Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Cancer Med. 2024 Feb;13(4):e6762. doi: 10.1002/cam4.6762.
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.
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.
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.
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.
西达本胺是一种选择性组蛋白去乙酰化酶抑制剂，已被批准用于治疗激素受体（HoR）阳性和 HER2 阴性转移性乳腺癌（MBC）患者。我们旨在研究西达本胺的疗效、安全性和治疗模式，并确定预测西达本胺在真实世界环境中疗效的临床病理因素。
本多中心回顾性研究纳入了 2020 年 1 月至 2021 年 8 月期间 11 家机构接受西达本胺治疗的连续 MBC 患者。纳入标准为绝经前或绝经后女性，经临床或组织学证实为 ER 阳性、HER2 阴性 MBC，东部肿瘤协作组（ECOG）体能状态为 0 或 1。排除有多种原发性恶性肿瘤或基线特征缺失的患者。患者接受 30mg 西达本胺口服，每周 2 次，联合使用芳香化酶抑制剂（AIs）或非 AIs。疗效分析包括无进展生存期（PFS）、客观缓解率（ORR）和临床获益率（CBR）。采用单变量和多变量 Cox 回归分析来确定潜在的疗效预测因素。
共纳入 157 例患者进行分析。西达本胺治疗前的中位治疗线数为 4 线。在整个队列中，中位 PFS 为 4.2 个月（95%置信区间 [CI] 3.8-4.5）。ORR 为 7.5%，CBR 为 31.3%。西达本胺在接受 CDK4/6 抑制剂治疗和接受不同内分泌联合治疗的患者中的疗效一致。多变量分析表明，有肝转移（调整 HR=1.66，95%CI 1.14-2.43，调整 p=0.008）或既往治疗线数≥3（调整 HR=1.80，95%CI 1.17-2.77，调整 p=0.008）的患者 PFS 明显更差。西达本胺最常见的不良反应是血小板减少、白细胞减少、中性粒细胞减少和贫血。
本研究为 HoR 阳性和 HER2 阴性 MBC 患者使用西达本胺提供了真实世界数据。我们的数据支持在接受 CDK4/6 抑制剂治疗和接受不同内分泌联合治疗的患者中使用西达本胺。
