来自monarchE和NATALEE试验的风险定义的预测影响
Luca Arecco1,2, Eva Blondeaux3, Marco Bruzzone3
1Department of Internal Medicine and Medical Specialties (DIMI), School of Medicine, University of Genova, Genova, Italy.
Journal of the National Cancer Institute
|February 5, 2025
概括
符合monarchE和NATALEE试验标准的高风险早期乳腺癌患者的无病和整体存活率明显降低. 这些发现突出了基于高风险早期乳腺癌试验纳入标准的预后差异.
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:
- 在monarchE和NATALEE试验中,为早期乳腺癌定义了不同的高风险标准.
- 了解基于这些标准的预后差异对于患者分层至关重要.
研究的目的:
- 根据monarchE和NATALEE试验的不同高风险纳入标准,评估早期乳腺癌患者的预后差异.
- 将患者分为一致的低风险,不一致的风险和一致的高风险队列.
主要方法:
- 分析了MIG1,GIM2和GIM3试验中患有激素受体阳性/HER2阴性早期乳腺癌的患者.
- 根据monarchE和NATALEE标准,患者被分为高风险队列 (HRC) 或低风险队列 (LRC).
- 在一致的LRC,不一致的风险和一致的HRC组中评估了无疾病生存率 (DFS) 和整体生存率 (OS).
主要成果:
- 根据NATALEE标准,相当一部分患者被归类为HRC (56.1%) 与monarchE (28.0%) 相比.
- 七年DFS为一致LRC的89%,不一致队列的84%,一致HRC的69%.
- 七年后的生存率为一致的LRC为96%,不一致的队列为95%,一致的HRC为84%,具有统计学上显著的差异 (P < .001).
结论:
- 根据monarchE和NATALEE标准分类为一致高风险 (HRC) 的患者的预后明显较差.
- 该研究表明,与这些主要临床试验的特定纳入标准相关的临床相关的预后差异.
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