Assessing Improvement in Detection of Breast Cancer with Three-dimensional Automated Breast US in Women with Dense Breast Tissue: The SomoInsight Study
Abstract
The results of this study indicated that there is an increase in cancer detection with use of automated breast US supplemented to mammography among women with dense breasts, producing detection of an additional 1.9 cancers, most of which were clinically important, per 1000 women screened at the cost of a higher recall rate.
Purpose
To determine improvement in breast cancer detection by using supplemental three-dimensional (3D) automated breast (AB) ultrasonography (US) with screening mammography versus screening mammography alone in asymptomatic women with dense breasts.
Materials and Methods
Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study. The SomoInsight Study was an observational, multicenter study conducted between 2009 and 2011. A total of 15 318 women (mean age, 53.3 years ± 10 [standard deviation]; range, 25–94 years) presenting for screening mammography alone with heterogeneously (50%–75%) or extremely (>75%) dense breasts were included, regardless of further risk characterization, and were followed up for 1 year. Participants underwent screening mammography alone followed by an AB US examination; results were interpreted sequentially. McNemar test was used to assess differences in cancer detection.
Results
Breast cancer was diagnosed at screening in 112 women: 82 with screening mammography and an additional 30 with AB US. Addition of AB US to screening mammography yielded an additional 1.9 detected cancers per 1000 women screened (95% confidence interval [CI]: 1.2, 2.7; P < .001). Of cancers detected with screening mammography, 62.2% (51 of 82) were invasive versus 93.3% (28 of 30) of additional cancers detected with AB US (P = .001). Of the 82 cancers detected with either screening mammography alone or the combined read, 17 were detected with screening mammography alone. Of these, 64.7% (11 of 17) were ductal carcinoma in situ versus 6.7% (two of 30) of cancers detected with AB US alone. Sensitivity for the combined read increased by 26.7% (95% CI: 18.3%, 35.1%); the increase in the recall rate per 1000 women screened was 284.9 (95% CI: 278.0, 292.2; P < .001).
Conclusion
Addition of AB US to screening mammography in a generalizable cohort of women with dense breasts increased the cancer detection yield of clinically important cancers, but it also increased the number of false-positive results.
© RSNA, 2014
References
- 1. . Breast Cancer Facts & Figures 2011-2012. Atlanta, Ga: American Cancer Society, 2012.
- 2. . The impact of organized mammography service screening on breast carcinoma mortality in seven Swedish counties. Cancer 2002;95(3):458–469.
- 3. . Effects of age, breast density, ethnicity, and estrogen replacement therapy on screening mammographic sensitivity and cancer stage at diagnosis: review of 183,134 screening mammograms in Albuquerque, New Mexico. Radiology 1998;209(2):511–518.
- 4. . Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology 2002;225(1):165–175.
- 5. . Mammographic density and breast cancer in three ethnic groups. Cancer Epidemiol Biomarkers Prev 2003;12(4):332–338.
- 6. . Mammographic features and breast cancer risk: effects with time, age, and menopause status. J Natl Cancer Inst 1995;87(21):1622–1629.
- 7. . Quantitative classification of mammographic densities and breast cancer risk: results from the Canadian National Breast Screening Study. J Natl Cancer Inst 1995;87(9):670–675.
- 8. . Mammographic parenchymal patterns as indicators of breast cancer risk. Am J Epidemiol 1989;129(3):518–526.
- 9. . Mammographic density and the risk and detection of breast cancer. N Engl J Med 2007;356(3):227–236.
- 10. . Quantitative assessment of mammographic breast density: relationship with breast cancer risk. Radiology 2004;230(1):29–41.
- 11. , dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev 2006;15(6):1159–1169.
- 12. . Analysis of parenchymal density on mammograms in 1353 women 25-79 years old. AJR Am J Roentgenol 1996;167(5):1261–1265.
- 13. . Genetic testing by cancer site: breast. Cancer J 2012;18(4):310–319.
- 14. . Real world performance of screening breast ultrasound following enactment of Connecticut Bill 458. Breast J 2013;19(1):64–70.
- 15. . 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 2012;307(13):1394–1404.
- 16. . Interpretation time of 3D automated breast ultrasound (ABUS) [abstr]. Presented at the 2012 annual meeting of the American Roentgen Ray Society, Vancouver, British Columbia, Canada, April 2012; 45.
- 17. . Breast Imaging Reporting and Data Systems, BI-RADS: Mammography. 4th ed. Reston, Va: American College of Radiology, 2003.
- 18. . Integration of automated 3D breast ultrasound (ABUS) into the routine workflow of a high-volume hospital-based breast cancer screening program in Stockholm, Sweden [abstr]. In: Radiological Society of North America scientific assembly and annual meeting program. Oak Brook, Ill: Radiological Society of North America, 2012; 238.
- 19. . Clinical reader study examining the performance of mammography and automatic breast ultrasound in breast cancer screening [abstr]. In: Radiological Society of North America scientific assembly and annual meeting program. Oak Brook, Ill: Radiological Society of North America, 2012; 180.
- 20. . National Institutes of Health State-of-the-Science Conference statement: diagnosis and management of ductal carcinoma in situ September 22-24, 2009. J Natl Cancer Inst 2010;102(3):161–169.
- 21. . The surgical management of ductal carcinoma in situ. Breast J 2010;16(suppl 1):S49–S52.
- 22. . Supplemental screening sonography in dense breasts. Radiol Clin North Am 2004;42(5):845–851, vi.
- 23. . The relative contributions of screen-detected in situ and invasive breast carcinomas in reducing mortality from the disease. Eur J Cancer 2003;39(12):1755–1760.
- 24. . Screening US in patients with mammographically dense breasts: initial experience with Connecticut Public Act 09-41. Radiology 2012;265(1):59–69.
- 25. . Clinical utility of bilateral whole-breast US in the evaluation of women with dense breast tissue. Radiology 2001;221(3):641–649.
- 26. . Mammography and subsequent whole-breast sonography of nonpalpable breast cancers: the importance of radiologic breast density. AJR Am J Roentgenol 2003;180(6):1675–1679.
- 27. . Influence of additional breast ultrasound on cancer detection in a cohort study for quality assurance in breast diagnosis: analysis of 102,577 diagnostic procedures. Eur Radiol 2010;20(5):1085–1092.
- 28. . The connecticut experiment: the role of ultrasound in the screening of women with dense breasts. Breast J 2012;18(6):517–522.
- 29. . Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA 2008;299(18):2151–2163.
- 30. . Diagnostic accuracy of mammography, clinical examination, US, and MR imaging in preoperative assessment of breast cancer. Radiology 2004;233(3):830–849.
- 31. . Breast cancer detection using automated whole breast ultrasound and mammography in radiographically dense breasts. Eur Radiol 2010;20(3):734–742.
- 32. . Breast cancer detection: radiologists’ performance using mammography with and without automated whole-breast ultrasound. Eur Radiol 2010;20(11):2557–2564.
- 33. . Surveillance of BRCA1 and BRCA2 mutation carriers with magnetic resonance imaging, ultrasound, mammography, and clinical breast examination. JAMA 2004;292(11):1317–1325.
Article History
Received December 12, 2013; revision requested January 10, 2014; final revision received May 28; accepted June 12; final version accepted July 31.Published online: Oct 17 2014
Published in print: Mar 2015