TP与GP方案治疗晚期非小细胞肺癌的随机对照临床研究

A randomized comparative trial of TP and GP regimen for treatment of advanced non-small cell lung cancer

目的:紫杉醇(paclitaxel,TAX)和吉西他滨(gemcitabine,GEM)是目前治疗肺癌的一线药物。本研究对这二药联合DDP的TP与GP方案治疗晚期NSCLC的近期疗效及不良反应进行对比。方法:采用前瞻性开放性随机对照临床研究方法,对56例入组患者随机采用TP(TAX、DDP)或GP(GEM、DDP)方案化疗,化疗至少2周期后评价疗效及不良反应。结果:TP组、GP组有效率分别是39.1%(9/23)和40.0%(8/20);中位生存期分别为8.8、9.2个月,无病生存期分别为3.6、3.7个月;1年生存率分别为32.3%和31.0%;各组间差异均无显著性。主要不良反应是Ⅲ-Ⅳ度骨髓抑制、恶心呕吐、乏力和静脉炎。GP组的白细胞减少(42.2%)、中性粒细胞减少(36.2%)发生率最低,血小板减少发生率(53.0%)最高,与TP组(71.0%、57.0%、13.0%)比较差异均具有显著性(P<0.01);GP组、TP组的恶心呕吐发生率分别为16.8%、25.8%;GP组的乏力症状发生率组(38.5%),显著高于TP组(P<0.01)。结论:TP和GP方案治疗晚期NSCLC近期疗效差异无显著性。

Objective：Paclitaxel（TAX）,and gemcitabine（GEM） are first-line chemotherapeutic drugs in the treatment for non-small cell lung cancer（NSCLC） currently.This randomized study was to investigate the efficacies and toxicities of these two regimens in NSCLC treatment.Methods：A total of 56 NSCLC patients were randomly assigned to regimen TP（TAX plus DDP）,or GP（GEM plus DDP）.Results：The response rates were 39.1%（9/23） in TP,and 40.0%（8/20） in GP group,and complete remission rates were 0%（0/23） and 0%（0/20） respectively,without significant difference.The median survival time disease-free survival time and 1-year survival rate were 8.8 months,3.6 months and 32.0%,9.2 months,3.7 months and 31.0%,respectively in TP and GP groups without significant difference.The major adverse reactions were stage 3 to 4 myelo-suppression,nausea/vomiting,fatigue and phlebitis.There were highest incidences of leucopenia（42.2%）,neutropenia（36.2%） and lowest incidence of thrombocytopenia（53.0%） in GP group compared to TP group（71.0%,57.0%,13.0%） statistically（P0.01）.The rates of nausea/vomiting in GP（16.8%） and TP group（25.8%）,the rate of fatigue in GP arm（38.5%） was most frequent among the two arms（P0.05）.Conclusion：There is no significant difference in short-term efficacy of chemotherapy regimen TP and GP.