Breast Imaging Reporting and Data System Category 3 Lesions Detected on Whole-Breast Screening Ultrasound.

PURPOSE: This study assessed the incidence and cancer rate of probably benign lesions detected on bilateral whole-breast screening ultrasound (US), which corresponded to US Breast Imaging Reporting and Data System (BI-RADS) category 3, and evaluated the proper management of those lesions.

METHODS: This study was approved by the Institutional Review Board in our institution, which waived informed patient consent. We retrospectively reviewed US images of 1,666 patients who underwent bilateral whole-breast screening US as a supplemental screening test to negative screening mammography or screening US only. The incidence, clinical course, and cancer rate of screening US-detected probably benign lesions corresponding to US BI-RADS category 3 were investigated, and the size and multiplicity of screening US-detected category 3 lesions were evaluated.

RESULTS: Probably benign lesions corresponding to US BI-RADS category 3 were detected in 689 of 1,666 patients (41.4%) who underwent screening US. Among them, 653 had follow-up US images for at least 24 months, and among these 653, 190 (29.1%) had multiple bilateral category 3 lesions. Moreover, 539 of 1,666 patients (32.4%) had lesions ≤1 cm in size and 114 of 1,666 (6.8%) had lesions >1 cm (median, 0.82 cm; range, 0.3-4.2 cm). Four of the 653 patients (0.6%) showed suspicious interval changes and were categorized into BI-RADS category 4. Biopsy analysis confirmed only one lesion as invasive ductal carcinoma at the 6-month follow-up; another lesion was an intraductal papilloma and the remaining two were fibroadenomas. Overall cancer rate of the screening US-detected BI-RADS category 3 lesions was 0.2%.

CONCLUSION: The incidence of category 3 lesions detected on screening US only was very high, but the cancer rate was very low. Therefore, in an average-risk population, routine screening US is preferable over short-term follow-up for BI-RADS category 3 lesions detected on whole-breast screening US.