Comparing accuracy of tomosynthesis plus digital mammography or synthetic 2D mammography in breast cancer screening: baseline results of the MAITA RCT consortium.
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Giorgi Rossi Paolo, Mancuso Pamela, Pattacini Pierpaolo, Campari Cinzia, Nitrosi Andrea, Iotti Valentina, Ponti Antonio, Frigerio Alfonso, Correale Loredana, Riggi Emilia, Giordano Livia, Segnan Nereo, Di Leo Giovanni, Magni Veronica, Sardanelli Francesco, Fornasa Francesca, Romanucci Giovanna, Montemezzi Stefania, Falini Patrizia, Auzzi Noemi, Zappa Marco, Ottone Marta, Mantellini Paola, Duffy Stephen W, Armaroli Paola, MAITA working group., following are also members of the MAITA working group., Coriani Chiara, Pescarolo Manuela, Stefanelli Gloria, Tondelli Giulio, Beretti Filippo, Caffarri Sabrina, Marchesi Vanessa, Canovi Laura, Colli Marco, Boschini Mirco, Bertolini Marco, Ragazzi Moira, Pattacini Pierpaolo, Giorgi Rossi Paolo, Iotti Valentina, Ginocchi Vladimiro, Ravaioli Sara, Vacondio Rita, Campari Cinzia, Caroli Stefania, Nitrosi Andrea, Braglia Luca, Cavuto Silvio, Mancuso Pamela, Djuric Olivera, Venturelli Francesco, Vicentini Massimo, Braghiroli Maria Barbara, Lonetti Jasmine, Davoli Elena, Bonelli Efrem, Fornasa Francesca, Montemezzi Stefania, Romanucci Giovanna, Lucchi Ilaria, Martello Gessica, Rossati Claudia, Mantellini Paola, Ambrogetti Daniela, Iossa Anna, Carnesciali Eva, Mazzalupo Vincenzo, Falini Patrizia, Puliti Donella, Zappa Marco, Battisti Francesca, Auzzi Noemi, Verdi Simona, Degl'Innocenti Carolina, Tramalloni Daniela, Cavazza Elena, Busoni Simone, Betti Elisa, Peruzzi Francesca, Regini Francesco, Sardanelli Francesco, Di Leo Giovanni, Carbonaro Luca Alessandro, Magni Veronica, Cozzi Andrea, Spinelli Diana, Monaco Cristian Giuseppe, Schiaffino Simone, Benedek Adrienn, Menicagli Laura, Ferraris Raffaella, Favettini Elisabetta, Dettori Davide, Falco Paolo, Presti Pietro, Segnan Nereo, Ponti Antonio, Frigerio Alfonso, Armaroli Paola, Correale Loredana, Marra Vincenzo, Milanesio Luisella, Artuso Franca, Di Leo Aurora, Castellano Isabella, Riggi Emilia, Casella Denise, Pitarella Sabina, Vergini Viviana, Giordano Livia, Duffy Stephen W, Graewingholt Axel, Lang Kristina, Falcini Fabio
Аннотация
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.