Assessing HER2 amplification in breast cancer: findings from the Australian In Situ Hybridization Program

Bilous, Michael, Adrienne L. Morey, Armes, Jane E., Bell, Richard, Button, Peter H., Cummings, Margaret C., Fox, Stephen B., Francis, Glenn D., Waite, Brigid, McCue, Glenda, Raymond, Wendy A., Robbins, Peter D. and Farshid, Gelareh (2012) Assessing HER2 amplification in breast cancer: findings from the Australian In Situ Hybridization Program. Breast Cancer Research and Treatment, 134 2: 617-624. doi:10.1007/s10549-012-2093-6

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Author Bilous, Michael
Adrienne L. Morey
Armes, Jane E.
Bell, Richard
Button, Peter H.
Cummings, Margaret C.
Fox, Stephen B.
Francis, Glenn D.
Waite, Brigid
McCue, Glenda
Raymond, Wendy A.
Robbins, Peter D.
Farshid, Gelareh
Title Assessing HER2 amplification in breast cancer: findings from the Australian In Situ Hybridization Program
Journal name Breast Cancer Research and Treatment   Check publisher's open access policy
ISSN 0167-6806
Publication date 2012-07
Sub-type Article (original research)
DOI 10.1007/s10549-012-2093-6
Volume 134
Issue 2
Start page 617
End page 624
Total pages 8
Place of publication New York, United States
Publisher Springer
Collection year 2013
Language eng
Abstract In August 2006, the Australian government approved subsidized trastuzumab therapy for human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, and it was mandated that HER2 testing should be performed using in situ hybridization (ISH) rather than immunohistochemistry (IHC). Here we review results of the first regulated, nationwide program to provide HER2 ISH testing for all newly diagnosed breast cancer patients, with a particular emphasis on cases where IHC and ISH results were discordant. Data from all laboratories participating in the program were collated. Cases with an equivocal ISH test result [by chromogenic ISH (CISH) or silver ISH (SISH)] were tested centrally by fluorescence ISH. Most laboratories also performed HER2 IHC, and 200 cases with discordant IHC and ISH results were selected for further analysis in a central laboratory. A total of 26 laboratories were involved and 53,402 tests were reported. Over a 4-year period the HER2 positivity rate decreased for primary cancers from 23.8 to 14.6 %, but remained relatively constant for samples from metastases. Average ISH reporting times were <5 days for all yearly reporting periods. Test-repeat rates decreased for CISH (8.9–3.6 %) and SISH (13.7–8.4 %). Only 12 of 196 cases remained discordant after retesting in a central laboratory. These findings demonstrate the successful implementation of a regulated, national program that continues to collect data on HER2 status. The results also highlight the differences in IHC interpretation between local laboratories and a central, more experienced, laboratory. This model could be used to establish future biomarker-testing programs in other countries.
Keyword Breast cancer
HER2 Genes
In situ hybridization
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: UQ Centre for Clinical Research Publications
Official 2013 Collection
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 12 times in Thomson Reuters Web of Science Article | Citations
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Created: Fri, 29 Jun 2012, 14:37:16 EST by Matthew Lamb on behalf of School of Medicine