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Background   Her2/neu  is an oncogene that plays an important role in the pathogenesis of many cancer types. In bladder carcinoma (BC), the clinical significance of  Her2/neu  status remains under-investigated and poorly linked to the patients’ clinic-pathological features and survival status. Thus, the current study was conducted to assess  Her2/neu  status in a cohort of patients’ in Saudi Arabia, and to explore its prognostic value in BC.    Methods  A total of 160 consent patients of transitional cell carcinoma (TCC) of bladder were arranged on a tissue microarray (TMA) and stained by immunohistochemistry (IHC) and bright-field dual in situ hybridization (BDISH) methods. The intensity of Her2/neu protein receptor immunostaining was evaluated, correlated to  Her2/neu  gene amplification status in TCC and assessed for potential clinical value by correlation measures.    Results  IHC data demonstrated that Her2/neu protein is expressed in 60 % (2+ and 3+) of our TCC patient’s cohort from Saudi Arabia.  Her2/neu  gene amplification is detected in 25 % by BDISH. There was a strong association between Her2/neu protein levels and lymph node invasion ( p  = 0.04), tumor stage ( p  = 0.002), vascular invasion and borderline significance with distant metastasis ( p  = 0.07). Amplification of  Her2/neu  gene was associated with tumor grade ( p  = 0.03) and poor disease-specific survival ( p  = 0.02), in that, patients with non-amplified  Her2/neu  gene live longer. Interestingly, there was a reasonable concordance rate (71 %) between IHC and BDISH data in the analyzed cohort.    Conclusion  The study showed that 25 % of our patients’ cohort has Her2/neu over-expression. This  Her2/neu  (over-expression/amplification) status was concordant using either IHC or BDISH and significantly associated with disease aggressiveness and poor outcome. These findings suggested a potential impact of anti-Her2 targeted therapy in the treatment of bladder cancer with amplified/overexpressed HER2 that needs further investigation.

Prognostic value of HER2 status in bladder transitional cell carcinoma revealed by both IHC and BDISH techniques