Journal
EUROPEAN JOURNAL OF CANCER
Volume 42, Issue 17, Pages 2946-2953Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.ejca.2006.06.020
Keywords
breast cancer; HER-2/neu; immunohistochemistry; inter-observer reproducibility; quality assurance; ring study
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The accurate determination of HER-2 in invasive breast cancer has become a critical issue, particularly in the context of the results of recent trastuzurriab (Herceptin (R)) adjuvant trials. This multicentre study evaluated inter-observer reproducibility in interpretation of HER-2 immunostains performed in different laboratories according to their in-house technique. A total of 74 HER-2 immunostains were evaluated by 16 pathologists and by a central review committee. As determined by central review, the HER-2 score was 0 in 33 cases (44%), 1+ in 10 cases (13%), 2+ in 9 cases (12%) and 3+ in 23 cases (31%). The overall kappa value was good (kappa = 0.75). Agreement was excellent for the 0/1+ group (kappa = 0.85) and for the 3+ group (kappa = 0.82). As expected, the score 2+ group showed poor agreement (kappa = 0.38). A quality assurance process showed that ring studies and adherence to national guidelines greatly improve inter-observer reproducibility. (c) 2006 Elsevier Ltd. All rights reserved.
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