Authors' objectives:

The present document presents a review of the diagnostic procedures for mammary lesions detected through mammography screening. The report also analyses the diagnostic accuracy and clinical usefulness of core-needle biopsy procedures for the diagnosis of breast malignant abnormalities.

Authors' recommendations: Breast core-needle biopsy has rapidly evolved in the last few years. The advances observed are dependent on two components, stereotactic guidance system and the tissue acquisition system. Some core biopsy devices have achieved a high specificity rate, can confirm the preoperative diagnosis and aid in surgical planning and treatment. These techniques can be useful to avoid other more invasive diagnostic procedures. Nevertheless, breast core-needle biopsy has diagnostic limitations and a non-negligible possibility of error (sampling error, inaccuracy, technical efficacy in tissue acquisition). Available evidence on diagnostic accuracy and comparative outcome efficacy is very small and the quality of the design and methods of the available studies, in general terms, is low. The Advanced Breast Biopsy Instrumentation (ABBI) is a biopsy procedure for small suspicious lesions of the breast. The ABBI uses a prone table, an independent digital stereotactic system for visual localisation and an advanced biopsy unit. The ABBI is an outpatient procedure, it is minimally invasive, performed under local anaesthesia, and lasts for approximately one hour. In the country where this procedure was initially developed (USA), the FDA authorises this medical device as a device for diagnostic biopsy. It is not approved as an indication for the therapeutic excision of mammary tissue, for which new clinical trials would be required prior to marketing. It is not proposed for the complete surgical exeresis of the lesion. Very few, purely descriptive studies of the procedure have been carried out, and only short term results of the ABBI have been presented. Most of the published studies on this technique present descriptive case series where comparison with a has not been car-ried out. The available studies do not provide enough information regarding the clinical utility of the technique and they present methodological shortcomings in the design that limit their internal and external validity. A correct assessment of the system would require the inclusion, in the results, of each one of the different gauge needle sizes used, the detailed histopathological description of the extracted lesions, as well as its subsequent surgical confirmation. A complete follow-up of the considered benign lesions should be carried out. Evidence to assess the clinical utility of ABBI compared to other alternative biopsy systems (mainly escisional biopsy) is not available. The present information does not allow clarification of the appropriate indications and the patients- profile that could benefit from ABBI. As other breast stereotactic core-needle biopsy procedures, the potential to reduce costs will only be achieved if the physician-s threshold for biopsy is not significantly lowered, and unnecessary multiple procedures for breast lesions most likely to be malignant are avoided. For patients with abnormalities suggestive of cancer, stereotactic core-needle biopsy is useful in distinguishing patients who need surgery from those who can have a follow-up. The probability of malignancy in this category ranges from 2% to 80%. Therefore, the probability of a woman benefiting from receiving a core biopsy or a follow-up with mammography is also variable. This leaves a wide range of decision making to the physician.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.isciii.es/unidad/aet/cdoc.htm

Year Published: 1999

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Luis M. Sánchez Gómez

Contact Email: luism.sanchez@isciii.es

Copyright: Agencia de Evaluacion de Tecnologias Sanitarias (AETS)