Understanding the Breast Density Law. 10th Annual Breast Cancer Connections Conference

Transcription

1 Understanding the Breast Density Law 10th Annual Breast Cancer Connections Conference Redwood Shores, California November 2, 2013 Debra M. Ikeda, M.D. Professor of Radiology Director of Breast Imaging Stanford University School of Medicine Stanford, California

2 Impact of California Dense Breast Bill SB 1538 on Women with Dense Breast Tissue

3 California Law SB 1538 (2012) What is the Law and what does it say? Why did it come about? What is breast density? How do women approach the law? How high does heterogeneously dense or dense breast tissue raise the average woman s risk of breast cancer? Who should get supplemental screening and what kind?

4 Breast Density The Breast Density and Mammography Reporting Act In Connecticut (2009) Radiologists were required to inform women who have dense breasts that mammograms may not find all cancers Connecticut requires that insurance companies pay for ultrasound screening

5 Breast Density Legislation Connecticut, Texas,Virginia, California, New York, Hawaii, Maryland, Tennessee, Alabama, Nevada, Oregon, N Carolina, Pennsylvania Radiologists to inform women of breast density Some states provide additional screening tests in women with heterogeneously dense or dense breasts FDA added consideration of a Breast Density Reporting regulatory amendment to MQSA scheduled as a notice of proposed rulemaking for December 2013

6 SB 1538 Comprehensive Breast Tissue Screening (California 2012) State Senator Joe Simitian 11 th District SECTION 1. Section is added to the Health and Safety Code lnavclient.xhtml?bill_id= sb 1538&search_keywords= No money allocated to subsequent screenings (site accessed 10/29/2013)

7 California Law SB 1538 (2012) SB 1538, Simitian. Health care: mammograms. Existing law requires specified information to be provided to patients regarding their health care. Existing federal law requires a written report of the results of each mammography examination and requires a summary of that report to be sent to the patient within a specified time period. Slide 1 of 10 SB 1538 Law original text

8 California Law SB 1538 (2012) This bill, from April 1, 2013, until January 1, 2019, would require, under specified circumstances, a health facility at which a mammography examination is performed to include in the summary of the written report that is sent to the patient a prescribed notice on breast density. Slide 2 of 10 SB 1538 Law original text

9 California Law SB 1538 (2012) SECTION 1. Section is added to the Health and Safety Code, to read: (a) A health facility at which a mammography examination is performed shall, if a patient is categorized by the facility as having heterogeneously dense breasts or extremely dense breasts Slide 3 of 10 SB 1538 Law original text

10 California Law SB 1538 (2012) SECTION 1. Section is added to the Health and Safety Code, to read: based on the Breast Imaging Reporting and Data System established by the American College of Radiology, include in the summary of the written report that is sent to the patient, as required by federal law, the following notice:... Slide 4 of 10 SB 1538 Law original text

11 California Law SB 1538 (2012) SECTION 1. Section (a) Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast cancer. Slide 5 of 10 SB 1538 Law original text

12 California Law SB 1538 (2012) SECTION 1. Section (a) This information about the results of your mammogram is given to you to raise your awareness and to inform your conversations with your doctor. Together, you can decide which screening options are right for you. A report of your results was sent to your physician. Slide 6 of 10 SB 1538 Law original text

13 California Law SB 1538 (2012) SECTION 1. Section (a) (b) This section shall become operative on April 1, (c) (1) Nothing in this section shall be construed to create or impose liability on a health care facility for failing to comply with the requirements of this section prior to April 1, Slide 7 of 10 SB 1538 Law original text

14 California Law SB 1538 (2012) SECTION 1. Section (a) (2) Nothing in this section shall be deemed to create a duty of care or other legal obligation beyond the duty to provide notice as set forth in this section. Slide 8 of 10 SB 1538 Law original text

15 California Law SB 1538 (2012) SECTION 1. Section (a) (3) Nothing in this section shall be deemed to require a notice that is inconsistent with the provisions of the federal Mammography Quality Standards Act (42 U.S.C. Sec. 263b) or any regulations promulgated pursuant to that act. Slide 9 of 10 SB 1538 Law original text

16 California Law SB 1538 (2012) SECTION 1. Section (a) (d) This section shall remain in effect only until January 1, 2019, and as of that date is repealed, unless a later enacted statute, that is enacted before January 1, 2019, deletes or extends that date. Slide 10 / 10 SB 1538 Law original text

17 California Dense Breast Bill SB 1538 Text added to lay letters sent to all California women with heterogeneously dense or dense breast tissue on mammograms Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast cancer. This information about the results of your mammogram is given to you to raise your awareness and to inform your conversations with your doctor. Together, you can decide which screening options are right for you. A report of your results was sent to your physician.

