Post-marketing safety surveillance of ado-trastuzumab emtansine: a real-world data retrospective cohort study using disproportionality analysis

doi:10.1080/14740338.2024.2438748

科研成果详情

题名	Post-marketing safety surveillance of ado-trastuzumab emtansine: a real-world data retrospective cohort study using disproportionality analysis
作者	Chen, Endong1; Gan, Yaowei 2; Chen, Yingying 3; Chen, Chen 2; Weng, Yujing 2; Zhang, Bowen2; Cai, Yefeng 4; Wang, Qingxuan4; Li, Quan1
发表日期	2024-12-11
发表期刊	EXPERT OPINION ON DRUG SAFETY 影响因子和分区
语种	英语
原始文献类型	Article ; Early Access
关键词	FAERS, US food and drug administration adverse events reporting system HER2-positive breast cancer ado-trastuzumab emtansine disproportionality analysis adverse events thrombocytopenia hemorrhage
摘要	BackgroundAdo-trastuzumab emtansine (T-DM1) is prescribed for HER2-positive, metastatic breast cancer or early breast cancer after neoadjuvant therapy. Although several adverse events (AEs) have been reported, there remains a need for a comprehensive evaluation of its safety profile.Research design and methodsTo quantify the signals of ado-trastuzumab emtansine associated AEs, we employed the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms.ResultsBetween Q1 2013 and Q4 2022, 3699 patient reports of AEs associated with ado-trastuzumab emtansine were received, including 440 cases of ado-trastuzumab emtansine-induced bleeding events. Of the 3699 patient reports, 142 significant disproportionality preferred terms (PTs) were identified. New AEs have been identified with ado-trastuzumab emtansine administration, including telangiectasia, spider nevus, pericardial effusion, pleural effusion, radiation necrosis, and corneal disorders. The most common bleeding events were observed in the digestive system (27.05%), respiratory system (35.00%), and nervous system (14.55%). Hemorrhagic adverse events exhibited early failure-type characteristics.ConclusionThis analysis offers the most comprehensive overview of ado-trastuzumab emtansine induced hemorrhage to date, shedding new light on this severe complication. Understanding the underlying mechanisms of these positive PTs can provide useful insights for further research.
资助项目	First Affiliated Hospital of Wenzhou Medical University [spy202114]; Science and Technology Plan Project of Wenzhou [Y20240042/Y2023156/Y2023153]; Zhejiang Province Traditional Chinese Medicine Science and Technology Plan Project [2024ZL610]; International Clinical Exchange Program of Health Commission of Zhejiang Province
出版者	TAYLOR & FRANCIS LTD
ISSN	1474-0338
EISSN	1744-764X
DOI	10.1080/14740338.2024.2438748
页数	12
WOS类目	Pharmacology & Pharmacy
WOS研究方向	Pharmacology & Pharmacy
WOS记录号	WOS:001372952900001
收录类别	SCIE ; PUBMED
URL	查看原文
PubMed ID	39639601
通讯作者地址	[Li, Quan]Wenzhou Med Univ, Affiliated Hosp 1, Dept Breast Surg, Nanbaixiang St, Wenzhou 325000, Zhejiang, Peoples R China.
引用统计
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/223534
专题	附属第一医院第一临床医学院（信息与工程学院）、附属第一医院附属第一医院_肛肠外科第一临床医学院（信息与工程学院）、附属第一医院_外科学_甲状腺外科
通讯作者	Li, Quan
作者单位	1.Wenzhou Med Univ, Affiliated Hosp 1, Dept Breast Surg, Nanbaixiang St, Wenzhou 325000, Zhejiang, Peoples R China; 2.Wenzhou Med Univ, Sch Med 1, Sch Informat & Engn, Wenzhou, Zhejiang, Peoples R China; 3.Wenzhou Med Univ, Affiliated Hosp 1, Dept Colorectal & Anal Surg, Wenzhou, Zhejiang, Peoples R China; 4.Wenzhou Med Univ, Affiliated Hosp 1, Dept Thyroid Surg, Wenzhou, Zhejiang, Peoples R China
第一作者单位	附属第一医院
通讯作者单位	附属第一医院
第一作者的第一单位	附属第一医院
推荐引用方式 GB/T 7714	Chen, Endong,Gan, Yaowei,Chen, Yingying,et al. Post-marketing safety surveillance of ado-trastuzumab emtansine: a real-world data retrospective cohort study using disproportionality analysis[J]. EXPERT OPINION ON DRUG SAFETY,2024.
APA	Chen, Endong., Gan, Yaowei., Chen, Yingying., Chen, Chen., Weng, Yujing., ... & Li, Quan. (2024). Post-marketing safety surveillance of ado-trastuzumab emtansine: a real-world data retrospective cohort study using disproportionality analysis. EXPERT OPINION ON DRUG SAFETY.
MLA	Chen, Endong,et al."Post-marketing safety surveillance of ado-trastuzumab emtansine: a real-world data retrospective cohort study using disproportionality analysis".EXPERT OPINION ON DRUG SAFETY (2024).