Breast Density Legislation and Clinical Evidence

Radiologic Clinics of North America

Volumn 55, Issue 3, 2017, Pages 513-526

  Hooley, Regina J ^a  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Breast; Cancer; Density; Legislation; Risk; Screening; Ultrasound

Indexed keywords

BREAST CANCER; BREAST DENSITY; BREAST DENSITY LEGISLATION; BREAST IMAGING REPORTING AND DATA SYSTEM; CANCER EPIDEMIOLOGY; CANCER RISK; CANCER SCREENING; DIGITAL BREAST TOMOSYNTHESIS; ECHOGRAPHY; EVIDENCE BASED MEDICINE; HEALTH CARE DELIVERY; HEALTH CARE DISPARITY; HEALTH INSURANCE; HIGH RISK POPULATION; HUMAN; IMAGING AND DISPLAY; LAW; LYMPH NODE METASTASIS; MAMMOGRAPHY; MEDICAL INFORMATION SYSTEM; MOLECULAR BREAST IMAGING; NUCLEAR MAGNETIC RESONANCE IMAGING; PATIENT DECISION MAKING; PATIENT EDUCATION; PREDICTIVE VALUE; RADIATION DOSE; REVIEW; RISK BENEFIT ANALYSIS; SENSITIVITY AND SPECIFICITY; SHARED DECISION MAKING; UNITED STATES; BREAST; BREAST TUMOR; DIAGNOSTIC IMAGING; ECHOMAMMOGRAPHY; FEMALE; LEGISLATION AND JURISPRUDENCE; PROCEDURES;

BREAST; BREAST DENSITY; BREAST NEOPLASMS; FEMALE; HEALTH INFORMATION EXCHANGE; HUMANS; MAGNETIC RESONANCE IMAGING; MAMMOGRAPHY; ULTRASONOGRAPHY, MAMMARY; UNITED STATES;

EID: 85014095919     PISSN: 00338389     EISSN: 15578275     Source Type: Journal    
DOI: 10.1016/j.rcl.2016.12.006     Document Type: Review

References (93)

