Fetica Bogdan, Blaga Mihaiela Luminita, Trifa Adrian Pavel, Bocean Cosmina Maria, Balacescu Ovidiu, Fulop Annamaria, Pop Bogdan
Department of Pathology, "Prof. Dr. Ion Chiricuta" Institute of Oncology, 400015 Cluj-Napoca, Romania.
Molecular Pathology Laboratory Pathos, 400394 Cluj-Napoca, Romania.
Medicina (Kaunas). 2025 Jun 11;61(6):1069. doi: 10.3390/medicina61061069.
: The assessment of HER2 status in invasive breast carcinomas (IBCs) is critical for determining treatment strategies. The aim of this study was to evaluate the FICTION technique as a potential method for assessing HER2 status and to compare it with the standard sequential immunohistochemistry (IHC)-in situ hybridization (ISH) assays. : This study included 49 patients diagnosed with invasive breast carcinomas. HER2 status was assessed using both IHC+FISH and FICTION techniques, and the results were compared. : Comparative analysis demonstrated an 83.67% categorical agreement between IHC and IF using the ASCO/CAP system. The percentage of cells showing any degree of HER2 protein expression was higher with IF (73.77%) than with IHC (60.71%) ( = 0.00026). The in situ hybridization assays showed an excellent agreement, with a 90% or higher concordance. The concordance of the ASCO/CAP group classification of cases using both ISH assays (FICTION and standard FISH) was high (85, 7%). Agreement was 100% for the final classification of cases (Her2 positive/negative). : We compared standard tests for Her2 protein expression and the gene copy number with a modified FICTION protocol. The study showed moderate agreement between IHC and IF for Her2 protein and excellent agreement between FISH and FICTION ISH for the gene copy number. Final Her2 status was unaffected by low IF IHC concordance. Optimizing the FICTION protocol could improve results. Combining protein and gene assays may enhance IBC patient stratification.
浸润性乳腺癌(IBC)中HER2状态的评估对于确定治疗策略至关重要。本研究的目的是评估FICTION技术作为评估HER2状态的一种潜在方法,并将其与标准的序贯免疫组织化学(IHC)-原位杂交(ISH)检测方法进行比较。 本研究纳入了49例诊断为浸润性乳腺癌的患者。使用IHC+FISH和FICTION技术评估HER2状态,并比较结果。 比较分析表明,使用ASCO/CAP系统时,IHC和IF之间的分类一致性为83.67%。显示任何程度HER2蛋白表达的细胞百分比,IF法(73.77%)高于IHC法(60.71%)(P = 0.00026)。原位杂交检测显示出极好的一致性,一致性达90%或更高。使用两种ISH检测方法(FICTION和标准FISH)对病例进行ASCO/CAP组分类的一致性很高(85.7%)。病例最终分类(Her2阳性/阴性)的一致性为100%。 我们将HER2蛋白表达和基因拷贝数的标准检测方法与改良的FICTION方案进行了比较。研究表明,IHC和IF对Her2蛋白的一致性中等,FISH和FICTION ISH对基因拷贝数的一致性极好。最终的Her2状态不受低IF IHC一致性的影响。优化FICTION方案可改善结果。结合蛋白和基因检测可能会增强IBC患者的分层。
Medicina (Kaunas). 2025-6-11
Appl Immunohistochem Mol Morphol. 2009-1
Breast Cancer Res Treat. 2021-5
Health Technol Assess. 2006-9
Cochrane Database Syst Rev. 2022-3-2
Cochrane Database Syst Rev. 2016-3-1
Cochrane Database Syst Rev. 2021-4-19
N Engl J Med. 2024-12-5
Arch Pathol Lab Med. 2023-9-1
N Engl J Med. 2022-7-7
JAMA Oncol. 2022-4-1