Detection of Breast Cancer with Addition of Annual Screening Ultrasound or a Single Screening MRI to Mammography in Women with Elevated Breast Cancer Risk

By W. Berg, Zheng Zhang, Daniel Lehrer, R. Jong, E. Pisano, R. Barr, M. Böhm-vélez, M. Mahoney, W. P. Evans, L. Larsen and 8 more. Journal of the American Medical Association (JAMA), 2012

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Context Annual ultrasound (US) may detect small, node-negative breast cancers not seen on mammography (M). MRI may depict additional breast cancers beyond mammography and ultrasound (M+US). Objective Determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer. Design, Setting, Participants From April 2004 to February 2006, 2809 women at 21 sites with elevated cancer risk and dense breasts consented to three annual independent screens with mammography and ultrasound in randomized order. After 3 rounds of mammography and US screening, 703 women from 14 sites consented to a single MRI. Main Outcome Measures Cancer detection rate (yield), sensitivity, specificity, positive predictive value of biopsies performed (PPV3 – rate of malignancy among cases positive on screening, who actually underwent biopsy), interval cancer rate. The diagnosis of breast cancer was based on a biopsy showing in situ or infiltrating ductal carcinoma or infiltrating lobular carcinoma in the breast or axillary lymph nodes. Reference standard was defined as a combination of pathology and 12-month follow-up and was available for 2662 women (7473 M+US screens) and 612 MRI participants. Results The 2662 patients underwent 7473 mammograms and US, with 110 women having 111 breast cancers detected, of which 33 were detected on mammography only, 32 on US only, 26 on both mammography and US, and 9 on MRI after mammography and US. Eleven were not detected by any imaging modality. Supplemental incidence-screening US identified 3.7 cancers per 1000 women-screens (95% CI 2.1 to 5.8, p<.001). Sensitivity, specificity, and PPV3 for M +US were 57/75 (0.76, 95% CI 0.65 to 0.85), 3987/4739 (0.84, 95% CI 0.83 to 0.85), and 55/339 (0.16, 95% CI 0.12 to 0.21); and for mammography alone 39/75 (0.52, 95% CI 0.40 to 0.64), 4325/4739 (0.91,95% 0.90 to 0.92), and 37/97 (0.38, 95% CI 0.28 to 0.49) (p<.001 all comparisons). Of 612 analyzable MRI participants, 16 (2.6%) had breast cancer diagnosed. Supplemental yield of MRI was 14.7 per 1000 (95% CI 3.5 to 25.9, p=.004). Sensitivity, specificity, and PPV3 for MRI+M+US were 16/16 (1.00, 95% CI 0.79 to 1.00), 390/596 (0.65, 95% CI 0.61 to 0.69), and 15/81 (0.19, 95% CI 0.11 to 0.29); and for M+US 7/16 (0.44, 95% CI 0.20 to 0.70, p=.004), 503/596 (0.84, 95% CI 0.81 to 0.87, p <.001), and 7/38 (0.18, 95% CI 0.08 to 0.34, p= .98) for M+US. Number of screens needed to detect one cancer was 127(95%CI 99 to 167) for mammography; 234(95%CI 173 to 345) for supplemental ultrasound, and 68 (95%CI 39 to 286) for MRI after negative M+US. Conclusions The addition of screening ultrasound or MRI to mammography in women at increased risk of breast cancer resulted in a higher cancer detection yield but also an increase in false positive findings.

Subfields: Cancer Research, Oncology, Pathology and Forensic Medicine

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