Department of Pathology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Gyeonggi, 13620, Republic of Korea.
Department of Pathology, Kangwon National University Hospital, Chuncheon, Kangwon, 24289, Republic of Korea.
Hum Pathol. 2020 Apr;98:10-21. doi: 10.1016/j.humpath.2020.01.003. Epub 2020 Feb 4.
The aim of the study was to evaluate the impact of the updated 2018 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline on human epidermal growth factor receptor 2 (HER2) interpretation in breast cancer compared with that of the previous guidelines and also the significance of in situ hybridization (ISH) groups proposed by the updated guideline. HER2 ISH reports and immunohistochemistry (IHC) data from 1,348 invasive breast cancers diagnosed at a single institution were included in this study. HER2 IHC was reassessed using the 2018 guideline, and HER2 ISH status was determined by the 2007, 2013, and 2018 guidelines. When applying the updated guideline, most of the HER2 ISH-equivocal cases as per the previous guidelines were reclassified as ISH negative, and 0.8% of HER2 ISH-positive tumors as per the 2007 guideline and 2.5% of those as per the 2013 guideline were changed to ISH negative. Accordingly, the negative HER2 ISH results significantly increased in the 2018 guideline compared with the 2013 guideline. HER2 ISH-positive tumors in ISH group 3 (HER2/chromosome enumeration probe 17 [CEP17] ratio <2.0 and average HER2 copy number ≥6.0 per cell) were characterized by equivocal HER2 protein expression, CEP17 copy number gain, and low HER2 copy numbers compared with classic HER2 ISH-positive tumors in ISH group 1 (HER2/CEP17 ratio ≥2.0 and average HER2 copy number ≥4.0 per cell). HER2 ISH-negative tumors in ISH group 4 (HER2/CEP17 ratio <2.0 with average HER2 copy number ≥4.0 and < 6.0 per cell) revealed more aggressive clinicopathologic features and poorer clinical outcomes than those in ISH group 5 (HER2/CEP17 ratio <2.0 and average HER2 copy number <4.0 per cell), especially in the hormone receptor-positive subgroup. In conclusion, implementation of the updated 2018 ASCO/CAP guideline leads to a significant increase in HER2 ISH-negative results compared with the 2013 guideline, mainly via reclassification of the ISH-equivocal cases to ISH-negative ones. ISH groups proposed by the updated guideline provide additional information on the clinicopathologic characteristics of the tumors.
本研究旨在评估与先前指南相比，2018 年美国临床肿瘤学会（ASCO）/美国病理学家协会（CAP）更新的人表皮生长因子受体 2（HER2）解读指南对乳腺癌的影响，以及更新指南中提出的原位杂交（ISH）分组的意义。本研究纳入了一家机构诊断的 1348 例浸润性乳腺癌的 HER2ISH 报告和免疫组织化学（IHC）数据。使用 2018 年指南重新评估了 HER2 IHC，并根据 2007 年、2013 年和 2018 年指南确定了 HER2ISH 状态。应用更新的指南时，先前指南中大多数 HER2ISH 不确定的病例被重新分类为 ISH 阴性，并且根据 2007 年指南，0.8%的 HER2ISH 阳性肿瘤和根据 2013 年指南的 2.5%的肿瘤被改为 ISH 阴性。因此，与 2013 年指南相比，2018 年指南中 HER2ISH 阴性结果显著增加。ISH 组 3（HER2/染色体计数探针 17[CEP17]比值<2.0，每个细胞的平均 HER2 拷贝数≥6.0）中的 HER2ISH 阳性肿瘤的特点是 HER2 蛋白表达不确定、CEP17 拷贝数增加和低 HER2 拷贝数与 ISH 组 1（HER2/CEP17 比值≥2.0，每个细胞的平均 HER2 拷贝数≥4.0）中的经典 HER2ISH 阳性肿瘤相比。ISH 组 4（HER2/CEP17 比值<2.0，每个细胞的平均 HER2 拷贝数≥4.0 和<6.0）中的 HER2ISH 阴性肿瘤与 ISH 组 5（HER2/CEP17 比值<2.0，每个细胞的平均 HER2 拷贝数<4.0）中的肿瘤相比，具有更具侵袭性的临床病理特征和更差的临床结局，尤其是在激素受体阳性亚组中。总之，与 2013 年指南相比，实施 2018 年 ASCO/CAP 更新指南会导致 HER2ISH 阴性结果显著增加，主要是通过将 ISH 不确定病例重新分类为 ISH 阴性病例。更新指南中提出的 ISH 组提供了有关肿瘤临床病理特征的更多信息。
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