The widespread introduction of national screening programmes for breast cancer has led to a significant increase in the number of nonpalpable breast lesions detected.1 The gold standard diagnostic test for such lesions is the needle localised open-breast biopsy.2 In the past decade, percutaneous biopsy techniques have been introduced as less-invasive alternatives for this surgical procedure. One of these alternatives is the stereotactic large-core needle biopsy on a prone biopsy table.3
In the United States, the stereotactic large-core needle biopsy is now generally accepted as an alternative for open-breast biopsy.4, 5 Much has been written about the diagnostic accuracy of this technique, but the number of studies with adequate surgical or clinical follow-up is limited6 and in several studies patient selection took place. Sensitivity rates reported in studies with good methodology vary greatly, from 94–99%.4, 7, 8 Because of low prevalence of malignancy among women referred for breast biopsy in the United States (10–30%), the risk of having breast cancer despite a benign large-core needle biopsy diagnosis is minor whether the sensitivity rate is 94% or 99%.4, 6 In the Netherlands, as in other European countries, approximately 60% of the patients referred for breast biopsy of nonpalpable lesions have breast cancer.1 In these populations, a 5% difference in sensitivity might have a major impact on the risk of malignancy despite a benign biopsy result.6 It is therefore of particular interest for the European population whether the diagnostic accuracy of stereotactic large-core needle biopsy is equal to that of the needle localised open-breast biopsy.
We conducted the prospective multicenter COBRA study (COre Biopsy after RAdiological localisation) to assess the diagnostic accuracy of stereotactic large-core needle biopsy in a population of Dutch women referred for histologic confirmation of nonpalpable breast disease.