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拉泽提尼布用于携带不常见EGFR突变的NSCLC患者:II期多中心试验

Sehhoon Park¹, Hee Kyung Ahn², Seoyoung Lee³

¹Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

|May 11, 2025

概括

拉泽提尼布对非小细胞肺癌 (NSCLC) 患者具有不常见的EGFR突变具有有希望的效果,其客观应答率为50%. 这种EGFR氨酸激酶抑制剂 (TKI) 为治疗选择有限的患者提供了新的选择.

科学领域:

在瘤学瘤学.
医学遗传学医学遗传学

背景情况:

不常见的EGFR突变在NSCLC中占EGFR突变的10-20%.
这些突变往往导致对EGFR氨酸激酶抑制剂 (TKI) 的敏感性降低.
拉泽提尼布是一种第三代EGFR-TKI,在常见的EGFR突变中已显示出有效性,但其在不常见突变中的作用尚不清楚.

研究的目的:

研究拉泽提尼布在患有不常见EGFR突变的NSCLC患者的疗效和安全性.
评估拉泽提尼布的客观反应率 (ORR) 作为主要终点.
评估二次终点,包括无进展生存率 (PFS),总生存率 (OS),反应持续时间 (DoR) 和安全性.

主要方法:

进行了一项单臂多中心II期试验.
纳入了患有晚期NSCLC和不常见EGFR突变的患者 (不包括EXON 20插入).
拉泽提尼布240毫克每天给药,直到疾病进展或不可接受的毒性.

主要成果:

该研究招募了36名患者,实现了主要终点ORR的50.0% (95%CI:34.5%-65.5%).
疾病控制率为88.9%. 患有G719X,L861Q或S768I突变的患者的ORR为54.8%.
中位数PFS为10.8个月,中位数DoR为15.1个月. G719X突变的反应最高 (ORR为61%,PFS为20.3个月).

结论:

拉泽提尼布在患有不常见EGFR突变的NSCLC患者中显示出有希望的疗效和可管理的安全性.
亚组分析强调了G719X,S768I和L861Q亚型的特别有效性.
拉泽提尼布对这个异质的患者群体具有有限的治疗选择,代表了潜在的有效治疗选择.

关键词:

非小细胞肺癌是非小细胞肺癌.铁氨酸激酶抑制剂铁氨酸激酶抑制剂不常见的EGFR突变

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