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Grand Rounds

DENSE RCT Results: Does Supplemental MRI Reduce Interval Cancers in Women with Extremely Dense Breast Tissue?

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BACKGROUND AND PURPOSE:

  • Bakker et al. (NEJM, 2019) investigated whether supplemental MRI reduced interval breast cancers in women with dense breast tissue
    • Assumption that reduction in interval cancers signifies earlier detection prior to a tumor becoming symptomatic

METHODS:

  • Multicenter, randomized, controlled trial (RCT)
    • Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial
    • Results from the initial 2 years
  • Setting
    • The Netherlands
  • Participants
    • Between ages 50 and 75 years
    • Extremely dense breast tissue and normal mammography results
  • Groups
    • MRI-invitation group: Invited to undergo supplemental MRI (did not have to undergo MRI)
    • Control group: Mammography screening only
  • Primary outcome
    • The between-group difference in the incidence of interval cancers during the 2-year screening period

RESULTS:

  • 40,373 women were included (1:4 randomization)
    • MRI group
      • 8061 patients invited | 59% accepted invitation
      • 454 recalled for suspicious findings
      • 300 biopsies performed
      • 79 cancers were detected
    • Control group: 32,312
  • The interval-cancer rate was lower in the MRI-invitation group than the control group (P<0.001)
    • MRI group: 2.5 per 1000 screenings
    • Control group: 5.0 per 1000 screenings
  • 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)
    • 16 in those who did not accept the invitation (4.9 per 1000 screenings)
  • 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)
  • PPV (number of cancers detected)
    • 17.4% (95% CI, 14.2 to 21.2) for recall for additional testing
    • 26.3% (95% CI, 21.7 to 31.6) for biopsy
  • False positive rate: 79.8 per 1000 screenings
  • Tumors in the MRI group were more likely to be
    • Smaller | Node negative | Earlier stage
  • 0.1% of women who underwent MRI had either an adverse event or a serious adverse event during or immediately after the screening
    • Vasovagal reactions to the MRI procedure or reaction to contrast

CONCLUSION:

  • The addition of MRI screening for women with extremely dense breast tissue resulted in significantly fewer interval cancers vs mammography alone
  • However, this study does not address whether a decrease in interval cancers will lead to improved survival
    • The authors plan to continue this study to determine impact on rate of advanced cancers and mortality

Learn More – Primary Sources:

Supplemental MRI Screening for Women with Extremely Dense Breast Tissue

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Related ObG Topics:

ACOG Reaffirms Breast Density Guidance – FDA Proposes New Notification Rule
BI-RADS: Standardizing Breast Imaging and Reporting 
Has Breast Density Legislation Had Any Impact on Breast Cancer Diagnosis? 
A Breast Cancer Diagnosis in the Interval Between Mammograms: Who is at Risk?
Can Ultrasonography in Addition to Mammography Improve Breast Cancer Screening Effectiveness?

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