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N Engl J Med. 2019 Nov 28;381(22):2091-2102. doi: 10.1056/NEJMoa1903986.

Supplemental MRI Screening for Women with Extremely Dense Breast Tissue.

Author information

1
From the Julius Center for Health Sciences and Primary Care (M.F.B., S.V.L., P.H.M.P., E.M.M., C.H.G.) and the Departments of Radiology (S.V.L., R.M.P., M.J.E., W.P.T.M.M., M.A.A.J.B., W.B.V.) and Pathology (P.J.D.), University Medical Center Utrecht, Utrecht University, Utrecht, the Dutch Expert Center for Screening (R.M.P.) and the Department of Radiology, Radboud University Nijmegen Medical Center (R.M.M., N.K.), Nijmegen, the Department of Radiology, Antoni van Leeuwenhoek Hospital (C.E.L.), and the Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam (K.M.D.), Amsterdam, the Department of Radiology, Albert Schweitzer Hospital, Dordrecht (R.H.C.B.), the Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and the Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen (M.B.I.L.), the Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch (M.D.F.J.), the Department of Radiology, Hospital Group Twente, Almelo (J.V.), and the Department of Public Health, Erasmus Medical Center, Rotterdam (H.J.K.) - all in the Netherlands; and the Department of Epidemiology and Biostatistics, School of Public Health, Faculty of Medicine, Imperial College London, London (P.H.M.P.).

Abstract

BACKGROUND:

Extremely 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.

METHODS:

In 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.

RESULTS:

The 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; P<0.001). Of the women who were invited to undergo MRI, 59% accepted the invitation. Of the 20 interval cancers that were diagnosed in the MRI-invitation group, 4 were diagnosed in the women who actually underwent MRI (0.8 per 1000 screenings) and 16 in those who did not accept the invitation (4.9 per 1000 screenings). The MRI cancer-detection rate among the women who actually underwent MRI screening was 16.5 per 1000 screenings (95% CI, 13.3 to 20.5). The positive predictive value was 17.4% (95% CI, 14.2 to 21.2) for recall for additional testing and 26.3% (95% CI, 21.7 to 31.6) for biopsy. The false positive rate was 79.8 per 1000 screenings. Among the women who underwent MRI, 0.1% had either an adverse event or a serious adverse event during or immediately after the screening.

CONCLUSIONS:

The 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. (Funded by the University Medical Center Utrecht and others; DENSE ClinicalTrials.gov number, NCT01315015.).

PMID:
31774954
DOI:
10.1056/NEJMoa1903986

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