乳腺断层合成联合数字乳腺摄影或合成二维乳腺摄影在乳腺癌筛查中的准确性比较：MAITA随机对照试验联盟的基线结果

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

作者信息

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, 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

机构信息

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

出版信息

Eur J Cancer. 2024 Mar;199:113553. doi: 10.1016/j.ejca.2024.113553. Epub 2024 Jan 17.

DOI:10.1016/j.ejca.2024.113553

PMID:38262307

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.

摘要

目的

本报告中的分析旨在比较数字断层合成（DBT）与乳腺钼靶摄影（DM）的筛查性能。

方法

MAITA是由四项意大利试验（REtomo、Proteus、Impeto和MAITA试验）组成的联盟。这些试验采用双臂随机设计，比较DBT加DM（REtomo和Proteus）或合成二维成像（Impeto和MAITA试验）与DM；纳入了多个供应商。45至69岁的女性被分别随机分配接受一轮DBT或DM检查。

研究结果

从2014年3月至2022年2月，分别有50856名和63295名女性被随机分配至DBT组和DM组。在DBT组中，6656名女性接受了DBT加合成二维成像筛查。DBT组的召回率更高（5.84%对4.96%），各中心之间存在差异。使用DBT时，每1000名女性中因良性病变接受手术治疗的人数多0.8例（95%置信区间0.3至1.3）。DBT的癌症检出率高51%，即每1000名女性中多检出2.6例癌症（95%置信区间1.7至3.6），浸润性癌和原位导管癌的相对增加幅度相似。在50岁上下、首轮和后续轮次以及DBT加DM和DBT加合成二维成像的情况下，结果相似。未观察到明显的学习曲线。两组中癌症直径≥20毫米、伴有2个或更多阳性淋巴结、III级、HER2阳性或三阴性的检出情况相似。