Department of Histopathology, Nottingham University Hospitals, City Hospital Campus, Nottingham, UK.
Histopathology. 2012 May;60(6):880-4. doi: 10.1111/j.1365-2559.2011.04144.x. Epub 2012 Feb 9.
Human epidermal growth factor receptor 2 (HER2) status of invasive breast cancers is vital for selection of patients for trastuzumab treatment. This study aimed to assess the level of agreement of HER2 status in core biopsy and excision specimens using immunohistochemistry, with in-situ hybridisation for equivocal cases.
300 consecutive invasive carcinomas with core biopsy and surgical specimens had HER2 assessed on both specimens. Immunohistochemistry was performed first. Fluorescence in-situ hybridization (FISH) was automatically performed if the immunohistochemistry was scored as equivocal (2+). There was agreement between the HER2 status of the two specimens in 294 tumours (98%). In two carcinomas the core was negative and the excision specimen showed focal strong staining with amplification. In four carcinomas the core biopsy was negative and the excision showed 2+ staining with amplification in at least one block (although in three there was no amplification in a second block).
There is excellent agreement between HER2 assessed in core biopsy and surgical specimens. Discrepancies arise most frequently due to focal amplification or levels of gene amplification around the cut-off for defining positivity.
人表皮生长因子受体 2（HER2）状态对曲妥珠单抗治疗患者的选择至关重要。本研究旨在评估免疫组织化学法检测核心活检和切除标本中 HER2 状态的一致性水平，并对可疑病例进行原位杂交检测。
对 300 例连续的浸润性乳腺癌患者的核心活检和手术标本进行了 HER2 评估。首先进行免疫组织化学检测。如果免疫组织化学检测结果为可疑（2+），则自动进行荧光原位杂交（FISH）检测。294 例肿瘤中，两种标本的 HER2 状态一致（98%）。在 2 例癌中，核心为阴性，而切除标本显示局灶性强染色伴扩增。在 4 例癌中，核心活检为阴性，而切除标本显示至少 1 个块中 2+染色伴扩增（尽管在 3 例中，第二个块中没有扩增）。
核心活检和手术标本中 HER2 的评估具有极好的一致性。差异最常由于局灶性扩增或定义阳性的截止值附近的基因扩增水平引起。
