Zhang X F, De-Sheng L V, Li M, Sun G E, Liu C H
Department of Thoracic Surgery, The Second Affiliated Hospital of Dalian Medical University, Dalian 116023, China.
Indian J Cancer. 2017 Jan-Mar;54(1):104-114. doi: 10.4103/0019-509X.219586.
Several clinical trials have shown that advanced nonsmall cell lung cancer (NSCLC) patients can benefit from treatment with epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) monotherapy than receiving platinum-based doublets chemotherapy in the first-line treatment of advanced NSCLC; the objective of this study was to evaluate whether patients could be treated with EGFR-TKI for advanced NSCLC in the first-line setting.
A literature search was conducted on the Cochrane Controlled Trials Register Databases, MEDLINE, EMBASE, Web of Science databases, and Chinese Biomedical Literature Database without exclusion of material published in any language. We performed a meta-analysis of five randomized studies that compared EGFR-TKI with platinum-based doublets chemotherapy for the patients of advanced NSCLC in the first-line setting. The primary end-point was the progression-free survival (PFS) of each treatment arm. The secondary end-points were overall survival (OS), objective response rate (ORR), adverse effects, and quality of life (qol).
Five randomized controlled trials totaling 2080 patients were included in the review. Meta-analysis results are as follows: There were statistically significant differences in overall PFS (hazard ratio [HR] =0.47; 95% confidence interval [CI]: [0.27, 0.83], P = 0.009) and the PFS of the EGFR-M + subgroup (HR = 0.29; 95% CI: [0.17-0.51], P < 0.0001). Compared with patients receiving the platinum-based doublets chemotherapy group, there were no statistically significant differences between the two groups with regard to overall OS (HR = 0.92; 95% CI: [0.80-1.06], P = 0.25).
Compared with the platinum-based doublets chemotherapy, EGFR-TKI significantly prolonged PFS, increased ORR, improved qol, not significantly increased the nonhematologic toxicity and at the same time decreased the nonhematologic toxicity but not significantly increased the transaminase toxicity for advanced NSCLC patients in East Asia. Although there is convincing evidence to confirm the results mentioned herein, they still need to be confirmed by large-sample trials.
多项临床试验表明，在晚期非小细胞肺癌（NSCLC）的一线治疗中，晚期非小细胞肺癌患者接受表皮生长因子受体-酪氨酸激酶抑制剂（EGFR-TKI）单药治疗比接受铂类双联化疗更有益；本研究的目的是评估晚期NSCLC患者在一线治疗中是否可以接受EGFR-TKI治疗。
在Cochrane对照试验注册数据库、MEDLINE、EMBASE、科学网数据库和中国生物医学文献数据库中进行文献检索，不排除任何语言发表的资料。我们对五项随机研究进行了荟萃分析，这些研究比较了EGFR-TKI与铂类双联化疗用于晚期NSCLC患者的一线治疗。主要终点是每个治疗组的无进展生存期（PFS）。次要终点是总生存期（OS）、客观缓解率（ORR）、不良反应和生活质量（qol）。
该综述纳入了五项随机对照试验，共2080例患者。荟萃分析结果如下：总体PFS存在统计学显著差异（风险比[HR]=0.47；95%置信区间[CI]：[0.27,0.83]，P=0.009）以及EGFR-M+亚组的PFS（HR=0.29；95%CI：[0.17 - 0.51]，P<0.0001）。与接受铂类双联化疗组的患者相比，两组在总体OS方面无统计学显著差异（HR=0.92；95%CI：[0.80 - 1.06]，P=0.25）。
与铂类双联化疗相比，EGFR-TKI显著延长了东亚晚期NSCLC患者的PFS，提高了ORR，改善了qol，未显著增加非血液学毒性，同时降低了非血液学毒性，但未显著增加转氨酶毒性。尽管有令人信服的证据证实本文所述结果，但仍需大样本试验予以证实。
