Abstract
IntroductionThe prognostic significance of HER-2/neu in breast cancer is a matter of controversy. We have performed a study in 101 node-negative breast cancer patients with long-term follow-up not treated in the adjuvant setting, and analysed the prognostic significance of immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH), both separately and in combination, in comparison with traditional prognostic factors.MethodsOverexpression was classified semiquantitatively according to a score (0 to 3+) (HER-2_SCO). FISH was used to analyse HER2/neu amplification (HER-2_AMP). Patients classified 2+ by IHC were examined with FISH for amplification (HER-2_ALG). Patients with 3+ overexpression as well as amplification of HER-2/neu were positive for the combined variable HER2_COM. These variables were compared with tumour size, histological grade and hormone receptor status.ResultsHER-2_SCO was 3+ in 20% of all tumours. HER-2_ALG was positive in 22% and amplification (HER-2_AMP) was found in 17% of all tumours. Eleven percent of the tumours showed simultaneous 3+ overexpression and amplification. Only histological grade (relative risk [RR] 3.22, 95% confidence interval [CI] 1.73–5.99, P = 0.0002) and HER-2_AMP (RR 2.47, 95% CI 1.12–5.48, P = 0.026) were significant for disease-free survival in multivariate analysis. For overall survival, both histological grade (RR 3.89, 95% CI 1.77–8.55, P = 0.0007) and HER-2_AMP (RR 3.08, 95% CI 1.24–7.66, P = 0.016) retained their independent significance.ConclusionThe prognostic significance of HER-2/neu in node-negative breast cancer depends on the method of testing: only the amplification of HER-2/neu is an independent prognostic factor for the long-term prognosis of untreated node-negative breast cancer.
Highlights
Introduction The prognostic significance ofHER-2/neu in breast cancer is a matter of controversy
Because the administration of adjuvant systemic therapy was not allowed in this study, we focused on node-negative breast cancer patients with pT1 and pT2 tumours and without any evidence of metastasis at the time of surgery
HER-2/neu overexpression classified as 3+ as assessed by IHC was found in 20% (HER2_SCO); 17% of tumours showed an amplification of HER-2/neu by fluorescence in situ hybridisation (FISH) (HER2_AMP)
Summary
Introduction The prognostic significance ofHER-2/neu in breast cancer is a matter of controversy. We have performed a study in 101 node-negative breast cancer patients with longterm follow-up not treated in the adjuvant setting, and analysed the prognostic significance of immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH), both separately and in combination, in comparison with traditional prognostic factors. The adverse prognostic impact of HER-2/neu in breast cancer was the main focus of research. Studies that supported the initially reported adverse prognosis in breast cancer [1,3] were later followed by reports that failed to show any association with prognosis [4,5]. The response of HER-2/neu-positive breast cancer patients to tamoxifen is significantly worse than for HER-2/neu-negative patients [6,7] even though this point of view is not unopposed [8,9]. It was shown that aromatase inhibitors might provide more benefit than tamoxifen in patients with tumours positive for erbB-1 and/or erbB-2 [10]
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