VIP与MVP方案治疗非小细胞肺癌的对照研究

A randomized trial of cisplatin plus vindesine plus ifosfamide versus cisplatin plus vindesine plus mitomycin C in the treatment of advanced non small cell lung cancer

目的 :通过前瞻性对照研究 ,比较VIP方案与MVP方案治疗晚期非小细胞肺癌的疗效及不良反应。方法 :共 5 3例晚期的非小细胞肺癌患者随机入组 ,治疗组应用VIP方案 (VDS +IFO +DDP) ,对照组应用MVP方案 (MMC +VDS +DDP) ,每例病人至少化疗 2疗程。疗效及不良反应评价均按WHO标准进行 ,每例病人随访生存期。结果 :治疗组中 1例CR ,15例PR ,8例SD ,1例PD ,有效率 (CR +PR)为 6 4 0 % ;对照组中 11例PR ,11例SD ,6例PD ,有效率 (CR +PR)为 3 9 3 %。治疗组有效率比对照组高 ,但无统计学差异 (P =0 0 72 )。治疗组中位生存期为 8个月 ,而对照组为 7月 ,两组无差异 (P >0 0 5 ) ,该组资料目前仍在继续进行随访。两组不良反应均主要为骨髓抑制、恶心呕吐、脱发。Ⅲ +Ⅳ的血白细胞下降治疗组为 5 6 0 % ,对照组为 5 0 0 % ,两组无差异 (P>0 0 5 )。结论 :初步的结果显示VIP方案对于非小细胞肺癌的有效性较高 。

Objective:To compare the response rate and the side effects of the regimen VIP (vindesine,ifosfomide,and cisplatin) with MVP (mitomycin C, vindesine,and cisplatin) in the treatment of advanced non small cell lung cancer (NSCLC) Methods:A total of 53 cases with advanced NSCLC entered this trial The patients were randomly divided into trial group and control group, and received chemotherapy of VIP regimen or MVP regimen respectively Each patient received at lest 2 cycles of chemotherapy The responses and the side effects were evaluated according to the WHO criteria Results:Overall responses were observed in 16 of 25(64 0%) patients in the VIP group and 11 of 28 (39 3%) patients in the MVP group The response rate of VIP regimen was superior to MVP regimen, but the difference between the two groups did not reach statistical significance (P=0 072) The median survival time was 8 months in VIP group, and 7 months in MVP group (P >0 05) The major side effects were leucopenia, nausea and alopenia in the two groups Conclusions:The results of this study demonstrated that VIP regimen had an better efficacy than MVP for NSCLC, and the toxicity was tolerable