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Comparing accuracy of tomosynthesis plus digital mammography or synthetic 2D mammography in breast cancer screening: baseline results of the MAITA RCT consortium

2024; Elsevier BV; Volume: 199; Linguagem: Inglês

10.1016/j.ejca.2024.113553

1879-0852

Paolo Giorgi Rossi, Pamela Mancuso, Pierpaolo Pattacini, Cinzia Campari, Andrea Nitrosi, Valentina Iotti, Antonio Ponti, Alfonso Frigerio, Loredana Correale, Emilia Riggi, Livia Giordano, Nereo Segnan, Giovanni Di Leo, Veronica Magni, Francesco Sardanelli, Francesca Fornasa, Giovanna Romanucci, Stefania Montemezzi, Patrizia Falini, Noemi Auzzi, Marco Zappa, Marta Ottone, Paola Mantellini, Stephen W. Duffy, Paola Armaroli, Chiara Coriani, Manuela Pescarolo, Gloria Stefanelli, Giulio Tondelli, Filippo Beretti, Sabrina Caffarri, Vanessa Marchesi, Laura Canovi, Marco Colli, Mirco Boschini, Marco Bertolini, Moira Ragazzi, Pierpaolo Pattacini, Paolo Giorgi Rossi, Valentina Iotti, Vladimiro Ginocchi, Sara Ravaioli, Rita Vacondio, Cinzia Campari, Stefania Caroli, Andrea Nitrosi, Luca Braglia, Silvio Cavuto, Pamela Mancuso, Olivera Djurić, Francesco Venturelli, Massimo Vicentini, Maria Barbara Braghiroli, Jasmine Lonetti, Elena Davoli, Efrem Bonelli, Francesca Fornasa, Stefania Montemezzi, Giovanna Romanucci, Ilaria Lucchi, Gessica Martello, Claudia Rossati, Paola Mantellini, Daniela Ambrogetti, Anna Iossa, Eva Carnesciali, Vincenzo Mazzalupo, Patrizia Falini, Donella Puliti, Marco Zappa, Francesca Battisti, Noemi Auzzi, Simona Verdi, Carolina Degl’Innocenti, Daniela Tramalloni, Elena Cavazza, S. Busoni, Elisa Betti, Francesca Peruzzi, Francesco Regini, Francesco Sardanelli, Giovanni Di Leo, Luca Alessandro Carbonaro, Veronica Magni, Andrea Cozzi, D. Spinelli, Cristian Giuseppe Monaco, Simone Schiaffino, Adrienn Benedek, Laura Menicagli, Raffaella Ferraris, Elisabetta Favettini, Davide Dettori, P. Di Falco, Pietro Presti, Nereo Segnan, Antonio Ponti, Alfonso Frigerio, Paola Armaroli, Loredana Correale, Vincenzo Marra, L Milanesio, Franca Artuso, Aurora Di Leo, Isabella Castellano, Emilia Riggi, Denise Casella, Sabina Pitarella, Viviana Vergini, Livia Giordano, Stephen W. Duffy, Axel Graewingholt, Kristina Lång, Fabio Falcini,

Global Cancer Incidence and Screening

Abstract Aim The analyses here reported aim to compare the screening performance of digital tomosynthesis (DBT) versus mammography (DM). Methods MAITA is a consortium of four Italian trials, REtomo, Proteus, Impeto, and MAITA trial. The trials adopted a two-arm randomised design comparing DBT plus DM (REtomo and Proteus) or synthetic-2D (Impeto and MAITA trial) versus DM; multiple vendors were included. Women aged 45 to 69 years were individually randomised to one round of DBT or DM. Findings From March 2014 to February 2022, 50,856 and 63,295 women were randomised to the DBT and DM arm, respectively. In the DBT arm, 6656 women were screened with DBT plus synthetic-2D. Recall was higher in the DBT arm (5·84% versus 4·96%), with differences between centres. With DBT, 0·8/1000 (95% CI 0·3 to 1·3) more women received surgical treatment for a benign lesion. The detection rate was 51% higher with DBT, ie. 2·6/1000 (95% CI 1·7 to 3·6) more cancers detected, with a similar relative increase for invasive cancers and ductal carcinoma in situ. The results were similar below and over the age of 50, at first and subsequent rounds, and with DBT plus DM and DBT plus synthetic-2D. No learning curve was appreciable. Detection of cancers >= 20 mm, with 2 or more positive lymph nodes, grade III, HER2-positive, or triple-negative was similar in the two arms. Interpretation Results from MAITA confirm that DBT is superior to DM for the detection of cancers, with a possible increase in recall rate. DBT performance in screening should be assessed locally while waiting for long-term follow-up results on the impact of advanced cancer incidence.