国产盐酸拓扑替康治疗复发性卵巢癌的Ⅱ期临床研究

Phase ⅡClinical Study of Topotecan Hydrochloride inPatients with Recurrent Advanced Ovarian Cancer

背景与目的:临床研究表明复发性卵巢癌患者采用以铂类为主的联合方案化疗疗效不理想,寻找二线补救化疗药物成为目前研究的重点。本研究目的是观察国产盐酸拓扑替康单药治疗复发性卵巢癌的近期疗效和不良反应。方法:采用多中心开放式研究。31例患者中29例符合入选标准,给予拓扑替康单药1.25mg·(m2·d)-1,静脉点滴,连用5天,每21天为一疗程,记录疗效和不良反应。结果:在可评价的21例的患者中,总缓解率为33.33%,而按ITT人群分析缓解率为24.14%(7/29),其中CR为3例,PR为4例。主要不良反应为血液学毒性,31.0%的患者和37.5%的疗程出现Ⅲ-Ⅳ度白细胞减少,而20.7%的患者和14.3%的疗程出现Ⅲ-Ⅳ度血小板减少。非血液学毒性较轻。结论:国产盐酸拓扑替康可作为治疗经铂类等药物治疗失败的晚期卵巢癌的有效药物。

Background and Objective: Clinical studies showed there was no satisfying treatment of the patients with recurrent advanced ovarian cancer by using chemotherapy of combining platinum, and it is very important for oncologist to seek the second line drugs to treat the patients with recurrent ovarian cancer. The current study was designed to evaluate the efficacy and toxicity of single agent Topotecan hydrochloride in the patients with recurrent advanced ovarian cancer. Material and Method:A total of 31 patients with recurrent ovarian cancer in a multiple centers clinical trial were treated with Topotecan 1 25 mg/m2 qd,iv inf.for 5 consecutive days every three weeks. Result:Among 21 evaluable cases, overall response rate was 33 33%. Among 29 ITT population the response rate was 24 14%, including 3 CR and 4 PR. Main side effects were hematologic toxicities, 31 0%patients and 37 5%courses developed Grade Ⅲ-Ⅳleukocytopenia, 20 7%patients and 14 3%courses developed Grade Ⅲ-Ⅳthrombocytopemia. Non hematologic toxicities were mild. Conclusion: Topotecan is effective for treating the patients with recurrent ovarian cancer who failed with platinum based regimes.