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Background Screening with digital breast tomosynthesis (DBT) improves breast cancer detection and recall rates compared with those obtained with digital mammography (DM); however, the impact of DBT on patient survival has not been established. False-negative (FN) screening examinations can be a surrogate for long-term outcomes, such as breast cancer morbidity and mortality. Purpose To determine if screening with DBT is associated with lower FN rates, detection of cancers with more favorable prognoses, and improved performance outcomes versus DM. Materials and Methods This retrospective study involved 10 academic and community practices. DM screening examinations 1 year prior to DBT implementation and DBT screening examinations from the start date until June 30, 2013, were linked to cancers through June 30, 2014, with data collection in 2016 and analysis in 2018-2019. Cancers after FN examinations were characterized by presentation, either symptomatic or asymptomatic. FN rates, sensitivity, specificity, cancer detection and recall rates, positive predictive values, tumor size, histologic features, and receptor profile were compared. Results A total of 380 641 screening examinations were included. There were 183 989 DBT and 196 652 DM examinations. With DBT, rates trended lower for overall FN examinations (DBT, 0.6 per 1000 screens; DM, 0.7 per 1000 screens; P = .20) and symptomatic FN examinations (DBT, 0.4 per 1000 screens; DM, 0.5 per 1000 screens; P = .21). Asymptomatic FN rates trended higher in women with dense breasts (DBT, 0.14 per 1000 screens; DM: 0.07 per 1000 screens; P = .07). With DBT, improved sensitivity (DBT, 89.8% [966 of 1076 cancers]; DM, 85.6% [789 of 922 cancers]; P = .004) and specificity (DBT, 90.7% [165 830 of 182 913 examinations]; DM, 89.1% [174 480 of 195 730 examinations]; P < .001) were observed. Overall, cancers identified with DBT were more frequently invasive ( P < .001), had fewer positive lymph nodes ( P = .04) and distant metastases ( P = .01), and had lower odds of an FN finding of advanced cancer (odds ratio, 0.9 [95% CI: 0.5, 1.5]). Conclusion Screening with digital breast tomosynthesis improves sensitivity and specificity and reveals more invasive cancers with fewer nodal or distant metastases. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Schattner in this issue.

Objective: The question of benefits versus harms of breast cancer screening for women younger than 50 years old has been the subject of debate. We investigate if the addition of tomosynthesis to mammography improves screening performance outcomes for women in this age group., Materials and Methods: Screening performance for 59,921 patients (41,542 digital mammography and 18,379 tomosynthesis) younger than 50 years old was collected from a community-based screening network from January 1, 2015, to December 31, 2015. Patients were offered tomosynthesis if it was available. Parameters including recall, biopsy, and cancer detection rates were compared. Mixed effects regression analysis was used to estimate rates with screening modality, age, and density as fixed effects and screening site as a random effect. Rates for patients with dense breast tissue were also evaluated., Results: Model adjusted rates per 1000 screenings with digital mammography were compared with digital mammography plus tomosynthesis, respectively: recall rate decreased from 117 to 108 (difference, -8.3; p = 0.003); biopsy rate increased from 13.5 to 16.6 (difference, 3.1; p = 0.003); and cancer detection rate increased from 1.9 to 2.6 (difference, 0.8; p = 0.060). Model adjusted rates for patients with dense breast tissue were: recall rate decreased from 135 to 132 (difference, -3.2; p = 0.44); biopsy rate increased from 16.0 to 20.5 (difference, 4.5; p = 0.004); and cancer detection rate increased from 2.1 to 3.5 (difference, 1.3; p = 0.03)., Conclusion: Tomosynthesis in a community setting resulted in decreased recall rates for patients younger than 50 years old. For the subgroup of women with dense breast tissue, cancer detection rates also increased.

Purpose: To determine the effect of tomosynthesis imaging as a function of age for breast cancer screening., Methods: Screening performance metrics from 13 institutions were examined for 12 months prior to introduction of tomosynthesis (period 1) and compared to those after introduction of tomosynthesis (period 2, range 3-22 months). Screening metrics for women ages 40-49, 50-59, 60-69, and 70+ , included rates per 1000 screens for recalls, biopsies, cancers, and invasive cancers detected., Results: Performance parameters were compared for women screened with digital mammography alone (n = 278,908) and digital mammography + tomosynthesis (n = 173,414). Addition of tomosynthesis to digital mammography produced significant reductions in recall rates for all age groups and significant increases in cancer detection rates for women 40-69. Largest recall rate reduction with tomosynthesis was for women 40-49, decreasing from 137 (95% CI 117-156) to 115 (95% CI 95-135); difference, -22 (95% CI -26 to -18; P < .001). Simultaneous increase in invasive cancer detection rate for women 40-49 from 1.6 (95% CI 1.2-1.9) to 2.7 (95% CI 2.2-3.1) with tomosynthesis (difference, 1.1; 95% CI 0.6-1.6; P < .001) was observed., Conclusions: Addition of tomosynthesis to digital mammography increased invasive cancer detection rates for women 40-69 and decreased recall rates for all age groups with largest performance gains seen in women 40-49. The similar performance seen with tomosynthesis screening for women in their 40s compared to digital mammography for women in their 50s argues strongly for commencement of mammography screening at age 40 using tomosynthesis.

