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参与肺癌主协议 (Lung-MAP) 的患者代表性
Riha Vaidya1,2, Joseph M Unger1,2, Lu Qian1
1Fred Hutchinson Cancer Center, Seattle, WA.
JCO precision oncology
|September 7, 2023
概括
像Lung-MAP这样的总体协议可能会为老年人和社会经济上脆弱的患者增加获得新型肺癌治疗的机会. 然而,在精准医学试验中,代表性不足的种族和民族少数群体的参与障碍仍然存在.
科学领域:
- 在瘤学瘤学.
- 临床试验设计 临床试验设计
- 生物标志物发现发现
背景情况:
- 肺癌主协议 (Lung-MAP) 是为了促进在肺癌中进行分子向治疗的生物标志物驱动的临床试验而建立的.
- 了解主协议中的患者积累对于评估其对临床试验准入的影响至关重要.
研究的目的:
- 为了比较 Lung-MAP 总协议中纳入的患者的社会人口统计特征与传统高级非小细胞肺癌 (NSCLC) 试验中的患者的社会人口统计特征.
- 确定总体协议是否可以改善不同患者群体对临床试验的准入.
主要方法:
- 分析了 Lung-MAP (2014-2020) 中3556名患者的社会人口统计数据.
- 这些数据与来自其他高级NSCLC试验 (2001-2020) 和美国高级NSCLC人口数据 (2014-2018) 的2,215名患者进行了比较.
- 在统计比较中,使用了比例的双面测试,其α值为0.01.
主要成果:
- 与其他NSCLC试验相比,肺MAP注册的老年患者 (≥65岁),来自农村地区的个人和来自社会经济贫困社区的患者比例更高.
- 肺部MAP显示,与其他NSCLC试验和美国一般高级NSCLC患者相比,女性,亚洲人和西班牙裔患者的入学率较低.
- 在65岁以下的患者中,Lung-MAP招募了更多的医疗补助或没有保险的患者.
结论:
- 总体协议可以提高对老年人和社会经济弱势群体在精确肺癌治疗中的试验准入.
- 总体协议中的特定患者排除标准可能会影响人口代表性.
- 需要进一步调查,以解决代表性不足的种族和少数民族在精准医学临床试验中的参与障碍.
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