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

Breast cancer screening Mammography Randomised trial Tomosynthesis

Journal

European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373

Informations de publication

Date de publication:
17 Jan 2024
Historique:
received: 20 09 2023
revised: 01 01 2024
accepted: 06 01 2024
medline: 24 1 2024
pubmed: 24 1 2024
entrez: 23 1 2024
Statut: aheadofprint

Résumé

The analyses here reported aim to compare the screening performance of digital tomosynthesis (DBT) versus mammography (DM). 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. 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. 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.

Identifiants

pubmed: 38262307
pii: S0959-8049(24)00029-7
doi: 10.1016/j.ejca.2024.113553
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

113553

Informations de copyright

Copyright © 2024 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

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.

Auteurs

Paolo Giorgi Rossi (P)

Epidemiology Unit, AUSL - IRCCS di Reggio Emilia, Italy. Electronic address: paolo.giorgirossi@ausl.re.it.

Pamela Mancuso (P)

Epidemiology Unit, AUSL - IRCCS di Reggio Emilia, Italy.

Pierpaolo Pattacini (P)

Radiology Department, AUSL - IRCCS di Reggio Emilia, Italy.

Cinzia Campari (C)

Screening coordinating centre, AUSL - IRCCS di Reggio Emilia, Italy.

Andrea Nitrosi (A)

Medical Physics unit, AUSL - IRCCS di Reggio Emilia, Italy.

Valentina Iotti (V)

Radiology Department, AUSL - IRCCS di Reggio Emilia, Italy.

Antonio Ponti (A)

SSD Epidemiologia e Screening. AOU Città della Salute e della Scienza, CPO Piemonte Torino, Italy.

Alfonso Frigerio (A)

SSD Senologia di Screening AOU Città della Salute e della Scienza, CPO Piemonte Torino, Italy.

Loredana Correale (L)

SSD Epidemiologia e Screening. AOU Città della Salute e della Scienza, CPO Piemonte Torino, Italy.

Emilia Riggi (E)

SSD Epidemiologia e Screening. AOU Città della Salute e della Scienza, CPO Piemonte Torino, Italy.

Livia Giordano (L)

SSD Epidemiologia e Screening. AOU Città della Salute e della Scienza, CPO Piemonte Torino, Italy.

Nereo Segnan (N)

SSD Epidemiologia e Screening. AOU Città della Salute e della Scienza, CPO Piemonte Torino, Italy.

Giovanni Di Leo (G)

IRCC Policlinico San Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy.

Veronica Magni (V)

Department of Biomedical Sciences for Health, Università degli Studi di Milano, Via Mangiagalli 31, 20133 Milan, Italy.

Francesco Sardanelli (F)

IRCC Policlinico San Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy; Department of Biomedical Sciences for Health, Università degli Studi di Milano, Via Mangiagalli 31, 20133 Milan, Italy.

Francesca Fornasa (F)

Breast Unit ULSS9 Scaligera, Ospedale Fracastoro, Via Circonvallazione, 1, 37047 San Bonifacio, VR, Italy.

Giovanna Romanucci (G)

Breast Unit ULSS9 Scaligera, Ospedale Fracastoro, Via Circonvallazione, 1, 37047 San Bonifacio, VR, Italy.

Stefania Montemezzi (S)

Radiology Unit - University Hospital of Verona, Italy.

Patrizia Falini (P)

ISPRO - Istituto per lo Studio, la Prevenzione e la Rete Oncologica, Firenze, Italy.

Noemi Auzzi (N)

ISPRO - Istituto per lo Studio, la Prevenzione e la Rete Oncologica, Firenze, Italy.

Marco Zappa (M)

ISPRO - Istituto per lo Studio, la Prevenzione e la Rete Oncologica, Firenze, Italy.

Marta Ottone (M)

Epidemiology Unit, AUSL - IRCCS di Reggio Emilia, Italy.

