一线伴随 EGFR-TKI 化疗与 EGFR-TKI 单药治疗晚期 - 突变型 NSCLC：随机 III 期试验的荟萃分析。
First-line concomitant EGFR-TKI + chemotherapy versus EGFR-TKI alone for advanced -mutated NSCLC: a meta-analysis of randomized phase III trials.
机构信息
Unité d'Oncologie et Gériatrie, HUPSSD, Hôpital René Muret, AP-HP, Sevran, France.
Department of Pneumology, Centre Hospitalier Intercommunal de Créteil, Créteil, France.
出版信息
Expert Rev Anticancer Ther. 2024 Aug;24(8):775-780. doi: 10.1080/14737140.2024.2362889. Epub 2024 Jun 3.
INTRODUCTION
A tyrosine-kinase inhibitor (TKI) is indicated as a first-line treatment for patients with non-small-cell lung cancer (NSCLC) harboring an epidermal growth-factor - receptor () mutation. Chemotherapy (ChT) given in combination with an EGFR-TKI in this setting is of interest.
METHODS
We conducted a meta-analysis of phase III randomized trials comparing EGFR-TKI + ChT vs. EGFR-TKI alone as first-line therapy for advanced NSCLC harboring an activating mutation.
RESULTS
Three studies evaluated gefitinib + ChT (NEJ009, GAP-Brain, and Noronha et al.) and another evaluated osimertinib + ChT (FLAURA-2). Those four eligible studies included 1413 patients with non-squamous NSCLCs, 826 (58%) with an exon-19 deletion (ex19del) and 541 (38%) with . The EGFR-TKI + ChT combination was significantly associated with prolonged PFS (hazard ratio [HR]: 0.52 [95% confidence interval (CI): 0.45-0.59]; < 0.0001) and OS (HR: 0.69 [0.52-0.93]; = 0.01). PFS was particularly improved for patients with brain metastases (HR: 0.41[0.33-0.51]; < 0.00001).
CONCLUSIONS
For patients with untreated, advanced, -mutated NSCLCs, the EGFR-TKI + ChT combination, compared to EGFR-TKI alone, was associated with significantly prolonged PFS and OS. However, further studies are needed to identify which patients will benefit the most from the combination.
REGISTRATION
PROSPERO CRD42024508055.
简介
一种酪氨酸激酶抑制剂（TKI）被指征用于携带表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者的一线治疗。在这种情况下，联合使用化疗（ChT）和 EGFR-TKI 具有一定的研究价值。
方法
我们对比较 EGFR-TKI+ChT 与 EGFR-TKI 单药一线治疗携带激活突变的晚期 NSCLC 的 III 期随机试验进行了荟萃分析。
结果
有三项研究评估了吉非替尼+ChT（NEJ009、GAP-Brain 和 Noronha 等人），另有一项研究评估了奥希替尼+ChT（FLAURA-2）。这四项合格研究纳入了 1413 例非鳞状 NSCLC 患者，其中 826 例（58%）存在外显子 19 缺失（ex19del），541 例（38%）存在 。EGFR-TKI+ChT 联合治疗与 PFS（风险比[HR]：0.52[95%置信区间（CI）：0.45-0.59]； < 0.0001）和 OS（HR：0.69[0.52-0.93]； = 0.01）的显著延长相关。对于存在脑转移的患者，PFS 得到了特别改善（HR：0.41[0.33-0.51]； < 0.00001）。
结论
对于未经治疗的、晚期、突变的 NSCLC 患者，与 EGFR-TKI 单药治疗相比，EGFR-TKI+ChT 联合治疗与 PFS 和 OS 的显著延长相关。然而，还需要进一步的研究来确定哪些患者将从联合治疗中获益最大。
注册
PROSPERO CRD42024508055。
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