A Comparison of Accuracy Rates Between Open Biopsy, Cutting-Needle Biopsy, and Fine-Needle Aspiration Biopsy of the Breast: A 3-Year Experience

The diagnostic accuracy of excisional biopsy is used as the “gold standard” for the diagnosis of breast nodules. In comparison studies involving the diagnostic accuracies of fine-needle aspiration cytology and cutting needle biopsy, the accuracy rate of open biopsy is often assumed to be 100%. While diagnostic accuracy rates are well reported for fine-needle aspiration (FNA) and large-gauge core needle biopsy, little data has been published documenting the accuracy of excisional biopsy. Hence, valid comparisons of relative diagnostic precision between the techniques are difficult to achieve. We report our experience with the sensitivity and specificity of open biopsy, cutting-needle biopsy and fine-needle aspiration biopsy over a three-year period. Between January 1992 and December 1994, histologic specimens from 412 open breast biopsies, and 17 non image guided Tru-cut® biopsies of palpable breast nodules were reviewed. These cases had either histologic follow-up (n= 388) or at least 2 years clinical follow-up (n= 25). Similarly, 450 FNAs were performed of which 215 had histologic study or cytologic follow-up. Within the 388 open biopsies with histologic follow-up, two false-negatives (sensitivity 99%) and one false-positive (specificity 99.5%) were detected based on subsequent biopsies or review of the initial material. No erroneous diagnoses were found in the 25 patients having only clinical follow-up. Among the 17 cutting needle-biopsies, two false-negatives (sensitivity 85%) were detected; no false-positives occurred (specificity 100%). One false-positive and five false-negatives were detected on follow-up of the 215 FNAs. This yielded a sensitivity of 96.2% and a specificity of 99.6%. Fine-needle aspiration compares favorably with both of these techniques, being inferior to open biopsy but of greater accuracy than cutting needle biopsy. These results demonstrate that care must be taken in using the histopathologic findings of open biopsy as the standard with which other methods of diagnosis are compared.