Frequency of malignancy seen in probably benign lesions at contrast-enhanced breast MR imaging: findings from ACRIN 6667.

PURPOSE To determine the frequency of malignancy in probably benign lesions seen at magnetic resonance (MR) screening of the contralateral breast in patients with known breast cancer enrolled in American College of Radiology Imaging Network (ACRIN) protocol 6667. MATERIALS AND METHODS ACRIN conducted a prospective multi-institutional MR imaging screening trial of the contralateral breast in women in whom breast cancer had been diagnosed recently. Each participating institution obtained institutional review board approval before patient accrual and was compliant with HIPAA. Informed consent was obtained from the patients. At enrollment, all women had negative clinical breast examination results and negative mammograms of the study breast. At image interpretation, radiologists scored lesions by using the Breast Imaging and Reporting and Data System (BI-RADS) lexicon. Of the 969 women who comprised the final study group, 106 were classified as having a BI-RADS category 3 lesion as their highest scoring lesion at MR imaging. There were 145 BI-RADS category 3 lesions in 106 patients. RESULTS In the 106 patients with at least one BI-RADS category 3 lesion, there were 37 masses (25.5%), 59 areas of nonmass enhancement (40.7%), and 47 foci of enhancement (32.4%). In two (1.4%) of these patients, no findings were reported. Eighty-three (78.3%) of the 106 patients had no evidence of malignancy in the study breast after 2 years of follow-up; the remaining 23 (21.7%) received a tissue diagnosis. Seventeen (16.0%) of the 106 patients elected to undergo biopsy. Biopsy was recommended in the remaining six patients (5.7%) on the basis of follow-up imaging findings. The biopsy results were benign in 18 (78%) of the 23 patients, whereas they showed atypical hyperplasia in two (9%). One (4%) of the 23 patients had ductal carcinoma in situ. Overall, malignancy was diagnosed in one (0.9%) of the 106 patients. CONCLUSION In a multi-institutional study, the frequency of malignancy in MR-detected BI-RADS category 3 lesions was 0.9% (95% confidence interval: 0.02%, 5.14%).