培美曲塞或吉西他滨联合顺铂一线治疗晚期非小细胞肺癌的临床随机对照研究

Randomized clinical study comparing pemetrexed plus cisplatin with gemcitabine plus cisplatin as first-line treatment in patients with advanced non-small cell lung cancer

目的:比较培美曲塞联合顺铂(PEM)方案与吉西他滨联合顺铂(GEM)方案一线治疗晚期非小细胞肺癌(NSCLC)的疗效及耐受性。方法:30例经组织学确诊的ⅢB期或Ⅳ期初治NSCLC患者随机分成PEM组和GEM组,每组各15例。结果:PEM组RR为40.0%,PFS为5.60个月,OS为18.07个月;GEM组RR为20.0%,PFS为6.50个月,OS为18.10个月,两组比较差异均无统计学意义,P值分别为0.182、0.431和0.516。肺腺癌中PEM组RR、PFS及OS均好于GEM组,但差异无统计学意义,P>0.05。两组主要毒副反应均为骨髓抑制和胃肠道反应,PEM组患者Ⅲ/Ⅳ度血液学毒性发生率均低于GEM组患者,差异无统计学意义,P>0.05。结论:培美曲塞联合顺铂一线治疗晚期非小细胞肺癌,特别是肺腺癌,疗效确切,耐受性良好。

OBJECTIVE：To evaluate the clinical efficacy and adverse effect of pemetrexed combined with cisplatin （PEM） and gemcitabine combined with cisplatin（GEM） to treat advanced first-line non-small cell lung cancer. METHODS： Thirty chemotherapy-navie patients with Ⅲ B/IV staged NSCLC were recruited in this study and randomly assigned to PEM and GEM. RESULTS： In arm PEM, the total response rate was 40.0%, median PFS was 5.60 months and median OS was 18.07 months. In arm GEM, the total response rate was 20.0%, median PFS was 6.50 months and median OS was 18.10 months. There was no significant difference between the two groups, respectively（P=0. 182; P=0. 431; P=0. 516）. Patients with adenocarcinoma showed superior RR, PFS and OS with PEM therapy compared with GEM, respectively. But no difference was observed （P=0.05）. The main common adverse reactions were myelosuppression and gastrointestinal response in both arms. There was no significant difference in the grade Ⅲ and Ⅳ toxicity between the arms （P〉0.05）. CONCLUSION： Cisplatin plus pemetrexed is an effective tolerable regimen with advanced NSCLC as a first-line therapy, specifically with advanced primary pulmonary adenocarcinoma.