9. Further assessment after the mammogram
9.1 Should digital breast tomosynthesis vs. assessment mammography be used to diagnose breast cancer in recalled women due to suspicious lesions at mammography screening?
Recommendation
The ECIBC's Guidelines Development Group (GDG) suggests using digital breast tomosynthesis (DBT) over diagnostic mammography projections in women at average risk for breast cancer recalled for suspicious lesions at mammography screening.
Issued in June 2018.
Justification
It is a conditional recommendation mainly due to the availability of the devices. In addition, despite moderate certainty in the high accuracy of the test results, and a balance that probably favours DBT, there are concerns about the associated moderate costs, increased training needed to correctly use this technology, absence of cost-effectiveness data and feasibility of its implementation.
Subgroup considerations
The GDG agreed that this recommendation applies to both subgroups of patients examined, those with calcified lesions and those with non calcified lesions.
Monitoring and evaluation
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
- Ultrasound is often included in the management of assessment after a positive finding in screening mammography. Further research should be conducted exploring which subgroups would avoid ultrasound after DBT-additional projections, as well as which lesions (usually masses) are assessed with ultrasound instead of additional projections/DBT.
- The use of DBT in high mammographic breast density should be explored, that is, whether or not accuracy results are affected by breast density.
- Members of the GDG raised the question of whether the evidence discussed applies to repeated assessments too, but there was no agreement in the GDG if this is a research priority.
- Whether or not to use one or two views for tomosynthesis in assessment should be explored.
Supporting material
9.2 Should needle core biopsy vs. fine needle aspiration cytology be used to diagnose breast cancer in women with suspicious breast lesions in mammography?
Recommendation
In individuals with suspicious breast lesions (including mass lesions, asymmetric breast density, calcifications and/or architectural distortions) in mammography, the ECIBC's Guidelines Development Group (GDG) recommends needle core biopsy (NCB) over fine needle aspiration cytology (FNAC) to diagnose breast cancer.
Issued in February 2017.
Subgroup considerations
Initially, the GDG had divided this question in three according to different types of subpopulations: 1. mass lesions and/or asymmetric density, 2. architectural distortions and 3. calcifications. As the literature search did not find studies giving information for the relevant outcomes separately, it was merged.
Considerations for implementation and policy making
- The GDG noted that FNAC may have utility in other medical conditions or contexts (e.g. FNAC of axilla lymph nodes) and as such reinforces that this recommendation applies only to the population addressed in this question. The GDG did not consider other populations.
- The GDG noted that there may be resistance to implementation in certain settings where providers are using FNAC over NCB. If monitoring the change to NCB should also imply to monitor other histopathology tests that are implemented in parallel to NCB.
Monitoring and evaluation
- The GDG notes that the Quality Assurance Scheme Development Group (QASDG) should be alerted to this recommendation and consider monitoring and evaluation issues for this question.
- Monitoring the positive predictive value of the intervention may be helpful for quality assurance. The GDG noted that centres currently performing FNAC instead of NCB (for the population in this question) should be monitored for the implementation of this intervention.
Research priorities
GDG encourages research on how to communicate more effectively with women so they can make an informed choice. This is particularly important in settings where FNAC is still used.
Supporting material
9.3 Should stereotactic-guided needle core biopsy or stereotactic-guided vacuum assisted needle core biopsy vs. ultrasound-guided needle core biopsy or ultrasound-guided vacuum assisted needle core biopsy be used to diagnose the presence of breast cancer in individuals presenting with breast calcifications?
Recommendation
In individuals presenting with breast calcifications, the ECIBC's Guidelines Development Group (GDG) recommends the use of stereotactic-guided needle core biopsy over ultrasound-guided needle core biopsy to diagnose the presence of breast cancer.
Issued in February 2017.
Justification
The GDG noted that while stereotactic guidance is favourable, in practice there was low certainty in the evidence reviewed that compared stereotactic to ultrasound guidance. Despite this, the GDG agreed that, when comparing stereotactic-guided NCB with open biopsy, the recommendation was strong and the certainty of this evidence was high. However, when comparing stereotactic guidance to ultrasound guidance, as there were no studies directly comparing both interventions, the overall certainty of the evidence was low, due to the low quality of the evidence for ultrasound guidance compared to open biopsy, as well as the fact that only two studies were found on ultrasound guidance. The GDG agreed to issue a strong recommendation in favour of the use of stereotactic guidance for biopsy evaluation of breast calcification despite the low certainty of the evidence.
The radiologist GDG members advised the group that this technique poses less risk for the individual and permits accurate visualisation and targeted biopsy of the calcification. The GDG histopathologists confirmed that their experience indicates that stereotactic-guided biopsy is far superior to ultrasound-guided biopsy in obtaining representative tissue samples of calcification for microscopic evaluation.
Considerations for implementation and policy making
- Training for radiologists who currently biopsy for calcifications using ultrasound-guided NCB.
- The GDG noted that effective communication strategies are critical so that women can make informed decisions throughout all phases of the screening process.
- In settings where stereotactic equipment is not widely available there may be a need to consider how to refer patients to a reference setting where they can have access to stereotactic-guided biopsy.
Research priorities
Research was suggested on communication strategies for diagnostic tests that are used in different settings, in order to promote informed decision-making by women.
Supporting material