Department of Surgery

Key Points

Question  Is digital breast tomosynthesis (DBT) associated with lower risk of interval invasive and advanced breast cancer (prognostic pathologic stage II or higher) compared with digital mammography among women with dense breasts?

Findings  In this cohort study that included 504 427 women undergoing 1 379 089 screening mammograms, interval cancer rates were not significantly different for DBT vs digital mammography. Among women with extremely dense breasts and high risk of breast cancer (3.6% of the study population), the advanced cancer rates for DBT vs digital mammography were 0.27 vs 0.80 per 1000 examinations over 12 months, respectively; the difference was statistically significant. Among women with nondense breasts, heterogeneously dense breasts, or with extremely dense breasts but at low to average risk of breast cancer (96.4% of the study population), there were no significant differences in advanced cancer rates.

Meaning  Among women with extremely dense breasts and at high risk of breast cancer, screening with DBT compared with digital mammography was associated with a lower risk of advanced breast cancer.

Importance  Digital breast tomosynthesis (DBT) was developed with the expectation of improving cancer detection in women with dense breasts. Studies are needed to evaluate interval invasive and advanced breast cancer rates, intermediary outcomes related to breast cancer mortality, by breast density and breast cancer risk.

Objective  To evaluate whether DBT screening is associated with a lower likelihood of interval invasive cancer and advanced breast cancer compared with digital mammography by extent of breast density and breast cancer risk.

Design, Setting, and Participants  Cohort study of 504 427 women aged 40 to 79 years who underwent 1 003 900 screening digital mammography and 375 189 screening DBT examinations from 2011 through 2018 at 44 US Breast Cancer Surveillance Consortium (BCSC) facilities with follow-up for cancer diagnoses through 2019 by linkage to state or regional cancer registries.

Exposures  Breast Imaging Reporting and Data System (BI-RADS) breast density; BCSC 5-year breast cancer risk.

Main Outcomes and Measures  Rates per 1000 examinations of interval invasive cancer within 12 months of screening mammography and advanced breast cancer (prognostic pathologic stage II or higher) within 12 months of screening mammography, both estimated with inverse probability weighting.

Results  Among 504 427 women in the study population, the median age at time of mammography was 58 years (IQR, 50-65 years). Interval invasive cancer rates per 1000 examinations were not significantly different for DBT vs digital mammography (overall, 0.57 vs 0.61, respectively; difference, −0.04; 95% CI, −0.14 to 0.06; P = .43) or among all the 836 250 examinations with BCSC 5-year risk less than 1.67% (low to average-risk) or all the 413 061 examinations with BCSC 5-year risk of 1.67% or higher (high risk) across breast density categories. Advanced cancer rates were not significantly different for DBT vs digital mammography among women at low to average risk or at high risk with almost entirely fatty, scattered fibroglandular densities, or heterogeneously dense breasts. Advanced cancer rates per 1000 examinations were significantly lower for DBT vs digital mammography for the 3.6% of women with extremely dense breasts and at high risk of breast cancer (13 291 examinations in the DBT group and 31 300 in the digital mammography group; 0.27 vs 0.80 per 1000 examinations; difference, −0.53; 95% CI, −0.97 to −0.10) but not for women at low to average risk (10 611 examinations in the DBT group and 37 796 in the digital mammography group; 0.54 vs 0.42 per 1000 examinations; difference, 0.12; 95% CI, −0.09 to 0.32).

Conclusions and Relevance  Screening with DBT vs digital mammography was not associated with a significant difference in risk of interval invasive cancer and was associated with a significantly lower risk of advanced breast cancer among the 3.6% of women with extremely dense breasts and at high risk of breast cancer. No significant difference was observed in the 96.4% of women with nondense breasts, heterogeneously dense breasts, or with extremely dense breasts not at high risk.