什么是RECIST 1.1进步的组成部分? 双读瘤学试验中的变异性
Hubert Beaumont1, Luca Cantini2, Kamal S Saini2,3
1Median Technologies, Valbonne, France. hubertbeaumont@hotmail.com.
European radiology
|February 9, 2026
概括
在瘤学试验中,关于疾病进展日期的读者分歧是常见的,主要是由于新的病变检测. 使用多个RECIST组件可以提高评估可靠性和试验精度.
科学领域:
- 瘤学 临床试验 临床试验
- 放射学和成像学 放射学和成像学
- 生物统计学 生物统计学
背景情况:
- 双重阅读和判断的盲目独立中央审查 (BICR) 对基于成像的临床试验的数据质量至关重要.
- 使用RECIST 1.1标准评估进展性疾病 (PD) 的差异可能会影响试验结果,特别是在3期瘤学研究中.
- 了解RECIST组件中疾病进展日期 (DoPD) 的不一致性对于准确的生存分析至关重要.
研究的目的:
- 检查RECIST组件 (目标病变,非目标病变,新病变) 中疾病进展日期 (DoPD) 的不一致性.
- 探索这些差异对瘤学临床试验中的生存曲线的影响.
- 为了确定不一致是否源于时间差异或真假PD检测.
主要方法:
- 五项临床试验数据的回顾性分析,涉及1932名肺癌患者.
- 使用双重阅读和裁决的盲目独立中央审查 (BICR).
- 检查了RECIST组件,以评估DoPD一致性,差异,判断者接受,检测时间和对生存曲线的影响.
主要成果:
- 在读者之间观察到DoPD评估中的不一致率为39.3%.
- 新病变 (NL) 是不一致的主要原因 (41.4%),其次是目标病变 (TL) 直径增加 (33.3%).
- 在49.2%的不一致病例中,PD是晚期报告的,通常是在一个治疗周期内,而62.5%的有争议的PD病例通过裁决被接受.
结论:
- 不同的RECIST组件对不一致性和判断者接受有不同的贡献.
- 新的病变检测是进展的关键指标,但也是读者之间分歧的重要来源.
- 整合多个RECIST组件可以提高临床试验中疾病进展评估的可靠性.
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