在乳腺癌中通过HercepTest和PATHWAY 4B5免疫组合化学测试对HER2状态的差异
Shinsuke Sasada1, Momoko Takaya2, Kanako Suzuki2
1Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan; shsasada@hiroshima-u.ac.jp.
Anticancer research
|January 30, 2026
概括
人类表皮生长因子受体2 (HER2) 测试显示,与HercepTest相比,4B5试验的染色率较低. 这影响了后祖马布-德鲁克斯坦 (T-DXd) 的适用性,特别是在HER2-ultralow病例中.
科学领域:
- 在瘤学瘤学.
- 病理学 病理学 病理学
- 生物标记分析 生物标记分析
背景情况:
- 准确的人体表皮生长因子受体2 (HER2) 评估对于指导乳腺癌治疗至关重要,包括对特拉斯图祖马布-德鲁克斯泰坎 (T-DXd) 的适用性.
- 不同的试剂之间存在HER2免疫组织化学 (IHC) 染色结果的差异,可能会影响治疗决策.
研究的目的:
- 通过使用HercepTest和PATHWAY 4B5 IHC测定来研究和比较乳腺癌中的HER2状态评估.
- 评估试剂差异对HER2评分的影响及其对T-DXd治疗的影响.
主要方法:
- 来自2,328个乳腺癌组织的HER2测试数据的回顾性审查 (2020年1月 - 2024年12月).
- 使用HercepTest (早期期) 和PATHWAY 4B5 (晚期) 获得的HER2染色结果的比较.
- 分析包括新鲜和存档的组织样本.
主要成果:
- 在新鲜样品中,PATHWAY 4B5测定显示HER2染色强度低于HercepTest.
- 在HER2阳性 (9.5% vs 8.6%),低 (59.5% vs 48.5%),超低 (18.2% vs 21.8%) 和零 (12.9% vs 21.1%) 类别中观察到显著的差异.
- 档案样本显示HER2状态的变化,其中53.3%显示变化 (1升级,7降级).
结论:
- 与HercepTest相比,HER2 IHC染色在4B5试验中始终较低.
- 对于确定T-DXd指示,特别是对HER2-超低病例,需要使用4B5试验作为辅助诊断方法.
- 标准化和对HER2结果的仔细解释对于最佳的患者管理至关重要.
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