Healthcare question

Should tailored screening with digital breast tomosynthesis vs. digital mammography be used for early detection of breast cancer in asymptomatic women with high mammographic breast density in organised screening programmes?

Recommendation

For asymptomatic women, with high mammographic breast density, in the context of an organised screening programme, the ECIBC's Guidelines Development Group (GDG) suggests screening with either digital breast tomosynthesis (DBT) (including synthesised 2D images) or digital mammography (DM).

Recommendation strength ­

  Conditional recommendation for either the intervention or the comparison

  Very low certainty of the evidence

Subgroup considerations

The only subgroup assessed in this recommendation was women with high mammographic breast density.

Considerations for implementation and policy making

The GDG members felt that information and education for women about dense breasts is critical. This includes information about limitations or uncertainty about the effects of tomosynthesis. For women with dense breast tissue, it is important that the context of increased risk and lesser accuracy of 2D mammography be explained. The opinion of women on tomosynthesis depends on the quality and impartiality of the education provided to them regarding the evidence behind this modality for tailored screening, including the limitations of tomosynthesis. The GDG members considered that this regimen would involve establishing a baseline, based on breast density, after the first examination, and a cut-off point which determines which women should be offered DBT. 

There is a need for improvement in data management and storage for screening organisations. Women will have to attend a breast screening centre that has DBT technology available.

Monitoring and evaluation

Feasibility and acceptability could be assessed in the monitoring of programmes.

Quality control procedures and quality standards should be further developed. Standards should be developed in particular for the image quality of synthesised 2D images from the tomosynthesis technology.

Research priorities

There is a need for research examining the classification of mammographic breast density and standardisation of the classification systems used for breast density, including technology for the automation of the determination of breast density.

Research should also aim at establishing the appropriate density threshold for changing imaging techniques.

Further research is needed to build the evidence on benefits and harms of DBT vs. DM through comparison of direct outcomes, including impacts of interval cancer incidence, stage of breast cancer at detection, and mortality reduction.

There is also a need for research evidence on repeated DBT examinations since the current evidence is mainly restricted to a single surveillance episode. Trials in this area are ongoing and their results will influence the revision of this recommendation in the future.

Further research should also assess the cost-effectiveness implications of tailored DBT screening for high mammographic breast density.

Additional research should also assess the comparison between DBT and DM plus ultrasound for dense breast screening.

Research is needed to define the quality parameters that need to be fulfilled for DBT-based breast cancer screening programmes to be implemented.

Supporting documents