RESUMEN
PURPOSE: To investigate the impact of adding digital breast tomosynthesis (DBT) to full field digital mammography (FFDM) in screening asymptomatic women with an elevated breast cancer life time risk (BCLTR) but without known genetic mutation. METHODS: This IRB-approved single-institution multi-reader study on prospectively acquired FFDM + DBT images included 429 asymptomatic women (39-69y) with an elevated BC risk on their request form. The BCLTR was calculated for each patient using the IBISrisk calculator v8.0b. The screening protocol and reader study consisted of 4-view FFDM + DBT, which were read by four independent radiologists using the BI-RADS lexicon. Standard of care (SOC) included ultrasound (US) and magnetic resonance imaging (MRI) for women with > 30 % BCLTR. Breast cancer detection rate (BCDR), sensitivity and positive predictive value were assessed for FFDM and FFDM + DBT and detection outcomes were compared with McNemar-test. RESULTS: In total 7/429 women in this clinically elevated breast cancer risk group were diagnosed with BC using SOC (BCDR 16.3/1000) of which 4 were detected with FFDM. Supplemental DBT did not detect additional cancers and BCDR was the same for FFDM vs FFDM + DBT (9.3/1000, McNemar p = 1). Moderate inter-reader agreement for diagnostic BI-RADS score was found for both study arms (ICC for FFDM and FFDM + DBT was 0.43, resp. 0.46). CONCLUSION: In this single institution study, supplemental screening with DBT in addition to standard FFDM did not increase BCDR in this higher-than-average BC risk group, objectively documented using the IBISrisk calculator.