アブストラクト | Trastuzumab (T) and tyrosine kinase inhibitors (TKIs) are among the first-line treatments recommended for HER2-positive breast cancer. More recently, antibody-drug conjugates (ADCs) such as trastuzumab deruxtecan (T-DXd) and trastuzumab emtansine (T-DM1) have been authorized, and they represent the second-line therapy in this type of cancer. The present study aimed to evaluate adverse drug reactions (ADRs) associated with T-based ADCs that were spontaneously reported in EudraVigilance-the European pharmacovigilance database. Out of 42,272 ADRs reported for currently approved ADCs on the market, 24% of ADRs were related to T-DM1, while 12% of ADRs were related to T-DXd. T-DM1 had a higher probability of reporting eye, ear and labyrinth, and cardiac and hepatobiliary ADRs, while T-DXd had a higher probability of reporting respiratory, thoracic and mediastinal, blood and lymphatic system, metabolism and nutrition, and gastrointestinal ADRs. The present research found that in terms of hematological disorders, T-DM1 and T-DXd had a higher probability of reporting ADRs than TKIs. Moreover, the data showed that T-DM1 seemed to have a higher risk of cardiotoxicity than T-DXd, while T-DXd had a higher probability of reporting metabolism and nutrition disorders than T-DM1. |
ジャーナル名 | Biomedicines |
投稿日 | 2024/5/25 |
投稿者 | Morgovan, Claudiu; Dobrea, Carmen Maximiliana; Butuca, Anca; Arseniu, Anca Maria; Frum, Adina; Rus, Luca Liviu; Chis, Adriana Aurelia; Juncan, Anca Maria; Gligor, Felicia Gabriela; Georgescu, Cecilia; Ghibu, Steliana; Vonica-Tincu, Andreea Loredana |
組織名 | Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu,;550169 Sibiu, Romania.;Faculty of Agriculture Science, Food Industry and Environmental Protection,;"Lucian Blaga" University of Sibiu, 550012 Sibiu, Romania.;Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy,;"Iuliu Hatieganu" University of Medicine and Pharmacy, 400012 Cluj-Napoca,;Romania. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38790915/ |