Recommendations from the European Breast Cancer Guidelines
Should tailored screening with automated breast ultrasound system (ABUS) based on high mammographic breast density, in addition to mammography, vs. mammography alone be used for early detection of breast cancer in asymptomatic women?
- Strong recommendation against the intervention
- ✓ Conditional recommendation against the intervention
- Conditional recommendation for either the intervention or the comparison
- Conditional recommendation for the intervention
- Strong recommendation for the intervention
A recommendation can be strong or conditional.
When a recommendation is strong, most women will want to follow it. When a recommendation is conditional, the majority of women want to follow it but may need more discussion with their healthcare professional first.
The conditional recommendation (rather than strong) against tailored screening with automated breast ultrasound system (ABUS) in addition to mammography screening over mammography screening alone in women with high mammographic breast density, in the context of an organised screening programme, was a result of a balance of the health effects that does not favour either the intervention nor the comparison, in the context of very low certainty in the evidence about these effects, concerns regarding the optimal quality control and workflow necessary for implementing ABUS and the large resource (cost) associated with ABUS.
The GDG noted the scarcity of evidence. There was an improved detection rate of ABUS plus mammography over mammography, however, this improvement was smaller as compared to alternative imaging modalities such as DBT (see recommendation for this intervention), although no direct comparison of ABUS and DBT was made. The GDG members expressed their concern about the quality assurance for ABUS in contexts where training is variable and screening is opportunistic and not organised. The GDG members also noted that for ABUS, the time needed by the physician to interpret the image is increased, although there is a saving with regards to the physician time in carrying out ABUS, as it is a technician who does this. In the future, evidence may be forthcoming which answers some of the questions outstanding, on resources, clinical endpoints etc., which may cause the recommendation to be reviewed.
Monitoring and Evaluation
EvidenceDownload the evidence profile
Detection rate for absolute effects in high risk vs low risk populations cannot be compared. However, relative effects should not differ.
GDG members pointed out that there is an interaction between risk factors (other than breast density) and detection rate, and therefore absolute or relative effects may not be comparable.
As agreement was not reached, voting was conducted among GDG members: Eight members voted the effects were "moderate"; seven members voted they "did not know".
The GDG members felt that interpretation time for ABUS is similar to Digital Breast Tomosynthesis (DBT). Whereas HHUS utilises the same ultrasound machines already used in a hospital, ABUS requires a new machine with significant increased costs.
However, a systematic review (JRC Technical Report PICO 16-17, contract FWC443094032016; available upon request) found a number of barriers associated with breast cancer screening with mammography. See the reviews of mammography screening for details. However, the results of these may not apply specifically to this population of women at enhanced risk and informed as such, due to breast density, and offered additional imaging as a result.
The GDG members felt ABUS would be very acceptable to screening participants, as ABUS-tailored screening has no radiation exposure and the physical discomfort associated with mammography would not be present. Payers may not find it acceptable due to larger costs of ABUS for minor increases in breast cancer detection rates.
- Brem RF(1), Tabár L, Duffy SW, Inciardi MF, Guingrich JA, Hashimoto BE, Lander MR, Lapidus RL, Peterson MK, Rapelyea JA, Roux S, Schilling KJ, Shah BA, Torrente J, Wynn RT, Miller DP. Assessing improvement in detection of breast cancer with three dimensional automated breast US in women with dense breast tissue: the SomoInsight Study. Radiology. 2015 Mar;274(3):663-73.
- Giuliano V(1), Giuliano C. Improved breast cancer detection in asymptomatic women using 3D-automated breast ultrasound in mammographically dense breasts. Clin Imaging. 2013 May-Jun;37(3):480-6.
- Kelly KM(1), Dean J, Comulada WS, Lee SJ. Breast cancer detection using automated whole breast ultrasound and mammography in radiographically dense breasts. Eur Radiol. 2010 Mar;20(3):734-42.
- Lee CI, Cevik M, Alagoz O, Sprague BL, Tosteson AN, Miglioretti DL, Kerlikowske K, Stout NK, Jarvik JG, Ramsey SD, Lehman CD. Comparative effectiveness of combined digital mammography and tomosynthesis screening for women with dense breasts. Radiology. 2015; 274(3): 772-8
- Not applicable
- For more details about the results see the full report (Contract: FWC 443094 012015 PICO 10-11).