Authors' objectives: Digital tomosynthesis is presented as a complement and/or alternative to mammography in the diagnosis of breast cancer both in screening programmes and in women with clinical suspicion. The systematic search, conducted with the aim of assessing the efficacy and safety of digital tomosynthesis compared with mammography or with anatomical pathology, recovered 5 summary reports and 5 original articles.

Authors' recommendations: Of the original studies, 4 were on tests aimed at breast cancer diagnosis and the other studied the correlation between tomosynthesis and mammography in the measurement of tumour size. In general, the quality of work was moderate although presenting methodological problems related to the double gold standard reference test, with the spectrum of patients or with losses in follow up. The results could be extrapolated; nevertheless, factors must be taken into account such as the low incidence of breast cancer in Spain compared to other European countries, and the lack of detailed information in the studies on the representativeness of the population and the risk factors. The studies that followed the conventional classification of breast cancer diagnosis obtained figures for sensitivity, specificity, positive likelihood ratio and negative likelihood ratio that ranged from 80 to 90%, 67.4 to 96%, 2.76 to 20.16 and 0.15 to 0.20, respectively. The analysis using non-conventional classification showed levels of sensitivity, specificity, positive likelihood ratio and negative likelihood ratio ranged from 90.9 to 92.9%, 64.4 to 84.4%, 2.58 to 5.95 and 0.08 to 0.11, respectively. In addition, the study that assessed the test performance between digital tomosynthesis and mammography obtained an area under the curve of 0.81 (95% CI: 0.67-0.90), higher than that calculated for other comparisons. In one of the studies there was a better match of tomosynthesis with tumour size (obtained by anatomical pathology) than with other techniques, with the Pearson correlation coefficient of 0.86 (p <0.001) and the mean of the differences obtained in the Bland-Altman analysis of -1.5% ± 5%. In addition, agreement was found with the TNM classification, where 79% of the expected T stages coincided with those seen with tomosynthesis. The findings in the studies suggest usefulness in the diagnosis of breast cancer. However, with regard to the use of digital tomosynthesis as a screening test in the general population, there was no evidence to determine its effectiveness, but there are current ongoing studies.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/tomosintesis-digital-de-mama/

Year Published: 2012

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/AETSA_2010_2-6_Tomosintesis.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)