We conducted a prospective observational study from 2006 to 2011. It included 607 patients with early-stage breast cancer and negative SLNB with a 5-year follow-up period.
The disease-free survival rate was 98.5% and 96.5% at 2 and 5 years, respectively. Multivariate analysis identified the following prognostic factors for disease recurrence: tumor necrosis (hazard ratio [HR], 4.89; 95% confidence interval [CI], 1.61-14.89; P = .005), lymphovascular invasion (HR, 3.46; 95% CI, 1.14-10.55; P = .029), T2 tumor size (HR, 4.35; 95% CI, 1.40-13.52; P = .011), and moderate to severe lymphoplasmacytic stromal infiltration (HR, 3.06; 95% CI, 1.18-7.96; P = .022).
Recurrence in patients with negative SLNB was satisfactorily low. Nevertheless, determining the prognostic factors related to a greater recurrence rate could help identify high-risk patients and influence systemic adjuvant therapy.