Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/116436
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Type: Journal article
Title: Determining HER2 (ERBB2) amplification status in women with breast cancer: final results from the Australian in situ hybridisation program
Author: Morey, A.
Brown, B.
Farshid, G.
Fox, S.
Francis, G.
McCue, G.
von Neumann-Cosel, V.
Bilous, M.
Citation: Pathology, 2016; 48(6):535-542
Publisher: Elsevier
Issue Date: 2016
ISSN: 0031-3025
1465-3931
Statement of
Responsibility: 
Adrienne L.Morey, Belinda Brown, Gelareh Farshid, Stephen B.Fox, Glenn D.Francis, Glenda McCue, Vita von Neumann-Cosel, Michael Bilous
Abstract: Appropriate and accurate determination of HER2 status in women with breast cancer is critical for stratifying anti-HER2 therapies, and for access to subsidised treatment in the Australian setting. We conducted a regulated, nationwide program providing HER2 in situ hybridisation (ISH) testing for patients with newly diagnosed breast cancer. Cases with equivocal or non-diagnostic ISH test results at the local laboratory were sent to a high volume central testing laboratory for analysis using fluorescence ISH (FISH). We tested 78,408 early breast cancers and 3469 metastatic cancers using ISH. Of these, 12,405 early breast cancers (15.8%) and 798 metastatic cancers (23.0%) were HER2 positive. During the testing period, the proportion of core biopsy samples increased, the number of repeat tests remained stable and testing turnaround time declined. Discordant 3+ IHC, ISH negative results dropped from 20% to 13% in early breast cancers and from 35% to 8% among metastatic breast cancers. Following central laboratory FISH testing only 87 samples remained non-diagnostic (1.9% of FISH-tested samples, 0.1% of the whole cohort), most being decalcified specimens. This is a successful story of a cohesive service determining HER2 status in women with breast cancer in a 'real-world' setting.
Keywords: Breast cancer; HER2 genes; in situ hybridisation; immunohistochemistry; clinical laboratory techniques
Rights: © 2016 Royal College of Pathologists of Australasia. Published by Elsevier B.V. All rights reserved.
DOI: 10.1016/j.pathol.2016.05.007
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