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. 2024 Mar:199:113553.
doi: 10.1016/j.ejca.2024.113553. Epub 2024 Jan 17.

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

Paolo Giorgi Rossi  1 , Pamela Mancuso  2 , Pierpaolo Pattacini  3 , Cinzia Campari  4 , Andrea Nitrosi  5 , Valentina Iotti  3 , Antonio Ponti  6 , Alfonso Frigerio  7 , Loredana Correale  6 , Emilia Riggi  6 , Livia Giordano  6 , Nereo Segnan  6 , Giovanni Di Leo  8 , Veronica Magni  9 , Francesco Sardanelli  10 , Francesca Fornasa  11 , Giovanna Romanucci  11 , Stefania Montemezzi  12 , Patrizia Falini  13 , Noemi Auzzi  13 , Marco Zappa  13 , Marta Ottone  2 , Paola Mantellini  13 , Stephen W Duffy  14 , Paola Armaroli  6 ; MAITA working group.; following are also members of the MAITA working group.; Chiara Coriani  15 , Manuela Pescarolo  15 , Gloria Stefanelli  15 , Giulio Tondelli  15 , Filippo Beretti  15 , Sabrina Caffarri  15 , Vanessa Marchesi  15 , Laura Canovi  15 , Marco Colli  15 , Mirco Boschini  15 , Marco Bertolini  15 , Moira Ragazzi  15 , Pierpaolo Pattacini  15 , Paolo Giorgi Rossi  15 , Valentina Iotti  15 , Vladimiro Ginocchi  15 , Sara Ravaioli  15 , Rita Vacondio  15 , Cinzia Campari  15 , Stefania Caroli  15 , Andrea Nitrosi  15 , Luca Braglia  15 , Silvio Cavuto  15 , Pamela Mancuso  15 , Olivera Djuric  15 , Francesco Venturelli  15 , Massimo Vicentini  15 , Maria Barbara Braghiroli  15 , Jasmine Lonetti  15 , Elena Davoli  15 , Efrem Bonelli  15 , Francesca Fornasa  11 , Stefania Montemezzi  16 , Giovanna Romanucci  11 , Ilaria Lucchi  11 , Gessica Martello  11 , Claudia Rossati  16 , Paola Mantellini  17 , Daniela Ambrogetti  17 , Anna Iossa  17 , Eva Carnesciali  17 , Vincenzo Mazzalupo  17 , Patrizia Falini  17 , Donella Puliti  17 , Marco Zappa  17 , Francesca Battisti  17 , Noemi Auzzi  17 , Simona Verdi  17 , Carolina Degl'Innocenti  17 , Daniela Tramalloni  17 , Elena Cavazza  17 , Simone Busoni  17 , Elisa Betti  17 , Francesca Peruzzi  17 , Francesco Regini  17 , Francesco Sardanelli  18 , Giovanni Di Leo  18 , Luca Alessandro Carbonaro  18 , Veronica Magni  18 , Andrea Cozzi  18 , Diana Spinelli  18 , Cristian Giuseppe Monaco  18 , Simone Schiaffino  18 , Adrienn Benedek  18 , Laura Menicagli  18 , Raffaella Ferraris  19 , Elisabetta Favettini  19 , Davide Dettori  19 , Paolo Falco  19 , Pietro Presti  19 , Nereo Segnan  19 , Antonio Ponti  19 , Alfonso Frigerio  19 , Paola Armaroli  19 , Loredana Correale  19 , Vincenzo Marra  19 , Luisella Milanesio  19 , Franca Artuso  19 , Aurora Di Leo  19 , Isabella Castellano  19 , Emilia Riggi  19 , Denise Casella  19 , Sabina Pitarella  19 , Viviana Vergini  19 , Livia Giordano  19 , Stephen W Duffy  20 , Axel Graewingholt  21 , Kristina Lang  22 , Fabio Falcini  23
Affiliations

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

Paolo Giorgi Rossi et al. Eur J Cancer. 2024 Mar.

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.

Keywords: Breast cancer screening; Mammography; Randomised trial; Tomosynthesis.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Paolo Giorgi Rossi reports financial support was provided by Italian Ministry of Health. Pierpaolo Pattacini reports was provided by Emilia-Romagna Regional Health Authority. Antonio Ponti reports financial support was provided by Piedmont Region (Department of Health). Antonio Ponti reports financial support was provided by foundation Edo Tempia (a non-profit organisation). Antonio Ponti reports equipment, drugs, or supplies was provided by Regional Consortium for Informative Systems (CSI). Antonio Ponti reports financial support was provided by University of Turin. Paola Mantellini reports financial support was provided by Tuscany Region. Pierpaolo Pattacini reports equipment, drugs, or supplies and travel were provided by GE Healthcare. Antonio Ponti reports equipment, drugs, or supplies was provided by im3D S.p.A Torino. Stephen Duffy has received indirect funding in the past from Hologic Inc. Valentina Iotti, Andrea Nitrosi reports travel was provided by GE Healthcare. Pierpaolo Pattacini, Valentina Iotti, Andrea Nitrosi, Francesco Sardanelli reports a relationship with GE Healthcare that includes: speaking and lecture fees. Valentina Iotti reports a relationship with Bayer that includes: speaking and lecture fees. Paolo Giorgi Rossi, Livia Giordano, Stephen Duffy, and Francesco Sardanelli are members of the European Commission Initiative on Breast Cancer working groups. They contributed to the development of new breast cancer screening recommendations and quality assurance scheme. Livia Giordano is past president of the Gruppo Italiano Screening Mammografico, the Italian scientific society on breast cancer screening. All remaining authors have declared no conflicts of interest.

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