Introduction of one-view tomosynthesis in population-based mammography screening: Impact on detection rate, interval cancer rate and false-positive rate

Bolette Mikela Vilmun*, George Napolitano, Martin Lillholm, Rikke Rass Winkel, Elsebeth Lynge, Mads Nielsen, Michael Bachmann Nielsen, Jonathan Frederik Carlsen, My von Euler-Chelpin, Ilse Vejborg

*Corresponding author for this work

Abstract

OBJECTIVE: To assess performance endpoints of a combination of digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) compared with FFDM only in breast cancer screening.

MATERIALS AND METHODS: This was a prospective population-based screening study, including eligible (50-69 years) women attending the Capital Region Mammography Screening Program in Denmark. All attending women were offered FFDM. A subgroup was consecutively allocated to a screening room with DBT. All FFDM and DBT underwent independent double reading, and all women were followed up for 2 years after screening date or until next screening date, whichever came first.

RESULTS: 6353 DBT + FFDM and 395 835 FFDM were included in the analysis and were undertaken in 196 267 women in the period from 1 November 2012 to 12 December 2018. Addition of DBT increased sensitivity: 89.9% (95% confidence interval (CI): 81.0-95.5) for DBT + FFDM and 70.1% (95% CI: 68.6-71.6) for FFDM only, p < 0.001. Specificity remained similar: 98.2% (95% CI: 97.9-98.5) for DBT + FFDM and 98.3% (95% CI: 98.2-98.3) for FFDM only, p = 0.9. Screen-detected cancer rate increased statistically significantly: 11.18/1000 for DBT + FFDM and 6.49/1000 for FFDM only, p < 0.001. False-positive rate was unchanged: 1.75% for DBT + FFDM and 1.73% for FFDM only, p = 0.9. Positive predictive value for recall was 39.0% (95% CI: 31.9-46.5) for DBT + FFDM and 27.3% (95% CI: 26.4-28.2), for FFDM only, p < 0.0005. The interval cancer rate decreased: 1.26/1000 for DBT + FFDM and 2.76/1000 for FFDM only, p = 0.02.

CONCLUSION: DBT + FFDM yielded a statistically significant increase in cancer detection and program sensitivity.

Original languageEnglish
JournalJournal of Medical Screening
Pages (from-to)9691413241262259
ISSN0969-1413
DOIs
Publication statusE-pub ahead of print - 25 Jul 2024

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