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Digital Breast Tomosynthesis for the Screening and Diagnosis of Breast Cancer: A Review of the Diagnostic Accuracy, Cost-Effectiveness and Guidelines

Last updated: October 28, 2019
Project Number: RC1204-000
Product Line: Rapid Response
Research Type: Devices and Systems
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical utility of 3D digital tomosynthesis with or without 2D mammography compared with 2D mammography alone for breast cancer screening or diagnosis?
  2. What is the diagnostic accuracy of 3D digital tomosynthesis with or without 2D mammography compared with 2D mammography alone for breast cancer screening or diagnosis?
  3. What is the cost effectiveness of 3D digital tomosynthesis with or without 2D mammography compared with 2D mammography alone for breast cancer screening or diagnosis?
  4. What are the evidence-based guidelines regarding the use of 3D digital tomosynthesis for breast cancer screening and diagnosis?

Key Message

Based on seven systematic reviews of nonrandomized studies, digital breast tomosynthesis in combination with digital mammography may improve detection rate and recall rate of breast cancer compared to digital mammography alone for screening, though there was heterogeneity in evidence with respect to the type of cancer (invasive versus noninvasive) and screening setting (frequency of screening, number of reads). Results were conflicting in the two eligible randomized controlled trials. Both found no benefit on detection rate for digital breast tomosynthesis in addition to digital mammography for screening, while one randomized controlled trial found benefit for recall rate and the other did not. There was limited evidence in the diagnostic setting. For diagnosis, two systematic reviews provided narrative comparisons of digital breast tomosynthesis alone or in combination with digital mammography to digital mammography alone. Both reported that digital breast tomosynthesis improved sensitivity, though results were conflicting for specificity. One systematic review found that digital breast tomosynthesis alone or in combination with digital mammography improved the detection rate of breast cancer for women with dense breasts in a diagnostic setting. No evidence on the clinical effectiveness or harms of digital breast tomosynthesis was identified. As such, the benefits and harms of digital breast tomosynthesis for screening and diagnosis are unclear. One cost-effectiveness study conducted in the United States found that digital breast tomosynthesis in combination with digital mammography was cost-effective compared to digital mammography alone in women age 40 to 79. Digital breast tomosynthesis and digital mammography was most cost-effective in those age 40 to 49, compared to those age 50 to 59, 60 to 69, and 70 or older. Two guidelines were identified, both of which recommended against using digital breast tomosynthesis for screening of breast cancer in asymptomatic women not at high risk of breast cancer. Recommendations were based on the insufficient evidence for digital breast tomosynthesis on benefits and harms.