培美曲塞单药与联合用药治疗复发晚期非小细胞肺癌的临床观察

Clinical observation of pemetrexed monotherapy or combination regimen as second-line treatment for advanced non-small cell lung cancer

目的观察培美曲塞单药或联合铂类二线治疗复发晚期非小细胞肺癌（NSCLC）的疗效及毒副反应。方法回顾性分析72例复治晚期NSCLC患者,其中应用培美曲塞单药治疗27例,培美曲塞联合铂类药物治疗45例。培美曲塞单药组：培美曲塞500mg/m2静滴,第1天。联合组：培美曲塞500mg/m2静滴,第1天;顺铂25mg/m2静滴,第1~3天;或卡铂300mg/m2,静滴,第1天。两组均21天为1周期。比较两组疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和1年生存率,并对老年患者（≥60岁）及病理类型分别作亚组分析。结果 72例患者均可评价疗效及毒副反应,无CR病例,获PR11例,SD 34例,PD 27例。单药组与联合组的DCR（55.6%vs.66.7%）、中位PFS（2.8个月vs.3.6个月）、中位OS（11.9个月vs.9.6个月）和1年生存率（32.0%vs.24.0%）差异均无统计学意义。两组主要毒副反应为骨髓抑制和胃肠道反应,差异均无统计学意义。在老年患者亚组分析中,单药组与联合组的DCR（61.1%vs.75.0%）、中位PFS（2.8个月vs.3.4个月）、中位OS（10.3个月vs.7.2个月）和1年生存率（31.0%vs.39.0%）差异均无统计学意义;但在毒副反应方面,联合组的白细胞减少和胃肠道反应均显著高于单药组。病理亚组中,非鳞癌组的DCR（70.0%vs.45.5%）和1年生存率（34.0%vs.15.0%）均高于鳞癌组（P〈0.05）,但两组的中位PFS（3.6个月vs.2.5个月）和中位OS（11.1个月vs.9.4个月）均无明显差异（P〉0.05）。结论培美曲塞单药或联合铂类方案用于复发晚期NSCLC的疗效和毒副反应均无显著差异,在疗效方面可能对非鳞癌具有一定的优势。与联合组比较,培美曲塞单药组对于≥60岁老年患者的安全性更高。

Objective To compare the efficacy and toxicities of advanced non-small cell lung cancer（NSCLC） patients treated by pemetrexed monotherapy or pemetrexed plus a platinum agent.Methods The clinical data of 72 patients with advanced NSCLC were retrospectively analyzed.Twenty-seven patients received the pemetrexed monotherapy（pemetrexed 500mg/m2 iv d1）,and the other 45 patients received the pemetrexed plus platinum regimen（pemetrexed 500mg/m2 iv d1 and cisplatin 25mg/m2 iv d1-d3,or carboplatin 300mg/m2 iv d1）.The disease control rate（DCR）,progress free survival（PFS）,overall survival（OS） and 1-year survival rate were compared between the two regimens.The elder patients（≥60 years old） and pathological types were analyzed separately as subgroups.Results The efficacy and side effects of all the patients could be evaluated.There was no case with CR,11 cases of PR,34 cases of SD and 27 cases of PD.No statistical significance were found between the two regimens in mPFS（2.8 vs.3.6 months）,mOS（11.9 vs.9.6 months）,DCR（55.6% vs.66.7%） and 1-year survival rate（32.0% vs.24.0%）.The common side effects of the two regimens were hematological and gastrointestinal toxicities.No significant difference was found in toxicity between the two regimens.In the subgroup of elder patients,no significant difference in mPFS（2.8 vs.3.4 months）,mOS（10.3 vs.7.2 months）,DCR（61.1% vs.75.0%） and 1-year survival rate（31.0%vs.39.0%） was found between the two regimens.The toxicity of the combination therapy was significantly higher in terms of hematological and gastrointestinal adverse events.In the subgroup of pathological types,pemetrexed showed the tendency of treating advantages in non-squamous cell carcinoma at DCR（70.0%vs.45.5%） and 1-year survival rate（34.0% vs.15.0%）.However,no significant difference in mPFS（3.6 vs.2.5 months） and mOS（11.1 vs.9.4 months） was found between the two groups.Conclusion There is no significant difference in the effects and toxicities of advanced NSCLC patients treated by the pemetrexed monotherapy or pemetrexed plus a platinum agent,and premetrexed may benefit non-squamous cell carcinoma in efficacy.Pemetrexed monotherapy is safer for elder patients compared with the combination therapy.