Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: Results of a large European phase II study
Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: Results of a large European phase II study
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DOI：
10.1200/jco.1996.14.12.3056
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发表时间：
1996-12-01
影响因子：
45.3
通讯作者：
Huinink, WWT
中科院分区：
文献类型：
--
作者：
Creemers, GJ;Bolis, G;Huinink, WWT
目的：拓扑替康是一种拓扑异构酶I抑制剂，对多种肿瘤类型具有临床前活性。我们进行了一项大型多中心II期研究，拓扑替康在卵巢癌患者中的应用，这些患者对一种先前的基于顺铂的化疗方案没有反应。托泊替康1.5 mg/m2/d，静脉输注30分钟，持续5天，每3周重复一次。由于停用顺铂的间隔时间与后续治疗的反应有关，因此将患者分为亚组，即，结果：111例患者进入研究。19例患者被认为不合格; 92例患者可评估缓解。总共提供了552个疗程（中位数，每例患者4个;范围，1到17个）。主要毒副反应为白细胞减少和中性粒细胞减少，3 ~ 4级分别占54.2%和69.1%，但4级中性粒细胞减少伴发热或感染性并发症仅占4.3%。在20.5%的疗程中给予预防性粒细胞集落刺激因子（G-CSF）以维持剂量强度。其他相对常见的副作用为脱发（82%）、恶心（36.4%）和呕吐（17.5%）。总有效率为16.3%，其中1例完全缓解（CR），14例部分缓解（PR）。在cispla！锡难治性、顺铂耐药和顺铂敏感性分层的有效率分别为5.9%、17.8%和26.7%。记录的反应时间的中位数为21.7周（范围，4.6至41.9周）。结论：拓扑替康在一个每天的时间为5倍的时间表是一个有效的方案作为二线治疗卵巢癌。拓扑替康在卵巢癌中的进一步研究，包括一线使用和与其他活性药物联合使用，表明。(C)1996年，美国临床肿瘤学会。
Purpose: Topotecan is a topoisomerase I inhibitor with preclinical activity against various tumor types. We conducted a large multicenter phase II study with topotecan in ovarian cancer in patients who held failed to respond to one prior cisplatin-based chemotherapeutic regimen.Patients and Methods: Topotecan 1.5 mg/m(2)/d was administered intravenously by 30-minute infusion for 5 days repeated every 3 weeks, As the cisplatin-free interval relates to response in subsequent treatment, patients were stratified in subgroups, ie, cisplatin-refractory, cisplatin-resistant, and cisplatin-sensitive.Results: One-hundred eleven patients entered the study. Nineteen patients were considered to be ineligible; 92 patients were assessable for response. A total of 552 courser were given (median, four per patient; range, one to 17). The major toxicities were leukocytopenia and neutropenia, which were grade 3 to 4 in 54.2% and 69.1% of courses, respectively, but with only 4.3% of these being grade 4 neutropenia plus fever or infectious complications. Prophylactic granulocyte colony-stimulating factor (G-CSF) was given in 20.5% of courses to maintain dose-intensity. Other relatively frequent side effects were alopecia (82%), nausea (36.4%), and vomiting (17.5%). The overall response rate was 16.3%, with one complete response (CR) and 14 partial responses (PRs). In the cispla!tin-refractory, cisplatin-resistant, and cisplatin-sensitive strata, the response rates were 5.9% 17.8%, and 26.7%, respectively. The median duration of time of documented response was 21.7 weeks (range, 4.6 to 41.9).Conclusion: Topotecan in a daily-times-five schedule is an effective regimen as second-line treatment in ovarian cancer. Further investigations of topotecan in ovarian cancer, including first-line use and combination with other active agents, are indicated. (C) 1996 by American Society of Clinical Oncology.