PDF(Pubmed)
Abstract：
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.
摘要：
曲妥珠单抗（T）和酪氨酸激酶抑制剂（TKIs）是推荐用于HER2阳性乳腺癌的一线治疗方法。最近,曲妥珠单抗(T-DXd)和曲妥珠单抗(T-DM1)等抗体-药物偶联物(ADC)已获得授权，它们代表了这种癌症的二线治疗。本研究旨在评估与欧洲药物警戒数据库EudraVigilance自发报告的基于T的ADC相关的药物不良反应（ADR）。在市场上目前批准的ADC报告的42,272个ADR中，24%的ADR与T-DM1有关，12%的ADR与T-DXd有关。T-DM1报告眼睛的概率更高，耳朵和迷宫，以及心脏和肝胆药物不良反应，而T-DXd报告呼吸的概率较高，胸部和纵隔，血液和淋巴系统，新陈代谢和营养，和胃肠道不良反应。目前的研究发现，在血液病方面，T-DM1和T-DXd报告ADRs的概率高于TKIs。此外，数据显示，T-DM1似乎比T-DXd具有更高的心脏毒性风险，而T-DXd报告代谢和营养紊乱的概率高于T-DM1.
