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Showing content from https://pubmed.ncbi.nlm.nih.gov/22474203/ below:

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

Randomized Controlled Trial

. 2012 Apr 4;307(13):1394-404. doi: 10.1001/jama.2012.388. Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk Zheng Zhang, Daniel Lehrer, Roberta A Jong, Etta D Pisano, Richard G Barr, Marcela Böhm-Vélez, Mary C Mahoney, W Phil Evans 3rd, 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; ACRIN 6666 Investigators

Collaborators, Affiliations

Collaborators

ACRIN 6666 Investigators: William R Poller, Michelle Huerbin, Wendie A Berg, Barbara E Levit, Kathy Wetzel, Janet K Baum, Valerie J Fein-Zachary, Suzette M Kelleher, Daniel E Lehrer, Maria S Ostertag, Mary Scott Soo, Brenda N Prince, Marilyn J Morton, Lori M Johnson, Ellen B Mendelson, Marysia Kalata, Handel Reynolds, Y Suzette Wheeler, Richard G Barr, Marilyn J Mangino, A Thomas Stavros, Margo Valdez, Roberta A Jong, Julie H Lee, Catherine W Piccoli, Christopher R B Merritt, Colleen Dascenzo, Anne C Hoyt, Roslynn Marzan, Mary C Mahoney, Monene M Kamm, Etta D Pisano, Laura A Tuttle, Linda H Larsen, Christina E Kiss, Gary J Whitman, Sharon R Rice, W Phil Evans, Kimberly T Taylor, Dione M Farria, Darlene J Bird, Marcela Böhm-Vélez, Antoinette Cockroft

Affiliation

¹ American College of Radiology Imaging Network, Philadelphia, Pennsylvania, USA. wendieberg@gmail.com

PMID: 22474203
PMCID: PMC3891886
DOI: 10.1001/jama.2012.388

Item in Clipboard

Randomized Controlled Trial

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 et al. JAMA. 2012.

. 2012 Apr 4;307(13):1394-404. doi: 10.1001/jama.2012.388. Authors Wendie A Berg¹, Zheng Zhang, Daniel Lehrer, Roberta A Jong, Etta D Pisano, Richard G Barr, Marcela Böhm-Vélez, Mary C Mahoney, W Phil Evans 3rd, 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; ACRIN 6666 Investigators Collaborators

ACRIN 6666 Investigators: William R Poller, Michelle Huerbin, Wendie A Berg, Barbara E Levit, Kathy Wetzel, Janet K Baum, Valerie J Fein-Zachary, Suzette M Kelleher, Daniel E Lehrer, Maria S Ostertag, Mary Scott Soo, Brenda N Prince, Marilyn J Morton, Lori M Johnson, Ellen B Mendelson, Marysia Kalata, Handel Reynolds, Y Suzette Wheeler, Richard G Barr, Marilyn J Mangino, A Thomas Stavros, Margo Valdez, Roberta A Jong, Julie H Lee, Catherine W Piccoli, Christopher R B Merritt, Colleen Dascenzo, Anne C Hoyt, Roslynn Marzan, Mary C Mahoney, Monene M Kamm, Etta D Pisano, Laura A Tuttle, Linda H Larsen, Christina E Kiss, Gary J Whitman, Sharon R Rice, W Phil Evans, Kimberly T Taylor, Dione M Farria, Darlene J Bird, Marcela Böhm-Vélez, Antoinette Cockroft

Affiliation

¹ American College of Radiology Imaging Network, Philadelphia, Pennsylvania, USA. wendieberg@gmail.com

PMID: 22474203
PMCID: PMC3891886
DOI: 10.1001/jama.2012.388

Item in Clipboard

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 703 women who chose to undergo an MRI had 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 of whom had 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 and third years combined, 75 women were diagnosed with cancer. Supplemental incidence-screening 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); and PPV3, 0.16 (95% CI, 0.12-0.21). For mammography alone, 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.

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Figures
Figure 1

Flowchart of protocol. Participants with…

Figure 1

Flowchart of protocol. Participants with negative results on both mammography and ultrasound were…

Figure 1

Flowchart of protocol. Participants with negative results on both mammography and ultrasound were imputed as having negative results on integrated reading: 1844 in year one; 1922 in year two; 1912 in year three. Reference standard was the most severe of biopsy results within 365 days of mammographic screening and/or clinical follow-up at one year. Biopsies prompted by an early subsequent screening examination were attributed to that subsequent screen.