1. 1 Cappello, N.M., Decade of ‘normal’ mammography reports—the happygram. J Am Coll Radiol 10:12 (2013), 903–908.
2. 2 Stomper, P.C., D'Souza, D.J., DiNitto, P.A., et al. Analysis of parenchymal density on mammograms in 1353 women 25-79 years old. AJR Am J Roentgenol 167:5 (1996), 1261–1265.
3. 3 Checka, C.M., Chun, J.E., Schnabel, F.R., et al. The relationship of mammographic density and age: implications for breast cancer screening. AJR Am J Roentgenol 198:3 (2012), W292–W295.
4. 4 Boyd, N.F., Byng, J.W., Jong, R.A., et al. Quantitative classification of mammographic densities and breast cancer risk: results from the Canadian National Breast Screening Study. J Natl Cancer Inst 87:9 (1995), 670–675.
5. 5 Mandelson, M.T., Oestreicher, N., Porter, P.L., et al. Breast density as a predictor of mammographic detection: comparison of interval and screen-detected cancers. J Natl Cancer Inst 92 (2000), 1081–1087.
6. 6 Harvey, J.A., Bovbjerg, V.E., Quantitative assessment of mammographic breast density: relationship with breast cancer risk. Radiology 230:1 (2004), 29–41.
7. 7 Holland, R., Hendriks, J.H., Mravunac, M., Mammographically occult breastcancer. A pathologic and radiologic study. Cancer 52 (1983), 1810–1819.
8. 8 Bird, R.E., Wallace, T.W., Yankaskas, B.C., Analysis of cancers missed at screening mammography. Radiology 184 (1992), 613–617.
9. 9 Ma, L.N., Fishell, E., Wright, B., et al. Case-control study of factors associated with failure to detect breast cancer by mammography. J Natl Cancer Inst 84 (1992), 781–785.
10. 10 Gordon, P.B., Goldenberg, S.L., Malignant breast masses detected only by ultrasound: a retrospective review. Cancer 76 (1995), 626–630.
11. 11 Buchberger, W., DeKoekkoek-Doll, P., Springer, P., et al. Incidental findings on sonography of the breast: clinical significance and diagnostic workup. AJR Am J Roentgenol 173 (1999), 921–927.
12. 12 Kaplan, S.S., Clinical utility of bilateral whole-breast US in the evaluation of women with dense breast tissue. Radiology 221 (2001), 641–649.
13. 13 Kolb, T.M., Lichy, J., Newhouse, J.H., 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 225 (2002), 165–175.
14. 14 LeConte, I., Feger, C., Galant, C., et al. Mammography and subsequent whole-breast sonography of nonpalpable breast cancers: the importance of radiologic breast density. AJR Am J Roentgenol 180 (2003), 1675–1679.
15. 15 Crystal, P., Strano, S.D., Shcharynski, S., et al. Using sonography to screen women with mammographically dense breasts. AJR Am J Roentgenol 181 (2003), 177–182.
16. 16 Berg, W.A., Blume, J.D., Cormack, J.B., et al., ACRIN 6666 Investigators. Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA 299:18 (2008), 2151–2163.
17. 17 Legislation and Regulations—what is required? In: Dense breast-info an education coalition. Available at: http://densebreast-info.org/legislation.aspx. Accessed July 10, 2016.
18. 18 Khong, K.A., Hargreaves, J., Aminololama-Shakeri, S., et al. Impact of the California breast density law on primary care physicians. J Am Coll Radiol 12:3 (2015), 256–260.
19. 19 Kressin, N.R., Gunn, C.M., Battaglia, T.A., Content, readability, and understandability of dense breast notifications by state. JAMA 315:16 (2016), 1786–1788.
20. 20 Rhodes, D.J., Radecki Breitkopf, C., Ziegenfuss, J.Y., et al. Awareness of breast density and its impact on breast cancer detection and risk. J Clin Oncol 33:10 (2015), 1143–1150.
21. 21 Moothathu, N.S., Philpotts, L.E., Busch, S.H., et al. Knowledge of Density and Screening Ultrasound. Breast J, 2016 [Epub ahead of print].
22. 22 Jones, B.A., Reams, K., Calvocoressi, L., et al. Adequacy of communicating results from screening mammograms to African American and white women. Am J Public Health 97:3 (2007), 531–538.
23. 23 Frequently asked questions about breast density, breast cancer risk, and the breast density notification law in California: a consensus document. In: Breast Density.Info. Available at: http://www.breastdensity.info. Accessed July 10, 2016.
24. 24 What is dense? In: Are you dense? Available at: http://www.areyoudense.org. Accessed July 10, 2016.
25. 25 Sprague, B.L., Gangnon, R.E., Burt, V., et al. Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst, 106(10), 2014.
