Cardiovascular adverse events in patients with HER2-positive breast cancer treated with trastuzumab-drug conjugates : a Bayesian disproportional real world study for signal detection leveraging the FDA Adverse Event Reporting System (FAERS).

HOME
>
論文・技術情報
>
Cardiovascular adverse events in patients with HER2-positive breast cancer treated with trastuzumab-drug conjugates : a Bayesian disproportional real world study for signal detection leveraging the FDA Adverse Event Reporting System (FAERS).

Cardiovascular adverse events in patients with HER2-positive breast cancer treated with trastuzumab-drug conjugates : a Bayesian disproportional real world study for signal detection leveraging the FDA Adverse Event Reporting System (FAERS).

アブストラクト	BACKGROUND: The cardiovascular risk profiles of trastuzumab drug conjugates (T-DCs) in the treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-positive breast cancer are uncertain. This study analyzed real-world adverse events data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to investigate the association between T-DCs and major adverse cardiovascular events (MACE). METHODS: We searched the FAERS database for reports of cardiovascular adverse events in patients with HER2-positive breast cancer receiving trastuzumab, ado-trastuzumab emtansine (T-DM1), and trastuzumab deruxtecan (T-Dxd). The primary endpoint was MACE and the secondary endpoint was other cardiovascular events. RESULTS: Between January 2015 and April 2024, out of the 135,226 drug-adverse event pairs analyzed, 8,497 were cardiovascular events, with 4,457 classified as MACE and 4,040 as other cardiovascular events. Trastuzumab reached pharmacovigilance for MACE (ROR = 1.39, 95%CI: 1.30-1.49, IC(025) = 0.25), while neither T-DM1 (ROR = 0.78, 95%CI: 0.69-0.88, IC(025)=-0.51) nor T-Dxd (ROR = 0.63, 95%CI: 0.52-0.76, IC(025)=-0.93) reached MACE-related pharmacovigilance. Among MACE, stroke linked to T-DM1 (ROR = 1.86, 95%CI: 1.42-2.43, IC(025) = 0.35) and T-Dxd (ROR = 2.44, 95%CI: 1.68-3.56, IC(025) = 0.57) both reached pharmacovigilance in younger patients (<65 years). Proportionate analysis showed age and weight were the two key factors contributing to the occurrence of T-DCs induced MACE. CONCLUSION: HER2-positive breast cancer patients receiving T-DCs require additional cardiac monitoring, particularly for stroke in younger patients.
ジャーナル名	Expert opinion on drug safety
Pubmed追加日	2024/12/16
投稿者	Hu, Jinfang; Chen, Siyu; Jia, Huanhuan; Cai, Nvlue; Hu, Runlong; Chen, Xi; Guan, Yezhi
組織名	Guangdong Provincial Biotechnology Research Institute (Guangdong Provincial;Laboratory Animals Monitoring Center), Guangzhou, Guangdong, China.;School of Information Science and Engineering, Shenyang Ligong University,;Shenyang, China.;School of Health, Brooks College (Sunnyvale), California, the United States.;Department of Epidemiology and Statistics, School of Public Health, Medical;College, Zhejiang University, Hangzhou, China.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/39675974/