Nguyen Thi Nhu Hoa, Van Quang Le, Thi Bich Phuong Nguyen, Thi Hau Tran, Nguyen Van Tai, Minh The Dao, Duc Lien Nguyen, Thanh Duong Phan, Le Lam Ngo, Van Chu Nguyen, Cong Hoang Nguyen, Dinh Duc Nguyen, Do Hung Kien
Department of Oncology, Hanoi Medical University, Hanoi, Vietnam.
Department of Medical Oncology I, National Cancer Hospital of Vietnam - K Hospital, Hanoi, Vietnam.
Cancer Control. 2025 Jan-Dec;32:10732748251348429. doi: 10.1177/10732748251348429. Epub 2025 Jun 12.
IntroductionThis study aimed to evaluate the therapeutic effect of osimertinib and further to compare the results of osimertinib plus brain radiation vs. osimertinib monotherapy in advanced EGFR-mutant non-small cell lung cancer (NSCLC) patients with brain metastases (BMs).MethodsA retrospective study was conducted involving 62 advanced EGFR-mutant NSCLC patients with BMs who were treated with first-line osimertinib at the Vietnam National Cancer Hospital between April 2019 and December 2023. Patients were categorised in two treatment groups: (1) osimertinib alone (33 patients) and (2) osimertinib combined with locoregional therapy, including stereotactic radiosurgery or whole-brain radiotherapy (29 patients). Endpoints included objective response rate (ORR), central nervous system response rate (CNS-ORR), progression-free survival (PFS), overall survival (OS).ResultsThe systemic ORR was 91.9% and the disease-control rate (DCR) was 96.8%. The CNS-ORR was 91.9% and the CNS-DCR was 100%. The median PFS and median OS achieved were 24.5 and 35.2 months, respectively. There was no significant difference in outcomes between patients in either treatment group with respect to CNS-ORR ( = 1.0), mean best percentage change from baseline in CNS target lesion size ( = .376), median PFS ( = .656), intracranial progression-free survival (iPFS) ( = .706), or OS ( = .734). The occurrence of any-grade adverse events (AEs) did not differ significantly between the two treatment groups ( = .762). However, in the osimertinib plus brain radiation cohort, 3/29 (10.3%) patients experienced radiotherapy-related AEs (2 cases of brain necrosis, 1 case of leukoencephalopathy), which consisted of one case of grade 3 brain radiation necrosis.ConclusionOsimertinib shows favorable real-world outcomes in improving PFS, OS, and CNS-ORR in advanced EGFR-mutant NSCLC Vietnamese patients with BMs, with no clear additional benefit from combining with brain radiotherapy.
引言
本研究旨在评估奥希替尼的治疗效果，并进一步比较奥希替尼联合脑部放疗与奥希替尼单药治疗对晚期表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）脑转移（BMs）患者的疗效。
方法
开展一项回顾性研究，纳入2019年4月至2023年12月期间在越南国家癌症医院接受一线奥希替尼治疗的62例晚期EGFR突变的NSCLC脑转移患者。患者被分为两个治疗组：（1）单纯奥希替尼组（33例患者）和（2）奥希替尼联合局部区域治疗组，包括立体定向放射外科或全脑放疗组（29例患者）。观察终点包括客观缓解率（ORR）、中枢神经系统缓解率（CNS-ORR）、无进展生存期（PFS）、总生存期（OS）。
结果
全身ORR为91.9%，疾病控制率（DCR）为96.8%。CNS-ORR为91.9%，CNS-DCR为100%。达到的中位PFS和中位OS分别为24.5个月和35.2个月。在CNS-ORR（P = 1.0）、CNS靶病灶大小相对于基线的平均最佳变化百分比（P = 0.376）、中位PFS（P = 0.656）、颅内无进展生存期（iPFS）（P = 0.706）或OS（P = 0.734）方面，两个治疗组患者的结局无显著差异。两个治疗组之间任何级别的不良事件（AE）发生率无显著差异（P = 0.762）。然而，在奥希替尼联合脑部放疗队列中，29例患者中有3例（10.3%）出现了放疗相关AE（2例脑坏死，1例白质脑病），其中1例为3级脑放射性坏死。
结论
奥希替尼在改善晚期EGFR突变的NSCLC越南脑转移患者的PFS、OS和CNS-ORR方面显示出良好的真实世界疗效，联合脑部放疗未显示出明显的额外获益。
