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Impact of the 2013 A merican S ociety of C linical O ncology/ C ollege of A merican P athologists guideline recommendations for human epidermal growth factor receptor 2 ( HER 2) testing of invasive breast carcinoma: a focus on tumours assessed as ‘equivocal’ for HER 2 gene amplification by fluorescence in‐situ hybridization
Aims The updated 2013 American Society of Clinical Oncology/College of American Pathologists ( ASCO / CAP ) human epidermal growth factor receptor 2 ( HER 2) testing guidelines include changes to HER 2 in‐situ hybridization ( ISH ) interpretation criteria. We conducted a retrospective review of a co...
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Published in: | Histopathology 2015-12, Vol.67 (6), p.880-887 |
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Main Authors: | , , , , , , |
Format: | Article |
Language: | English |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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Summary: | Aims
The updated 2013 American Society of Clinical Oncology/College of American Pathologists (
ASCO
/
CAP
) human epidermal growth factor receptor 2 (
HER
2) testing guidelines include changes to
HER
2
in‐situ
hybridization (
ISH
) interpretation criteria. We conducted a retrospective review of a consecutive cohort of primary breast carcinomas to assess the impact of updated guidelines on
HER
2 classification and laboratory resource utilization, and to characterize the pathobiology of
HER
2 equivocal tumours.
Methods and results
A total of 904 dual‐probe
HER
2/chromosome enumeration probe (
CEP
17)
FISH
tests on invasive breast carcinomas were studied. Eighty‐five (9.4%) cases had a classification change with the updated guidelines; 66 (7.3%) went from
HER
2‐negative to ‐equivocal, 15 cases (1.7%) were reclassified as
HER
2‐positive and four cases from
HER
2‐equivocal to ‐negative. A subset of primary breast cancers, reported initially as
HER
2‐negative but ‐equivocal by 2013 guidelines, was identified. Traditional pathological factors of this subset were compared to
HER
2‐negative and ‐positive control cases. The three
HER
2 groups demonstrated statistically significant differences with respect to prognostic factors, including tumour size, grade and nodal involvement.
Conclusions
The updated
HER
2 testing guidelines will result in the reclassification of approximately 9.4% of primary breast cancers with uncertainty regarding the clinical impact of this reclassification in the majority of cases. Resource utilization will increase as a result of the recommendation for retesting. |
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ISSN: | 0309-0167 1365-2559 |
DOI: | 10.1111/his.12723 |