High-Dose Aumolertinib for Untreated EGFR -Variant Non–Small Cell Lung Cancer With Brain Metastases

作者：Hui Li, Kaiyan Chen, Lei Gong, Jing Qin, Ying Jin, Rongrong Zhou, Zhiyu Huang, Yanjun Xu, Xiaoling Xu, Jingdong He, Junfei Zhu, Sizhe Yu, Hongyang Lu, Yujin Xu, Xiaoling Yu, Guang Han, Jun Chen, Wei Tan, Guangyuan Lou, Biyong Ren, Xiangqi Chen, Dianbao Zhang, Wenxian Wang, Xun Shi, Fajun Xie, Jun Zhao, Na Han, Bing Li, Yun Fan · 发表于：JAMA Oncology · 年份：2025 · DOI：10.1001/jamaoncol.2025.1779 · 被引用次数：9 · 研究领域：Lung Cancer Treatments and Mutations、Brain Metastases and Treatment、Lung Cancer Research Studies

Importance: Central nervous system (CNS) metastases remain a significant challenge in the management of EGFR-variant non-small cell lung cancer (NSCLC). Objective: To evaluate the activity and safety of high-dose aumolertinib in patients with untreated EGFR-variant NSCLC and brain metastases. Design, Setting, and Participants: This was a phase 2 nonrandomized clinical trial conducted at 10 centers in China. Patients with untreated EGFR-variant metastatic NSCLC and brain metastases were enrolled between July 6, 2021, and August 31, 2022. The data cutoff date was October 10, 2024. Interventions: Patients received aumolertinib, 165 mg, orally once daily until disease progression or unacceptable toxic effects. Main Outcomes and Measures: The primary end point was 12-month progression-free survival (PFS) rate assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1. Results: A total of 63 patients (39 female [61.9%]; median age, 60 [range, 47-76] years) were enrolled (full analysis set), and 49 had at least 1 measurable brain lesion (CNS evaluable-for-response set). Median follow-up duration was 28.8 months (95% CI, 27.0-29.8). In the full analysis set, the 12-month PFS rate was 62.1% (95% CI, 48.7-73.0), the median PFS was 20.5 months (95% CI, 12.0-26.9), the 12-month intracranial PFS rate was 76.8% (95% CI, 63.2-85.9), and the median intracranial PFS and overall survival were not reached. Systemic and intracranial objective re...