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表皮生长因子受体酪氨酸激酶抑制剂治疗作为 EGFR 突变的晚期非小细胞肺癌的一线治疗是有效的:来自六项 III 期随机对照试验的荟萃分析。

Epidermal growth factor receptor-tyrosine kinase inhibitor therapy is effective as first-line treatment of advanced non-small-cell lung cancer with mutated EGFR: A meta-analysis from six phase III randomized controlled trials.

机构信息

Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Tongji University Cancer Institute, Shanghai 200433, People's Republic of China.

出版信息

Int J Cancer. 2012 Sep 1;131(5):E822-9. doi: 10.1002/ijc.27396. Epub 2012 Jan 27.

Abstract

Gefiinib and erlotinib are two similar small molecules of selective and reversible epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), which have been approved for second-line or third-line indication in previously treated advanced Non-small-cell lung cancer (NSCLC) patients. The results of comparing the EGFR-TKI with standard platinum-based doublet chemotherapy as the first-line treatment in advanced NSCLC patients with activated EGFR mutation were still controversial. A meta-analysis was performed to derive a more precise estimation of these regimens. Finally, six eligible trials involved 1,021 patients were identified. The patients receiving EGFR-TKI as front-line therapy had a significantly longer progression-free survival (PFS) than patients treated with chemotherapy [median PFS was 9.5 versus 5.9 months; hazard ratio (HR)=0.37; 95% confidence intervals (CI)=0.27-0.52; p<0.001]. The overall response rate (ORR) of EGFR-TKI was 66.60%, whereas the ORR of chemotherapy regimen was 30.62%, which was also a statistically significant favor for EGFR-TKI [relative risk (RR)=5.68; 95% CI=3.17-10.18; p<0.001]. The overall survival (OS) was numerically longer in the patients received EGFR-TKI than patients treated by chemotherapy, although the difference did not reach a statistical significance (median OS was 30.5 vs. 23.6 months; HR=0.94; 95% CI=0.77-1.15; p=0.57). Comparing with first-line chemotherapy, treatment of EGFR-TKI achieved a statistical significantly longer PFS, higher ORR and numerically longer OS in the advanced NSCLC patients harboring activated EGFR mutations, thus, it should be the first choice in the previously untreated NSCLC patients with activated EGFR mutation.

摘要

吉非替尼和厄洛替尼是两种类似的、选择性和可逆的表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)小分子药物,已被批准用于先前治疗的晚期非小细胞肺癌(NSCLC)患者的二线或三线治疗。将 EGFR-TKI 与标准铂类双联化疗作为晚期 NSCLC 患者中激活的 EGFR 突变的一线治疗进行比较的结果仍存在争议。进行了一项荟萃分析,以更精确地评估这些方案。最终,确定了六项符合条件的试验,共涉及 1021 名患者。接受 EGFR-TKI 作为一线治疗的患者无进展生存期(PFS)明显长于接受化疗的患者[中位 PFS 分别为 9.5 个月和 5.9 个月;风险比(HR)=0.37;95%置信区间(CI)=0.27-0.52;p<0.001]。EGFR-TKI 的总缓解率(ORR)为 66.60%,而化疗方案的 ORR 为 30.62%,这也是 EGFR-TKI 的一个统计学优势[相对风险(RR)=5.68;95%CI=3.17-10.18;p<0.001]。接受 EGFR-TKI 治疗的患者的总生存(OS)在数值上长于接受化疗的患者,尽管差异没有达到统计学意义(中位 OS 分别为 30.5 个月和 23.6 个月;HR=0.94;95%CI=0.77-1.15;p=0.57)。与一线化疗相比,在携带激活的 EGFR 突变的晚期 NSCLC 患者中,EGFR-TKI 的治疗可实现统计学上更长的 PFS、更高的 ORR 和数值上更长的 OS,因此,它应成为携带激活的 EGFR 突变的未经治疗的 NSCLC 患者的首选治疗方法。

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