在早期癌症临床试验中,抗癌药物的纵向毒性存在种族差异
Junki Mizusawa1,2, Hioryuki Sato3, Larry V Rubinstein4
1Biostatistics Section, Clinical Research Support Office, National Cancer Center Hospital/Biostatistics Division, Center for Research Administration & Support, National Cancer Center, Tokyo, Japan.
Cancer medicine
|July 31, 2023
概括
这项研究使用大型临床试验数据库分析了抗癌药物毒性的种族差异. 黑人患者的腹较少,而亚洲患者的高血糖率较高,尽管大多数毒性是低级的.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 健康差异 在健康上的差异
背景情况:
- 在抗癌药物毒性的种族差异被注意到,但通常是基于缺乏纵向数据的小型研究.
- 之前的研究通常只报告了最大的毒性等级,限制了对毒性进展的理解.
- 本研究通过检查来自大型临床试验数据库的纵向毒性数据来解决这些局限性.
研究的目的:
- 调查与抗癌药物治疗相关的纵向毒性种族差异.
- 分析毒性等级的患病率,每周期的平均等级,以及跨种族群体严重毒性的时间.
- 利用大规模的临床试验数据库,对治疗结果的种族差异进行可靠的分析.
主要方法:
- 国家癌症研究所的早期临床试验分析 (2000年3月至2012年12月).
- 包括评估细胞毒性和分子向药物的试验.
- 根据种族对患者进行分类 (白人,黑人或非裔美国人,亚洲人) 并评估毒性指标.
主要成果:
- 总共分析了697项试验中的25442名患者.
- 与白人和亚洲患者相比,黑人患者的任何级别腹率分别降低了26%和21%.
- 亚洲患者表现出任何级别的高血糖率显著更高,并且平均时间到2级+毒性因种族而异.
结论:
- 在纵向抗癌药物毒性的几个种族差异被确定.
- 大多数观察到的毒性种族差异通常是较低等级的.
- 需要进一步的研究来阐明治疗毒性这些种族差异的根本原因.
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