向治疗分析,化疗的总缓解率为 53.2%。中位总生存期为 10.4 个月,中位无进展生存期为 4.6 个月,1 年生存率为 49.9%。最常见的毒性为血液学毒性。71.0%的患者发生 3/4 级中性粒细胞减少症,12.9%的患者发生 3/4 级血小板减少症。3/4 级非血液学毒性较低。结果表明,贝洛替康作为单药治疗广泛期 SCLC 患者具有一定的活性和良好的耐受性。需要进一步研究铂类或其他活性药物。

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