Potential impact of HercepTest™ mAb PharmDx (Dako Omnis) (ge001) in breast cancer diagnosis.

IF 0.7 4区医学 Q4 PATHOLOGY

Polish Journal of Pathology Pub Date : 2023-01-01 DOI:10.5114/pjp.2023.129352

Andrzej Marszałek, Agata Kubicka, Inga Jagiełło, Anna Malicka-Durczak

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引用次数: 0

Abstract

The HER2 gene is a biomarker for breast cancer prognosis and treatment. Overexpression of HER2 protein determined by immunohistochemistry (IHC) or amplification of the HER2 gene determined by fluorescence in situ hybridization (FISH) is a condition for qualifying patients for anti-HER2 therapy. Due to the high toxicity of anti-HER2 treatment, proper patient selection is essential. In our study we compared 40 cases with IHC staining of HER2 antibody determined by Ventana PATHWAY anti-HER2/neu antibody (4B5) as HER2 2+ with the new antibody (HercepTest™ mAb PharmDx [Dako Omnis] [GE001]). Then using a double-blind study we compared the (IHC) evaluation with FISH results. In 65% of cases (26/40) the IHC 2+ score remained unchanged, in 32.5% of cases (13/40) expression of HER2 protein after IHC with new antibody was indicated as 3+ score, and in one case we observed a decrease of HER2 protein expression to 1+. In all cases but one, in which we found IHC HER 3+ with new antibody, there was FISH amplification. We have reason to believe that the new antibody will reduce the diagnostic time and avoid unnecessary costs. Due to the small study group, further investigation is needed.

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HercepTest的潜在影响™ mAbPharmDx（DakoOmnis）（ge001）在乳腺癌症诊断中的应用。

HER2基因是癌症预后和治疗的生物标志物。通过免疫组织化学（IHC）测定的HER2蛋白的过度表达或通过荧光原位杂交（FISH）测定的HER2基因的扩增是使患者有资格接受抗HER2治疗的条件。由于抗HER2治疗的高毒性，正确的患者选择至关重要。在我们的研究中，我们比较了40例通过Ventana PATHWAY抗HER2/neu抗体（4B5）确定为HER2+的HER2抗体的IHC染色与新抗体（HercepTest™ mAb PharmDx[Dako Omnis][GE001]）。然后使用双盲研究，我们将（IHC）评估与FISH结果进行了比较。在65%的病例（26/40）中，IHC 2+评分保持不变，在32.5%的病例（13/40）中，用新抗体进行IHC后HER2蛋白的表达显示为3+评分，在一个病例中，我们观察到HER2蛋白表达降至1+。在除一例外的所有病例中，我们发现了带有新抗体的IHC HER3+，均存在FISH扩增。我们有理由相信，新抗体将缩短诊断时间，避免不必要的成本。由于研究小组规模较小，需要进一步调查。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Polish Journal of Pathology PATHOLOGY-

CiteScore

1.00

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Polish Journal of Pathology is an official magazine of the Polish Association of Pathologists and the Polish Branch of the International Academy of Pathology. For the last 18 years of its presence on the market it has published more than 360 original papers and scientific reports, often quoted in reviewed foreign magazines. A new extended Scientific Board of the quarterly magazine comprises people with recognised achievements in pathomorphology and biology, including molecular biology and cytogenetics, as well as clinical oncology. Polish scientists who are working abroad and are international authorities have also been invited. Apart from presenting scientific reports, the magazine will also play a didactic and training role.