培美曲塞或吉西他滨联合卡铂治疗老年晚期非小细胞肺癌临床对照研究

Study on Clinical Efficacy of Pemetrexed or Gemcitabine Combined with Carboplatin for Treating Elderly Advanced Non-Small Lung Cancer

目的比较培美曲塞联合卡铂与吉西他滨联合卡铂治疗老年晚期非小细胞肺癌（NSCLC）的临床疗效及毒副作用。方法将64例Ⅲb/Ⅳ期老年（≥70岁）晚期NSCLC患者随机分为观察组和对照组,各32例。观察组给予培美曲塞500 mg/m^2和卡铂400 mg/m^2,第1天静脉滴注,对照组给予吉西他滨1 000 mg/m^2,第1,8天静脉滴注,卡铂400 mg/m^2,第1天静脉滴注。两组均以21 d为1个周期,治疗2个周期后评价其临床疗效及毒副作用。结果治疗有效率和疾病控制率观察组分别为28.12%和81.25%,对照组分别为21.86%和71.88%,组间比较均无明显差异（P〉0.05）;两组患者的中位生存时间均为11.0个月,平均生存时间分别为12.0个月和11.8个月,差异无统计学意义（P〉0.05）;两组患者的主要毒副反应为血液学毒性和胃肠道反应,观察组粒细胞减少、血小板降低及胃肠道反应（Ⅲ~Ⅳ级）的发生率显著低于对照组（P〈0.05）。结论培美曲塞联合卡铂与吉西他滨联合卡铂一线治疗老年NSCLC的临床疗效相当,但培美曲塞联合卡铂毒副反应相对较轻。

Objective To observe the clinical efficacy,toxic reactions and side effects of pemetrexed or gemcitabine combined with carbo-platin for treating elderly advanced non-small cell lung cancer（NSCLC）. Methods 64 elderly patients with stage Ⅲb/Ⅳ NSCLC were randomly divided into the observation group and the control group,32 cases in each group. The observation group was given pemetrexed 500 mg/m^2 and carboplatin 400 mg/m^2,intravenous drip on 1 d;the control group was given gemcitabine 1 000 mg/m^2,intravenous drip on 1,8 d,carboplatin 400 mg/m^2,intravenous drip on 1 d. Both groups were treated for 21 d as a cycle. The efficacy,toxic reactions and side effects after 2-cycle therapy were evaluated and compared between the two groups. Results The response rate（RR） and disease control rate（DCR）in the observation group were 28. 12% and 81. 25% respectively,while which in the control group were 21. 86% and 71. 88% respectively,the differences between the two groups had no statistical significance （ P 〉 0. 05）. The median survival time was 11. 0 months in the two groups. The average survival time in the observation group and the control group were 12. 0 months and 11. 8 months respectively,no statistical difference was observed between the two groups（ P 〉 0. 05）;the main toxic reactions and side effects were hematologic toxicity and gastrointestinal reactions in the two groups. The incidence rates of neutropenia,thrombocytopenia and gas-trointestinal reactions with stage Ⅲ-Ⅳ in the observation group were significantly lower than that in the control group（ P 〈 0. 05）. Conclusion Pemetrexed or gemcitabine combined with carboplatin as the first therapy shows the similar efficacy for treating elderly NSCLC,however,the toxicities and side effects in pemetrexed plus carboplatin are milder than those in gemcitabine plus carboplatin.