两种不同含铂类方案治疗晚期非小细胞肺癌随机对照研究

The Randomized Trial of Gemcitabine Plus Cisplatin Versus Paclitaxel Plus Cisplatin in Treating Advanced Non-small Cell Lung Cancer

目的：评价吉西他滨联合顺铂（GP方案）与紫杉醇联合顺铂（TP方案）治疗晚期非小细胞肺癌（NSCLC）的疗效和毒性反应。方法：79例患者随机分为GP组和TP组,GP组：吉西他滨1 000 mg/m^2,30min,d1、d8;顺铂30 mg/m^2,d1~d3;TP组：紫杉醇135 mg/m^2,d1;DDP 30 mg/m^2d1－d3;对两组的临床疗效和毒性反应进行对比观察。结果：GP组有效率（RR）为41.0%,中位生存期（MST）10.9个月,中位疾病进展时间（TTP）4.5个月;TP组RR为42.5%,MST 10.5个月,TTP 4.3个月;两组比较差异无统计学意义（P〉0.05）,GP组不良反应以血小板降低为主,TP组以乏力和外周神经毒性为主,均可耐受。结论：吉西他滨或紫杉醇联合DDP治疗晚期NSCLC具有较好的耐受性和临床疗效,二者疗效和生存率比较没有显著性差异,不良反应有所不同但都可以耐受,应根据患者特点,尽可能选择个体化治疗。

Objective： To observe the efficacy and side effect of Gemcitabine or Paclitaxel Combined with Cisplatin in treating advanced nonsmall cell lung cancer. Methods： 79 advanced NSCLC patients were randomized into 2 groups, 39 in GP group （gemcitabine plus cisplatin）and 40 in TP group （paclitaxel plus eisplatin）. GP group： gemcitabine 1000 mg/m^2, day1,8, cisplatin 30 mg/m^2 day 1--3;TP group：paclitaxel 135 mg/m^2, day1, cisplatin 30 mg/m^2 day 1-3. Results： The RR with group GP and TP were 41.0 % and 42.5 % , respectively. The TTP was 4.5 months in GP group and 4.3 months in TP group. The MST was 10.9 months in GP group and 10.5 months in TP group. The difference of RR, TTP and MST was not significant. The major cy- totoxicity of GP group was thrombocytopenia, The major cytotoxicity of TP group was fatigue and neurotoxicity All adverse reactions were tolerable. Conclusion： GP and TP regimens have good anti- tumor activity on ad- vanced non- small cell lung cancer with manageable toxicity. The difference in treatment effieacies of GP and TP group were not significant. Side effects with TP and GP group were difference.