Automated breast US as the primary screening test for breast cancer among East Asian women aged 40–49 years: a multicenter prospective study

Objectives: To prospectively evaluate the diagnostic performance of screening ABUS as the primary screening test for breast cancer among Korean women aged 40–49 years. Methods: This prospective, multicenter study included asymptomatic Korean women aged 40–49 years from three academic centers between February 2017 and October 2019. Each participant underwent ABUS without mammography, and the ABUS images were interpreted at each hospital with double-reading by two breast radiologists. Biopsy and at least 1 year of follow-up was considered the reference standard. Diagnostic performance of ABUS screening and subgroup analyses according to patient and tumor characteristics were evaluated. Results: Reference standard data were available for 959 women. The recall rate was 9.8% (95% confidence interval [CI]: 7.9%, 11.7%; 94 of 959 women) and the cancer detection yield was 5.2 per 1000 women (95% CI: −0.6, 11.1; 5 of 959 women). There was only one interval cancer. The sensitivity was 83.3% (95% CI: 53.5%, 100%; 5 of 6 cancers) and the specificity was 90.7% (95% CI: 88.8%, 92.5%; 864 of 95. women). The positive predictive values of biopsies performed (PPV₃) was 20.0% (95% CI: 4.3%, 35.7%; 5 of 25 women). Women with heterogeneous background echotexture had a higher recall rate (p =.009) and lower specificity (p =.036). Women with body mass index values < 25 kg/m² had a higher mean recall rate (p =.046). Conclusion: In East Asia, screening automated breast US may be an alternative to screening mammography for detecting breast cancers in women aged 40–49 years. Key Points: • Automated breast US screening for breast cancer in asymptomatic women aged 40–49 is effective with 5.2 per 1000 cancer detection yield. • Women with heterogeneous background echotexture had a higher recall rate and lower specificity. • Women with body mass index < 25 kg/m²had a higher recall rate.