26. 26 Bahl, M., Baker, J.A., Bhargavan-Chatfield, M., et al. Impact of breast density notification legislation on radiologists' practices of reporting breast density: a multi-state study. Radiology, 28, 2016, 152457.
27. 27 Lee, C.I., Bassett, L.W., Lehman, C.D., Breast density legislation and opportunities for patient-centered outcomes research. Radiology 264:3 (2012), 632–636.
28. 28 Kerlikowske, K., Zhu, W., Tosteson, A.N., et al., Breast Cancer Surveillance Consortium. Identifying women with dense breasts at high risk for interval cancer: a cohort study. Ann Intern Med 162:10 (2015), 673–681.
29. 29 Gierach, G.L., Ichikawa, L., Kerlikowske, K., et al. Relationship between mammographic density and breast cancer death in the Breast Cancer Surveillance Consortium. J Natl Cancer Inst 104:16 (2012), 1218–1227.
30. 30 Tabár, L., Vitak, B., Chen, T.H., et al. Swedish two-county trial: impact of mammographic screening on breast cancer mortality during 3 decades. Radiology 260:3 (2011), 658–663.
31. 31 Duffy, S.W., Tabar, L., Olsen, A.H., Absolute numbers of lives saved and over diagnosis in breast cancer screening, from a randomized trial and from the Breast Screening Programme in England. J Med Screen 17:1 (2010), 25–30.
32. 32 Winkler, N.S., Raza, S., Mackesy, M., et al. Breast density: clinical implications and assessment methods. Radiographics 35:2 (2015), 316–324.
33. 33 Wolfe, J., Breast patterns as an index of risk for developing breast cancer. AJR Am J Roentgenol, 126, 1976, 1130e7.
34. ® Atlas, Breast imaging reporting and data system. 2013, American College of Radiology, Reston (VA).
35. 35 D'Orsi, C.J., Mendelson, E.B., Ikeda, D.M., et al. Breast imaging reporting and data system: ACR BI-RADS – breast imaging atlas. 2003, American College of Radiology, Reston (VA).
36. 36 Gur, D., Klym, A.H., King, J.L., et al. Impact of the new density reporting laws: radiologist perceptions and actual behavior. Acad Radiol 22:6 (2015), 679–683.
37. 37 Kerlikowske, K., Grady, D., Barclay, J., et al. Variability and accuracy in mammographic interpretation using the American College of Radiology Breast Imaging Reporting and Data System. J Natl Cancer Inst 90 (1998), 1801–1809.
38. 38 Berg, W.A., Campassi, C., Langenberg, P., et al. Breast imaging reporting and data system: inter- and intraobserver variability in feature analysis and final assessment. Am J Roentgenol 174 (2000), 1769–1777.
39. 39 Ciatto, S., Houssami, N., Apruzzese, A., et al. Categorizing breast mammographic density: intra- and interobserver reproducibility of BI-RADS density categories. Breast 14 (2005), 269–275.
40. 40 Gard, C.C., Aiello Bowles, E.J., Miglioretti, D.L., et al. Misclassification of Breast Imaging Reporting and Data System (BI-RADS) mammographic density and implications for breast density reporting legislation. Breast J 21:5 (2015), 481–489.
41. 41 Ekpo, E.U., Ujong, U.P., Mello-Thoms, C., et al. Assessment of interradiologist agreement regarding mammographic breast density classification using the fifth edition of the BI-RADS Atlas. AJR Am J Roentgenol 206:5 (2016), 1119–1123.
42. 42 Raza, S., Mackesy, M.M., Winkler, N.S., et al. Effect of training on qualitative mammographic density assessment. J Am Coll Radiol 13:3 (2016), 310–315.
43. 43 Kopans, D.B., Basic physics and doubts about relationship between mammographically determined tissue density and breast cancer risk. Radiology 246:2 (2008), 348–353.
44. 44 Freer, P.E., Mammographic breast density: impact on breast cancer risk and implications for screening. Radiographics 35:2 (2015), 302–315.
45. 45 Yaffe, M.J., Mammographic density: measurement of mammographic density. Breast Cancer Res, 10(3), 2008, 209.
46. 46 Ekpo, E.U., McEntee, M.F., Measurement of breast density with digital breast tomosynthesis—a systematic review. Br J Radiol, 87(1043), 2014, 20140460.
47. 47 Chen, J.H., Lee, Y.W., Chan, S.W., et al. Breast density analysis with automated whole-breast ultrasound: comparison with 3-D magnetic resonance imaging. Ultrasound Med Biol 42:5 (2016), 1211–1220.
48. 48 Chen, J.H., Chan, S., Lu, N.H., et al. Opportunistic breast density assessment in women receiving low-dose chest computed tomography screening. Acad Radiol 23:9 (2016), 1154–1161.
49. 49 Lewis, M.C., Irshad, A., Ackerman, S., et al. Assessing the relationship of mammographic breast density and proliferative breast disease. Breast J 22:5 (2016), 541–546.
