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To enable individualized risk-oriented adjuvant treatment of breast cancer, validated parameters are needed to help evaluate the individual relapse risk. The clinical significance of these factors is assessed by published evidence (level of evidence) and its utility in the clinical setting (utility score). The traditional prognostic factors (age, TNM stage, grading, and steroid hormone receptor status are of established clinical relevance, and their determination should be obligatory. Of the "new" tumor-biologic parameters, only the measurement of the urokinase-type plasminogen activator (uPA) and its inhibitor (PAI-1) in the primary tumor of node-negative patients has been adequately validated and can therefore be recommended for clinical application. Promising recent prognostic markers are the expression of Her2/neu, detection of disseminated tumor cells in bone marrow aspirates, various different surrogates for proliferative activity, and tumor-specific gene expression profiles. Currently, however, the data available are insufficient to allow recommendation of the parameters for routine clinical use at this time.

Objective: In 90 patients with primary node-negative breast carcinomas we compared the prognostic impact of total S-phase fraction (SPF) and MIB1 proliferation rate (MIB1-PR) after a median follow-up of 34 months (9-72 months)., Methods: SPF was determined flow cytometrically and MIB1 (Ki-67) immunohistochemically in parallel-cut, paraffin-embedded tissue sections., Results: SPF was significantly correlated to tumor size and steroid hormone receptor status, MIB1-PR to grading. In univariate analysis both SPF and MIB1-PR were significant prognostic factors for disease-free survival. In multivariate analysis however, S-phase fraction was the only significant prognostic factor when compared to MIB1-PR, tumor size, steroid hormone receptor status, menopausal status, grading, lymph vessel invasion, and tumor necrosis., Conclusions: In our study SPF was of higher prognostic strength and may therefore be better suited for clinical application than MIB1-PR in node-negative breast cancer.