Early screening outcomes before, during, and after a randomized controlled trial with digital breast tomosynthesis

Åsne Sørlien Holen; Marie Burns Bergan; Christoph I Lee; Sophia Zackrisson; Nataliia Moshina; Hildegunn Siv Aase; Ingfrid Salvesen Haldorsen; Solveig Hofvind

doi:10.1016/j.ejrad.2023.111069

Early screening outcomes before, during, and after a randomized controlled trial with digital breast tomosynthesis

Eur J Radiol. 2023 Oct:167:111069. doi: 10.1016/j.ejrad.2023.111069. Epub 2023 Sep 1.

Authors

Åsne Sørlien Holen¹, Marie Burns Bergan², Christoph I Lee³, Sophia Zackrisson⁴, Nataliia Moshina⁵, Hildegunn Siv Aase⁶, Ingfrid Salvesen Haldorsen⁷, Solveig Hofvind⁸

Affiliations

¹ Section for Breast Cancer Screening, Cancer Registry of Norway, Oslo, Norway. Electronic address: asho@kreftregisteret.no.
² Section for Breast Cancer Screening, Cancer Registry of Norway, Oslo, Norway. Electronic address: mbbe@kreftregisteret.no.
³ Department of Radiology, University of Washington School of Medicine, Seattle, WA, USA; Department of Health Systems and Population Health, University of Washington School of Public Health, Seattle, WA, USA. Electronic address: stophlee@gmail.com.
⁴ Department of Translational Medicine, Diagnostic Radiology, Lund University, Malmö, Sweden; Department of Imaging and Functional Medicine, Skåne University Hospital, Malmö, Sweden. Electronic address: sophia.zackrisson@med.lu.se.
⁵ Section for Breast Cancer Screening, Cancer Registry of Norway, Oslo, Norway. Electronic address: namo@kreftregisteret.no.
⁶ Department of Radiology, Haukeland University Hospital, Bergen, Norway. Electronic address: hildegunn.siv.aase@helse-bergen.no.
⁷ Mohn Medical Imaging and Visualization Center, Department of Radiology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway. Electronic address: ingfrid.helene.salvesen.haldorsen@helse-bergen.no.
⁸ Section for Breast Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Department of Health and Care Sciences, Faculty of Health Sciences, UiT, The Arctic University of Norway, Tromsø, Norway. Electronic address: sshh@kreftregisteret.no.

PMID: 37708674
DOI: 10.1016/j.ejrad.2023.111069

Abstract

Purpose: To describe and compare early screening outcomes before, during and after a randomized controlled trial with digital breast tomosynthesis (DBT) including synthetic 2D mammography versus standard digital mammography (DM) (To-Be 1) and a follow-up cohort study using DBT (To-Be 2).

Methods: Retrospective results of 125,020 screening examinations from four consecutive screening rounds performed in 2014-2021 were described and compared for pre-To-Be 1 (DM), To-Be 1 (DM or DBT), To-Be 2 (DBT), and post-To-Be 2 (DM) cohorts. Descriptive analyses of rates of recall, biopsy, screen-detected and interval cancer, distribution of histopathologic tumor characteristics and time spent on image interpretation and consensus were presented for the four rounds including five cohorts, one cohort in each screening round except for the To-Be 1 trail, which included a DBT and a DM cohort. Odds ratios (OR) with 95% CIs was calculated for recall and cancer detection rates.

Results: Rate of screen-detected cancer was 0.90% for women screened with DBT in To-Be 2 and 0.64% for DM in pre-To-Be 1. The rates did not differ for the To-Be 1 DM (0.61%), To-Be 1 DBT (0.66%) and post-To-Be 2 DM (0.67%) cohorts. The interval cancer rates ranged between 0.13% and 0.20%. The distribution of histopathologic tumor characteristics did not differ between the cohorts.

Conclusions: Screening all women with DBT following a randomized controlled trial in an organized, population-based screening program showed a temporary increase in the rate of screen-detected cancer.

Keywords: Breast neoplasm; Digital breast tomosynthesis; Digital mammography; Mass screening; Randomized controlled trial.

Publication types

Randomized Controlled Trial

MeSH terms

Biopsy
Consensus
Female
Follow-Up Studies
Humans
Mammography*
Retrospective Studies