A Phase II Clinical Trial of Topotecan in Japanese Patients with Relapsed Ovarian Carcinoma
A Phase II Clinical Trial of Topotecan in Japanese Patients with Relapsed Ovarian Carcinoma
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DOI：
10.1093/jjco/hyq192
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发表时间：
2011-03-01
影响因子：
2.4
通讯作者：
Noda, Kiichiro
中科院分区：
文献类型：
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作者：
Aoki, Daisuke;Katsumata, Noriyuki;Noda, Kiichiro
目的：本项 II 期研究旨在探讨拓扑替康在日本复发性卵巢癌患者中的疗效、安全性和药代动力学。方法：接受过一种含铂类化疗方案的复发性卵巢癌患者符合本研究的条件。拓扑替康以 1.2 mg/m(2)/天的剂量连续给药 5 天，每 3 周重复一次。 结果：72 名患者参加了该研究。响应率为 28.2%（95% 置信区间，18.1-40.1%）。骨髓抑制症状，如中性粒细胞减少（3级，12.5%；4级，83.3%）、血小板减少（3级，36.2%；4级，4.2%）和血红蛋白降低（3级，36.1%；4级，11.1%）是最常见的血液学毒性。 5 名（6.9%）患者出现 3 级发热性中性粒细胞减少症。托泊替康的药代动力学几乎没有个体间或个体间差异。结论：1.2 mg/m(2)/天的托泊替康对于日本复发性卵巢癌患者是一种有效且可耐受的治疗选择。
Objective: This Phase II study was carried out to investigate the efficacy, safety and pharmacokinetics of topotecan in Japanese patients with relapsed ovarian carcinoma.Methods: Patients with relapsed ovarian carcinoma after having received one regimen containing platinum-based chemotherapy were eligible for this study. Topotecan was administered at 1.2 mg/m(2)/day for five consecutive days, repeated every 3 weeks.Results: Seventy-two patients were enrolled in the study. The response rate was 28.2% (95% confidence interval, 18.1-40.1%). Signs of myelosuppression, such as neutropenia (Grade 3, 12.5%; Grade 4, 83.3%), thrombocytopenia (Grade 3, 36.2%; Grade 4, 4.2%) and decreased hemoglobin (Grade 3, 36.1%; Grade 4, 11.1%), were the most common hematological toxicities. Grade 3 febrile neutropenia occurred in 5 (6.9%) patients. There was little intraindividual or interindividual variability in the pharmacokinetics of topotecan.Conclusions: Topotecan at 1.2 mg/m(2)/day is an effective and tolerable therapeutic option for Japanese patients with relapsed ovarian carcinoma.