乳腺癌中ki-67测试:通过评分方法和样本类型评估可变性,以及对治疗资格的潜在后续影响
Therese Bocklage1, Virgilius Cornea1, Caylin Hickey1
1Departments of Pathology and Laboratory Medicine.
概括
这项研究突出了Abemaciclib资格的Ki-67评分的显著差异. 精细的Ki-67评估方法对于减少变异性和确保准确的患者选择ER阳性/HER2阴性乳腺癌治疗至关重要.
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:
- 阿贝马西克利布已批准用于治疗ER阳性/HER2阴性乳腺癌,基基67≥20%.
- 缺乏对Ki-67测试和评分方法的标准化指南,造成了模两可.
- 患者接受abemaciclib治疗的资格可能会受到评分变化的影响.
研究的目的:
- 评估不同样本类型和评分方法中Ki-67表达的变异性.
- 将手动Ki-67评分技术 (估计,未加权,加权) 与定量图像分析 (QIA) 相比较.
- 评估评分变化的影响,以确定对abemaciclib治疗的资格.
主要方法:
- 从50名符合abemaciclib.lib.条件的患者获得的乳房样本的全面分析.
- 三位病理学家使用估计 (EST),未加权 (UNW) 和加权 (WT) 手动评分方法进行了盲目审查.
- 使用HALO平台的定量图像分析 (QIA) 用于比较.
- 在核心针活检 (CNB),切除 (RES) 和带淋巴结转移 (ALN) 样本中评估Ki-67表达.
主要成果:
- 平均Ki-67表达因得分方法而异:EST (14.68%),UNW (14.46%),WT (14.15%) 和QIA (11.15%). 这两种表达方式均有所不同.
- 与EST (ICC1=0.922) 和UNW (ICC1=0.949) 相比,加权 (WT) 方法显示了较低的观察者间变异性 (ICC1=0.959).
- 基于Ki-67 ≥20%的治疗资格范围从24% (QIA) 到40% (EST),表明存在显著差异.
- 在CNB,RES和ALN标本中没有发现Ki-67表达的统计学上显著差异.
结论:
- 在Ki-67评分中存在显著的临床变化,以确定abemaciclib的资格.
- 权重评分方法和QIA显示了减少观察者间变异性的潜力.
- 进一步完善Ki-67评分方法是必不可少的,以确保准确的患者选择针对性乳腺癌治疗.
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