紫杉醇单药维持治疗中晚期非小细胞肺癌的临床研究

Clinical Study of Paclitaxel Alone in Maintenance Treatment of Advanced Non-small Cell Lung

目的观察紫杉醇单药维持治疗中晚期非小细胞肺癌(NSCLC)的疗效及无进展生存期。方法 90例中晚期非小细胞肺癌患者给予一线含铂类的方案4周期化疗后,将达完全缓解(CR)、部分缓解(PR)及稳定(SD)患者53例分为2组。治疗组27例,给予紫杉醇维持治疗加最佳支持治疗3周期;对照组26例,仅给予最佳支持治疗,比较2组的有效率、无进展生存期及毒副反应。结果治疗组与对照组无进展生存期分别为(3.63±0.28)个月和(2.62±0.18)个月(P<0.05);疾病控制率(CR+PR+SD)分别为92.56%和57.69%(P<0.05);2组生活质量差异无统计学意义(P>0.05)。结论紫杉醇单药维持治疗中晚期非小细胞肺癌可提高疾病控制率、延长无进展生存期,生活质量不受影响,且毒副反应能耐受。

Objective To assess the efficacy and safety of Paclitaxel alone in the maintenance treatment of advanced non - small cell lung cancer. Methods Ninety patients who were diagnosed with advanced non - small cell lung cancer were enrolled in this study. After 4 cycles of standard eisplatin and other drugs （ Paclitaxel or gemcitabine and Navelbine） chemotherapy, 53 patients who did not progress were chosen and then they were randomly divided into treatment group （ n = 27） and control group （ n = 26）. The patients in treatment group received paclitaxel alone and best supportive care, while the patients in control group received best supportive care. Pro- gression - free survival, total effective rates and drug adverse effects of two groups were compared and analyzed. Results Progression - free survival time （ PFS ） was 3.63 ± 0.28 months and 2.62 ± 0.18 months （ P = O. 004） for maintenance therapy group and control group respectively ;The total effective rates was 92.56% and 57.69% （P 〈 0.01 ） for maintenance therapy group and control group respective- ly. Quality of life between groups were not significant difference （ P 〉 0.05 ）. Conclusions Paclitaxel alone in the maintenance treatment of advanced non - small cell lung cancer has satisfactory clinical efficacy, high PFS and high safety, and it is one of the best treatment options.