国产多西他赛联合顺铂治疗晚期乳腺癌和非小细胞肺癌的随机对照研究  

Efficacy and tolerance of two generic versions of docetaxel in combination with cisplatin in treatment of advanced breast cancer and non-small cell lung cancer:A comparative study

作　　者：何小慧[1] 石远凯[1] 杨晟[1] 刘基巍[2] 高亚杰[2] 李凯[3] 王华庆[3] 冯威健[4] 高雅苓[5] 韩少梅[6] 

机构地区：[1]中国医学科学院北京协和医学院肿瘤医院肿瘤研究所,北京100021 [2]大连医科大学附属第一医院,辽宁大连116011 [3]天津市肿瘤医院,天津300060 [4]北京世纪坛医院,北京100038 [5]辽宁省肿瘤医院,辽宁沈阳110042 [6]中国医学科学院北京协和医学院基础医学研究所,北京100730

出　　处：《实用肿瘤杂志》2008年第6期524-528,共5页Journal of Practical Oncology

摘　　要：目的评价多西他赛注射液(辽宁省药业有限公司)与对照药物(已上市国产多西他赛)的临床疗效和不良反应,比较两者联合顺铂治疗晚期乳腺癌及非小细胞肺癌的临床疗效和安全性。方法晚期和(或)转移性乳腺癌患者或非小细胞癌患者以1:1的比例随机分配至多西他赛75mg/m2+顺铂90mg/m2研究组或对照药物75mg/m2+顺铂90mg/m2对照组,21天为1周期,2周期后评价疗效,未进展的病例继续治疗至4周期。结果134例患者中120例可评价疗效,134例可评价不良反应。非小细胞肺癌有效率多西他赛研究组14.7、对照药组11.5;乳腺癌有效率多西他赛研究组27.6、对照药组32.3;各组间有效率差异均无统计学意义。不良反应主要为骨髓抑制、恶心、呕吐、脱发。多西他赛与对照药物比较,疗效和不良反应相似。结论多西他赛联合顺铂方案治疗乳腺癌和非小细胞肺癌安全有效,耐受性好,与对照药物疗效和不良反应相似。Objective To evaluate the efficacy and safety of docetaxel （Liaoning Pharmaceutical Company, Ltd） in patients with advanced breast cancer or non-small cell lung cancer. Methods Patients with advanced breast cancer were randomly assigned to receive docetaxel （Liaoning Pharmaceutical Company,Ltd） 75 mg/m^2iv plus cisplatin 90 mg/m^2（Group A） every 3 weeks or docetaxel （domestic generic product on the markets） 75 mg/m^2 iv plus cisplatin 90 mg/m^2 iv every 3 weeks （Group B）. Patients with advanced non-small cell lung cancer were also randomly assigned to regimens of docetaxel （Liaoning Pharmaceutical Company,Ltd） plus cisplatin （Group C） and docetaxel （domestic product on the markets） plus cisplatin（Group D）. Patients were treated for four treatment cycles or until progressive disease,death,or intolerable toxicity occur. Results 120 of 134 patients were evaluable for efficacy,and all patients evaluable for side effects. Overall response rates of Group A, B,C, D were 27. 6%32. 3%,14. 7% ,and 11. 5%,respectively. There was no statistically significant difference in overall response rate between Group A and B, or C and D. The major side effects were myelosuppression, nausea,vomiting,and alopecia. Conclusion The docetaxel （Liaoning Pharmaceutical Company,Ltd） has similar efficacy with docetaxel （domestic product on the markets）,and good tolerance.

关 键 词：乳腺肿瘤/药物疗法 顺铂/投药和剂量 癌 非小细胞肺/药物疗法 紫杉酚/投药和剂量 抗肿瘤联合化疗方案/治疗应用 

分 类 号：R737.9[医药卫生—肿瘤]