50. 50 Boyd, N.F., Jensen, H.M., Cooke, G., et al. Relationship between mammographic and histologic risk factors for breast cancer. J Natl Cancer Inst 84 (1992), 1170–1179.
51. 51 McCormack, V.A., dos Santos Silva, I., Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev 15:6 (2006), 1159–1169.
52. 52 Singletary, S.E., Rating the risk factors for breast cancer. Ann Surg 237:4 (2003), 474–482.
53. 53 Collaborative Group on Hormonal Factors in Breast Cancer. Familial breast cancer: collaborative reanalysis of individual data from 52 epidemiological studies including 58,209 women with breast cancer and 101,986 women without the disease. Lancet 358:9291 (2001), 1389–1399.
54. 54 Clemons, M., Loijens, L., Goss, P., Breast cancer risk following irradiation for Hodgkin's disease. Cancer Treat Rev, 26, 2000, 29.
55. 55 Page, D.L., Dupont, W.D., Rogers, L.W., et al. Atypical hyperplastic lesions of the female breast: a long-term follow-up study. Cancer 55:11 (1985), 2698–2708.
56. 56 Antoniou, A., Pharoah, P.D., Narod, S., et al. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case Series unselected for family history: a combined analysis of 22 studies. Am J Hum Genet 72:5 (2003), 1117–1130 [Erratum appears in Am J Hum Genet 2003;73(3):709].
57. 57 Sickles, E.A., The use of breast imaging to screen women at high risk for cancer. Radiol Clin North Am 48:5 (2010), 859–878.
58. 58 Boyd, N.F., Guo, H., Martin, L.J., et al. Mammographic density and the risk and detection of breast cancer. N Engl J Med 356:3 (2007), 227–236.
59. 59 Kerlikowske, K., Grady, D., Barclay, J., et al. Effect of age, breast density, and family history on the sensitivity of first screening mammography. JAMA 276 (1996), 33–38.
60. 60 Carney, P.A., Miglioretti, D.L., Yankaskas, B.C., et al. Individual and combined effects of age, breast density, and hormone replacement therapy use on the accuracy of screening mammography. Ann Intern Med 138:3 (2003), 168–175.
61. 61 Pisano, E.D., Gatsonis, C., Hendrick, E., et al., Digital Mammographic Imaging Screening Trial (DMIST) Investigators Group. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med 353:17 (2005), 1773–1783.
62. 62 Kerlikowske, K., Hubbard, R.A., Miglioretti, D.L., Breast Cancer Surveillance Consortium. Comparative effectiveness of digital versus film-screen mammography in community practice in the United States: a cohort study. Ann Intern Med 155:8 (2011), 493–502.
63. 63 Webb, M.L., Cady, B., Michaelson, J.S., et al. A failure analysis of invasive breast cancer: most deaths from disease occur in women not regularly screened. Cancer 120:18 (2014), 2839–2846.
64. 64 Henderson, L.M., Miglioretti, D.L., Kerlikowske, K., et al. Breast cancer characteristics associated with digital versus film-screen mammography for screen-detected and interval cancers. AJR Am J Roentgenol 205:3 (2015), 676–684.
65. 65 Rhodes, D.J., Hruska, C.B., Conners, A.L., et al. Journal club: molecular breast imaging at reduced radiation dose for supplemental screening in mammographically dense breasts. AJR Am J Roentgenol 204:2 (2015), 241–251.
66. 66 Hendrick, R.E., Tredennick, T., Benefit to radiation risk of breast-specific gamma imaging compared with mammography in screening asymptomatic women with dense breasts. Radiology 281:2 (2016), 583–588.
67. 67 Hooley, R.J., Greenberg, K.L., Stackhouse, R.M., et al. Screening US in patients with mammographically dense breasts: initial experience with Connecticut Public Act 09-41. Radiology 265:1 (2012), 59–69.
68. 68 Berg, W., Screening ultrasound. Berg, W.A., Yang, W.T., (eds.) Diagnostic imaging: breast, 2nd edition, 2014, Amirsys, Salt Lake City (UT) p. 9-38–9-40.
69. 69 Rosenberg, R.D., Yankaskas, B.C., Abraham, L.A., et al. Performance benchmarks for screening mammography. Radiology 241:1 (2006), 55–66.
70. 70 Berg, W.A., Sechtin, A.G., Marques, H., et al. Cystic breast masses and the ACRIN 6666 experience. Radiol Clin North Am 48:5 (2010), 931–987.
71. 71 Barr, R.G., Zhang, Z., Cormack, J.B., et al. Probably benign lesions at screening breast US in a population with elevated risk: prevalence and rate of malignancy in the ACRIN 6666 trial. Radiology 269:3 (2013), 701–712.
72. 72 Tagliafico, A.S., Calabrese, M., Mariscotti, G., et al. Adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts: interim report of a prospective comparative trial. J Clin Oncol 34:16 (2016), 1882–1888.
