TY - JOUR
T1 - Supplemental MRI Screening for Women with Extremely Dense Breast Tissue
AU - Bakker, Marije F.
AU - de Lange, Stephanie V.
AU - Pijnappel, Ruud M.
AU - Mann, Ritse M.
AU - Peeters, Petra H. M.
AU - Monninkhof, Evelyn M.
AU - Emaus, Marleen J.
AU - Loo, Claudette E.
AU - Bisschops, Robertus H. C.
AU - Lobbes, Marc B. I.
AU - de Jong, Matthijn D. F.
AU - Duvivier, Katya M.
AU - Veltman, Jeroen
AU - Karssemeijer, Nico
AU - de Koning, Harry J.
AU - van Diest, Paul J.
AU - Mali, Willem P. T. M.
AU - van den Bosch, Maurice A. A. J.
AU - Veldhuis, Wouter B.
AU - van Gils, Carla H.
AU - DENSE Trial Study Group
N1 - Funding Information:
Supported by the University Medical Center Utrecht (project number, UMCU DENSE), the Netherlands Organization for Health Research and Development (project numbers, ZonMW-200320002-UMCU and ZonMW Preventie 50-53125-98-014), the Dutch Cancer Society (project numbers, DCS-UU-2009-4348, UU-2014-6859, and UU-2014-7151), the Dutch Pink Ribbon–A Sister’s Hope (project number, Pink Ribbon-10074), Bayer Pharmaceuticals (project number, BSP-DENSE), and Stichting Kankerpreventie Midden-West. For research purposes, Volpara Health Technologies provided Volpara Imaging Software, version 1.5, for installation on servers in the screening units.
Funding Information:
On November 11, 2011, the trial was approved by the Dutch Minister of Health, Welfare, and Sport, under advisement from the Health Council of the Netherlands. The trial was financially supported by the University Medical Center Utrecht, the Netherlands Organization for Health Research and Development, the Dutch Cancer Society, the Dutch Pink Ribbon–A Sister’s Hope organization, Stich-ting Kankerpreventie Midden-West, and Bayer Pharmaceuticals, with an in-kind contribution from Volpara Health Technologies. The authors designed the trial, gathered and analyzed the data, and wrote the manuscript. With the exception of the University Medical Center Utrecht, none of the funders had any role in these tasks. All the authors vouch for the accuracy and completeness of the data and analysis and for the adherence of the trial to the protocol (available at NEJM.org).
Funding Information:
Supported by the University Medical Center Utrecht (project number, UMCU DENSE), the Netherlands Organization for Health Research and Development (project numbers, ZonMW- 200320002-UMCU and ZonMW Preventie 50-53125-98-014), the Dutch Cancer Society (project numbers, DCS-UU-2009-4348, UU-2014-6859, and UU-2014-7151), the Dutch Pink Ribbon-A Sister's Hope (project number, Pink Ribbon-10074), Bayer Pharmaceuticals (project number, BSP-DENSE), and Stichting Kankerpreventie Midden-West. For research purposes, Volpara Health Technologies provided Volpara Imaging Software, version 1.5, for installation on servers in the screening units.
Publisher Copyright:
Copyright © 2019 Massachusetts Medical Society.
PY - 2019/11/28
Y1 - 2019/11/28
N2 - BACKGROUNDExtremely dense breast tissue is a risk factor for breast cancer and limits the detection of cancer with mammography. Data are needed on the use of supplemental magnetic resonance imaging (MRI) to improve early detection and reduce interval breast cancers in such patients.METHODSIn this multicenter, randomized, controlled trial in the Netherlands, we assigned 40,373 women between the ages of 50 and 75 years with extremely dense breast tissue and normal results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The groups were assigned in a 1:4 ratio, with 8061 in the MRI-invitation group and 32,312 in the mammography-only group. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period.RESULTSThe interval-cancer rate was 2.5 per 1000 screenings in the MRI-invitation group and 5.0 per 1000 screenings in the mammography-only group, for a difference of 2.5 per 1000 screenings (95% confidence interval [CI], 1.0 to 3.7; PCONCLUSIONSThe use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography resulted in the diagnosis of significantly fewer interval cancers than mammography alone during a 2-year screening period.
AB - BACKGROUNDExtremely dense breast tissue is a risk factor for breast cancer and limits the detection of cancer with mammography. Data are needed on the use of supplemental magnetic resonance imaging (MRI) to improve early detection and reduce interval breast cancers in such patients.METHODSIn this multicenter, randomized, controlled trial in the Netherlands, we assigned 40,373 women between the ages of 50 and 75 years with extremely dense breast tissue and normal results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The groups were assigned in a 1:4 ratio, with 8061 in the MRI-invitation group and 32,312 in the mammography-only group. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period.RESULTSThe interval-cancer rate was 2.5 per 1000 screenings in the MRI-invitation group and 5.0 per 1000 screenings in the mammography-only group, for a difference of 2.5 per 1000 screenings (95% confidence interval [CI], 1.0 to 3.7; PCONCLUSIONSThe use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography resulted in the diagnosis of significantly fewer interval cancers than mammography alone during a 2-year screening period.
KW - CANCER
KW - MAMMOGRAPHY
KW - TRIALS
KW - NONCOMPLIANCE
KW - RISK
U2 - 10.1056/NEJMoa1903986
DO - 10.1056/NEJMoa1903986
M3 - Article
C2 - 31774954
SN - 0028-4793
VL - 381
SP - 2091
EP - 2102
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 22
T2 - Clinical Trials in Radiology Session at the European Congress of Radiology
Y2 - 27 February 2019 through 3 March 2019
ER -