Summary
This Australian human epidermal growth factor receptor 2 (HER2) testing program aimed
to analyse >800 cases tested in a coordinated setting to further evaluate the criteria
to establish HER2 status in advanced gastric and gastro-oesophageal junction (GOJ)
cancer. Heterogeneity, and minimum number of biopsy fragments for reliable HER2 assessment
were also examined in a subset of samples.
Five laboratories tested 891 samples referred to determine HER2 status for potential
anti-HER2 treatment. Cancer site, specimen type (endoscopic biopsy/resection/metastases),
immunohistochemistry (IHC) score, HER2 gene and CEP17 copy number (CN) and HER2:CEP17
ratios were recorded. Samples were derived from stomach (53.1%), GOJ (28.2%) or metastases
(18.5%). IHC for HER2 and dual probe HER2:CEP17 in situ hybridisation (ISH) were performed in parallel. A stringent definition (SD) of HER2
positivity was used (IHC2+/3+ plus CN>6 and ratio>2) and compared with other published
criteria.
HER2 positive rate was 13.9% (114/820) by SD, and 12.9–16.0% using other definitions.
There was higher concordance between IHC and HER2 CN by ISH than with ratio. The HER2
positive rate was significantly higher in GOJ samples than others (p = 0.03) and in endoscopic biopsies than resections (p = 0.047). In a subset of 98 positive cases, 39 (39.8%) showed heterogeneity, and
in 282 endoscopic biopsies positivity rate plateaued at five tumour fragments, suggesting
this is the minimum number of biopsies that should be examined.
Key words
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Article info
Publication history
Published online: August 17, 2017
Accepted:
May 21,
2017
Received in revised form:
May 15,
2017
Received:
February 27,
2017
Identification
Copyright
© 2017 Royal College of Pathologists of Australasia. Published by Elsevier B.V. All rights reserved.