基于特拉斯图祖马布的ADC的安全概况:分析EudraVigilance中注册的真实世界数据
Claudiu Morgovan1, Carmen Maximiliana Dobrea1, Anca Butuca1
1Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.
Biomedicines
|May 25, 2024
概括
特拉斯图祖马布德鲁克斯泰坎 (T-DXd) 和特拉斯图祖马布埃姆坦辛 (T-DM1) 是针对HER2阳性乳腺癌的抗体-药物结合体. T-DM1显示心脏风险更高,而T-DXd则有更多的胃肠道和代谢不良事件.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
背景情况:
- HER2阳性乳腺癌的治疗包括trastuzumab (T) 和氨酸激酶抑制剂 (TKI) 作为一线疗法.
- 抗体-药物联结物 (ADC) 如特拉斯图祖马布埃姆坦辛 (T-DM1) 和特拉斯图祖马布德鲁克斯坦 (T-DXd) 已被批准作为二线治疗.
- 评估T基ADCs的药物不良反应 (ADRs) 对患者安全至关重要.
研究的目的:
- 使用自发报告评估和比较T-DM1和T-DXd的ADR概况.
- 确定与每个T基ADC相关的特定器官系统和ADR类型.
- 为了比较T-DM1和T-DXd之间的血液学疾病和心脏毒性风险.
主要方法:
- 对EudraVigilance数据库中自发报告的已批准的基于T的ADCs的ADR进行分析.
- 根据受影响的器官系统和药物对ADR进行分类和比较.
- 对特定的副作用和药物类别的报告概率的统计评估.
主要成果:
- 在报告的42272个ADCs的ADR中,24%与T-DM1和12%与T-DXd有关.
- 在T-DM1中,眼睛,耳朵,心脏和肝胆道ADR的报告率更高.
- 在T-DXd中,呼吸道,血液,代谢和胃肠道ADR报告率较高.
- 两种T-DM1和T-DXd都比TKI更高的血液学疾病报告概率.
- T-DM1表明心脏毒性风险更高,而T-DXd显示代谢和营养障碍的可能性更高.
结论:
- T-DM1和T-DXd具有不同的ADR概况,T-DM1与更高的心脏风险相关,T-DXd与更多的胃肠道和代谢不良事件相关.
- 与TKIs相比,这两种ADC都具有显著的血液学疾病风险.
- 了解这些差异性ADR概况对于优化治疗选择和患者监测HER2阳性乳腺癌至关重要.
关键词:
欧德拉 警 监控 监控 监控HER2阳性乳腺癌是什么意思针对HER2的向疗法.不良反应是不良反应.抗体 - 药物联合体描述性分析 描述性分析不成比例性分析分析药物监督和药物监督特拉斯图祖马布可以脱.特拉斯图祖马布 (Trastuzumab) 是一种素.更多相关视频
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