Twenty-year results of the Naples GUN randomized trial: predictive factors of adjuvant tamoxifen efficacy in early breast cancer.

摘要: Purpose: Tamoxifen (TAM) is increasingly administered to new early breast cancer patients. Because it not devoid of toxic effects, we studied factors potentially predictive its efficacy. Experimental Design: From 1978 1983, 433 patients were enrolled in the GUN randomized trial: 206 assigned TAM versus 227 controls (no-TAM). Premenopausal with axillary lymph node involvement (60 65 no-TAM) also received nine CMF cycles. Eight biological markers retrospectively assayed for most patients: estrogen; progesterone; prolactin receptors (PrlRs); microvessel count (MVC); S-phase fraction; tumor ploidy; epidermal growth factor receptor (EGFR); and HER2. We performed a multivariate test TAM/covariate interactions establish whether these variables predicted Estimates effect expressed as hazard ratio (HR) death over no-TAM 95% confidence intervals (95% CIs). Results: At median follow-up 15 years, PrlRs, MVC, fraction, ploidy, EGFR did influence Differently, HER2 had an overall significant effect: HR = 0.59 CI: 0.40–0.87) HER2-negative subjects 1.09 0.63–1.87) HER2-positive (interaction test: P 0.04). The was evident subgroup steroid receptor-positive tumors (HER2 positive: 1.33, 0.70–2.51; negative: 0.73, 0.47–1.14). Conclusions: With statistical power present trial, S-phase, EGFR, PrlR, MVC do seem predict Conversely, our data support hypothesis that overexpressing might benefit from adjuvant TAM.