BACKGROUND Vacuum‐assisted breast biopsy (VAB) can replace surgical biopsy for the diagnosis of breast carcinoma. The authors evaluated the accuracy and clinical utility of VAB in a multicenter setting using a strict quality assurance protocol. METHODS In the current study, VABs were performed successfully for 2874 patients at 5 sites. Benign lesions were verified by follow‐up. Surgery was recommended for malignant and borderline lesions. VAB was performed on patients with lesions rated as highly suspicious (6%), intermediate to suspicious (85%), or probably benign (9%). Fifty‐eight percent of the lesions were < 10 mm and 70% had microcalcifications. RESULTS The authors identified 7% of patients with invasive carcinomas, 15% with ductal carcinomas in situ (DCIS), 5% with atypical ductal hyperplasias (ADH), and 0.6% with lobular carcinomas in situ. The results of the VAB necessitated an upgrade of 24% of patients with ADH to DCIS or DCIS and invasive carcinoma. Twelve percent of patients with DCIS proved to have invasive carcinoma. Seventy‐three percent of the patients had benign lesions. Only 1 false‐negative result was encountered (negative predictive value, 99.95%). Minor side effects were reported to occur in 1.4% of patients and 0.1% of patients required a subsequent intervention. Scarring relevant for mammography was rare among patients (i.e., 0.3% of patients had relevant scarring). CONCLUSIONS Quality‐assured VAB was found to be highly reliable. VAB effectively identified patients with benign lesions and assisted therapeutic decisions. Most important, only a single case of malignancy was missed. A close interdisciplinary approach assured optimal results. Cancer 2004;100:245–51. © 2003 American Cancer Society.

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The reimbursement of breast biopsies must be improved in order to guarantee nationwide care of the population using the breast biopsy methods recommended in the S 3 guidelines and to avoid disincentives with respect to breast biopsy indications.

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The multistep model of carcinogenesis in the breast suggests a transition from normal epithelium to invasive carcinoma via non-atypical and atypical hyperplasia and in situ carcinoma. The introduction of mammographic screening has led to the increased detection of preinvasive disease, and this has highlighted deficiencies in the biology and classification of such lesions. The excitement surrounding the development of DNA microarray analysis and proteomics has raised expectations about the role of these techniques in understanding the biology and translating these data to clinical practice. Only a few years ago, scientists studied disease initiation and progression in a linear fashion, identifying and examining one cancer-related molecule at a time. The recent development of technologies that allow a large number of genes and gene products to be analysed simultaneously has brought renewed interest to breast cancer research, with the hope of identifying a unique 'fingerprint' for each tumour and hence individualised treatment. To date, histopathological assessment has been at the heart of clinical management -does the new technology herald the end? Hormone replacement therapy (HRT): indications and side effects