Objectives Digital breast tomosynthesis (DBT) plus digital mammography (DM) in screening is problematic due to increased radiation by the double exposure. Synthesised two-dimensional mammography (s2D) calculated from DBT datasets at no additional dose appears a sensible alternative compared to adding DM. This systematic review and meta-analysis focuses on screening performance outcomes in women screened with DBT plus s2D compared to DM alone. Methods PubMed was searched from January 1, 2010, to September 2, 2020. Studies comparing DBT plus s2D to DM alone in breast cancer screening were included. Pooled risk ratios (RR) were estimated for cancer detection rates (CDR), recall rates, interval cancer rates (ICR), biopsy rates, and positive predictive values for recalls (PPV-1), for biopsies recommended (PPV-2), and for biopsies performed (PPV-3). Sensitivity analyses were performed using the leave-one-out approach. Risk of bias (RoB) was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool. Results Twelve papers covering 414,281 women were included from 766 records identified. CDR is increased ([RR, 95% CI] 1.35, 1.20–1.52), recall rates are decreased (0.79, 0.64–0.98), and PPV-1 is increased (1.69, 1.45–1.96) when using DBT plus s2D compared to DM alone. ICR and biopsy rates did not differ, but PPV-2 respectively PPV-3 increased with DBT plus s2D (1.57, 1.08–2.28 respectively 1.36, 1.17–1.58). Overall RoB of studies was assessed to be low. Conclusion Results show improved diagnostic outcomes with DBT plus s2D compared to DM alone and underline the value of DBT in combination with s2D in breast cancer screening. Key Points • DBT plus s2D is associated with higher CDR, lower recall rates, and a higher PPV-1 compared to DM alone in breast cancer screening. • No differences in biopsy rates were found between screening modalities, but PPV-2 and PPV-3 were higher in women screened with DBT plus s2D compared to DM alone. • We identified inconsistent results of ICR in two studies comparing DBT plus s2D to DM alone—resulting in no differences when pooling ICR in meta-analysis.

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