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JAMA. 2014 Jun 25;311(24):2499-507. doi: 10.1001/jama.2014.6095.

Breast cancer screening using tomosynthesis in combination with digital mammography.

Author information

  • 1Caldwell Breast Center, Advocate Lutheran General Hospital, Park Ridge, Illinois.
  • 2Department of Radiology, Massachusetts General Hospital, Boston.
  • 3TOPS Comprehensive Breast Center, Houston, Texas4Solis Women's Health, Dallas, Texas.
  • 4Breast Imaging Section, Department of Diagnostic Radiology, Yale University School of Medicine, New Haven, Connecticut.
  • 5Department of Radiology, University Hospitals Case Medical Center, Cleveland, Ohio.
  • 6Washington Radiology Associates, Fairfax, Virginia.
  • 7Radiology Associates of Hollywood and Memorial Healthcare System, Hollywood, Florida.
  • 8Department of Diagnostic Radiology, Albert Einstein Healthcare Network, Philadelphia, Pennsylvania.
  • 9Evergreen Health Breast Center and Radia Inc, Kirkland, Washington.
  • 10Edith Sanford Breast Health Institute, Sioux Falls, South Dakota.
  • 11Invision Sally Jobe Breast Centers and Radiology Imaging Associates, Denver, Colorado.
  • 12John C. Lincoln Breast Health and Research Center, Phoenix, Arizona.
  • 13ICON Clinical Research, San Francisco, California.
  • 14Department of Radiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Abstract

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.

PMID:
25058084
DOI:
10.1001/jama.2014.6095
[PubMed - indexed for MEDLINE]
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