培美曲塞二钠治疗晚期非小细胞肺癌的效果及毒副作用

Observation of short-term and long-term efficacy and toxicity of pemetrexed disodium in the treatment of advanced NSCLC after first-line chemotherapy failure

目的 探讨经一线化疗失败的晚期非小细胞肺癌(NSCLC)患者使用培美曲塞二钠单药治疗的近远期效果及毒副作用,为晚期NSCLC患者二线治疗药物选择提供参考。方法 共收集84例经一线化疗失败的晚期NSCLC患者,临床分期Ⅲb-Ⅳ期。采用单盲随机数表法将其分为对照组和观察组,两组各42例。其中对照组接受多西他赛单药化疗,剂量75mg/m2;观察组采用培美曲塞二钠化疗,500mg/m2,两组均21天/周期。持续4个周期后采用实体瘤评价标准(RECIST)判定疗效,采用美国国家癌症研究院(NCI)制定的毒性评价标准(CTC)评估两组毒性作用情况。结合1年随访统计两组远期生存情况。结果 对照组肿瘤治疗有效率(RR)(完全缓解是CR,部分缓解是PR;RR是CR+PR例数占总例数比例)和疾病控制率(DCR)分别为14.29%(6/42)、64.29%(27/42),观察组RR和DCR分别为16.67%(7/42)、69.05%(29/42),两组间差异均无统计学意义(P>0.05)。观察组白细胞下降、恶心呕吐、脱发、肝功能损伤发生率均显著低于对照组,差异有统计学意义(χ^2=4.421、4.613、4.459、5.126,P均<0.05)。对照组和观察组6个月、1年生存率和总生存期(OS)比较,差异均无统计学意义(P均>0.05)。结论 一线化疗失败的晚期NSCLC患者采用培美曲塞二钠治疗,化疗近远期效果同多西他赛,但毒性作用明显减轻,未出现严重不良反应,安全性良好,可作为晚期NSCLC患者二线治疗药物的优先选择。

Objective To investigate the short-term and long-term efficacy and toxicity of pemetrexed disodium monotherapy in patients with advanced non-small cell carcinoma (NSCLC) who failed to first-line chemotherapy,and to provide references for the selection of second-line drugs for advanced NSCLC patients. Methods A total of 84 patients with advanced NSCLC who failed to first-line chemotherapy were enrolled in this hospital.The clinical stage was stage Ⅲb to Ⅳ.The patients were divided into control group and observation group by single blind random number table,42 cases in each group.The control group received docetaxel single-drug chemotherapy at a dose of 75 mg/m 2,while the observation group received pemetrexed disodium chemotherapy at a dose of 500 mg/m 2.Both groups received 21 days/cycle for four cycles.The efficacy was assessed by Response Evaluation Criteria in Solid Tumors(RECIST) solid tumor evaluation criteria,and the toxicity and side effects were assessed by the Common Terminology Criteria (CTC) developed by the National Cancer Institute (NCI).The long-term survival of the two groups was analyzed with 1-year follow-up. Results Response rate (RR) and disease control rate(DCR) were 14.29%(6/42) and 64.29%(27/42) in the control group,while RR and DCR in the observation group were 16.67%(7/42) and 69.05%(29/42),respectively.There were no significant difference between the two groups ( P> 0.05).The incidences of leukopenia,nausea,vomiting,alopecia and liver function damage in the observation group were significantly lower those in the control group (χ^ 2= 0.035,0.032,0.035,0.024.all P< 0.05).There were 2 cases and 3 cases in the control group and the observation group who lost follow-up in one year.There was no significant difference in the 6-month,1-year survival rate and total survival time (OS) between the two groups ( P >0.05). Conclusion Pemetrexed disodium can be used for advanced NSCLC patients with first-line chemotherapy failure.The short-term and long-term effect of chemotherapy is similar to that of docetaxel,and the toxicity and side effects are obviously reduced.The safety of pemetrexed disodium is remarkable.It can be used as a preferred choice for second-line therapy.