紫杉醇联合草酸铂对比紫杉醇联合顺铂一线方案治疗晚期非小细胞肺癌临床研究

A randomized clinical trial on taxol plus oxaliplatin versus taxol plus cisplatin as first-line treatment in advanced non-small cell lung cancer

背景与目的 紫杉醇与顺铂联合治疗非小细胞肺癌有明确疗效，但顺铂毒副反应较大。本试验选择毒副反应较小的草酸铂替代顺铂治疗晚期非小细胞肺癌，观察其疗效及不良反应。方法 2002年1月～2004年10月共83例确诊为非小细胞肺癌患者入组，随机分成试验组（紫杉醇175mg／m^2，第1天，草酸铂130mg／m^2，第1天，每21天重复，连用2--周期）和对照组（给予紫杉醇175mg／m^2，第1天，顺铂80mg／m^2，第1天，每21天重复一次，连用2～6周期），比较两组的有效率和不良反应发生率。结果 83例均顺利完成2周期以上化疗，可评价疗效。试验组有效率为34．1％（14／41），对照组为33．3％（14／42），试验组中位无进展生存时间为6．0个月，对照组为5．5个月，试验组中位生存时间为10．7个月，对照组为10．5个月，试验组1年生存率为39．0％（16／41），对照组为40．5％（17／42），均无统计学差异。毒副反应方面，试验组Ⅲ＋Ⅳ白细胞下降率为4．9％，对照组为28．6％，试验组无Ⅲ＋Ⅳ血小板下降者，对照组为14．3％，试验组Ⅲ＋Ⅳ恶心呕吐率为7．3％，对照组为26．2％，均有统计学差异。试验组Ⅲ＋Ⅳ神经损害率为9．8％，对照组为9．5％，试验组无Ⅲ＋Ⅳ肾功能损害者，对照组为7．1％，试验组无Ⅲ＋Ⅳ肌肉关节疼痛者，对照组为2．4％，均无统计学差异。结论 紫杉醇联合草酸铂方案与紫杉醇联合顺铂治疗晚期非小细胞肺癌的疗效相似，但不良反应明显减少。

Objective and background Paclitaxel plus cisplatin is an effective regimen in the treatment of non-small cell lung cancer （ NSCLC）, but it has severe adverse toxicities. The aim of this clinical trial is to evaluate the effect and safety of paclitaxel plus oxaliplatin compared with paclitaxel plus cisplatin in the treatment of advanced NSCLC. Methods From January, 2002 to October, 2004, 83 initially treated patients with advanced NSCLC were randomized into two groups., the trial group was treated with paclitaxel 175 mg/m^2 , and oxaliplatin 130 mg/m^2 on day 1 ;and the control group was treated with paclitaxel 175 mg/m^2 and cisplatin 80 mg/m^2 on day 1. Both of them were repeated every 21 days and 2-6 cycles were given to patients. The evaluation of efficacy and safety was performed after chemotherapy regularly. Results All patients were evaluable and received 2 cycles chemotherapy at least. The response rate of the trial group and control group was 34.1% （14/41） and 33.3% （14/42） respectively, median time to progression of them was 6.0 months and 5.5 months, median survival time was 10. 7 months and 10.5 months, 1-year survival was 39.0% （16/41） and 40.5 % （17/42） respectively. The following adverse effects of the two groups were different： the incidence rate of Ⅲ ＋Ⅳ leukopenia was 4.9 % and 28.6 % in the trial group and the control group respectively, Ⅲ＋Ⅳ thrombocytopemia was 0 and 14.3%, Ⅲ＋Ⅳ nausea and vomiting was 7.3% and 26.2%. The difference of the incidence rate of Ⅲ＋Ⅳ nerve abnormality （9. 8% and 9.5%）, imparied renal function （0 and 7. 1%）, myalgia and anthralgia （0 and 2.4%） was insignificant. Conclusion The regimen of paclitaxel plus oxaliplatin have the similar efficacy and less adverse toxicities as compared to Paclitaxel plus Cisplatin in treatment of advanced NSCLC.