GP与TP方案治疗晚期非小细胞肺癌随机对照研究

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(DDP)(GP方案)与紫杉醇联合DDP(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/m2,30 min,d1、d8。DDP总量90 mg/m2,分为d2～d6。TP组:紫杉醇135 mg/m2,d1;DDP总量90 mg/m2分为d2～d6。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%,MST10.5个月,TTP 4.3个月;两组比较无显著性差异(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 non-small cell lung cancer （NSCLC）.Methods： Seventy-nine advanced NSCLC patients were divided into 2 groups randomly, 39 in GP group （gemcitabine plus cisplatin）and 40 in TP group （paclitaxel plus cisplatin）. GP group： gemcitabine 1 000 mg/m2, 30 min day1,8, cisplatin 90 mg/m^2 in day 2-6;TP group：paclitaxel 135 mg/m^2, dayl, cisplatin 90 mg/m^2 in day 2-6. 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 differences of RR, TTP and MST between group GP and TP were not significant. The major cytotoxicity of TP group was thrombocytopenia. The major cytotoxicity of GP group was fatigue and neurotoxicity. All adverse reactions were tolerable. Conclusion： GP and TP regimens with manageable toxicity have good anti-tumor activity on advanced NSCLC, and have not significant difference. As side effects in TP and GP group are difference, the regimen should be chosen according to the condition of patient.