Outcomes of High-Risk Breast MRI Screening in Women Without Prior History of Breast Cancer: Effectiveness Data from a Tertiary Care Center.

Objective: To evaluate the diagnostic performance outcomes of a breast MRI screening program in high-risk women without prior history of breast cancer.

Methods: Retrospective cohort study of 1 405 consecutive screening breast MRI examinations in 681 asymptomatic women with high risk of breast cancer without prior history of breast cancer from January 1, 2015, to December 31, 2019. Outcomes (sensitivity, specificity, positive predictive value, negative predictive value, false-negative rate [FNR], cancer detection rate [CDR]) and characteristics of cancers were determined based on histopathology or 12-month follow-up. MRI examinations performed, BI-RADS assessments, pathology outcomes, and CDRs were analyzed overall and by age decade. Results in incidence screening round (MRI in last 18 months) and nonincidence round were compared.

Results: Breast MRI achieved CDR 20/1000, sensitivity 93.3% (28/30), and specificity 83.4% (1 147/1375). Twenty-eight (28/1 405, CDR 20/1000) screen-detected cancers were identified: 18 (64.3%, 18/28) invasive and 10 (35.7%, 10/28) ductal carcinoma in situ. Overall, 92.9% (26/28) of all cancers were stage 0 or 1 and 89.3% (25/28) were node negative. All 14 incidence screening round malignancies were stage 0 or 1 with N0 disease. Median size for invasive carcinoma was 8.0 mm and for ductal carcinoma in situ was 9.0 mm. There were two false-negative exams for an FNR 0.1% (2/1 405).

Conclusion: High-risk screening breast MRI was effective at detecting early breast cancer and associated with favorable outcomes.