Background: Most population breast cancer (BC) screening programs use double-reading of 2D-mammography. We recently reported the screening with tomosynthesis or standard mammography-2 (STORM-2) trial, showing that double-read tomosynthesis (pseudo-3D-mammography) detected more BC than double-read 2D-mammography. In this study, we compare screen-detection measures for single-reading of 3D-mammography with those for double-reading of 2D-mammography, to inform screening practice.
Methods: This is a secondary analysis based on STORM-2 which prospectively compared 3D-mammography and 2D-mammography in sequential screen-readings. Asymptomatic women ≥49 years who attended population-based screening (Trento, 2013-2015) were recruited. Participants recalled at any screen-read from parallel double-reading arms underwent further testing and/or biopsy. Single-reading of 3D-mammography, integrated with acquired or synthetized 2D-mammograms, was compared to double-reading of 2D-mammograhy alone for screen-detection measures: number of detected BCs, cancer detection rate (CDR), number and percentage of false-positive recall (FPR). Paired binary data were compared using McNemar's test.
Results: Screening detected 90, including 74 invasive, BCs in 85 of 9672 participants. CDRs for single-reading using integrated 2D/3D-mammography (8.2 per 1000 screens; 95% CI 6.5-10.2) or 2D synthetic/3D-mammography (8.4 per 1000 screens; 95% CI: 6.7-10.4) were significantly higher than CDR for double-reading of 2D-mammography (6.3 per 1000 screens; 95% CI: 4.8-8.1), P<0.001 both comparisons. FPR% for single-read 2D/3D-mammography (2.60%; 95% CI: 2.29-2.94), or single-read 2D synthetic/3D-mammography (2.76%; 95% CI: 2.45-3.11), were significantly lower than FPR% for double-read 2D-mammography (3.42%; 95% CI: 3.07-3.80), P<0.001 and P=0.002 respectively.
Conclusions: Single-reading of 3D-mammography (integrated 2D/3D or 2Dsynthetic/3D) detected more BC, and had lower FPR, compared to current practice of double-reading 2D-mammography alone - these findings have implications for population BC screening programs.
Keywords: Breast cancer screening; Digital breast tomosynthesis; Mammography; Population screening; Screen-reading.
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