癌症试验资格和治疗修改对于达菲零关联中性粒细胞计数的个体
Stephen P Hibbs1, Laura Aiken2, Kruti Vora3
1Wolfson Institute of Population Health, Queen Mary University of London, London, United Kingdom.
JAMA network open
|September 11, 2024
概括
大多数癌症临床试验都排除了中性粒细胞数量较低的患者,不成比例地影响了非洲和中东祖先的个体. 系统性抗癌疗法方案也对这一群体的剂量进行了修改,突出显示需要修订试验标准.
科学领域:
- 瘤学和血液学 在线
- 临床试验设计 临床试验设计
- 健康差异 在健康上的差异
背景情况:
- 绝对中性粒细胞计数 (ANC) 对癌症临床试验 (CCT) 资格和全身抗癌疗法 (SACT) 剂量至关重要.
- 达菲零关联ANC (DANC) 是非病理性,低ANC表型,在非洲和中东血统的人群中很常见.
- DANC对CCT适用性和SACT剂量修改的影响尚不清楚.
研究的目的:
- 调查DANC参考范围内的ANC患者在CCT中的排除率.
- 检查DANC参考范围内的ANC患者的SACT疗法剂量修改.
主要方法:
- 针对美国/英国流行癌症 (前列腺癌,乳腺癌,黑色素瘤,结直肠癌,肺癌) 的成年人,第三期CCT的横截面研究,开始时间为2021年11月至2023年11月.
- 分析包括CCT排除标准和SACT疗法剂量修改政策,用于DANC参考范围内的ANC.
- 数据来源于clinicaltrials.gov,SACT疗法与国家综合癌症网络指南保持一致.
主要成果:
- 75.7%的符合条件的CCT排除了在DANC参考范围内的ANC患者.
- 结肠直肠癌和肺癌试验显示了最高的排除率 (分别为86.4%和81.7%).
- 53.5%的SACT疗法包括DANC参考范围内的ANC剂量修改,肺癌疗法最常被修改 (74.2%).
结论:
- 显著比例的CCT将患者排除在外,SACT方案根据DANC参考范围修改剂量.
- 这些做法造成了对非洲和中东血统患者的结构性歧视.
- 建议对CCT排除标准进行修订,同时需要对最佳SACT剂量修改进行进一步研究.
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