Xue-Xue Xiao, Peng-Fei Xu, Ming-Wei Wang, Su Jin, Na Fang, Jun-Qiu Yue
{"title":"Study on Different Staining Platforms for HER2 Cytoplasmic Granular Staining Pattern in Pure Apocrine Carcinoma of the Breast.","authors":"Xue-Xue Xiao, Peng-Fei Xu, Ming-Wei Wang, Su Jin, Na Fang, Jun-Qiu Yue","doi":"10.1016/j.clbc.2025.07.016","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Accurate interpretation of HER2 low/ultralow expression has attracted increasing attention. This study aimed to explore the characteristics and interpretation strategies for the HER2 cytoplasmic granular staining pattern observed in pure apocrine carcinoma (AC), while investigating its impact on the interpretation of HER2 low/ultra-low expression cases.</p><p><strong>Methods: </strong>The clinicopathologic information of 74 patients with pure AC and their previous HER2 (PATHWAY 4B5, Ventana platform) IHC results were retrospectively collected. All enrolled cases underwent Dako HER2 (HercepTest [poly]) IHC staining, among which 43 cases were further subjected to FISH testing. Clinical targeted drug information was collected concurrently.</p><p><strong>Results: </strong>Previous PATHWAY 4B5 staining revealed punctate and/or diffuse cytoplasmic granular staining in 35.14% (26/74) of pure AC. In contrast, only 9 cases (12.16%, 9/74) of HercepTest staining exhibited cytoplasmic granular staining, all of which belonged to the PATHWAY 4B5 cytoplasmic granular staining subset (34.62%, 9/26). HercepTest IHC interpretation demonstrated 89.19% (66/74) concordance with PATHWAY 4B5 interpretations. Furthermore, 88.46% (23/26) of PATHWAY 4B5 cytoplasmic granular staining cases exhibited concordant interpretations between both antibody platforms. 44.59% (33/74) were HER2-positive, and 55.41% (41/74) were triple-negative apocrine carcinoma (TNAC). About 18.19% (6/33) of HER2-positive cases and 48.78% (20/41) of TNAC cases showed cytoplasmic granular staining on PATHWAY 4B5, and 95.00% (19/20) of the latter cases were HER2 low expression.</p><p><strong>Conclusions: </strong>Pure ACs on the PATHWAY 4B5 platform primarily present HER2 cytoplasmic granular staining in TNAC and HER2 low expression cases. The rate of HER2 cytoplasmic granular staining on HercepTest platform was significantly lower than that of PATHWAY 4B5, and is more suitable for the detection and interpretation of HER2 0 and low expression cases.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.5000,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical breast cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.clbc.2025.07.016","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Objective: Accurate interpretation of HER2 low/ultralow expression has attracted increasing attention. This study aimed to explore the characteristics and interpretation strategies for the HER2 cytoplasmic granular staining pattern observed in pure apocrine carcinoma (AC), while investigating its impact on the interpretation of HER2 low/ultra-low expression cases.
Methods: The clinicopathologic information of 74 patients with pure AC and their previous HER2 (PATHWAY 4B5, Ventana platform) IHC results were retrospectively collected. All enrolled cases underwent Dako HER2 (HercepTest [poly]) IHC staining, among which 43 cases were further subjected to FISH testing. Clinical targeted drug information was collected concurrently.
Results: Previous PATHWAY 4B5 staining revealed punctate and/or diffuse cytoplasmic granular staining in 35.14% (26/74) of pure AC. In contrast, only 9 cases (12.16%, 9/74) of HercepTest staining exhibited cytoplasmic granular staining, all of which belonged to the PATHWAY 4B5 cytoplasmic granular staining subset (34.62%, 9/26). HercepTest IHC interpretation demonstrated 89.19% (66/74) concordance with PATHWAY 4B5 interpretations. Furthermore, 88.46% (23/26) of PATHWAY 4B5 cytoplasmic granular staining cases exhibited concordant interpretations between both antibody platforms. 44.59% (33/74) were HER2-positive, and 55.41% (41/74) were triple-negative apocrine carcinoma (TNAC). About 18.19% (6/33) of HER2-positive cases and 48.78% (20/41) of TNAC cases showed cytoplasmic granular staining on PATHWAY 4B5, and 95.00% (19/20) of the latter cases were HER2 low expression.
Conclusions: Pure ACs on the PATHWAY 4B5 platform primarily present HER2 cytoplasmic granular staining in TNAC and HER2 low expression cases. The rate of HER2 cytoplasmic granular staining on HercepTest platform was significantly lower than that of PATHWAY 4B5, and is more suitable for the detection and interpretation of HER2 0 and low expression cases.
期刊介绍:
Clinical Breast Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of breast cancer. Clinical Breast Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of breast cancer. The main emphasis is on recent scientific developments in all areas related to breast cancer. Specific areas of interest include clinical research reports from various therapeutic modalities, cancer genetics, drug sensitivity and resistance, novel imaging, tumor genomics, biomarkers, and chemoprevention strategies.