Impact of the 2013 American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing of invasive breast carcinoma: a focus on tumours assessed as 'equivocal' for HER2 gene amplification by fluorescence in-situ hybridization
Impact of the 2013 American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing of invasive breast carcinoma: a focus on tumours assessed as 'equivocal' for HER2 gene amplification by fluorescence in-situ hybridization
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DOI：
10.1111/his.12723
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发表时间：
2015-12-01
期刊：
影响因子：
6.4
通讯作者：
Barnes, Penny J.
中科院分区：
文献类型：
--
作者：
Bethune, Gillian C.;van Zanten, Daniel Veldhuijzen;Barnes, Penny J.
目的：更新的 2013 年美国临床肿瘤学会/美国病理学家学院 (ASCO/CAP) 人表皮生长因子受体 2 (HER2) 检测指南包括对 HER2 原位杂交 (ISH) 解释标准的更改。我们对连续的原发性乳腺癌队列进行了回顾性审查，以评估更新指南对 HER2 分类和实验室资源利用的影响，并描述 HER2 模棱两可肿瘤的病理学特征。 方法和结果：对浸润性乳腺癌总共进行了 904 例双探针 HER2/染色体计数探针 (CEP17) FISH 检测。 研究过。根据更新的指南，85 例 (9.4%) 病例的分类发生了变化； 66 例 (7.3%) 从 HER2 阴性转为模糊，15 例 (1.7%) 被重新分类为 HER2 阳性，4 例从 HER2 模糊转为阴性。原发性乳腺癌的一个子集最初被报道为 HER2 阴性，但在 2013 年指南中却模棱两可，最终被确定。该子集的传统病理因素与 HER2 阴性和阳性对照病例进行了比较。三个 HER2 组在预后因素（包括肿瘤大小、分级和淋巴结受累）方面表现出统计学显着差异。 结论：更新的 HER2 检测指南将导致约 9.4% 的原发性乳腺癌重新分类，但在大多数病例中，这种重新分类的临床影响尚不确定。由于建议重新测试，资源利用率将会增加。
Aims: The updated 2013 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) testing guidelines include changes to HER2 in-situ hybridization (ISH) interpretation criteria. We conducted a retrospective review of a consecutive cohort of primary breast carcinomas to assess the impact of updated guidelines on HER2 classification and laboratory resource utilization, and to characterize the pathobiology of HER2 equivocal tumours.Methods and results: A total of 904 dual-probe HER2/chromosome enumeration probe (CEP17) FISH tests on invasive breast carcinomas were studied. Eighty-five (9.4%) cases had a classification change with the updated guidelines; 66 (7.3%) went from HER2-negative to -equivocal, 15 cases (1.7%) were reclassified as HER2-positive and four cases from HER2-equivocal to negative. A subset of primary breast cancers, reported initially as HER2-negative but -equivocal by 2013 guidelines, was identified. Traditional pathological factors of this subset were compared to HER2-negative and -positive control cases. The three HER2 groups demonstrated statistically significant differences with respect to prognostic factors, including tumour size, grade and nodal involvement.Conclusions: The updated HER2 testing guidelines will result in the reclassification of approximately 9.4% of primary breast cancers with uncertainty regarding the clinical impact of this reclassification in the majority of cases. Resource utilization will increase as a result of the recommendation for retesting.