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特拉斯图祖马布埃姆坦辛和特拉斯图祖马布德鲁克斯之间的不良事件概况差异:一个现实世界的药监测研究

Fen Liu¹, Guisen Yin², Shuyi Xue³

¹Department of Pharmacy, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410011, Hunan, China.

Journal of Cancer

|November 6, 2023

概括

这项研究比较了在转移性乳腺癌中使用trastuzumab emtansine (T-DM1) 和trastuzumab deruxtecan (T-DXd) 的安全性. T-DXd显示出更高的致命血液和呼吸事件,而T-DM1则有更多致命的肝胆事件.

科学领域:

在瘤学瘤学.
药物监督药物监督药物监督
临床药理学临床药理学

背景情况:

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干 (T-DXd) 是用于转移性乳腺癌的HER2向抗体-药物联合体 (ADC).
在现实世界中,T-DM1和T-DXd的安全性概况需要直接比较,以告知临床实践.
美国食品和药物管理局的不良事件报告系统 (FAERS) 为药监提供了宝贵的数据来源.

研究的目的:

使用FAERS数据比较T-DM1和T-DXd的不良事件 (AE) 概况.
确定与每个ADC相关的特定安全信号和风险因素,特别是关于致命结果的风险因素.

主要方法:

对T-DM1和T-DXd的FAERS数据 (2004年1月至2023年6月) 的回顾性分析.
使用报告概率比率 (ROR) 和比例报告比率 (PRR) 来检测安全信号的不成比例分析.
单变量和多变量逻辑回归用于评估致命不良事件的风险因素.

主要成果:

对T-DM1 (例如,血小板数减少,肝肺综合征) 和T-DXd (例如,间歇性肺病,肺炎) 均发现了重要的安全信号.
T-DXd显示出更高比例的致命的血液和呼吸系统AE,而T-DM1具有更致命的肝胆AE.
高龄 (≥65岁),男性性别和组合疗法 (特别是T-DXd的CYP3A4抑制剂) 是致命的AE的风险因素.

结论:

T-DXd与显著的致命血液和呼吸系统毒性相关,而T-DM1具有更高的致命肝胆毒性风险.
根据已识别的风险因素,加强对特定毒性的监测对于每个ADC至关重要.
了解这些差异性安全概况对于优化转移性乳腺癌治疗中的患者管理至关重要.

关键词:

公平的人是公平的.不良事件是不良事件.药物监督和药物监督现实世界的真实世界.特拉斯图祖马布可以脱.特拉斯图祖马布 (Trastuzumab) 是一种素.

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