BACKGROUND: The rapidly growing knowledge regarding factors controlling tumour growth, with the new modalities of therapy acting on the biological activity of the tumours draw the attention of most cancer researches nowadays and represent a major focus for clinical oncology practice. For the detection of HER2/neu protein overexpression and gene amplification, immunohistochemistry (IHC) and in-situ hybridisation (ISH) is the recommended techniques, respectively, with high concordance between the two techniques. The current United Kingdom recommendations for HER2/neu testing are either for a two-tier system using IHC with reflex ISH testing in equivocal positive cases, or a one-tier ISH strategy. AIM: To compare the results of HER2/neu gene status in patients with breast carcinoma obtained by chromogenic in situ hybridisation with those obtained by immunohistochemistry, and to compare these results with hormonal receptors expression by immunohistochemistry and with age of patients.METHODS: Immunohistochemistry technique was used for evaluation of status of estrogen receptors (ER) and progesterone receptors (PR) and HER2/neu protein expression in 448 Iraqi patients with invasive breast carcinoma with different grades and histological types and then chromogenic in situ hybridization (CISH) technique was applied for all scores of HER2/neu to detect the gene status and compare the results in all negative, equivocal and positive cases by immunohistochemistry (IHC). The cases were referred from different centres, and IHC and CISH techniques were done in central public health laboratory in Baghdad over 28 months, from July 2013 to November 2015. A comparison of the results was made to find the relationship between HER2/neu and hormone receptors status and other clinical parameters like patients age. RESULTS: The mean age of the study cases was 49.08 years, ranging from 24 to 83 years. Of the 448 cases of breast carcinoma, 44 (9.8%) cases were of score 0 by IHC, none of them (0%) showed HER2/neu gene amplification by CISH. 71(15.8%) cases were of score 1 by IHC, 15 (21.12%) of them showed HER2/neu gene amplification by CISH, all were of low amplification. There were 306 (68.3%) cases of score 2 by IHC, of which 102 (33.33%) cases showed HER2/neu gene amplification by CISH, with 79 (25.81%) of them with low amplification and 23 (7.51%) cases with high amplification, while only one case (0.32%) remained in equivocal category. In score 3, all the 27 (6.0%) cases showed gene amplification with 12 (44.44%) cases with low amplification and 15 (55.55) cases with high amplification with overall percentage of gene amplification in score 3 of 100%. There was a significant inverse relationship between hormone receptors (ER and PR) status and HER2/neu gene amplification. No significant relationship was found between the patient’s age and HER2/neu gene amplification.CONCLUSION: Although immunohistochemistry is a widely used, less expensive and reliable test, we strongly advice performance of chromogenic in situ hybridization in assessment of HER2/neu gene status in all cases diagnosed with breast carcinoma as significant number of cases that were reported as negative by immunohistochemistry showed positive amplification by chromogenic in situ hybridization and can get benefit from anti-HER2 targeted treatments.