Paola Mantellini (P)

ISPRO - Istituto per lo Studio, la Prevenzione e la Rete Oncologica, Firenze, Italy.

Stephen W Duffy (SW)

Wolfson Institute of Population Health, Queen Mary University of London, Charterhouse Square, London EC1M 6BQ, UK.

Paola Armaroli (P)

SSD Epidemiologia e Screening. AOU Città della Salute e della Scienza, CPO Piemonte Torino, Italy.

Chiara Coriani (C)

AUSL-IRCCS di Reggio Emilia, Italy.

Manuela Pescarolo (M)

AUSL-IRCCS di Reggio Emilia, Italy.

Gloria Stefanelli (G)

AUSL-IRCCS di Reggio Emilia, Italy.

Giulio Tondelli (G)

AUSL-IRCCS di Reggio Emilia, Italy.

Filippo Beretti (F)

AUSL-IRCCS di Reggio Emilia, Italy.

Sabrina Caffarri (S)

AUSL-IRCCS di Reggio Emilia, Italy.

Vanessa Marchesi (V)

AUSL-IRCCS di Reggio Emilia, Italy.

Laura Canovi (L)

AUSL-IRCCS di Reggio Emilia, Italy.

Marco Colli (M)

AUSL-IRCCS di Reggio Emilia, Italy.

Mirco Boschini (M)

AUSL-IRCCS di Reggio Emilia, Italy.

Marco Bertolini (M)

AUSL-IRCCS di Reggio Emilia, Italy.

Moira Ragazzi (M)

AUSL-IRCCS di Reggio Emilia, Italy.

Pierpaolo Pattacini (P)

AUSL-IRCCS di Reggio Emilia, Italy.

Paolo Giorgi Rossi (P)

AUSL-IRCCS di Reggio Emilia, Italy.

Valentina Iotti (V)

AUSL-IRCCS di Reggio Emilia, Italy.

Vladimiro Ginocchi (V)

AUSL-IRCCS di Reggio Emilia, Italy.

Sara Ravaioli (S)

AUSL-IRCCS di Reggio Emilia, Italy.

Rita Vacondio (R)

AUSL-IRCCS di Reggio Emilia, Italy.

Cinzia Campari (C)

AUSL-IRCCS di Reggio Emilia, Italy.

Stefania Caroli (S)

AUSL-IRCCS di Reggio Emilia, Italy.

Andrea Nitrosi (A)

AUSL-IRCCS di Reggio Emilia, Italy.

Luca Braglia (L)

AUSL-IRCCS di Reggio Emilia, Italy.

Silvio Cavuto (S)

AUSL-IRCCS di Reggio Emilia, Italy.

Pamela Mancuso (P)

AUSL-IRCCS di Reggio Emilia, Italy.

Olivera Djuric (O)

AUSL-IRCCS di Reggio Emilia, Italy.

Francesco Venturelli (F)

AUSL-IRCCS di Reggio Emilia, Italy.

Massimo Vicentini (M)

AUSL-IRCCS di Reggio Emilia, Italy.

Maria Barbara Braghiroli (MB)

AUSL-IRCCS di Reggio Emilia, Italy.

Jasmine Lonetti (J)

AUSL-IRCCS di Reggio Emilia, Italy.

Elena Davoli (E)

AUSL-IRCCS di Reggio Emilia, Italy.

Efrem Bonelli (E)

AUSL-IRCCS di Reggio Emilia, Italy.

Francesca Fornasa (F)

Breast Unit ULSS9 Scaligera, Ospedale Fracastoro, Via Circonvallazione, 1, 37047 San Bonifacio, VR, Italy.

Stefania Montemezzi (S)

Radiology Unit - University Hospital of Verona.

Giovanna Romanucci (G)

Breast Unit ULSS9 Scaligera, Ospedale Fracastoro, Via Circonvallazione, 1, 37047 San Bonifacio, VR, Italy.

