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'Non-classical' HER2 FISH results in breast cancer: a multi-institutional study.

乳腺癌HER2 FISH检测“非经典”结果:一项多机构研究

Ballard M,Jalikis F,Krings G,Schmidt RA,Chen YY,Rendi MH,Dintzis SM,Jensen KC,West RB,Sibley RK,Troxell ML,Allison KH
阅读:1428 Modern PathologyFeb 2017; 30 (2): 158 - 313:227-235 

Abstract

The 2013 CAP/ASCO HER2 Testing Guidelines Update modified HER2 FISH categories such that some cases with 'monosomy', 'co-amplification/polysomy', low-level increased HER2 signals or clustered heterogeneity now are considered amplified or equivocal. This study examines the frequency and clinico-pathologic characteristics of breast cancers with equivocal or 'non-classical' HER2 FISH results. Breast cancers (2001-2014) with HER2 FISH results, HER2 immunohistochemistry, ER, grade, and age from three institutions (Stanford, UCSF, UWMC) were collected. HER2 FISH was interpreted using the updated recommendations. Amplified cases with non-classical results were grouped into the following categories: (1) 'monosomy' (ratio ≥2.0, mean HER2/cell<4.0); (2) 'co-amplified' (ratio<2.0, mean HER2/cell ≥6.0); (3) 'low amplified' (ratio ≥2.0, mean HER2/cell 4.0-5.9). Heterogeneous cases with clustered HER2-positive cells were also included. Of 8068 cases, 5.2% were equivocal and 4.6% had a 'non-classical' HER2 amplified result; 1.4% 'monosomy', 0.8% 'co-amplified', 2.1% 'low amplified', and 0.3% clustered heterogeneity. These cancers had a high frequency of ER positive (80.4%), Nottingham grade 3 (52.1%) results. The highest percentage of grade 3 cancers (66.7%) and positive HER2 immunohistochemistry (31.7%) was in the 'co-amplified' group. The 'monosomy' group had the highest percent grade 1 cancers (13.3%) and was most frequently HER2 immunohistochemistry negative (30.1%). Equivocal cases had very similar characteristics to the 'low-amplified' category. Cases with non-classical HER2 amplification or equivocal results are typically ER positive, higher grade cancers. 'Co-amplified' cases have the highest frequencies of aggressive characteristics and 'monosomy' cases the highest frequencies of lower risk features. With little clinical outcomes data currently available on these non-classical HER2 results, these results support the current classification scheme for HER2 FISH, with case-by-case correlation with additional clinical-pathologic factors when evaluating whether to offer HER2-targeted therapies in these non-classical cases.

摘要

2013年CAP/ASCO HER2检测指南更新修订了HER2 FISH分类,比如一些“单倍体”、“共同扩增/多倍体”的病例。低水平增加的HER2信号或集群的异质性现在被认为是扩增的或不确定的。这项研究发现了乳腺癌HER2 FISH检测中有着大量的不确定或“非经典”结果的病例及其临床病理特征。这项研究收集了三家机构(Stanford, UCSF, UWMC)从2001年至2014年的乳腺癌病例,收集的指标包括HER2 FISH结果、HER2 免疫组织化学结果、ER、组织学分级以及年龄。HER2 FISH结果的判读使用更新后的推荐规范。“非经典”结果的病例被分为以下几个组:(1)“单倍体”组(比率≥2.0,平均HER2拷贝数/细胞<4.0);(2)“共同扩增”组(比率<2.0,平均HER2拷贝数/细胞≥6.0);(3)“低水平扩增”组(比率≥2.0,平均HER2拷贝数/细胞 4.0-5.9)。有成簇的HER2阳性细胞聚集的异质性病例也囊括在内。在8068例病例中,5.2%为不确定结果,4.6%为“非经典”HER2 扩增结果;其中1.4%为“单倍体”,0.8%为“共同扩增”,2.1%为“低水平扩增”,以及0.3%为成簇的异质性病例。这些癌症病例有着很高的ER阳性率(80.4%),Nottingham3级的结果约占52.1%。在“共同扩增”组中,3级癌症(66.7%)及HER2免疫组织化学法阳性结果(31.7%)所占的比例最高。在“单倍体”组中,1级癌症(13.3%)及HER2免疫组织化学法阴性结果 (30.1%)所占的比例最高。不确定的病例与“低水平扩增”组的病例有着极为相似的特征。“非经典”结果或不确定结果的病例都是典型的ER阳性、组织学级别更高的癌症。共同扩增”组的癌症常常更具有侵略性,而“单倍体”组往往有着更低的风险特征。目前尚无这些HER2 FISH检测“非经典”结果病例的临床结局数据,我们的研究结果通过逐个关联附加的临床-病理因素,为目前的HER2 FISH分类提供了支持,也为评估是否对这些非经典病例进行HER2靶向疗法提供了依据。

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