拓扑替康治疗小细胞肺癌和复发性卵巢癌的临床研究

Clinical study of topotecan in the treatment of small cell lung cancer and recurrent ovarian cancer

目的 评价国产拓扑替康 (TPT)单药治疗小细胞肺癌及复发卵巢癌的临床疗效和不良反应。方法 患者 141例。TPT 1 2mg·(m2 ) -1·d-1,静脉滴注 30min ,1次 /d连用 5d ,2 1d为 1周期。可评价疗效者 118例 ,其中小细胞肺癌 89例 ,复发卵巢癌 2 9例。 141例患者和 2 86个周期可评价毒副作用。结果 在可评价疗效的 118例中 ,完全缓解 (CR) 5例 ,部分缓解 (PR) 35例 ,有效率 (RR)33 8%。其中小细胞肺癌CR 3例 ,PR 2 6例 ,RR 32 6 % ,初治与复治的RR分别为 5 0 0 %和 15 6 % ;复发卵巢癌CR 2例 ,PR 9例 ,RR 37 9%。在可评价毒副作用的 141例和 2 86个周期中 ,主要的毒副作用是骨髓抑制 ,III、IV度的中性粒细胞减少 6 1例 (43 2 % )和 81个周期 (2 8 3% )。III、IV度血小板减少18例 (12 7% )和 2 1个周期 (7 3% )。非血液学毒性一般较轻 ,可耐受。结论 TPT是治疗小细胞肺癌和复发卵巢癌有效的药物 ,对一些常规化疗方案失败的病例仍有效 ,主要的剂量限制性毒性是骨髓抑制。国产TPT治疗小细胞肺癌和晚期卵巢癌的疗效和毒性 ,与国外同类产品相似。

Objective To evaluate the effect and adverse reaction of China made topotecan in the treatment of smallcell lung cancer (ACLC) and recurrent ovarian cancer(OV). Methods[WT5”BZ] From January to July, 2000, topotecan was used to treat 141 patients at a dose of 12 mg/m 2, given daily as 30min iv infusion for 5 days. Treatment was repeated once every 3 weeks. Of the 141 patients, 118 were evaluable for therapeutic efficacy. All the patients received a total of 286 cycles of treatment were assessable for analysis of adverse reactions. Results Among the evaluable patients, there were 5 CR, 35 PR, with an overall response rate (RR) of 33.8%. There were 3 CR and 26 PR in 89 patients with SCLC (RR 325%). The response rate of patients with or without prior chemotherapy was 15.6% and 50%, respectively. In 29 patients with recurrent OV, there were 2 CR and 9 PR (RR 379%). The major toxic effect was myelosuppression. Nonhematopoietic toxicities were mild and tole rable. Conclusion[WT5”BZ] Topotecan is an effective drug for the treatment of SCLC and recurrent OV. It is still efficacious in some patients who previously received standard chemotherapy. The major doselimiting toxicity is myelosuppression. The response rate and toxicity of the domestically made topotecan are comparable with those of the imported one.