Abstract
BackgroundThe concordance rate between IHC and FISH according to clinical performance is still controversial. We report a prospective study to reflect the concordance between IHC and FISH in Guilin city, People's Republic of China.MethodsFifty cases of invasive ductal carcinoma of breast tested by IHC and scored as 0, 1+, 2+ and 3+ by pathologists were further analyzed by FISH using a commercially available double-color probe, and the FISH findings were compared with IHC test results.ResultsA total concordance of 82.0% was observed with a Kappa coefficient of 0.640 (P < 0.001). A high discordance was observed in 30.0% of the patients with IHC 2+, 7.1% in IHC 3+, 19.2% overall in IHC 0 and 1+.ConclusionThe IHC can be used firstly to screen the HER-2 status, and FISH can be used as a supplementary role to IHC and 2+ and some negative cases. And only those cases with Her-2 status of IHC 3+ or FISH positive should be treated with Herceptin.
Highlights
The concordance rate between IHC and fluorescence in situ hybridization (FISH) according to clinical performance is still controversial
Five of the IHC 0 and 1+ cases, seven of the 10 IHC 2+ cases and 13 of the 14 IHC 3+ cases were found to be Her2 FISH positive. They had a total concordance of 82.0% and a Kappa coefficient of 0.640 (P < 0.001), which was defined as IHC 2+/3+ and human epidermal growth factor receptor-2/neu (Her-2) FISH positive, or IHC 0/ 1+ and Her-2 FISH negative
Discordance was defined as a discrepancy between the IHC and Her-2 FISH, including the following two conditions: (1) IHC 2+ or 3+ but Her-2 FISH negative; (2) IHC
Summary
The concordance rate between IHC and FISH according to clinical performance is still controversial. We report a prospective study to reflect the concordance between IHC and FISH in Guilin city, People's Republic of China. The incidence of breast cancer in China is 20 per 100,000 population, and the incidence is growing [2]. The benefit of humanized anti-Her-2 monoclonal antibody trastuzumab (Herceptin) in Her-2-positive breast cancers has been well documented as noted by prolonged survival [8]. This therapy is effective only if the detection of Her-2 status is accurate
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