Growing BI-RADS category 3 lesions on follow-up breast ultrasound: malignancy rates and worrisome features.

  To determine the frequency and malignancy rate among growing Breast Imaging Reporting and Data System (BI-RADS) category 3 lesions diagnosed on follow-up breast ultrasound and to evaluate the radiological and clinical features associated with malignancy.  Methods:  Of the 38,482 women who underwent breast ultrasound between January 2010 and December 2011, 11,582 (30.1%) patients had 12,514 BI-RADS category 3 lesions. Patients whose lesions showed ≥20% enlargement on follow-up ultrasound were selected for this study. Radiological and clinical features including increase in the maximum diameter and anteroposterior dimension, morphological changes determined via ultrasound, palpability, multiplicity, new mass, baseline breast ultrasound indication and mammographic BI-RADS category were evaluated to determine their association with malignancy. Multivariate analyses were used to identify independent predictors of malignancy.  Results:  The frequency of growing BI-RADS category 3 lesions on follow-up ultrasound was 5.9% (738 of 12,514). Of 527 lesions examined in 459 patients with a follow-up duration of at least 24 months or with available pathological results, 26 proved to be malignant (4.9%). Multivariate analyses further indicated that sonographic morphological changes (OR, 7.662, p < 0.001) and development of suspicious features on follow-up mammography (OR, 3.812, p = 0.009) were associated with malignancy. Enlargement without associated suspicious mammography or sonographic morphological abnormalities had only 1.9 % (BI-RADS category 3) chance of malignancy.  Conclusion:  The malignancy rate for growing BI-RADS category 3 lesions is 4.9%. Sonographic morphological changes and suspicious mammographic features in these tumors are significantly associated with malignancy. Advances in knowledge: For lesions with an interval growth in the anteroposterior dimension of ≤50% without morphological changes, together with a benign mammogram, follow-up rather than an immediate biopsy can be recommended to reduce false-positive biopsy results. The risk of malignancy in lesions with a size increment but with no morphologic change on sonography is only 1.9%, compatible with continued BI-RADS category 3 classification.