Ilaria Lucchi (I)

Breast Unit ULSS9 Scaligera, Ospedale Fracastoro, Via Circonvallazione, 1, 37047 San Bonifacio, VR, Italy.

Gessica Martello (G)

Breast Unit ULSS9 Scaligera, Ospedale Fracastoro, Via Circonvallazione, 1, 37047 San Bonifacio, VR, Italy.

Claudia Rossati (C)

Radiology Unit - University Hospital of Verona.

Paola Mantellini (P)

ISPRO Firenze, Italy.

Daniela Ambrogetti (D)

ISPRO Firenze, Italy.

Anna Iossa (A)

ISPRO Firenze, Italy.

Eva Carnesciali (E)

ISPRO Firenze, Italy.

Vincenzo Mazzalupo (V)

ISPRO Firenze, Italy.

Patrizia Falini (P)

ISPRO Firenze, Italy.

Donella Puliti (D)

ISPRO Firenze, Italy.

Marco Zappa (M)

ISPRO Firenze, Italy.

Francesca Battisti (F)

ISPRO Firenze, Italy.

Noemi Auzzi (N)

ISPRO Firenze, Italy.

Simona Verdi (S)

ISPRO Firenze, Italy.

Carolina Degl'Innocenti (C)

ISPRO Firenze, Italy.

Daniela Tramalloni (D)

ISPRO Firenze, Italy.

Elena Cavazza (E)

ISPRO Firenze, Italy.

Simone Busoni (S)

ISPRO Firenze, Italy.

Elisa Betti (E)

ISPRO Firenze, Italy.

Francesca Peruzzi (F)

ISPRO Firenze, Italy.

Francesco Regini (F)

ISPRO Firenze, Italy.

Francesco Sardanelli (F)

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Giovanni Di Leo (G)

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Luca Alessandro Carbonaro (LA)

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Veronica Magni (V)

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Andrea Cozzi (A)

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Diana Spinelli (D)

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Cristian Giuseppe Monaco (CG)

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Simone Schiaffino (S)

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Adrienn Benedek (A)

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Laura Menicagli (L)

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Raffaella Ferraris (R)

CPO Piemonte, Italy.

Elisabetta Favettini (E)

CPO Piemonte, Italy.

Davide Dettori (D)

CPO Piemonte, Italy.

Paolo Falco (P)

CPO Piemonte, Italy.

Pietro Presti (P)

CPO Piemonte, Italy.

Nereo Segnan (N)

CPO Piemonte, Italy.

Antonio Ponti (A)

CPO Piemonte, Italy.

Alfonso Frigerio (A)

CPO Piemonte, Italy.

Paola Armaroli (P)

CPO Piemonte, Italy.

Loredana Correale (L)

CPO Piemonte, Italy.

Vincenzo Marra (V)

CPO Piemonte, Italy.

Luisella Milanesio (L)

CPO Piemonte, Italy.

Franca Artuso (F)

CPO Piemonte, Italy.

Aurora Di Leo (A)

CPO Piemonte, Italy.

Isabella Castellano (I)

CPO Piemonte, Italy.

Emilia Riggi (E)

CPO Piemonte, Italy.

Denise Casella (D)

CPO Piemonte, Italy.

Sabina Pitarella (S)

CPO Piemonte, Italy.

Viviana Vergini (V)

CPO Piemonte, Italy.

Livia Giordano (L)

CPO Piemonte, Italy.

Stephen W Duffy (SW)

Queen Mary University of London, UK.

Axel Graewingholt (A)

Mammographiescreening-Zentrum Paderborn, Breast Cancer Screening, Paderborn, NRW, Germany.

Kristina Lang (K)

Departement of Translational Medicine, Lund University, Unilabs Mammography Unit, Skåne University Hospital, Malmö, Sweden.

Fabio Falcini (F)

IRST Meldola, Italy.

Classifications MeSH