Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/76388
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Type: Journal article
Title: Gastric HER2 Testing Study (GaTHER): An Evaluation of Gastric/Gastroesophageal Junction Cancer Testing Accuracy in Australia
Author: Fox, S.
Kumarasinghe, M.
Armes, J.
Bilous, M.
Cummings, M.
Farshid, G.
Fitzpatrick, N.
Francis, G.
McCloud, P.
Raymond, W.
Morey, A.
Citation: American Journal of Surgical Pathology, 2012; 36(4):577-582
Publisher: Lippincott Williams & Wilkins
Issue Date: 2012
ISSN: 0147-5185
1532-0979
Statement of
Responsibility: 
Stephen B. Fox, Marian Priyanthi Kumarasinghe, Jane E. Armes, Michael Bilous, Margaret C. Cummings, Gelareh Farshid, Nicole Fitzpatrick, Philip I. McCloud, Wendy Ann Raymond and Adrienne Morey
Abstract: rastuzumab provides a survival benefit in patients with human epidermal growth factor receptor 2 (HER2)-amplified/overexpressed advanced gastric and gastroesophageal junction cancers (GC/GJCs). However, the optimal method for testing is unclear. The aim of this study was to assess interlaboratory agreement on HER2 scoring in GC/GJC to aid the development of a robust testing algorithm for diagnostic practice in Australia. Nine laboratories assessed the HER2 status of 100 GC/GJC tissue samples by immunohistochemistry (IHC) and in situ hybridization (ISH) [chromogenic (CISH) or silver (SISH)] using both HER2 copy number and HER2:chr17 (chromosome 17) ratio. Results were compared with reference fluorescence ISH (FISH). Interlaboratory agreement on IHC3+ scoring was good ([kappa]=0.76), and there was good/very good agreement between IHC (positivity defined as IHC3+) and ISH when HER2 copy number was used ([kappa]=0.72 to 0.87). Agreement on CISH/SISH scoring was good/very good when HER2 copy number was used ([kappa]=0.68 to 0.86), and agreement between CISH/SISH and FISH using HER2 copy number was very good ([kappa]=0.88 to 0.91). Agreement was reduced when HER2:chr17 ratio was used. The good agreement for HER2 copy number determined by bright-field ISH suggests that this is the optimal method for testing in GC/GJC cases. An IHC3+ score was strongly predictive of a positive ISH result, although agreement for all IHC scores was only moderate, suggesting that IHC triage before ISH testing would be the most cost-effective strategy. However, because of the unique features of GC/GJC samples and the difficulty of ensuring consistent HER2 staining in the community setting, it is recommended that HER2 status in advanced GC/GJC be determined by both IHC and ISH in the same laboratory.
Keywords: HER2; immunohistochemistry; in situ hybridization; gastric cancer; trastuzumab
Rights: © 2012 by Lippincott Williams & Wilkins
RMID: 0020118228
DOI: 10.1097/PAS.0b013e318244adbb
Appears in Collections:Pathology publications

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