比较培美曲塞维持治疗与二线治疗晚期非小细胞肺癌的临床疗效

The Clinical Curative Effect Comparison of Maintenance Chemotherapy and Second-line Chemotherapy with Pemetrexed in Non-small Cell Lung Cancer

目的:评价晚期非小细胞肺癌(NSCLC)诱导化疗获益后二线化疗药物培美曲塞(PEM)应用于早期维持治疗与延迟二线治疗的疗效。方法:81例晚期NSCLC患者(ⅢB或Ⅳ期)均接受以铂类为基础的一线治疗4～6周期后,病情获得缓解或稳定的患者随机分为早期组(n=58)和延迟组(n=23)。所有患者均予PEM(500mg/m2,第1天)联合最佳支持治疗,21d为一周期,同时维生素B12、叶酸、地塞米松预防毒副反应。结果:早期组的中位无进展生存期(PFS)较延迟组显著延长(6.8±0.7个月比2.7±0.5个月,字2=54.878,P<0.001),而中位总生存期(OS)较延迟组有所延长(14.7±0.6个月比12.4±0.5个月,字2=3.018,P=0.082),但差异无统计学意义,腺癌患者中位OS较鳞癌患者显著延长(16.5±0.6个月比11.2±0.5个月;字2=14.734,P<0.001),两组间的药物的安全性与毒性发生率差异无统计学意义。结论:提早应用二线化疗药物培美曲塞维持治疗明显延长患者的PFS,并且没有增加毒性反应,腺癌患者可获得较好的生存期。

Objective ： To assess the efficacy and safety of pemetrexcd administered either immediately after front-line treatment for advanced nonsmall-eell lung eancer（NSCLC） or at disease progression.Methods ： 81 patients with stage Ⅲ B or Ⅳ NSCLC who had not progressed on four to six cycles of platinum-based chemotherapy were randomly assigned either to an immediate pemctrexed group（n=58） or to a delayed pemetrexed group（n=23）.All patients receive pemetrexed（500 mg/m^2, on day i every 21 days） plus best supportive care, patients also received oral dexamethasone, oral folic acid and i.m.vitamin B12 supplementation to reduce toxicity.Results ： Median PFS for immediate pemetrexed was significantly greater than for delayed pemetrexed （6.8 ± 0.7 months vs 2.7± 0.5 months ; X^2=54.878, P〈0.001）.Median OS for immediate docetaxel （14.7 ± 0.6 months） was greater than for delayed pemetrexed （12.4 ± 0.5 months）, but the difference was not statistically significant（x2=3.018, P=0.082）.However, overall survival was statistically superior for adenocarcinoma subgroup versus squamous subgroup（16.5 ± 0.6 months vs 11.2 ± 0.5 months ; X^2=14.734, P〈0.001）.Toxicity was not statistically different between two groups.Conclusion ： Pcmetrexed was administered immediately after front-line therapy, which can extended significantly PFS, without increasing toxicity.The patients with adenocareinoma histology have the survival advantage.