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Original Investigation
June 25, 2014

Breast Cancer Screening Using Tomosynthesis in Combination With Digital Mammography

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

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.