对阿法替尼 (afatinib) 用于治疗非小细胞肺癌的II期研究,该研究涉及非常见的表皮生长因子受体突变,包括通过下一代测序检测到的复合突变
Nobuaki Mamesaya1, Keita Mori2, Haruki Kobayashi1
1Division of Thoracic Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.
阿法替尼在患有不常见EGFR突变的非小细胞肺癌 (NSCLC) 患者中显示出有希望的疗效. 这项研究强调了它对于这个特定的患者群体的可管理的安全性.
科学领域:
- 在瘤学瘤学.
- 医学遗传学 医学遗传学
- 临床药理学 临床药理学
背景情况:
- 有限的前性数据存在于阿法替尼在非小细胞肺癌 (NSCLC) 具有不常见的表皮生长因子受体 (EGFR) 突变的疗效.
- 下一代测序 (NGS) 能够检测出各种EGFR突变,需要对向疗法的临床评估.
研究的目的:
- 评估阿法替尼在患有不常见EGFR突变的NSCLC患者的疗效和安全性.
- 为经常被排除在临床试验之外的患者子组提供前性临床数据.
主要方法:
- 一个前性的,单中心,单臂II期临床研究.
- 纳入标准:转移性或复发性NSCLC与不常见的EGFR突变 (不包括外显子20插入和T790M) 被NGS检测到.
- 治疗方法:口服阿法提尼布40毫克每天服用一次;主要终点:客观反应率 (ORR).
主要成果:
- 招募了17名患者,平均年龄为71岁.
- 常见的突变包括G719X,S768I和L861Q,以及其他罕见的EGFR突变.
- 观察到的ORR为82.4%,中位数无进展生存 (PFS) 为11.3个月,中位数整体生存 (OS) 为27.8个月.
结论:
- 阿法替尼在患有不常见EGFR突变的NSCLC患者中表现出显著的抗瘤活性.
- 治疗表现出可管理的安全性,常见的不良事件包括腹和.
- 亚法替尼布对于携带这些特定遗传变异的NSCLC患者来说是一个可行的治疗选择.
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