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可能与CDK4/6抑制剂相关的血液事件:来自欧洲自发不良事件报告系统的分析
Vera Martins1, Mafalda Jesus1,2, Luísa Pereira3
1Health Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilhã, Portugal.
Pharmaceuticals (Basel, Switzerland)
|October 28, 2023
概括
循环素依赖性激酶4和6 (CDK4/6) 抑制剂,包括abemaciclib,palbociclib和ribociclib,表现出不同的不良药物反应概况. 药物监测数据显示,这些晚期乳腺癌治疗的白血病和血小板缺血报告有差异.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 药品安全 药品安全
背景情况:
- 循环素依赖性激酶4和6 (CDK4/6) 抑制剂代表了激素受体阳性 (HR+),人体表皮生长因子受体2阴性 (HER2-) 晚期乳腺癌的向治疗.
- 阿贝马西利布,帕尔博西利布和里博西利布是已批准的CDK4/6抑制剂,它们显示出有效性,但在不良事件概况中观察到差异.
研究的目的:
- 分析和比较疑似不良药物反应 (ADRs),特别是与abemaciclib,palbociclib和ribociclib相关的白血病和血小板衰竭.
- 调查这些ADR的特征及其在EudraVigilance数据库中的报告.
主要方法:
- 利用EudraVigilance (EV) 数据库提取与CDK4/6抑制剂相关的个体病例安全报告 (ICSR).
- 分析了1611个ICSR,重点关注副作用,病例的严重性,患者的康复和同时使用的疗法 (例如,富尔韦斯特兰特,莱特).
主要成果:
- 帕尔博西基利布和里博西基利布报告主要是针对白血病和血小板减少的严重病例,尽管大多数病例得到解决.
- 与abemaciclib相关的ADR报告大多被描述为不严重.
- 同时使用模式有所不同:abemaciclib和palbociclib通常与富尔韦斯特兰; ribociclib通常与莱特.
结论:
- 药监测研究对于早期检测ADR和在现实环境中区分CDK4/6抑制剂的毒性概况至关重要.
- 了解这些细微的安全概况有助于优化晚期乳腺癌的治疗策略.
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