Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk

Wendie A. Berg, Zheng Zhang, Daniel Lehrer, Roberta A. Jong, Etta D. Pisano, Richard G. Barr, Marcela Böhm-Vélez, Mary C. Mahoney, W. Phil Evans, Linda H. Larsen, Marilyn J. Morton, Ellen B. Mendelson, Dione M. Farria, Jean B. Cormack, Helga S. Marques, Amanda Adams, Nolin M. Yeh, Glenna Gabrielli

Research output: Contribution to journalArticle

581 Scopus citations

Abstract

Context: Annual ultrasound screening may detect small, node-negative breast cancers that are not seen on mammography. Magnetic resonance imaging (MRI) may reveal additional breast cancers missed by both mammography and ultrasound screening. Objective: To determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer. Design, Setting, and Participants: From April 2004-February 2006, 2809 women at 21 sites with elevated cancer risk and dense breasts consented to 3 annual independent screens with mammography and ultrasound in randomized order. After 3 rounds of both screenings, 612 of 703womenwhochose to undergo anMRIhad complete data. The reference standard was defined as a combination of pathology (biopsy results that showed in situ or infiltrating ductal carcinoma or infiltrating lobular carcinoma in the breast or axillary lymph nodes) and 12-month follow-up. Main Outcome Measures: Cancer detection rate (yield), sensitivity, specificity, positive predictive value (PPV3) of biopsies performed and interval cancer rate. Results: A total of 2662 women underwent 7473 mammogram and ultrasound screenings, 110 ofwhomhad 111 breast cancer events: 33 detected by mammography only, 32 by ultrasound only, 26 by both, and 9 by MRI after mammography plus ultrasound; 11 were not detected by any imaging screen. Among 4814 incidence screens in the second andthird years combined,75womenwere diagnosed with cancer. Supplemental incidencescreening ultrasound identified 3.7 cancers per 1000 screens (95% CI, 2.1-5.8; P<.001). Sensitivity for mammography plus ultrasound was 0.76 (95% CI, 0.65-0.85); specificity, 0.84(95%CI, 0.83-0.85);andPPV3, 0.16(95%CI, 0.12-0.21). Formammographyalone, sensitivity was 0.52(95%CI, 0.40-0.64); specificity, 0.91(95%CI, 0.90-0.92); and PPV3, 0.38 (95% CI, 0.28-0.49; P<.001 all comparisons). Of the MRI participants, 16 women (2.6%) had breast cancer diagnosed. The supplemental yield of MRI was 14.7 per 1000 (95% CI, 3.5-25.9; P=.004). Sensitivity for MRI and mammography plus ultrasound was 1.00 (95% CI, 0.79-1.00); specificity, 0.65 (95% CI, 0.61-0.69); and PPV3, 0.19 (95% CI, 0.11-0.29). For mammography and ultrasound, sensitivity was 0.44 (95% CI, 0.20- 0.70, P=.004); specificity 0.84 (95% CI, 0.81-0.87; P<.001); and PPV3, 0.18 (95% CI, 0.08 to 0.34; P=.98). The number of screens needed to detect 1 cancer was 127(95%CI, 99-167) for mammography; 234(95%CI, 173-345) for supplemental ultrasound; and 68 (95% CI, 39-286) for MRI after negative mammography and ultrasound results. Conclusion: The addition of screening ultrasound or MRI to mammography in women at increased risk of breast cancer resulted in not only a higher cancer detection yield but also an increase in false-positive findings. Trial Registration: clinicaltrials.gov Identifier: NCT00072501.

Original languageEnglish (US)
Pages (from-to)1394-1404
Number of pages11
JournalJAMA - Journal of the American Medical Association
Volume307
Issue number13
DOIs
StatePublished - Mar 28 2012

ASJC Scopus subject areas

  • Medicine(all)

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    Berg, W. A., Zhang, Z., Lehrer, D., Jong, R. A., Pisano, E. D., Barr, R. G., Böhm-Vélez, M., Mahoney, M. C., Evans, W. P., Larsen, L. H., Morton, M. J., Mendelson, E. B., Farria, D. M., Cormack, J. B., Marques, H. S., Adams, A., Yeh, N. M., & Gabrielli, G. (2012). Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk. JAMA - Journal of the American Medical Association, 307(13), 1394-1404. https://doi.org/10.1001/jama.2012.388