Supplemental Breast MRI for Women with Extremely Dense Breasts: Results of the Second Screening Round of the DENSE Trial
Veenhuizen, Stefanie G A; de Lange, Stéphanie V; Bakker, Marije F; Pijnappel, Ruud M; Mann, Ritse M; Monninkhof, Evelyn M; Emaus, Marleen J; de Koekkoek-Doll, Petra K; Bisschops, Robertus H C; Lobbes, Marc B I; de Jong, Mathijn D F; Duvivier, Katya M; Veltman, Jeroen; Karssemeijer, Nico; de Koning, Harry J; van Diest, Paul J; Mali, Willem P T M; van den Bosch, Maurice A A J; van Gils, Carla H; Veldhuis, Wouter B; DENSE Trial Study Group
(2021) Radiology, volume 299, issue 2, pp. 278 - 286
(Article)
Abstract
Background: In the first (prevalent) supplemental MRI screening round of the Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial, a considerable number of breast cancers were found at the cost of an increased false-positive rate (FPR). In incident screening rounds, a lower cancer detection rate (CDR) is expected due
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to a smaller pool of prevalent cancers, and a reduced FPR, due to the availability of prior MRI examinations. Purpose: To investigate screening performance indicators of the second round (incidence round) of the DENSE trial. Materials and Methods: The DENSE trial (ClinicalTrials.gov: NCT01315015) is embedded within the Dutch population-based biennial mammography screening program for women aged 50-75 years. MRI examinations were performed between December 2011 and January 2016. Women were eligible for the second round when they again had a negative screening mammogram 2 years after their first MRI. The recall rate, biopsy rate, CDR, FPR, positive predictive values, and distributions of tumor characteristics were calculated and compared with results of the first round using 95% CIs and x 2 tests. Results: A total of 3436 women (median age, 56 years; interquartile range, 48-64 years) underwent a second MRI screening. The CDR was 5.8 per 1000 screening examinations (95% CI: 3.8, 9.0) compared with 16.5 per 1000 screening examinations (95% CI: 13.3, 20.5) in the first round. The FPR was 26.3 per 1000 screening examinations (95% CI: 21.5, 32.3) in the second round versus 79.8 per 1000 screening examinations (95% CI: 72.4, 87.9) in the first round. The positive predictive value for recall was 18% (20 of 110 participants recalled; 95% CI: 12.1, 26.4), and the positive predictive value for biopsy was 24% (20 of 84 participants who underwent biopsy; 95% CI: 16.0, 33.9), both comparable to that of the first round. All tumors in the second round were stage 0-I and node negative. Conclusion: The incremental cancer detection rate in the second round was 5.8 per 1000 screening examinations-compared with 16.5 per 1000 screening examinations in the first round. This was accompanied by a strong reduction in the number of false-positive results.
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Keywords: Radiology Nuclear Medicine and imaging
ISSN: 0033-8419
Publisher: Radiological Society of North America Inc.
Note: Funding Information: The DENSE trial is financially supported by the University Medical Center Utrecht (Universitair Medisch Centrum Utrecht, project number UMCU DENSE), the Netherlands Organization for Health Research and Development (ZonMw, project numbers ZONMW-200320002-UMCU and ZonMW Preventie 50-53125-98-014), the Dutch Cancer Society (KWF Kankerbestrijding; project numbers DCS-UU-2009-4348, UU-2014-6859, and UU2014-7151), Dutch Pink Ribbon/A Sister's Hope Organization (project number Pink Ribbon-10074), Bayer AG Pharmaceuticals, Radiology (project number BSP-DENSE), and Stichting Kankerpreventie Midden-West. Acknowledgment: For research purposes, Volpara Health Technologies provided Volpara imaging software version 1.5 for installation on servers in the screening units of the Dutch screening program. Funding Information: The DENSE trial is financially supported by the University Medical Center Utrecht (Universitair Medisch Centrum Utrecht, project number UMCU DENSE), the Netherlands Organization for Health Research and Development (ZonMw, project numbers ZONMW-200320002-UMCU and ZonMW Preventie 50-53125-98-014), the Dutch Cancer Society (KWF Kankerbestrijding; project numbers DCS-UU-2009-4348, UU-2014-6859, and UU2014-7151), Dutch Pink Ribbon/A Sister’s Hope Organization (project number Pink Ribbon-10074), Bayer AG Pharmaceuticals, Radiology (project number BSP-DENSE), and Stichting Kankerpreventie Midden-West. Publisher Copyright: © RSNA, 2021
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