评估患者负担和益处:十年的卡博桑提尼布临床试验
Griffin K Hughes1, Nicholas B Sajjadi2, Brooke Gardner1
1Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.
International journal of cancer
|December 18, 2023
概括
卡博桑提尼布的试验显示患者的风险增加,随着时间的推移,临床益处减少. 需要更严格的试验来评估这种癌症药物.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 药物开发 药物开发
背景情况:
- 药物开发是复杂的,昂贵的,并且涉及参与者的风险.
- 确保参与者安全和试验效率至关重要.
- 识别过度负荷时期可以为试验设计提供信息,并防止损害.
研究的目的:
- 在已发表的卡博桑提尼布临床试验中评估患者随时间推移的益处和负担.
- 分析不良事件,生存率和反应率的趋势.
- 评估cabozantinib试验的方法严谨性和一致性.
主要方法:
- 对卡博赞提尼布在固体癌症中的干预性临床试验的回顾性横截面审查.
- 在PubMed/MEDLINE,Embase,Cochrane (CENTRAL) 和clinicalTrials.gov.gov.网站进行了搜索.
- 提取了不良事件发生率,无进展生存率 (PFS),总生存率和客观反应率 (ORR).
主要成果:
- 包括54篇出版物,涉及6372名参与者和21种癌症.
- 从2011年至2016年,参与者的累积风险增加了,并且仍然很高.
- 临床益处,包括客观反应率 (ORR),随着时间的推移而下降.
- 许多试验 (57.41%) 是单臂试验,42.60%的结果是负面的.
- 观察到相互矛盾的结果和各种适应症的不一致性.
结论:
- 卡博赞提尼布的风险概况有所增加,而其临床益处随着时间的推移而减少.
- 非随机和单臂试验的流行程度令人担忧,需要更严格的研究.
- 针对各种适应症的不一致结果表明与经验管理和疗效的潜在问题.
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