Nonsurgical management of high-risk lesions diagnosed at core needle biopsy: can malignancy be ruled out safely with breast MRI?

OBJECTIVE: The purpose of this study was to investigate whether breast MRI can be used to rule out malignancy in patients with high-risk lesions diagnosed at imaging-guided core needle biopsy. SUBJECTS AND METHODS: The subjects were women consecutively registered between October 2004 and April 2010 who had high-risk lesions diagnosed at mammographically or sonographically guided core needle biopsy and subsequently underwent MRI and surgical excision. MR images were reviewed by two experienced breast radiologists. Lesions assessed as BI-RADS category 1-3 were considered negative for malignancy, and BI-RADS 4 and 5 lesions were considered malignant. Histologic findings at surgical excision were the reference standard. The sensitivity, specificity, and positive and negative predictive values of MRI in the detection of associated malignancy were calculated for the entire set of lesions and for each histologic subtype. RESULTS: The final sample consisted of 169 high-risk lesions in 166 patients. At MRI analysis, 116 (68.6%) lesions were considered negative for malignancy, and the other 53 (31.4%) malignant. At surgical excision, 22 malignant lesions were found. The overall sensitivity, specificity, and positive and negative predictive values of MRI were 72.7% (16/22), 74.8% (110/147), 30.2% (16/53), and 94.8% (110/116). The negative predictive values for papilloma, radial scar, lobular neoplasia, and atypical ductal hyperplasia were 97.4% (38/39), 97.6% (41/42), 88.0% (22/25), and 90.0% (9/10). CONCLUSION: Patients with high-risk lesions associated with the lowest likelihood of malignancy (papilloma and radial scar) and without suspicious MRI findings can safely undergo follow-up instead of surgery. Because of the low negative predictive value, however, MRI is not helpful in cases of lobular neoplasia and atypical ductal hyperplasia, and all these lesions should be excised.