Sun C T, Xu X, Sheng W, Wang X W, Wen S L, Han J Q
Bratisl Lek Listy. 2014;115(4):233-7. doi: 10.4149/bll_2014_048.
This meta-analysis investigated pemetrexed-based doublet compared with pemetrexed alone as second-line therapy for patients with advanced non-small cell lung cancer.
Randomized controlled trials which compared pemetrexed-based doublet with single-agent pemetrexed in patients as second-line treatment of advanced non-small cell lung cancer were searched. Overall survival (OS) was the primary end point, while secondary end points included progression-free survival, overall response rate, 1-year survival rate, and grade 3 or 4 toxicity.
Four eligible randomized clinical trials including 1,084 patients were selected. Meta-analysis demonstrated that pemetrexed-based doublet arm significantly improved the overall response rate (OR=2.70, 95% CI: 1.76-4.15, p=0.000), compared with docetaxel alone group, while there were no significant differences in overall survival (HR=0.88, 95% CI: 0.74-1.04, p=0.132), progression-free survival (HR=0.91, 95% CI: 0.73-1.15, p=0.443), and 1-year survival rate (OR=1.43, 95% CI: 0.85-2.40, p=0.178) between the two arms. However, there were more frequencies of grade 3-4 leucopenia (OR=2.86, 95% CI: 1.32-6.20, p=0.008), neutropenia (OR=2.69, 95% CI: 1.55-4.68, p=0.000) and thrombocytopenia (OR=6.92, 95% CI: 2.51-19.07, p=0.000) in pemetrexed-based doublet group. Grade 3-4 anemia (OR=0.62, 95% CI: 0.33-1.18, p=0.144) and fatigue (OR=1.15, 95% CI: 0.73-1.79, p=0.550) had equivalent incidences in the two groups.
This is the first meta-analysis to compare pemetrexed-based doublet with single-agent pemetrexed in second-line therapy of non-small cell lung cancer. Our meta-analysis suggested that pemetrexed combination chemotherapy was not superior to single-agent arm and was not recommended as the second-line chemotherapy for patients with non-small cell lung cancer (Tab. 2, Fig. 6, Ref. 20).
本荟萃分析比较了培美曲塞联合化疗与单药培美曲塞作为晚期非小细胞肺癌患者二线治疗方案的疗效。
检索比较培美曲塞联合化疗与单药培美曲塞用于晚期非小细胞肺癌患者二线治疗的随机对照试验。总生存期（OS）为主要终点，次要终点包括无进展生存期、总缓解率、1年生存率和3/4级毒性反应。
选取4项符合条件的随机临床试验，共1084例患者。荟萃分析表明，与单药多西他赛组相比，培美曲塞联合化疗组显著提高了总缓解率（OR = 2.70，95%CI：1.76 - 4.15，p = 0.000），但两组在总生存期（HR = 0.88，95%CI：0.74 - 1.04，p = 0.132）、无进展生存期（HR = 0.91，95%CI：0.73 - 1.15，p = 0.443）和1年生存率（OR = 1.43，95%CI：0.85 - 2.40，p = 0.178）方面无显著差异。然而，培美曲塞联合化疗组3/4级白细胞减少（OR = 2.86，95%CI：1.32 - 6.20，p = 0.008）、中性粒细胞减少（OR = 2.69，95%CI：1.55 - 4.68，p = 0.000）和血小板减少（OR = 6.92，95%CI：2.51 - 19.07，p = 0.000）的发生率更高。两组3/4级贫血（OR = 0.62，95%CI：0.33 - 1.18，p = 0.144）和疲劳（OR = 1.15，95%CI：0.73 - 1.79，p = 0.550）的发生率相当。
这是第一项比较培美曲塞联合化疗与单药培美曲塞用于非小细胞肺癌二线治疗的荟萃分析。我们的荟萃分析表明，培美曲塞联合化疗并不优于单药治疗组，不推荐作为非小细胞肺癌患者的二线化疗方案（表2，图6，参考文献20）。
