能否根据临床因素选择将表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）用于晚期非小细胞肺癌的一线治疗？——基于文献的荟萃分析。
Can EGFR-TKIs be used in first line treatment for advanced non-small cell lung cancer based on selection according to clinical factors? - A literature-based meta-analysis.
机构信息
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Science, 106 Zhongshan Er Road, Guangzhou, 510080 Guangdong, PR China.
出版信息
J Hematol Oncol. 2012 Oct 10;5:62. doi: 10.1186/1756-8722-5-62.
BACKGROUND
In the first line treatment of non-small cell lung cancer (NSCLC), several clinical trials have shown that not all NSCLC patients can benefit from treatment with tyrosine kinase inhibitors (TKIs) than receiving chemotherapy. Some trials treated patients with TKI according to their clinical characteristics. A few studies only chose patients with an epidermal growth factor receptor (EGFR) mutation for TKI therapy. We aimed to determine whether patients could be treated with TKIs based on clinical factors in the first-line setting.
METHODS
We performed a meta-analysis of randomized trials involving patients with advanced NSCLC treated with chemotherapy or TKIs by different selections. Efficacy outcomes of interest were the objective response rate (ORR), progression-free survival (PFS) and the overall survival (OS) of each treatment arm.
RESULTS
Four trials enrolled unselected patients, and two trials selected East Asian patients using the clinical factors of gender and smoking history. Five trials chose patients with an EGFR mutation who were randomized for treatment with TKI or chemotherapy. For unselected patients, the risk ratio (RR) of the ORR was 3.52, the hazard ratio (HR) of the PFS was 1.29 and the HR of the OS was 1.35. For the clinically selected patients, the RR of the ORR was 0.64. The HRs of the PFS and OS were 0.83 and 0.92, respectively. The ORR and PFS were better for TKIs than for chemotherapy in patients with an EGFR mutation. The ORR was 0.47, and the HRs of the PFS and OS were 0.36 and 1.00, respectively.
CONCLUSIONS
Advanced NSCLC patients with an EGFR mutation benefit most from TKIs. EGFR-TKI treatment is justified for patients with unknown EGFR status,and those who cannot tolerate chemotherapy owing to age, poor performance status (PS) or other medical conditions, when selected according to clinical factors in the first-line setting.
背景
在非小细胞肺癌（NSCLC）的一线治疗中，多项临床试验表明，并非所有 NSCLC 患者都能从酪氨酸激酶抑制剂（TKI）治疗中获益，而接受化疗的患者获益更多。一些试验根据患者的临床特征对患者进行 TKI 治疗。少数研究仅选择表皮生长因子受体（EGFR）突变的患者进行 TKI 治疗。我们旨在确定在一线治疗中能否根据临床因素选择 TKI 治疗患者。
方法
我们对涉及接受化疗或 TKI 不同选择治疗的晚期 NSCLC 患者的随机试验进行了荟萃分析。疗效观察终点为各治疗组的客观缓解率（ORR）、无进展生存期（PFS）和总生存期（OS）。
结果
四项试验纳入了未经选择的患者，两项试验选择了东亚患者，使用了性别和吸烟史等临床因素。五项试验选择了 EGFR 突变的患者，这些患者被随机分为 TKI 或化疗治疗组。对于未经选择的患者，ORR 的风险比（RR）为 3.52，PFS 的危险比（HR）为 1.29，OS 的 HR 为 1.35。对于经临床选择的患者，ORR 的 RR 为 0.64。PFS 和 OS 的 HR 分别为 0.83 和 0.92。EGFR 突变患者接受 TKI 治疗比接受化疗的 ORR 和 PFS 更好。ORR 为 0.47，PFS 和 OS 的 HR 分别为 0.36 和 1.00。
结论
存在 EGFR 突变的晚期 NSCLC 患者从 TKI 中获益最大。在一线治疗中，根据临床因素选择 EGFR-TKI 治疗是合理的，包括未知 EGFR 状态的患者，以及因年龄、较差的表现状态（PS）或其他医疗状况而不能耐受化疗的患者。
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