• Pierpaolo Pattacini, Andrea Nitrosi, Paolo Giorgi Rossi, Valentina Iotti, Vladimiro Ginocchi, Sara Ravaioli, Rita Vacondio, Luca Braglia, Silvio Cavuto, Cinzia Campari, and RETomo Working Group.
• From the Radiology Unit (P.P., V.I., V.G., S.R., R.V.), Medical Physics Unit (A.N.), Epidemiology Unit (P.G.R.), Scientific Directorate (L.B., S.C.), and Screening Coordinating Centre (C.C.), AUSL Reggio Emilia, IRCCS, Via Amendola 2, Reggio Emilia 42122, Italy.
• Radiology. 2018 Aug 1; 288 (2): 375-385.

AbstractPurpose To compare digital mammography (DM) plus digital breast tomosynthesis (DBT) versus DM alone for breast cancer screening in the Reggio Emilia Tomosynthesis trial, a two-arm test-and-treat randomized controlled trial. Materials and Methods For this trial, eligible women (45-70 years old) who previously participated in the Reggio Emilia screening program were invited for mammography. Consenting women were randomly assigned 1:1 to undergo DBT+DM or DM (both of which involved two projections and double reading). Women were treated according to the decision at DBT+DM. Sensitivity, recall rate, and positive predictive value (PPV) at baseline were determined; the ratios of these rates for DBT+DM relative to DM alone were determined. Results From March 2014 to March 2016, 9777 women were recruited to the DM+DBT arm of the study, and 9783 women were recruited to the DM arm (mean age, 56.2 vs 56.3 years). Recall was 3.5% in both arms; detection was 4.5 per 1000 (44 of 9783) and 8.6 per 1000 (83 of 9777), respectively (+89%; 95% confidence interval [CI]: 31, 72). PPV of the recall was 13.0% and 24.1%, respectively (P = .0002); 72 of 80 cancers found in the DBT+DM arm and with complete DBT imaging were positive at least at one DBT-alone reading. The greater detection rate for DM+DBT was stronger for ductal carcinoma in situ (+180%, 95% CI: 1, 665); it was notable for small and medium invasive cancers, but not for large ones (+94 [95% CI: 6, 254]; +122 [95% CI: 18, 316]; -12 [95% CI: -68, 141]; for invasive cancers < 10 mm, 10-19 mm, and ≥ 20 mm, respectively). Conclusion DBT+DM depicts 90% more cancers in a population previously screened with DM, with similar recall rates.© RSNA, 2018 Online supplemental material is available for this article.

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