A randomised controlled trial of Digital Breast Tomosynthesis versus Digital Mammography as primary screening tests: screening results over subsequent episodes of the Proteus Donna study
Mené sur 73 866 femmes âgées de 46 à 68 ans (durée de suivi : 36 mois), cet essai randomisé évalue l'efficacité, du point de vue de la détection des cancers du sein et des cancers de l'intervalle, d'une tomosynthèse numérique par rapport à une mammographie numérique
Proteus Donna is a randomised controlled trial aimed at prospectively evaluating screening with Digital Breast Tomosynthesis (DBT), including interval cancer detection (ICD) and cancer detection (CD) in the analysis as a cumulative measure over subsequent screening episodes.
Consenting women aged 46-68 attending the regional Breast Screening Service were randomly assigned to conventional digital mammography (DM, control arm), or DBT in addition to DM (DBT, study arm). At the subsequent round all participants underwent DM. 36-months follow-up allowed for the identification of cancers detected in the subsequent screening and inter-screening interval. Relative risk (RR) and 95% confidence interval (95%CI) were computed. Cumulative CD and Nelson-Aalen incidence were analysed over the follow-up period.
Between 31/12/2014 and 31/12/2017, 43022 women were randomised to DM and 30844 to DBT. At baseline, CD was significantly higher (RR 1·44; 95%CI 1·21-1·71) in the study arm. ICD did not differ significantly between the two arms. (RR 0·92; 95%CI 0·62-1·35). At subsequent screening with DM, the CD was lower (nearly significant) in the study arm (RR 0·83; 95%CI 0·65-1·06). Over the follow-up period, the cumulative CD (comprehensive of ICD) was slightly higher in the study arm (RR 1·15; 95%CI 1·01–1·31). The Nelson-Aalen cumulative incidence over time remained significantly higher in the study arm for approximately 24 months. Benign lesions detection was higher in the study arm at baseline and lower at subsequent tests.
Outcomes are consistent with a lead time gain of DBT compared to DM, with an increase in false positives and moderate overdiagnosis.
International Journal of Cancer , résumé, 2022