Background: Lazertinib is a third-generation tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR-TKI) that selectively inhibit common EGFR mutation and T790M mutation in non-small-cell lung cancer (NSCLC) patients. No previous studies have compared lazertinib to platinum-based chemotherapy. We have compared lazertinib with platinum-based chemotherapy in EGFR-mutated NSCLC patients after previous EGFR-TKI therapy. Methods: We retrospectively compared 200 patients from LASER201, LASER301, and LASER-PMS studies to 334 patients who were treated with platinum-based chemotherapy after previous EGFR-TKI from the Samsung Medical Center. After propensity score matching (PSM), we selected 156 patients from each group. The primary outcome was progression-free survival (PFS), with overall survival (OS), objective response rate (ORR), and time to treatment discontinuation (TTD) as secondary outcomes. Results: The median follow-up of PFS was 15.61 months in the lazertinib group and 21.67 months in the external control group. The PFS was significantly longer in patients who were treated with lazertinib than those treated with platinum-based chemotherapy (10.97 months vs. 5.10 months; adjusted hazard ratio (HR) 0.40; 95% confidence interval (CI), 0.29–0.55;p< 0.01) after PSM. Lazertinib showed superior OS (32.23 months vs. 18.73 months; adjusted HR 0.45; 95% CI, 0.29–0.69;p< 0.001), ORR (64.1% vs. 47.4%), and TTD (11.66 months vs. 6.73 months; adjusted HR 0.54; 95% CI, 0.39–0.75;p< 0.001) compared to platinum-based chemotherapy. Conclusion: Based on this retrospective, external control study, lazertinib has demonstrated significantly better efficacy compared with platinum-based chemotherapy. The external controls provide important context to evaluate efficacy in single-arm studies.
背景：拉泽替尼是一种表皮生长因子受体第三代酪氨酸激酶抑制剂，可选择性抑制非小细胞肺癌患者常见的EGFR突变及T790M突变。既往尚无研究将拉泽替尼与铂类化疗方案进行直接比较。本研究旨在对比拉泽替尼与铂类化疗在既往接受过EGFR-TKI治疗的EGFR突变非小细胞肺癌患者中的疗效。 方法：本研究回顾性分析了来自LASER201、LASER301和LASER-PMS研究的200例患者，并与三星医疗中心既往接受EGFR-TKI治疗后采用铂类化疗的334例患者进行对比。经倾向评分匹配后，每组各纳入156例患者。主要研究终点为无进展生存期，次要终点包括总生存期、客观缓解率及治疗终止时间。 结果：拉泽替尼组与外部对照组的中位PFS随访时间分别为15.61个月和21.67个月。经倾向评分匹配后，拉泽替尼治疗组患者的中位无进展生存期显著优于铂类化疗组（10.97个月 vs 5.10个月；校正风险比0.40；95%置信区间0.29-0.55；p<0.01）。与铂类化疗相比，拉泽替尼在总生存期（32.23个月 vs 18.73个月；校正风险比0.45；95%置信区间0.29-0.69；p<0.001）、客观缓解率（64.1% vs 47.4%）及治疗终止时间（11.66个月 vs 6.73个月；校正风险比0.54；95%置信区间0.39-0.75；p<0.001）方面均显示出更优疗效。 结论：基于此项回顾性外部对照研究，拉泽替尼相较于铂类化疗方案展现出显著更优的疗效。外部对照组为单臂研究的疗效评估提供了重要参照依据。
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