在富集的HER2低表达乳腺癌队列中HER2免疫组织化学评分的观察者间及抗体间再现性
Interobserver and Interantibody Reproducibility of HER2 Immunohistochemical Scoring in an Enriched HER2-Low-Expressing Breast Cancer Cohort
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影响因子:1.9
分区:医学4区 / 病理学3区
发表日期:2023 May 02
作者:
Cansu Karakas, Haley Tyburski, Bradley M Turner, Xi Wang, Linda M Schiffhauer, Hani Katerji, David G Hicks, Huina Zhang
DOI:
10.1093/ajcp/aqac184
摘要
我们评估了在富集的HER2低表达乳腺癌队列中HER2免疫组织化学评分的观察者间和抗体间的再现性。共分析114个乳腺癌标本，采用HercepTest（Agilent Dako）和PATHWAY抗-HER2（4B5）（Ventana）抗体检测，并由6位乳腺病理学专家根据当前HER2指南独立评分。通过Cohen κ分析评估一致性水平。尽管两种抗体的观察者间一致率均达到了实质性一致，但HercepTest的平均一致率明显高于4B5克隆（74.3%对比65.1%；P=0.002）。两抗体之间的整体抗体间一致率为57.8%。HercepTest达成完全观察者间一致的病例为44.7%，4B5为45.6%。绝对一致率在HER2 0-1+的病例中提高，从HercepTest的78.1%和4B5的72.2%（中等一致）提升至2-3+病例中的91.9%和86.3%（几乎完美一致）。我们的结果显示，在评估HER2免疫组化时，观察者间及抗体间存在显著变异，尤其是在评分为0-1+的病例中，尽管专业乳腺病理学家对HER2低表达概念的认识显著改善了检测性能。未来需要更为准确和可重复的方法，以便筛选可能受益于新批准的HER2靶向药物的HER2低表达乳腺癌患者。
Abstract
We assessed the interobserver and interantibody reproducibility of HER2 immunohistochemical scoring in an enriched HER2-low-expressing breast cancer cohort.A total of 114 breast cancer specimens were stained by HercepTest (Agilent Dako) and PATHWAY anti-HER2 (4B5) (Ventana) antibody assays and scored by 6 breast pathologists independently using current HER2 guidelines. Level of agreement was evaluated by Cohen κ analysis.Although the interobserver agreement rate for both antibodies achieved substantial agreement, the average rate of agreement for HercepTest was significantly higher than that for the 4B5 clone (74.3% vs 65.1%; P = .002). The overall interantibody agreement rate between the 2 antibodies was 57.8%. Complete interobserver concordance was achieved in 44.7% of cases by HercepTest and 45.6% of cases by 4B5. Absolute agreement rates increased from HER2 0-1+ cases (78.1% by HercepTest and 72.2% by 4B5; moderate agreement) to 2-3+ cases (91.9% by HercepTest and 86.3% by 4B5; almost perfect agreement).Our results demonstrated notable interobserver and interantibody variation on evaluating HER2 immunohistochemistry, especially in cases with scores of 0-1+, although the performance was much more improved among breast-specialized pathologists with the awareness of HER2-low concept. More accurate and reproducible methods are needed for selecting patients who may benefit from the newly approved HER2-targeting agent on HER2-low breast cancers.