在III期瘤学试验中,治疗后进展治疗和估计治疗对整体存活时间的影响的混
Alexander D Sherry1, Pavlos Msaouel2,3, Timothy A Lin4
1Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
BMJ oncology
|January 31, 2025
概括
后进展疗法 (PPT) 在癌症试验中显著影响总生存率 (OS) 估计. 然而,很少进行考虑PPT效应的分析,这可能会混治疗效应结果.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 整体存活率 (OS) 是瘤学临床试验中的关键终点.
- 后进展疗法 (PPT) 可以显著影响OS估计.
- 人工智能技术对操作系统分析的影响尚不清楚.
研究的目的:
- 为了确定总生存率 (OS) 的流行率,分析在III期瘤学试验中考虑后进展疗法 (PPT).
- 确定与将PPT调整纳入OS分析相关的因素.
主要方法:
- 对第三期随机优势瘤学试验的横截面分析报告了OS.
- 从ClinicalTrials.gov发布的2004年至2020年期间的试验的选.
- 后勤回归用于评估OS分析中试验级共变量和PPT调整之间的关联.
主要成果:
- 在334项试验中,47%报告了PPT,但只有12% (41项试验) 在OS分析中进行了调整.
- 在交叉研究中,PPT调整更常见,在交叉研究中和那些具有不一致的代用OS发现的研究中,PPT调整更常见.
- 在本地区域/一线治疗 (8%) 和为OS提供动力 (11%),这些调整在试验中不常见.
结论:
- 后进展疗法经常被使用,但在整体存活分析中很少被考虑.
- 如果不适应PPT,可能会引入混和偏差治疗效果估计.
- 在试验设计和报告过程中,考虑PPT和调整方法至关重要.
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