Stereotactic core-needle breast biopsy by surgeons - Minimum 2-year follow-up of benign lesions

Objective To evaluate the reliability of stereotactic core-needle breast bi opsy (SCNB) performed by surgeons to detect histologically benign tissue. Summary Background Data Stereotactic core-needle breast biopsy is widely us ed to obtain tissue for definitive pathologic diagnosis of mammographically suspicious breast lesions. It has an incidence of malignancy detection sim ilar to that of open biopsy. The potential for sampling error is a concern. Minimal data regarding follow-up and failure rate are available, especiall y from series performed exclusively by surgeons. Methods Pertinent medical records of all patients who underwent SCNB betwee n April 1995 and October 1997 were reviewed. Breast lesions were classified by mammographic Breast Imaging-Reporting and Data Systems (BI-RADS) catego ries before SCNB. Benign biopsy specimens were classified as nonproliferati ve or proliferative. Malignant lesions and those with atypical histopatholo gy by SCNB were excluded from this analysis. All lesions initially reported as benign were followed up mammographically for at least 2 years for any s uspicious change requiring repeat biopsy. Results During the 31-month period, SCNB was performed on 694 lesions in 61 9 patients. Histologic evidence of malignancy was found in 112 lesions (16% ). The initial histologic diagnosis for the remaining 582 lesions was benig n. Four hundred lesions were available for follow-up; of these, 373 (93%) w ere mammographically categorized as BI-RADS 3 (probably benign) or 4 (suspi cious). Three hundred forty-three lesions were categorized as nonproliferat ive and 151 as proliferative (94 had combined nonproliferative and prolifer ative histology). Follow-up ranged from 24 to 48 months (mean 33 months). D uring the follow-up period, 87 lesions (21.8%) underwent either image-guide d or open biopsy. At the time of follow-up rebiopsy, ductal carcinoma in si tu 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 pre dictive value of 98.8% (395/400). For the five false-negative cases, the in terval from initial SCNB to definitive diagnosis ranged from 9 to 36 months . No correlation was found between the type of initial histopathology and d evelopment 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, g iven the possibility of sampling error and the nature of breast disease, cl ose mammographic and clinical follow-up is necessary. The false-negative ra te and negative predictive value in this series compare favorably with thos e in other reports, supporting the fact that surgeons can confidently use S CNB in the evaluation and treatment of breast disease.