盐酸拓扑替康治疗小细胞肺癌和晚期卵巢癌的Ⅱ期临床观察

Phase Ⅱ Study on Domestic Topotecan in the Treatment of SCLC and Advanced Ovarian Cancer

目的：本研究为国产注射用盐酸拓扑替康（Topotecan）Ⅱ期临床研究。评价国产拓扑替康单药治疗小细胞肺癌及晚期卵巢癌的临床疗效和不良反应。方法：入选病例115例，可评价疗效111例，小细胞肺癌77例，晚期卵巢癌34例；可评价毒副反应者115例。拓扑替康每日1次，1．2mg／m2，静脉滴注，连续5日，21天为1周期，2周期评价疗效。结果：小细胞肺癌有效率 27．27％ （21／77），初治有效率39．29％（11／28），复治有效率20．41％（10／49）。晚期卵巢癌有效率23．53％（8／34），初治有效病例2例（2／4），复治有效率20％（6／30）。盐酸拓扑替康主要毒副作用为血液学毒性，表现为白细胞减少，调整剂量或辅助治疗后可以恢复正常。受试患者非血液学毒性较轻。结论：通过Ⅱ期临床试验证实注射用盐酸拓扑替康为安全、有效的抗癌药物。参照国外文献报道的结果，本试验的疗效和毒副反应与国外同品种基本一致。

Objective To evaluate the efficacy and safty of domestic Topotecan in the treatment of small cell lung cancer SCLC and advanced ovarian cancer． Methods In enrolled 115 cases the efficacy could be assessed in 111 cases including SCLC 77 advanced ovarian cancer 34 and toxicity could be assessed in 115 cases． All patients were treated with Topotecan 1．2mg／m2 iv／d on day 1－5 and it was repeated every three weeks． Results The total response rate of SCLC was 27．3％21／77 in which the response rate of initial treatment was 39．3％11／28 and for retreatment group was 20．4％10／49． The total response rate of advanced ovarian cancer was 23．5％8／34 in which 2 of 4 cases had response in initial treatment and the retreatment response rate was 20％6／30． Neutropenia was the main toxicity but it was reversible and noncumulative． G－CSF support and reduction of dosage were sometimes needed． Conclusion Domestic Topotecan is effective and safe for treatment of SCLC and advanced ovarian cancer． Our results is consistent with that of the oversea products．