Clinical performance metrics of 3D digital breast tomosynthesis compared with 2D digital mammography for breast cancer screening in community practice.

OBJECTIVE: The objective of our study was to assess the clinical performance of combined 2D-3D digital breast tomosynthesis (DBT), referred to as "3D DBT," compared with 2D digital mammography (DM) alone for screening mammography in a community-based radiology practice. MATERIALS AND METHODS: Performance outcomes measures were assessed for 14 radiologists who interpreted more than 500 screening mammography 3D DBT studies after the initiation of tomosynthesis. Outcomes from screening mammography during the study period between August 9, 2011, and November 30, 2012, using 3D DBT (n = 23,149 patients) versus 2D DM (n = 54,684 patients) were compared. RESULTS: For patients screened with 3D DBT, the relative change in recall rate was 16.1% lower than for patients screened with 2D DM (p > 0.0001). The overall cancer detection rate (CDR), expressed as number of cancers per 1000 patients screened, was 28.6% greater (p = 0.035) for 3D DBT (6.3/1000) compared with 2D DM (4.9/1000). The CDR for invasive cancers with 3D DBT (4.6/1000) was 43.8% higher (p = 0.0056) than with 2D DM (3.2/1000). The positive predictive value for recalls from screening (PPV1) was 53.3% greater (p = 0.0003) for 3D DBT (4.6%) compared with 2D DM (3.0%). No significant difference in the positive predictive value for biopsy (PPV3) was found for 3D DBT versus 2D DM (22.8% and 23.8%, respectively) (p = 0.696). CONCLUSION: In community-based radiology practice, mammography screening with 3D DBT yielded lower recall rates, an increased CDR for cancer overall, and an increased CDR for invasive cancer compared with 2D DM. The PPV1 was significantly greater in the group screened using 3D DBT.

Breast cancer screening using tomosynthesis in combination with digital mammography.

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.