Background: The aim of the present study was to evaluate a series of biomarkers with regard to long-term prognostic value in patients with T1 (≤2 cm) node-negative breast cancer. Method: The prognostic value of Ki-67, p53, oestrogen receptor (ER) immunohistochemical labelling, flow-cytometric S phase fraction and ploidy was evaluated in 212 patients with pT1N0M0 breast cancer. The median follow-up time was 15.9 years (range 0.2–27.2 years). Results: In an analysis of breast cancer-specific survival up to 5 years, high Ki-67 (≧10%; p = 0.002), high p53 (≧20%; p = 0.01), negative ER (<30%; p = 0.01) as well as aneuploidy of the tumour (p = 0.02) were significant prognostic factors. When the follow-up was extended to 10 years, only Ki-67 (p = 0.03) was significantly associated with outcome and beyond 15 years none of the studied markers provided significant prognostic information when analyzed separately. There was a weak but significant difference in long-term survival when patients with a combination of high Ki-67 (≧10%), high SPF (>3%) and high p53 (≧20%) were compared to patients with other combinations (p = 0.03). Conclusion: According to the results of our series, it seems that several prognostic markers which are associated with short-term survival (≤5 years) in pT1N0M0 breast cancer may not be significant predictors of long-term (>15 years) breast cancer-specific survival.

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