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

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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 compare the efficacy and tolerability of first-line treatment of advanced non-small cell lung cancer (NSCLC) with pemetrexed plus cisplatin (PEM) and gemcitabine plus cisplatin (GEM). Methods: Thirty patients with stage ⅢB or Ⅳ NSCLC diagnosed by histology were randomly divided into PEM group and GEM group, with 15 cases in each group. Results: The RR of PEM group was 40.0%, PFS was 5.60 months and OS was 18.07 months. In GEM group, RR was 20.0%, PFS was 6.50 months and OS was 18.10 months. There was no significant difference between two groups P values ​​were 0.182, 0.431 and 0.516 respectively. Pneumothorax in PEM group RR, PFS and OS were better than GEM group, but the difference was not statistically significant, P> 0.05. The main adverse reactions of both groups were myelosuppression and gastrointestinal reaction. The incidence of grade Ⅲ / Ⅳ hematologic toxicity in PEM group was lower than that in GEM group, the difference was not statistically significant (P> 0.05). Conclusion: Pemetrexed combined with cisplatin in the treatment of advanced non-small cell lung cancer, especially lung adenocarcinoma, is effective and well tolerated.
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