73. 73 Ohuchi, N., Suzuki, A., Sobue, T., et al. Sensitivity and specificity of mammography and adjunctive ultrasonography to screen for breast cancer in the Japan Strategic Anti-cancer Randomized Trial (J-START): a randomised controlled trial. Lancet 387:10016 (2016), 341–348.
74. 74 Tohno, E., Umemoto, T., Sasaki, K., et al. Effect of adding screening ultrasonography to screening mammography on patient recall and cancer detection rates: a retrospective study in Japan. Eur J Radiol 82:8 (2013), 1227–1230.
75. 75 Berg, W.A., Blume, J.D., Cormack, J.B., et al. Training the ACRIN 6666 Investigators and effects of feedback on breast ultrasound interpretive performance and agreement in BI-RADS ultrasound feature analysis. AJR Am J Roentgenol 199:1 (2012), 224–235.
76. 76 Berg, W.A., Mendelson, E.B., Technologist-performed handheld screening breast US imaging: how is it performed and what are the outcomes to date?. Radiology 272:1 (2014), 12–27.
77. 77 Tohno, E., Takahashi, H., Tamada, T., et al. Educational program and testing using images for the standardization of breast cancer screening by ultrasonography. Breast Cancer 19:2 (2012), 138–146.
78. 78 Brem, R.F., Tabár, L., Duffy, S.W., Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: the SomoInsight Study. Radiology 274:3 (2015), 663–673.
79. 79 An, Y.Y., Kim, S.H., Kang, B.J., The image quality and lesion characterization of breast using automated whole-breast ultrasound: a comparison with handheld ultrasound. Eur J Radiol 84:7 (2015), 1232–1235.
80. 80 Jeh, S.K., Kim, S.H., Choi, J.J., et al. Comparison of automated breast ultrasonography to handheld ultrasonography in detecting and diagnosing breast lesions. Acta Radiol 57:2 (2016), 162–169.
81. 81 Niell, B.L., Gavenonis, S.C., Motazedi, T., et al. Auditing a breast MRI practice: performance measures for screening and diagnostic breast MRI. J Am Coll Radiol 11:9 (2014), 883–889.
82. 82 Berg, W.A., Zhang, Z., Lehrer, D., et al. ACRIN 6666 investigators: 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 307:13 (2012), 1394–1404.
83. 83 Kuhl, C.K., Schrading, S., Strobel, K., et al. Abbreviated breast magnetic resonance imaging (MRI): first postcontrast subtracted images and maximum-intensity projection-a novel approach to breast cancer screening with MRI. J Clin Oncol 32:22 (2014), 2304–2310.
84. 84 McDonald, E.S., Hammersley, J.A., Chou, S.H., et al. Performance of DWI as a rapid unenhanced technique for detecting mammographically occult breast cancer in elevated-risk women with dense breasts. Am J Roentgenol 207:1 (2016), 205–216.
85. 85 Emaus, M.J., Bakker, M.F., Peeters, P.H., et al. MR imaging as an additional screening modality for the detection of breast cancer in women aged 50-75 years with extremely dense breasts: the DENSE trial study design. Radiology 277:2 (2015), 527–537.
86. 86 King, V., Brooks, J.D., Bernstein, J.L., et al. Background parenchymal enhancement at breast MR imaging and breast cancer risk. Radiology 260:1 (2011), 50–60.
87. 87 Dontchos, B.N., Rahbar, H., Partridge, S.C., et al. Are qualitative assessments of background parenchymal enhancement, amount of fibroglandular tissue on MR images, and mammographic density associated with breast cancer risk?. Radiology 276:2 (2015), 371–380.
88. 88 Haas, B.M., Kalra, V., Geisel, J., et al. Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. Radiology 269:3 (2013), 694–700.
89. 89 Friedewald, S.M., Rafferty, E.A., Rose, S.L., et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA 311:24 (2014), 2499–2507.
90. 90 Durand, M.A., Haas, B.M., Yao, X., et al. Early clinical experience with digital breast tomosynthesis for screening mammography. Radiology 274:1 (2015), 85–92.
91. 91 Rose, S.L., Tidwell, A.L., Bujnoch, L.J., et al. Implementation of breast tomosynthesis in a routine screening practice: an observational study. AJR Am J Roentgenol 200:6 (2013), 1401–1408.
92. 92 Skaane, P., Bandos, A.I., Gullien, R., et al. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology 267:1 (2013), 47–56.
93. 93 Rafferty, E.A., Durand, M.A., Conant, E.F., et al. Breast cancer screening using tomosynthesis and digital mammography in dense and non dense breasts. JAMA 315:16 (2016), 1784–1786.