Rationale and Objectives: To compare performance of prospective interpretations of clinical tomosynthesis (digital breast tomosynthesis [DBT]) plus full-field digital mammography (FFDM) examinations with retrospective readings of the corresponding FFDM examinations alone., Methods and Materials: Seven Mammography Quality Standard Act-qualified radiologists retrospectively interpreted 10,878 FFDM examinations that had been interpreted by other radiologists during prospective clinical interpretations of DBT plus FFDM. The radiologists were blinded to the Breast Imaging Reporting and Data System (BIRADS) category given during the clinical interpretations and the verified outcome by follow-up and/or any diagnostic workup that may have followed. Ratings (BIRADS 0, 1, or 2) were recorded. Group performance levels in terms of recall rates and attributable cancer detection rates were compared to the prospective clinical interpretations of the same examinations (DBT plus FFDM) using McNemar test (two sided/tailed) with significance level of .05., Results: During the prospective clinical interpretations of DBT plus FFDM, 588 cases were recalled (588 of 10,878, 5.41%) compared to 888 cases recalled (888 of 10,878, 8.16%) during the FFDM-alone retrospective interpretations (absolute difference, 35%; P<.0001). There were 59 and 38 suspicious abnormalities later verified as cancers detected during the DBT plus FFDM and the FFDM-alone interpretations, respectively (absolute increase, 55%; P<.0001). Invasive cancer detections were 48 and 29, respectively (absolute increase, 66%; P<.0001)., Conclusions: The combination of DBT plus FFDM for screening asymptomatic women resulted in a significant reduction in recall rates and a simultaneous increase in cancer detection rates when compared to retrospective interpretations of corresponding FFDM examinations alone., (Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.)

Importance: Mammography plays a key role in early breast cancer detection. Single-institution studies have shown that adding tomosynthesis to mammography increases cancer detection and reduces false-positive results., Objective: To determine if mammography combined with tomosynthesis is associated with better performance of breast screening programs in the United States., Design, Setting, and Participants: Retrospective analysis of screening performance metrics from 13 academic and nonacademic breast centers using mixed models adjusting for site as a random effect., Exposures: Period 1: digital mammography screening examinations 1 year before tomosynthesis implementation (start dates ranged from March 2010 to October 2011 through the date of tomosynthesis implementation); period 2: digital mammography plus tomosynthesis examinations from initiation of tomosynthesis screening (March 2011 to October 2012) through December 31, 2012., Main Outcomes and Measures: Recall rate for additional imaging, cancer detection rate, and positive predictive values for recall and for biopsy., Results: A total of 454,850 examinations (n=281,187 digital mammography; n=173,663 digital mammography + tomosynthesis) were evaluated. With digital mammography, 29,726 patients were recalled and 5056 biopsies resulted in cancer diagnosis in 1207 patients (n=815 invasive; n=392 in situ). With digital mammography + tomosynthesis, 15,541 patients were recalled and 3285 biopsies resulted in cancer diagnosis in 950 patients (n=707 invasive; n=243 in situ). Model-adjusted rates per 1000 screens were as follows: for recall rate, 107 (95% CI, 89-124) with digital mammography vs 91 (95% CI, 73-108) with digital mammography + tomosynthesis; difference, -16 (95% CI, -18 to -14; P < .001); for biopsies, 18.1 (95% CI, 15.4-20.8) with digital mammography vs 19.3 (95% CI, 16.6-22.1) with digital mammography + tomosynthesis; difference, 1.3 (95% CI, 0.4-2.1; P = .004); for cancer detection, 4.2 (95% CI, 3.8-4.7) with digital mammography vs 5.4 (95% CI, 4.9-6.0) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001); and for invasive cancer detection, 2.9 (95% CI, 2.5-3.2) with digital mammography vs 4.1 (95% CI, 3.7-4.5) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001). The in situ cancer detection rate was 1.4 (95% CI, 1.2-1.6) per 1000 screens with both methods. Adding tomosynthesis was associated with an increase in the positive predictive value for recall from 4.3% to 6.4% (difference, 2.1%; 95% CI, 1.7%-2.5%; P < .001) and for biopsy from 24.2% to 29.2% (difference, 5.0%; 95% CI, 3.0%-7.0%; P < .001)., Conclusions and Relevance: Addition of tomosynthesis to digital mammography was associated with a decrease in recall rate and an increase in cancer detection rate. Further studies are needed to assess the relationship to clinical outcomes.

Objective: Digital mammography combined with tomosynthesis is gaining clinical acceptance, but data are limited that show its impact in the clinical environment. We assessed the changes in performance measures, if any, after the introduction of tomosynthesis systems into our clinical practice., Materials and Methods: In this observational study, we used verified practice- and outcome-related databases to compute and compare recall rates, biopsy rates, cancer detection rates, and positive predictive values for six radiologists who interpreted screening mammography studies without (n = 13,856) and with (n = 9499) the use of tomosynthesis. Two-sided analyses (significance declared at p < 0.05) accounting for reader variability, age of participants, and whether the examination in question was a baseline were performed., Results: For the group as a whole, the introduction and routine use of tomosynthesis resulted in significant observed changes in recall rates from 8.7% to 5.5% (p < 0.001), nonsignificant changes in biopsy rates from 15.2 to 13.5 per 1000 screenings (p = 0.59), and cancer detection rates from 4.0 to 5.4 per 1000 screenings (p = 0.18). The invasive cancer detection rate increased from 2.8 to 4.3 per 1000 screening examinations (p = 0.07). The positive predictive value for recalls increased from 4.7% to 10.1% (p < 0.001)., Conclusion: The introduction of breast tomosynthesis into our practice was associated with a significant reduction in recall rates and a simultaneous increase in breast cancer detection rates.