西达本胺不良反应管理中国专家共识(2021年版)

Chinese expert consensus on management of adverse events of chidamide(2021 version)

西达本胺是全球首个口服的亚型选择性组蛋白去乙酰化酶(HDAC)抑制剂,属于全新抗肿瘤作用机制的表观遗传调控剂类药物,被批准用于复发难治外周T细胞淋巴瘤(PTCL),以及联合芳香化酶抑制剂用于激素受体阳性、人表皮生长因子受体2阴性、绝经后、经内分泌治疗复发或进展的局部晚期或转移性乳腺癌,其疗效确切,安全可控。西达本胺的不良反应包括血液学异常、代谢及营养物质异常、胃肠道反应及乏力等。本专家共识总结了西达本胺常见不良反应的发生率和特征,评估了不良反应的症状和分级,参考相关研究进展并结合临床经验制定了相应的预防和治疗措施,旨在为临床医师提供切实可行的管理策略,提高患者应用西达本胺的治疗效果和依从性。

Chidamide is the world's first oral subtype-selective histone deacetylase(HDAC)inhibitor,and it is an epigenetic modulator with new anti-tumor mechanisms.It has received approvals in relapsed/refractory peripheral T cell lymphoma(PTCL),and combined with aromatase inhibitors for hormone receptor-positive,human epidermal growth factor receptor 2-negative,postmenopausal,locally advanced or metastatic breast cancer that has recurred or progressed after endocrine therapies.Its curative effect is accurate,safe and controllable.The general adverse events of chidamide include hematological abnormalities,metabolic and nutritional abnormalities,gastrointestinal reactions,fatigue,etc.This expert consensus summarized the incidence and characteristics of adverse events of chidamide,evaluated the manifestations and severity of adverse events,and formulated the corresponding preventive and therapeutic measures based on relevant research progress and combined with clinical experience,so as to provide clinicians with practical and feasible management strategies to improve the therapeutic efficacy and compliance of patients treated with chidamide.