NEC与IEC方案治疗非小细胞肺癌的对照研究

A randomized trial of vinorelbine, etopside and carboplatin versus ifosfamide, etopside and carboplatin in the treatment of advanced non-small cell lung cancer

目的 比较NEC方案与IEC方案治疗晚期非小细胞肺癌的疗效及不良反应。方法 本研究为前瞻性随机对照研究 ,共 43例晚期的非小细胞肺癌患者随机入组 ,NEC组 2 2例 ,应用NEC方案 (NVB +VP1 6 +CBP) ,IEC组 2 1例 ,应用IEC方案 (IFO +VP1 6 +CBP)。每 4周为 1周期 ,至少化疗 2周期。按WHO标准观察疗效及不良反应以及生存期。结果 NEC组中 2例CR ,1 1例PR ,6例SD ,3例PD ,有效率 (CR +PR)为 59.1 % ;IEC组中 8例PR ,9例SD ,4例PD ,有效率 (CR +PR)为 38.1 %。NEC组有效率比IEC组高 ,但无统计学差异 (P >0 .0 5)。NEC组中位生存期为 9个月 ,而IEC组为 7月 ,两组无差异 (P >0 .0 5)。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NEC组为 35 .0 % ,IEC组为 2 5 .0 % ,两组无差异 (P >0 .0 5)。NEC组的末梢神经炎和局部静脉炎稍高于IEC组。结论 初步的结果显示 ,NEC方案治疗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 NEC (vinorelbine, etoposide and carboplatin) with IEC (ifosfamide, etoposide and carboplatin) in the treatment of advanced non small cell lung cancer (NSCLC).Methods A total of 43 cases with advanced NSCLC entered this trial. The patients were randomly divided into NEC group (22 cases) and IEC group (21 cases), and received chemotherapy of NEC regimen or IEC regimen respectively for every 4 weeks and at least 2 cycles of chemotherapy. The responses and the side effects were evaluated according to the WHO criteria.Results Overall responses were observed in 13 of 22(59.1%) patients in the NEC group and 8 of 21 (38.1%) patients in the IEC group. The response rate of NEC regimen was superior to IEC regimen (P>0.05). The median survival time was 9 months in the NEC group and 7 months in the IEC group (P>0.05). The major side effects were granulocytopenia, nausea and alopenia in the two groups. Peripheral neuritis and phlebitis in NEC group were more often than that in IEC group. Conclusion This study demonstrated that NEC regimen has a better efficacy than IEC for NSCLC, and the toxicity is tolerable.