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https://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 |
DOI: | 10.1097/PAS.0b013e318244adbb |
Published version: | http://dx.doi.org/10.1097/pas.0b013e318244adbb |
Appears in Collections: | Aurora harvest Pathology publications |
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