Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening.

PURPOSE: To compare screening recall rates and cancer detection rates of tomosynthesis plus conventional digital mammography to those of conventional digital mammography alone.

MATERIALS AND METHODS: All patients presenting for screening mammography between October 1, 2011, and September 30, 2012, at four clinical sites were reviewed in this HIPAA-compliant retrospective study, for which the institutional review board granted approval and waived the requirement for informed consent. Patients at sites with digital tomosynthesis were offered screening with digital mammography plus tomosynthesis. Patients at sites without tomosynthesis underwent conventional digital mammography. Recall rates were calculated and stratified according to breast density and patient age. Cancer detection rates were calculated and stratified according to the presence of a risk factor for breast cancer. The Fisher exact test was used to compare the two groups. Multivariate logistic regression was used to assess the effect of screening method, breast density, patient age, and cancer risk on the odds of recall from screening.

RESULTS: A total of 13 158 patients presented for screening mammography; 6100 received tomosynthesis. The overall recall rate was 8.4% for patients in the tomosynthesis group and 12.0% for those in the conventional mammography group (P < .01). The addition of tomosynthesis reduced recall rates for all breast density and patient age groups, with significant differences (P < .05) found for scattered fibroglandular, heterogeneously dense, and extremely dense breasts and for patients younger than 40 years, those aged 40-49 years, those aged 50-59 years, and those aged 60-69 years. These findings persisted when multivariate logistic regression was used to control for differences in age, breast density, and elevated risk of breast cancer. The cancer detection rate was 5.7 per 1000 in patients receiving tomosynthesis versus 5.2 per 1000 in patients receiving conventional mammography alone (P = .70).

CONCLUSION: Patients undergoing tomosynthesis plus digital mammography had significantly lower screening recall rates. The greatest reductions were for those younger than 50 years and those with dense breasts. A nonsignificant 9.5% increase in cancer detection was observed in the tomosynthesis group.