NP与MNP方案治疗NSCLC近期疗效及毒性的对比分析

A Clinical Study on efficacy and toxicity of NP in Contrast to the MNP Combination Chemotherapy in Patients with Advanced Non-small Cell Lung Cancer

目的 :对比观察二药和三药联合化疗方案治疗非小细胞肺癌 (NSCLC)的近期疗效和毒性反应。方法 :6 2例初治的Ⅲb～Ⅳ期NSCLC ,随机分成A组 (去甲长春新碱 2 5mg/m2 静注第 1、8天 +顺铂 80mg/m2 静滴 ,分 2天 ,即NP方案 )、B组 (丝裂霉素 6mg/m2 静注第 1天 +去甲长春新碱 2 5mg/m2 静注第 1、8天 +顺铂 80mg/m2 静滴 ,分 2天 ,即MNP方案 )两组 ,分别化疗 2周期 ,每 4周为一周期。结果 :A组有效率为 33 3%、B组有效率为 37 9% (P >0 0 5 ) ;血小板降低A组为33 3% ,B组为 5 8 6 % (P <0 0 5 )。两组其余毒性反应无显著差异。结论 :二药联合可能比三药联合毒性低 ,而有效率无显著差异。

Objective:The study was to investigate the activity and toxicity of a three-drug regimen vs a two-drug combination in the treatment of advanced non-small cell lung cancer.Methods:62 cases with newly diagnosed NSCLC (Stage Ⅲb～Ⅳ) were recruited into the study. Patients were randomized to receive one of the following regimens for two cycles: Cisplatin (80 mg/m 2 inl-2day) + Domestic Vinorelbine (25 mg/m 2 days 1, 8) every 4 weeks (NP-arm A); Cisplatin (80mg/m 2 in 1-2day) + Mitomycin (6mg/m 2 days 1) + Domestic Vinorelbine (25 mg/m 2 days 1, 8)every 4 weeks (MNP-arm B).Results:The over all response rate was 33.3% and 37.9% for the patients in arm A and arm B (P>0.05), respectively. The thrombocytopenia of arm A and arm B was 33.3% and 58.6%(P<0.05), respectively. Both groups were no significant different in the other toxicity.Conclusion:The two-drug combination therapy is probably less toxic than the three-drug therapy. But there are no significant difference in response rate between two regimens.