Digital Mammography versus Digital Mammography Plus Tomosynthesis for Breast Cancer Screening: The Reggio Emilia Tomosynthesis Randomized Trial

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]; -12 [95% CI: -68, 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.

Breast Cancer Detection—A Synopsis of Conventional Modalities and the Potential Role of Microwave Imaging

“…In a randomized clinical trial of women aged 45 to 75 years, cancer detection for patients screened with mammography and DBT was higher (n = 9777, 8.6 per 1000) than patients who underwent mammography alone (n = 9783, 4.5 per 1000, RR 1.9) [35]. This is counterbalanced by increased radiation dose, increased cost, and increased radiologist interpretation time [35]. Overall, the procedure is well-tolerated by patients, and its use is becoming increasingly widespread, usually at the discretion of the radiologist.…”

“…The addition of DBT to conventional digital mammography has been shown to increase rates of cancer detection. In a randomized clinical trial of women aged 45 to 75 years, cancer detection for patients screened with mammography and DBT was higher (n = 9777, 8.6 per 1000) than patients who underwent mammography alone (n = 9783, 4.5 per 1000, RR 1.9) [35]. This is counterbalanced by increased radiation dose, increased cost, and increased radiologist interpretation time [35].…”

Women’s health 2019: Osteoporosis, breast cancer, contraception, and hormone therapy

“…Some studies have shown that combining DBT with digital mammography may be superior to digital mammography alone in detecting cancers. 18 However, digital mammography is currently the gold standard for breast cancer screening and is the only test proven to reduce mortality. 18,19 In a retrospective US study of 13 medical centers, 20 breast cancer detection rates increased by 41% the year after DBT was introduced, from 2.9 to 4.1 per 1,000 cases.…”

“…18 However, digital mammography is currently the gold standard for breast cancer screening and is the only test proven to reduce mortality. 18,19 In a retrospective US study of 13 medical centers, 20 breast cancer detection rates increased by 41% the year after DBT was introduced, from 2.9 to 4.1 per 1,000 cases. DBT was associated with 16 fewer patients recalled for repeat imaging out of 1,000 women screened (as opposed to mammography alone).…”

“…In a 2-arm study by Pattacini et al, 18 nearly 20,000 women ages 45 to 70 were randomized to undergo either digital mammography or digital mammography plus DBT for primary breast cancer screening. Women were enrolled over a 2-year period and were followed for 4.5 years, and the development of a primary invasive cancer was the primary end point.…”