Van Pham Thai, Vu Thanh Ha, Nguyen Hoa Thai Thi, Pham Phuong Cam, Do Anh Tu, Nguyen Tuan Khoi, Hoang Thi Anh Thu, Le Tuan Anh, Vuong Dinh Thy Hao, Nguyen Dac Nhan Tam, Dang Van Khiem, Nguyen Thi Oanh, Pham Van Luan, Nguyen Minh Hai, Vo Thi Huyen Trang, Mai Khoa Trong, Do Hung Kien, Nguyen Thi Thuy Hang, Trinh Le Huy, Nguyen Hoang Gia, Truong Cong Minh, Pham Tran Minh Chau
Department of Oncology, Hanoi Medical University, Hanoi, Vietnam.
The Nuclear Medicine and Oncology center, Bach Mai Hospital, Hanoi, Vietnam.
Asia Pac J Clin Oncol. 2025 Jun;21(3):281-289. doi: 10.1111/ajco.14147. Epub 2024 Dec 18.
The role of afatinib in the first-line treatment of EGFR-mutant advanced non-small cell lung cancer (NSCLC) patients has been proven through clinical trials and real-world studies. However, additional data on the effectiveness of afatinib in patients with brain metastases are lacking.
EGFR-mutant NSCLC patients with brain metastases were retrospectively reviewed across nine cancer centers in Vietnam from April 1, 2018 to June 1, 2022. The primary endpoints included central nervous system progression-free survival (CNS-PFS) and overall survival (OS). The secondary endpoints were the objective response rate (ORR) and CNS-ORR.
Among 87 enrolled patients, 21.8%, 17.2%, and 60.9% received whole-brain radiation, gamma knife, and no locoregional therapy, respectively. With a median follow-up of 32.2 months for CNS-PFS and 35.3 months for OS, the median CNS-PFS and OS were 17.9 and 29.9 months, respectively. In multivariate analysis, patients receiving whole-brain radiation had significantly shorter CNS-PFS than those untreated with local therapy (16.1 vs. 22.6 months, p = 0.019), but not translating to an inferior OS. Furthermore, both the CNS-PFS and OS of patients with uncommon mutations were significantly worse than those of patients with Del19 (11.3 vs. 24.2 months, p = 0.013 and 17.7 vs. 34.0 months, p = 0.003, respectively). Univariate and multivariate analyses showed that a lower afatinib starting dose did not significantly affect CNS-PFS or OS. The CNS-ORR and ORR were 77.4% and 71.3%, respectively.
In our real-world study, afatinib showed encouraging effectiveness in Vietnamese patients with EGFR-mutant NSCLC and brain metastases at baseline.
阿法替尼在表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌（NSCLC）患者一线治疗中的作用已通过临床试验和真实世界研究得到证实。然而，关于阿法替尼在脑转移患者中的有效性，还缺乏更多数据。
回顾性分析了2018年4月1日至2022年6月1日期间越南9个癌症中心的EGFR突变NSCLC脑转移患者。主要终点包括中枢神经系统无进展生存期（CNS-PFS）和总生存期（OS）。次要终点为客观缓解率（ORR）和中枢神经系统客观缓解率（CNS-ORR）。
在87例入组患者中，分别有21.8%、17.2%和60.9%接受了全脑放疗、伽马刀治疗以及未接受局部区域治疗。CNS-PFS的中位随访时间为32.2个月，OS的中位随访时间为35.3个月，CNS-PFS和OS的中位数分别为17.9个月和29.9个月。多因素分析显示，接受全脑放疗的患者CNS-PFS显著短于未接受局部治疗的患者（16.1个月对22.6个月，p = 0.019），但这并未转化为较差的总生存期。此外，罕见突变患者的CNS-PFS和OS均显著差于Del19突变患者（分别为11.3个月对24.2个月，p = 0.013；17.7个月对34.0个月，p = 0.003）。单因素和多因素分析均显示，较低的阿法替尼起始剂量对CNS-PFS或OS无显著影响。CNS-ORR和ORR分别为77.4%和71.3%。
在我们的真实世界研究中，阿法替尼在基线时对越南EGFR突变NSCLC脑转移患者显示出令人鼓舞的有效性。
