Digital mammography versus digital mammography plus tomosynthesis for breast cancer screening: The reggio emilia tomosynthesis randomized trial

Pierpaolo Pattacini, Andrea Nitrosi, Paolo Giorgi Rossi, Valentina Iotti, Vladimiro Ginocchi, Sara Ravaioli, Rita Vacondio, Luca Braglia, Silvio Cavuto, Cinzia Campari

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Abstract

Purpose: To compare digital mammography (DM) plus digital breast tomosynthesis (DBT) versus DM alone for breast cancer screening in the Reggio Emilia Tomosynthesis trial, a two-arm test-and-treat randomized controlled trial. Materials and Methods: For this trial, eligible women (45–70 years old) who previously participated in the Reggio Emilia screening program were invited for mammography. Consenting women were randomly assigned 1:1 to undergo DBT+DM or DM (both of which involved two projections and double reading). Women were treated according to the decision at DBT+DM. Sensitivity, recall rate, and positive predictive value (PPV) at baseline were determined; the ratios of these rates for DBT+DM relative to DM alone were determined. Results: From March 2014 to March 2016, 9777 women were recruited to the DM+DBT arm of the study, and 9783 women were recruited to the DM arm (mean age, 56.2 vs 56.3 years). Recall was 3.5% in both arms; detection was 4.5 per 1000 (44 of 9783) and 8.6 per 1000 (83 of 9777), respectively (+89%; 95% confidence interval [CI]: 31, 72). PPV of the recall was 13.0% and 24.1%, respectively (P = .0002); 72 of 80 cancers found in the DBT+DM arm and with complete DBT imaging were positive at least at one DBT-alone reading. The greater detection rate for DM+DBT was stronger for ductal carcinoma in situ (+180%, 95% CI: 1, 665); it was notable for small and medium invasive cancers, but not for large ones (+94 [95% CI: 6, 254]; +122 [95% CI: 18, 316]; 212 [95% CI: 268, 141]; for invasive cancers, 10 mm, 10–19 mm, and 20 mm, respectively). Conclusion: DBT+DM depicts 90% more cancers in a population previously screened with DM, with similar recall rates.

Original languageEnglish
Pages (from-to)375-385
Number of pages11
JournalRadiology
Volume288
Issue number2
DOIs
Publication statusPublished - Aug 1 2018

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Mammography
Early Detection of Cancer
Breast Neoplasms
Confidence Intervals
Reading
Neoplasms

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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Digital mammography versus digital mammography plus tomosynthesis for breast cancer screening : The reggio emilia tomosynthesis randomized trial. / Pattacini, Pierpaolo; Nitrosi, Andrea; Rossi, Paolo Giorgi; Iotti, Valentina; Ginocchi, Vladimiro; Ravaioli, Sara; Vacondio, Rita; Braglia, Luca; Cavuto, Silvio; Campari, Cinzia.

In: Radiology, Vol. 288, No. 2, 01.08.2018, p. 375-385.

Research output: Contribution to journalArticle

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abstract = "Purpose: To compare digital mammography (DM) plus digital breast tomosynthesis (DBT) versus DM alone for breast cancer screening in the Reggio Emilia Tomosynthesis trial, a two-arm test-and-treat randomized controlled trial. Materials and Methods: For this trial, eligible women (45–70 years old) who previously participated in the Reggio Emilia screening program were invited for mammography. Consenting women were randomly assigned 1:1 to undergo DBT+DM or DM (both of which involved two projections and double reading). Women were treated according to the decision at DBT+DM. Sensitivity, recall rate, and positive predictive value (PPV) at baseline were determined; the ratios of these rates for DBT+DM relative to DM alone were determined. Results: From March 2014 to March 2016, 9777 women were recruited to the DM+DBT arm of the study, and 9783 women were recruited to the DM arm (mean age, 56.2 vs 56.3 years). Recall was 3.5{\%} in both arms; detection was 4.5 per 1000 (44 of 9783) and 8.6 per 1000 (83 of 9777), respectively (+89{\%}; 95{\%} confidence interval [CI]: 31, 72). PPV of the recall was 13.0{\%} and 24.1{\%}, respectively (P = .0002); 72 of 80 cancers found in the DBT+DM arm and with complete DBT imaging were positive at least at one DBT-alone reading. The greater detection rate for DM+DBT was stronger for ductal carcinoma in situ (+180{\%}, 95{\%} CI: 1, 665); it was notable for small and medium invasive cancers, but not for large ones (+94 [95{\%} CI: 6, 254]; +122 [95{\%} CI: 18, 316]; 212 [95{\%} CI: 268, 141]; for invasive cancers, 10 mm, 10–19 mm, and 20 mm, respectively). Conclusion: DBT+DM depicts 90{\%} more cancers in a population previously screened with DM, with similar recall rates.",
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T1 - Digital mammography versus digital mammography plus tomosynthesis for breast cancer screening

T2 - The reggio emilia tomosynthesis randomized trial

AU - Pattacini, Pierpaolo

AU - Nitrosi, Andrea

AU - Rossi, Paolo Giorgi

AU - Iotti, Valentina

AU - Ginocchi, Vladimiro

AU - Ravaioli, Sara

AU - Vacondio, Rita

AU - Braglia, Luca

AU - Cavuto, Silvio

AU - Campari, Cinzia

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N2 - Purpose: To compare digital mammography (DM) plus digital breast tomosynthesis (DBT) versus DM alone for breast cancer screening in the Reggio Emilia Tomosynthesis trial, a two-arm test-and-treat randomized controlled trial. Materials and Methods: For this trial, eligible women (45–70 years old) who previously participated in the Reggio Emilia screening program were invited for mammography. Consenting women were randomly assigned 1:1 to undergo DBT+DM or DM (both of which involved two projections and double reading). Women were treated according to the decision at DBT+DM. Sensitivity, recall rate, and positive predictive value (PPV) at baseline were determined; the ratios of these rates for DBT+DM relative to DM alone were determined. Results: From March 2014 to March 2016, 9777 women were recruited to the DM+DBT arm of the study, and 9783 women were recruited to the DM arm (mean age, 56.2 vs 56.3 years). Recall was 3.5% in both arms; detection was 4.5 per 1000 (44 of 9783) and 8.6 per 1000 (83 of 9777), respectively (+89%; 95% confidence interval [CI]: 31, 72). PPV of the recall was 13.0% and 24.1%, respectively (P = .0002); 72 of 80 cancers found in the DBT+DM arm and with complete DBT imaging were positive at least at one DBT-alone reading. The greater detection rate for DM+DBT was stronger for ductal carcinoma in situ (+180%, 95% CI: 1, 665); it was notable for small and medium invasive cancers, but not for large ones (+94 [95% CI: 6, 254]; +122 [95% CI: 18, 316]; 212 [95% CI: 268, 141]; for invasive cancers, 10 mm, 10–19 mm, and 20 mm, respectively). Conclusion: DBT+DM depicts 90% more cancers in a population previously screened with DM, with similar recall rates.

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