Efficacy and Safety of Anlotinib-Based Regimens in Metastatic Breast Cancer: A Multicenter Real-World Study

Abstract

Background: Anlotinib, a multi-target small-molecule receptor tyrosine kinase inhibitor, can inhibit tumor angiogenesis proliferation and remains underexplored in metastatic breast cancer (MBC). Therefore, we aimed to analyze the efficacy and safety of anlotinib for MBC treatment in a real-world study.

Methods: In this multicenter, retrospective study, patients with MBC who received anlotinib at four Chinese centers between January 2021 and December 2022 were enrolled (data cut-off date: February 1, 2025). The primary end point was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate, and adverse events (AEs). Statistical significance was defined at p < 0.05.

Results: In total, 153 patients were included in this study (median age, 51 years). Median follow-up time was 30.0 months. A total of 86 (56.2%) patients were hormone receptor-positive/human epidermal growth factor receptor 2-negative, whereas the others were human epidermal growth factor receptor 2-positive (9.8%) or triple-negative breast cancer (34.0%). The median PFS and OS were 6.0 months (95% confidence interval [CI] 4.5–7.5) and 28.5 months (95% CI 20.3–36.7). The number of metastatic sites and Eastern Cooperative Oncology Group performance status were significant in Cox multivariate analysis (p = 0.012 and p = 0.030, respectively) and were significantly associated with PFS of anlotinib. Most AEs were clinically manageable, whereas Grade III/IV AEs included neutropenia (29.4%) and fatigue (6.5%).

Conclusion: Anlotinib exhibits effective and safe anti-tumor activity in the treatment of MBC.

Keywords

anlotinib / Chinese women / metastatic breast cancer / predictive factors / real-world study

RIGHTS & PERMISSIONS

2025 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.