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Original Investigation |

Breast Cancer Screening Using Tomosynthesis in Combination With Digital Mammography

Sarah M. Friedewald, MD1; Elizabeth A. Rafferty, MD2; Stephen L. Rose, MD3,4; Melissa A. Durand, MD5; Donna M. Plecha, MD6; Julianne S. Greenberg, MD7; Mary K. Hayes, MD8; Debra S. Copit, MD9; Kara L. Carlson, MD10; Thomas M. Cink, MD11; Lora D. Barke, DO12; Linda N. Greer, MD13; Dave P. Miller, MS14; Emily F. Conant, MD15
[+] Author Affiliations
1Caldwell Breast Center, Advocate Lutheran General Hospital, Park Ridge, Illinois
2Department of Radiology, Massachusetts General Hospital, Boston
3TOPS Comprehensive Breast Center, Houston, Texas
4Solis Women’s Health, Dallas, Texas
5Breast Imaging Section, Department of Diagnostic Radiology, Yale University School of Medicine, New Haven, Connecticut
6Department of Radiology, University Hospitals Case Medical Center, Cleveland, Ohio
7Washington Radiology Associates, Fairfax, Virginia
8Radiology Associates of Hollywood and Memorial Healthcare System, Hollywood, Florida
9Department of Diagnostic Radiology, Albert Einstein Healthcare Network, Philadelphia, Pennsylvania
10Evergreen Health Breast Center and Radia Inc, Kirkland, Washington
11Edith Sanford Breast Health Institute, Sioux Falls, South Dakota
12Invision Sally Jobe Breast Centers and Radiology Imaging Associates, Denver, Colorado
13John C. Lincoln Breast Health and Research Center, Phoenix, Arizona
14ICON Clinical Research, San Francisco, California
15Department of Radiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia
JAMA. 2014;311(24):2499-2507. doi:10.1001/jama.2014.6095.
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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.

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Combined Change in Cancer Detection Rate and Recall Rate for Each Institution After Implementation of Tomosynthesis

Lines demonstrate combined change in performance for each institution, labeled by site number. Pooled performance across all institutions is shown in blue. The model estimate is shown in orange.

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