评估血液癌症抗癌疗法的随机对照试验:全球研究活动概述
Manju Sengar1, Wilma M Hopman2, Ghulam Rehman Mohyuddin3
1Tata Memorial Centre, Homi Bhabha National Institute, Mumbai 400012, India.
Ecancermedicalscience
|July 3, 2023
概括
对血液癌症的随机对照试验很少将整体存活率作为终点,通常选择代用标记物. 这引发了对结果对患者护理的有效性的担忧.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 血液学 血液学 血液学
背景情况:
- 瘤学随机对照试验 (RCT) 已经显著发展.
- 这项研究分析了血液癌症与固体瘤 (2014-2017年) 的全球RCT.
研究的目的:
- 为了比较血液癌症和固体瘤的RCT的设计,终点和资金.
- 确定瘤学试验方法的趋势.
主要方法:
- 一项系统的文献搜索确定了全球发布的第3期RCT (2014-2017年).
- 描述性统计和统计测试比较了癌症类型之间的试验特征.
主要成果:
- 总体存活率 (OS) 是只有12%的血液癌症RCT的主要终点,而固体瘤的RCT为35%.
- 无进展生存期 (PFS) 等代用终点在血液学试验中更常见 (47%vs. 31%).
- 工业资金很高 (78%的血液瘤与70%的固体瘤),低收入国家的领导力有限.
结论:
- 低比例的血液癌症RCT使用OS作为主要终点,这令人担忧.
- 经常使用替代终点,通常不适用于OS,使解释和患者护理复杂化.
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