Cathepsin D, a lysosomal protease, was examined by immunohistochemistry in 481 breast carcinomas. The immunoreactivity for cathepsin D was registered in the tumour cells, in the surrounding stroma, and in the macrophages and correlated with clinicopathological parameters. In univariate analysis of survival data, less than 25% positive tumour cells, any positivity in the stroma, and moderate or strong positivity in the macrophages were poor prognostic parameters. In multivariate analysis, all three parameters were of independent prognostic significance; therefore a cathepsin D index was constructed. In multivariate analysis the cathepsin D index was also found to be of independent poor prognostic significance both in patients with and without lymph node metastases. Progesterone receptor status was an independent prognostic parameter in patients with lymph node metastases. From the present study we concluded that the cathepsin D index was a independent poor prognostic parameter.

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