奥希替尼改善了不论 T790M 突变状态如何的伴有脑膜转移的 EGFR 突变型 NSCLC 患者的总生存期。
Osimertinib Improves Overall Survival in Patients With EGFR-Mutated NSCLC With Leptomeningeal Metastases Regardless of T790M Mutational Status.
机构信息
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
出版信息
J Thorac Oncol. 2020 Nov;15(11):1758-1766. doi: 10.1016/j.jtho.2020.06.018. Epub 2020 Jul 9.
INTRODUCTION
Osimertinib, a third-generation EGFR tyrosine kinase inhibitor, efficiently penetrates the blood-brain barrier. This study explored whether treatment with osimertinib leads to improved overall survival (OS) for patients with EGFR-mutated NSCLC with leptomeningeal metastases (LM) compared with those not treated with osimertinib.
METHODS
From October 2008 to October 2019, patients with EGFR-mutated NSCLC and cytologically confirmed LM were retrospectively analyzed for OS according to osimertinib treatment and T790M mutational status. The OS was defined as the time from the diagnosis of LM to death.
RESULTS
For the 351 patients with LM included in the analysis, the median OS (mOS) was 8.1 months (95% confidence interval [CI]: 7.2-9.0). T790M mutation was detected in 88 of 197 patients tested, and a total of 110 patients were treated with osimertinib after LM. No difference in mOS according to T790M mutational status (10.1 mo [95% CI: 4.31-15.82] versus 9.0 [95% CI: 6.81-11.21], p = 0.936) was found. Nevertheless, patients treated with osimertinib had a superior OS of 17.0 months (95% CI: 15.13-18.94) compared with those not treated with osimertinib who had a mOS of 5.5 months (95% CI: 4.34-6.63), regardless of T790M mutational status (hazard ratio: 0.36 [95% CI: 0.28-0.47], p < 0.001). This was also considerably longer even than the mOS of 8.7 months (95% CI: 7.01-10.39) of those who were never treated with osimertinib but had first- or second-generation EGFR tyrosine kinase inhibitors.
CONCLUSIONS
Osimertinib is a promising treatment option for EGFR-mutated NSCLC with LM regardless of T790M mutational status.
简介
奥希替尼是一种第三代 EGFR 酪氨酸激酶抑制剂，能有效穿透血脑屏障。本研究旨在探讨与未接受奥希替尼治疗的患者相比，奥希替尼治疗是否能改善有脑转移的 EGFR 突变型非小细胞肺癌（NSCLC）患者的总生存期（OS）。
方法
本回顾性研究纳入了 2008 年 10 月至 2019 年 10 月期间经细胞学证实存在脑膜转移（LM）且 EGFR 突变的 NSCLC 患者，根据奥希替尼治疗和 T790M 突变状态分析 OS。OS 定义为从 LM 诊断到死亡的时间。
结果
在纳入分析的 351 例 LM 患者中，中位 OS（mOS）为 8.1 个月（95%置信区间 [CI]：7.2-9.0）。在 197 例接受检测的患者中，有 88 例检测到 T790M 突变，共有 110 例患者在 LM 后接受奥希替尼治疗。T790M 突变状态对 mOS 无影响（10.1 个月[95% CI：4.31-15.82]与 9.0 个月[95% CI：6.81-11.21]，p=0.936）。然而，与未接受奥希替尼治疗且 mOS 为 5.5 个月（95% CI：4.34-6.63）的患者相比，接受奥希替尼治疗的患者 OS 明显更长，mOS 为 17.0 个月（95% CI：15.13-18.94），无论 T790M 突变状态如何（风险比：0.36 [95% CI：0.28-0.47]，p<0.001）。这甚至比从未接受奥希替尼治疗但接受过第一代或第二代 EGFR 酪氨酸激酶抑制剂治疗的患者的 mOS（95% CI：7.01-10.39）还要长。
结论
奥希替尼是一种有前途的治疗方法，无论 T790M 突变状态如何，对有脑转移的 EGFR 突变型 NSCLC 均有效。
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