Validation of minimal risk of recurrence classification by the Breast Cancer Index in early stage breast cancer

Abstract

The Breast Cancer Index (BCI) was previously shown to identify similar to 20% of postmenopausal patients with early stage, hormone receptor positive (HR+), node negative (N0) breast cancer with minimal (<5%) risk of 10-year distant recurrence (DR) even without receiving adjuvant endocrine therapy (ET). This prospective-retrospective study further validated the BCI minimal risk classification in postmenopausal patients with early-stage, HR + HER2- N0 breast cancer from the Netherlands Cancer Registry (NCR) and the Tamoxifen and Exemestane Adjuvant Multinational (TEAM, NCT00279448, NCT00032136) randomized trial who received 5 years of primary adjuvant ET. BCI classified approximately 15% of patients as minimal risk. In the NCR cohort (n = 1264 out of 15,053 HR+ patients in the registry), risks of DR in the minimal, low, intermediate, and high groups were 4.8%, 3.3%, 8.0%, and 12.4%, respectively (P < 0.001). In the TEAM cohort (n = 978 out of 3544 in the BCI study), DR risks were 3.8%, 8.3%, 12.6% and 22.7% (P < 0.001). In multivariate analyses, BCI risk scores provided independent information over standard prognostic factors (P < 0.001). This study confirmed the ability of the adjusted BCI model to identify postmenopausal women with HR + HER2- N0 breast cancer who are at minimal risk of DR and may consider de-escalating adjuvant ET.