205 - Anlotinib Combined with Whole-Brain Radiotherapy for Brain Metastases in Patients Diagnosed with Small Cell Lung Cancer: A Single-Arm, Phase 2 Trial

10:55am - 11:05am PT

Room 20/21

Presenter(s)

Chang Liu, PhD - Peking University International Hospital, Beijing,

L. Deng; National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, China

Purpose/Objective(s):

Whole-brain radiotherapy (WBRT) is the mainstay treatment for patients diagnosed with small cell lung cancer (SCLC) accompanied by brain metastases (BMs); however, its efficacy remains unsatisfactory. As such, this prospective phase 2 trial aimed to evaluate the efficacy and safety of WBRT combined with anlotinib, a novel, anti-angiogenic, multitarget, tyrosine kinase inhibitor (TKI) in patients diagnosed with SCLC and BMs.

Materials/Methods:

Patients with SCLC and BMs, who underwent = 1 line(s) of treatment were eligible for enrollment. All patients were treated with anlotinib combined with WBRT, followed by maintenance therapy with anlotinib until disease progression or treatment intolerance. The primary endpoint was intracranial progression-free survival (iPFS), while secondary endpoints included overall survival (OS), intracranial objective response rate (iORR), intracranial disease control rate (iDCR), and treatment safety.

Results:

Forty-three patients were enrolled between January 2021 and December 2023. The median follow-up was 28.9 months; the median iPFS was 9.9 months (95% confidence interval [CI] 6.9–13.8 months); the median OS was 14.6 months (95% CI 7.8–19.3 months); and the iORR and iDCR were 72.5% and 95%, respectively. The most commonly observed adverse events included hypertension (52.5%) and fatigue (57.5%). None of the patients developed adverse events graded = 4; moreover, no intracranial hemorrhage occurred during treatment.

Conclusion:

The combination of anlotinib and WBRT yielded a positive effect in terms of iPFS and OS while exhibiting a manageable level of toxicity in patients diagnosed with SCLC complicated by BMs.