We examined the expression of Her2/neu and Cox-2 in bladder cancer and its relationship to clinicopathological factors, survival data and patient outcome. From 153 consecutive patients who had undergone radical cystectomy for bladder cancer, tumour tissue was analysed for Her2/neu amplification by fluorescent in situ hybridisation and for Her2/neu and Cox-2 protein expression by immunohistochemistry. Results were correlated with clinical data and survival times. Cox-2 and Her2/neu co-expression was present in 44 (33%) of 132 transitional cell carcinomas. Although this association was significant (p=0.003), there was no significant association between Cox-2 and Her2/neu amplification status. Each marker was independent of primary tumour stage and lymph node status, as well as histological grading. However, the co-existence of Her2/neu amplification and Cox-2 expression correlated with distant metastases: of 5 Cox-2-positive samples, 2 (40%) showed Her2/neu amplification. This was only a trend, amounting to no more than borderline statistical significance (p=0.046). Kaplan-Meier survival analysis did not demonstrate any relationship between Cox-2 or Her2/neu expression or amplification alone or in combination with respect to overall and disease-free survival. Analysing the co-expression of Cox-2 and Her2/neu status does not add any prognostic information in patients with bladder cancer. Nevertheless, combined treatment with Her2/neu and Cox-2 inhibitors may be beneficial for the subgroup of Her2/neu- and Cox-2-expressing tumours and will have to be assessed in further preclinical and clinical studies.

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