Treatment patterns and clinical outcomes of chidamide combined with endocrine therapy in hormone receptor‐positive, HER2‐negative metastatic breast cancer: A real‐world multicenter study

• Published in: Cancer medicine (Malden, MA) MA), 2024-02, Vol.13 (4), p.e6762-n/a
• Main Authors: Li, Doudou, Jin, Yizi, Lin, Mingxi, Zeng, Cheng, Guo, Qing, Liu, Yanfei, Zhang, Jian
• Format: Article
• Language: English
• Subjects: Aromatase; Breast cancer; Cancer therapies; Cell cycle; Chemotherapy; chidamide; Cyclin-dependent kinase 4; Endocrine therapy; Epigenetics; ErbB-2 protein; Estrogens; Growth factors; Histone deacetylase; hormone receptor‐positive; Leukopenia; Malignancy; Menstruation; Metastases; Metastasis; metastatic breast cancer; Multivariate analysis; Neutropenia; Oncology; Patients; Post-menopause; real‐world data; Thrombocytopenia; Toxicity
• ISSN: 2045-7634; 2045-7634
• DOI: 10.1002/cam4.6762

Background Chidamide is a selective histone deacetylase inhibitor approved for patients with hormone receptor (HoR)‐positive and HER2‐negative metastatic breast cancer (MBC). We aimed to investigate the efficacy, safety, and treatment patterns of chidamide and identify clinicopathological factors that predict the efficacy of chidamide in real‐world scenarios. Methods Consecutive MBC patients treated with chidamide from January 2020 to August 2021 across 11 institutions were enrolled in this multicenter, retrospective study. Eligible patients were pre‐ and postmenopausal women who had clinically or histologically confirmed ER‐positive, HER2‐negative MBC, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients with multiple primary malignancies or missing baseline characteristics were excluded. Patients received 30 mg chidamide orally twice a week, combined with aromatase inhibitors (AIs) or non‐AIs. Efficacy analyses included progression‐free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR). Univariate and multivariate Cox regression analyses were performed to identify the potential efficacy predictors. Results A total of 157 patients were finally included for analysis. The median number of lines prior to chidamide was four. In the whole cohort, the median PFS was 4.2 months (95% confidence interval [CI] 3.8–4.5). The ORR was 7.5% and the CBR was 31.3%. The efficacy of chidamide was consistent in patients pretreated with CDK4/6 inhibitors and patients treated with different endocrine combinations. Multivariate analysis indicated that patients who had liver metastases (adjusted HR = 1.66, 95% CI 1.14–2.43, adjusted p = 0.008) or ≥3 prior lines of treatment (adjusted HR = 1.80, 95% CI 1.17–2.77, adjusted p = 0.008) had significantly worse PFS. The most common AEs with chidamide were thrombocytopenia, leucopenia, neutropenia, and anemia. Conclusion This study provided real‐world data for the use of chidamide in patients with HoR‐positive and HER2‐negative MBC. Our data endorsed the use of chidamide in patients pretreated with CDK4/6 inhibitors and patients treated with different endocrine combinations.