Changes in HER2 Amplification Status for Breast Cancer Patients After Immunohistochemistry Directed In Situ Hybridization.

IF 1.2 4区医学 Q3 ANATOMY & MORPHOLOGY Applied Immunohistochemistry & Molecular Morphology Pub Date : 2025-03-01 Epub Date: 2025-01-27 DOI:10.1097/PAI.0000000000001247

Cameron Beech, Diane M Wilcock, Kristina H Moore, Leslie Rowe, Jonathan Mahlow, Jolanta Jedrzkiewicz, Allison S Cleary, Lesley Lomo, Ana L Ruano, Maarika Gering, Derek Bradshaw, Meghan Maughan, Phuong Tran, Richard Davis, Kajsa Affolter, Daniel J Albertson, Parisa Adelhardt, JongTaek Kim, Joshua F Coleman, Georgios Deftereos, Evin H Gulbahce, Deepika Sirohi

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Abstract

The 2018 ASCO/CAP guidelines for HER2 testing for breast cancer implemented the addition of immunohistochemistry (IHC) directed in situ hybridization (ISH) recount to resolve equivocal results. The implementation of an additional 2+ IHC-directed ISH recount adds additional complexity to the testing workflow for an unclear impact on HER2 results. A retrospective review of all equivocal ISH cases (groups 2, 3, and 4) that underwent 2+ IHC-directed ISH, since the 2018 guidelines, which were finalized as either amplified or not amplified, was performed. HER2 group number and final HER2 amplification status frequently changed after IHC guided ISH assessment, which was due to significant changes in HER2/CEP17 ratio and average HER2 signal number per cell. Equivocal groups 2, 3, and 4 samples with a result of HER2 amplified after 2+ IHC-directed ISH counts were closer to the threshold for amplification on the original ISH count, yet their counts also increased significantly after IHC-directed count in comparison to those samples, which were not amplified. Groups 2 and 4 ISH counts significantly increased after IHC directed ISH for HER2/CEP17 ratio and HER2 signal number per cell. This study represents the most extensive examination of efforts to resolve equivocal HER2 ISH results, highlighting a significant shift in therapeutic options after IHC-guided ISH for a subset of breast cancer patients.

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免疫组化原位杂交后乳腺癌患者HER2扩增状态的变化

2018年ASCO/CAP乳腺癌HER2检测指南增加了免疫组织化学（IHC）定向原位杂交（ISH）重新计数，以解决模棱两可的结果。实施额外的2+ ihc导向的ISH重新计数增加了测试工作流程的复杂性，对HER2结果的影响不明确。自2018年指南最终确定为扩增或未扩增以来，对所有模棱两可的ISH病例（2、3和4组）进行了回顾性审查，这些病例接受了2+ ihc指导的ISH。在IHC引导下的ISH评估后，HER2组数和最终HER2扩增状态经常发生变化，这是由于HER2/CEP17比值和每个细胞平均HER2信号数发生了显著变化。2+ ihc定向ISH计数后HER2扩增结果不明确的2、3、4组样品的原始ISH计数更接近扩增阈值，但与未扩增的样品相比，ihc定向计数后其计数也显著增加。IHC诱导ISH后，2组和4组细胞中HER2/CEP17比值和HER2信号数显著增加。这项研究代表了对解决模棱两可的HER2 ISH结果的最广泛的研究，强调了ihc引导的ISH治疗对一部分乳腺癌患者的治疗选择的重大转变。

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来源期刊

Applied Immunohistochemistry & Molecular Morphology ANATOMY & MORPHOLOGY-MEDICAL LABORATORY TECHNOLOGY

CiteScore

3.20

自引率

0.00%

发文量

153

期刊介绍： Applied Immunohistochemistry & Molecular Morphology covers newly developed identification and detection technologies, and their applications in research and diagnosis for the applied immunohistochemist & molecular Morphologist. Official Journal of the International Society for Immunohistochemisty and Molecular Morphology.