AIHTA - Publications - Search - Testing for HER2 positive breast cancer. Challenge for improvement of current conditions and practice

Korencan, A. and Guba, B. and Wild, C. (2007): Testing for HER2 positive breast cancer. Challenge for improvement of current conditions and practice. HTA-Projektbericht 08.

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Background: The availability of a targeted therapeutic antibody (trastuzumab) for HER2 positive tumours stresses the necessity to identify patients reliably who might benefit from trastuzumab treatment not only important for clinical reasons - positive clinical effects, but severe adverse events with grade 3 or 4 cardiotoxicity - but also for economic ones because of the high treatment costs. The research question is: What is the gold standard for diagnosing HER2 positive tumours? Which is the most accurate and reproducible method to find out the candidates for potential therapy with monoclonal antibodies, and are the applied tests reliable for selecting HER2 positive patients?

Method: Systematic review of studies on questions of validity and standardization of the 2 most commonly used methods IHC (immuno histochemistry) and FISH (fluorescence in situ hybridization), furthermore the inter-observer and the inter-laboratory concordance the diagnosis of borderline results.

Results: The review discusses - systematically - the HER2 testing results of more than 23 000 specimens, achieved in local, central or reference laboratories. IHC results show much greater variability than FISH test results, particularly for the FISH negative cases. The results of most presented studies indicate that high-level HER2 amplification and an IHC score of 3+ will identify HER2 positive breast carcinoma; the low-level amplification and/or IHC score of 2+ should be carefully interpreted. There is agreement that the most (cost-)effective testing strategy is to screen all patients with IHC, followed by FISH for IHC of 2+ (or of 2+ and 3+). Findings concerning different results from local/central laboratories point at moderate inter-observer and inter-laboratory reliability of test results. A volume/experience relationship is observed.

Item Type:Project Report
Keywords:HER2 testing, diagnosis, laboratory techniques, biochemic methods, diagnostic tests, fluorescence in situ hybridization/hybridisation (FISH), immunohistochemistry (IHC), breast cancer, women
Subjects:WP Gynaecology > WP 800-910 Breast
WA Public health > WA 309 Women´s health
QY Clinical pathology
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Series Name:HTA-Projektbericht
Deposited on:14 Jan 2008 18:21
Last Modified:15 Jul 2020 17:34

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