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

Objective: 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).

Conclusions: In East Asia, screening automated breast US may be an alternative to screening mammography for detecting breast cancers in women aged 40-49 years. Conclusions: • 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/m2 had a higher recall rate.