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#Grand Rounds

Results from the FaMRIsc Trial: MRI or Just Mammography for Women with Strong Family History of Breast Cancer but Negative Genetic Testing

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BACKGROUND AND PURPOSE:

  • There is a significant percentage of women with strong family history for breast cancer, but no known pathogenic genetic variant has yet been identified
  • Saadatmand et al. (The Lancet Oncology, 2019) compared MRI with mammography for the detection of cancers in women at high risk for breast cancer based on family history

METHODS:

  • Multicenter, randomized controlled trial (RCT)
    • Intention to treat
  • Participants
    • Women aged 30-55 years
    • Cumulative lifetime breast cancer risk of ≥20% due to familial predisposition
    • BRCA1, BRCA2 and TP53 wild-type (no pathogenic variant identified)
    • No personal history invasive carcinoma
  • Groups (1:1 randomization)
    • MRI group: Annual MRI & clinical breast exam | Biennial mammography
    • Mammography group: Annual mammography & clinical breast exam
  • Registration group
    • If consent for randomization not obtained, women could still register for either MRI or mammography protocol in “joint decision with their physician”
    • This data only used in the analyses stratified by breast density
  • Primary outcomes: Analysis of detected cancers (DCIS invasive)
    • Number | Size | Nodal status
  • Secondary outcomes
    • False-positive results | Sensitivity and specificity | PPV of BI-RADS score ≥3 | PPV of biopsies

RESULTS:

  • 1,355 women randomized | 231 registered without randomization
    • 675 of 1,355 women in MRI group | 680 to the mammography group
    • 218 of 231 registered (non-randomized) women were in mammography group | 13 were in the MRI group
  • More breast cancers were detected in the MRI group (40) vs mammography (15) group (p=0.0017)
    • Screen detected cancers: MRI 98% | Mammography 87%
  • Sensitivity was not statistically different between groups | Specificity was lower in MRI group (increased false-positives)
  • Invasive cancers in the MRI group compared to mammography
    • Were smaller in the MRI group (p=0.010)
      • MRI group: Median size 9mm
      • Mammography group: 17 mm
    • Were less frequently node positive (p=0.023)
      • MRI group: 17%
      • Mammography group: 63%
  • Tumor stages were significantly earlier in the MRI group during incident rounds (p=0.035)
    • Stage T1a and T1b cancers
      • MRI group: 48%
      • Mammography group: 7%
    • Stage T2 or higher
      • MRI group: 4%
      • Mammography group: 13%
  • Node-positive tumors were less frequent in the MRI group (p=0.014)
    • MRI group: 11%
    • Mammography group: 63%
  • Stage ≥T2 tumors were in the two highest breast density categories (C and D); p=0.0077
  • One mortality reported from breast cancer during follow-up (mammography registration group)

CONCLUSION:

  • For women at high familial risk, but negative genetic testing, MRI screening led to detection of cancers at an earlier stage than mammography which could impact
    • Choice and use of chemotherapy
    • Breast cancer-related mortality might be reduced with MRI screening
  • MRI screening, consistent with previous studies, has a higher rate of  false-positive results (lower specificity), especially with high breast density
  • Cost-effectiveness and breast cancer mortality will be reported in future analyses

Learn More – Primary Sources:

MRI versus mammography for breast cancer screening in women with familial risk (FaMRIsc): a multicentre, randomised, controlled trial

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Related ObG Topics:

Mammography Guidelines for Average-Risk Women
ACOG Reaffirms Breast Density Guidance – FDA Proposes New Notification Rule
A Breast Cancer Diagnosis in the Interval Between Mammograms: Who is at Risk?
How Effective Is Mammography in Reducing the Number of Advanced Breast Cancer Diagnoses?
Breast Cancer Screening using MRI vs Mammography – How Do They Compare?

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