KEY TAKEAWAYS
- The study aimed to assess chidamide’s effectiveness, safety, and treatment patterns while identifying clinicopathological factors predicting its efficacy in real-world settings.
- Real-world data supported chidamide use in HoR-positive, HER2-negative MBC patients.
Chidamide, a selective histone deacetylase inhibitor, is approved for metastatic breast cancer (MBC) patients with hormone receptor (HoR)-positive and HER2-negative status.
Doudou Li and the team spearheaded a study that aimed to assess chidamide’s efficacy, safety, and treatment patterns while identifying clinicopathological factors predicting its effectiveness in real-world scenarios.
In a multicenter retrospective design, the study enrolled consecutive MBC patients treated with chidamide from January 2020 to August 2021 across 11 institutions. Premenopausal and postmenopausal women with ER-positive, HER2-negative MBC that had been clinically or histologically proven were eligible, as long as they had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Multiple primary malignancies or missing baseline characteristics were exclusion criteria. Patients received oral chidamide at 30 mg twice weekly, combined with either aromatase inhibitors (AIs) or non-AIs. Efficacy analyses encompassed progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR). Univariate and multivariate Cox regression analyses were conducted to identify potential predictors of efficacy.
About 157 patients were included for analysis, with a median of four prior treatment lines before chidamide. The median PFS for the total population was 4.2 months (95% CI 3.8-4.5). The CBR was 31.3 percent, and the ORR was 7.5%. The effectiveness of chidamide was not affected by individuals receiving different endocrine combinations or those who had previously had treatment with CDK4/6 inhibitors.
According to the multivariate analysis, patients with liver metastases (adjusted HR = 1.66, 95% CI 1.14-2.43, adjusted P = 0.008) or ≥3 prior treatment lines (adjusted HR = 1.80, 95% CI 1.17-2.77, adjusted P = 0.008) showed significantly worse PFS. The most frequent adverse events (AEs) linked to chidamide were anemia, leukopenia, neutropenia, and thrombocytopenia.
Based on real-world evidence, the study indicated that chidamide effectively cures HoR-positive and HER2-negative MBC, especially in patients who have already had treatment with CDK4/6 inhibitors and those undergoing different endocrine combinations.
Research funding was provided by the Beijing Science and Technology Innovation Medical Development Foundation, Chinese Young Breast Experts Research project, and CSCO-ROCHE Cancer Research Fund 2019.
Source: https://pubmed.ncbi.nlm.nih.gov/38457252/
Li D, Jin Y, Lin M, et al.(2024) ‘’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.’’ Cancer Med. 2024 Feb;13(4):e6762. doi: 10.1002/cam4.6762. PMID: 38457252; PMCID: PMC10923034.
