Stereotactische dikkenaaldbiopsie bij de diagnostiek van niet-palpabele afwijkingen in de mamma: Een betrouwbaar alternatief voor excisiebiopsie

Objective. To determine the reliability of stereotactic histological-needle biopsy in the diagnosis of non-palpable breast abnormalities. Design. Prospective. Method. In 19 Dutch hospitals during the period i April 1997-31 January 2000, all successive women with non-palpable breast abnormalities were offered a stereotactic histologicalneedle biopsy (14 gauge). When the diagnosis of 'breast cancer' was established on the basis of this needle biopsy, the patient was planned for definite surgery. If the needle biopsy revealed no malignancy, a wire-localised excision biopsy was advised. An expert panel evaluated all cases where the histological diagnosis established with the aid of needle biopsy, differed from that established with the aid of the excision biopsy. Treatment guidelines were drawn up on the basis of the falsepositive and false-negative findings. Then the sensitivity and specificity of the needle biopsy were calculated using the study results, with the 'diagnosis' to be recognised being situations that require a subsequent intervention. Results. There were 973 women with 1029 abnormalities. Forty-five women decided not to participate and 113 (11%) planned stereotactic histological-needle biopsies were prematurely discontinued. A total of 871 procedures were carried out in 826 patients with an average age of 58 years (range: 29-85). Of these 871 biopsy procedures, 94% were followed by a surgical intervention and on 13 (1.5%) occasions insufficient material was obtained with the biopsy to establish a diagnosis. Fifty-six percent of the remaining 858 needle biopsies were classified as malignant (290 invasive mammary carcinoma and 190 ductal carcinoma in situ); 5 of these were false-positive. In addition to this, a malignancy was found in the surgical preparation of 13 of the 322 abnormalities with the diagnosis 'benign abnormality' (4%; 95%-CI: 2-7), 6 of the 26 abnormalities with the diagnosis 'high-risk abnormality' (23%; 9-44) and 5 of the 30 biopsies with the diagnosis 'normal breast tissue' (17%; 6-35). Assuming that for a diagnosis of 'benign abnormality' a mammographic follow-up is sufficient, the sensitivity and specificity of the stereotactic histological-needle biopsy were 97% (95-98) and 99% (97-100) respectively. Conclusion. The stereotactic histological-needle biopsy is a reliable instrument for the diagnosis of non-palpable abnormalities in the breast. It can be used safely in practice as long as the intervention in the case of the diagnoses 'high-risk abnormality' and 'normal breast tissue' are followed by a repeat biopsy or wire localised excision biopsy.