Objective To evaluate the reliability of stereotactic core-needle breast biopsy (SCNB) performed by surgeons to detect histologically benign tissue. Summary Background Data Stereotactic core-needle breast biopsy is widely used to obtain tissue for definitive pathologic diagnosis of mammographically suspicious breast lesions. It has an incidence of malignancy detection similar to that of open biopsy. The potential for sampling error is a concern. Minimal data regarding follow-up and failure rate are available, especially from series performed exclusively by surgeons. Methods Pertinent medical records of all patients who underwent SCNB between April 1995 and October 1997 were reviewed. Breast lesions were classified by mammographic Breast Imaging-Reporting and Data Systems (BI-RADS) categories before SCNB. Benign biopsy specimens were classified as nonproliferative or proliferative. Malignant lesions and those with atypical histopathology by SCNB were excluded from this analysis. All lesions initially reported as benign were followed up mammographically for at least 2 years for any suspicious change requiring repeat biopsy. Results During the 31-month period, SCNB was performed on 694 lesions in 619 patients. Histologic evidence of malignancy was found in 112 lesions (16%). The initial histologic diagnosis for the remaining 582 lesions was benign. Four hundred lesions were available for follow-up; of these, 373 (93%) were mammographically categorized as BI-RADS 3 (probably benign) or 4 (suspicious). Three hundred forty-three lesions were categorized as nonproliferative and 151 as proliferative (94 had combined nonproliferative and proliferative histology). Follow-up ranged from 24 to 48 months (mean 33 months). During the follow-up period, 87 lesions (21.8%) underwent either image-guided or open biopsy. At the time of follow-up rebiopsy, ductal carcinoma in situ was found in four lesions and infiltrating ductal carcinoma was found in one, for an overall false-negative rate of 4.3% (5/117) and a negative predictive value of 98.8% (395/400). For the five false-negative cases, the interval from initial SCNB to definitive diagnosis ranged from 9 to 36 months. No correlation was found between the type of initial histopathology and development of malignancy. Conclusions These results support SCNB as an alternative to open biopsy and show the reliability of SCNB when benign pathology is obtained. However, given the possibility of sampling error and the nature of breast disease, close mammographic and clinical follow-up is necessary. The false-negative rate and negative predictive value in this series compare favorably with those in other reports, supporting the fact that surgeons can confidently use SCNB in the evaluation and treatment of breast disease.
