在早期乳腺癌的新辅助随机临床试验中,代孕终点对整体生存的终点
Fabio Conforti1,2, Valentina Nekljudova3, Isabella Sala4,5
1Medical Oncology Unit, Humanitas Gavazzeni, Bergamo, Italy.
概括
在早期乳腺癌 (BC) 试验中,无侵袭性疾病生存率 (iDFS) 是整体生存率 (OS) 的可靠替代品. 病理完整反应 (pCR) 与OS的关联较弱,突出显示iDFS是首选的替代终点.
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:
- 准确的代孕终点对于加速早期乳腺癌 (BC) 药物开发至关重要.
- 总体生存率 (OS) 是黄金标准,但需要长时间的随访.
- 病理完整反应 (pCR) 和无侵袭性疾病生存率 (iDFS) 是潜在的替代终点.
研究的目的:
- 评估pCR和iDFS用于OS的试验级别代孕在早期BC的随机临床试验 (RCT) 中.
- 量化治疗对OS和这些替代终点的影响之间的关联.
主要方法:
- 分析了来自新辅助性RCT的个体患者数据.
- 使用权重线性回归模型来评估治疗对OS和替代终点 (pCR,iDFS) 的影响之间的关联.
- 确定系数 (R2 ) 量化了代孕的价值.
主要成果:
- 包括11个RCT (15个治疗比较,12,247名患者).
- pCR显示与OS的相关性很弱 (R2 = 0.07).
- 对于OS,iDFS表明了中度的代孕 (R2 = 0.46),在特定的子组中具有强烈的代孕 (例如,HR-/HER2-,等级1-2,叶状瘤).
- 随着随访时间的延长,iDFS代孕改善了,在48个月后停滞不前.
结论:
- 在早期的BC新辅助RCT中,iDFS是OS的可接受替代品,前提是有足够的随访.
- 代孕在大多数子组中都是强大的,除了激素受体阳性 (HR +) 疾病.
- 作为HR+早期BC的终点,OS的实用性需要重新评估.
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