18 California Law SB 1538 (2012) What is the Law and what does it say? Why did it come about? What is breast density? How do women approach the law? How high does heterogeneously dense or dense breast tissue raise the average woman s risk of breast cancer? Who should get supplemental screening and what kind?

19 Breast Density Areyoudense.org

20 Areyoudense.org n Mammography Fatty breast Dense breast Are You Dense, Inc. Exposing the Best-Kept Secret TM 96 Rowley Road Woodbury CT A 501(c)(3)Public Charity nancy@areyoudense.org There are too many women who rely on their happy gram when the mammography report states no significant findings and are at risk of a late-stage diagnosis. Dr. Nancy M. Cappello, President & Founder, Are You Dense, Inc. To read compelling stories of brave dense- Are You Dense, Inc. Know the facts... because your life matters Every 3 minutes a woman in the United States is diagnosed with breast cancer. Every 13 minutes a woman in the U.S. dies from breast cancer. 38%of breast cancers in the U.S. are diagnosed at a later stage where the cancer has spread beyond the breast. Breast density is one of the strongest predictors of the failure of mammography screening to detect cancer. Forty percent of women have dense breast tissue. Women with extremely dense breast tissue have a 6 times greater risk of cancer than women with fatty breasts. The addition of a screening ultrasound to mammogram increases detection of cancers that are small and node negative. Only one in 10 women learn about breast density from their physician. In 2009, Connecticut became the first state to mandate the communication of breast density to the patient. Know your breast density it is a matter of life!

21 California Law SB 1538 (2012) What is the Law and what does it say? Why did it come about? What is breast density? How do women approach the law? How high does heterogeneously dense or dense breast tissue raise the average woman s risk of breast cancer? Who should get supplemental screening and what kind?

22 Normal Mammography and Breast Density What is breast density on mammograms? Normal breasts are made up of fat and fibroglandular tissue. The normal breast is dense in young women, fatty in older women On mammography: Normal Fat is black Normal Glandular tissue is white ***Cancer is also white (mass) or shown by calcifications which are also white Dense glandular tissue is white, the denser the breast tissue, the harder it is to find cancers

23 Normal Mammograms and Examples of Normal Breast Density

24 Normal MammogramMammogram- Craniocaudal View ( looking down views)

25 Normal MammogramMammogramMediolateral Oblique Views (side view)

26 Cancer is easy to see in a Fatty Breast because it is a white mass on a black background

27 Cancer in a Fatty Breast

28 Cancer on the Excised Breast Specimen after Surgery After Preoperative Needle/Wire Localization

29 Breast Cancer is Harder to see in a Dense Breast When the mass is large enough or produces spciulations, you can see the cancer in a dense breast With smaller cancers, the white cancer mass or calcifications can be obscured by dense tissue We will show examples of a larger cancer displayed on a dense breast, and a smaller cancer obscured by dense breast tissue

30 Large Cancer in the Left breast is white: white mass, calcification, skin thickening (Craniocaudal View)

31 Cancer in the Left Breast is whiter than the Right breast

32 The Left breast cancer is black on Ultrasound

33 Metastatic Lymph Node

34 Dense Breast Tissue Hides a small Cancer on the Right Side (Craniocaudal View)

35 The Cancer is hard to see on the Right side, High in the Breast Tissue

36 Special Spot Compression Mammogram Shows the Cancer, Obscured by Dense Tissue

37 Ultrasound Directed to the Upper Breast Shows the Cancer (Black Mass)

38 US-Guided Core biopsy Diagnosed the Right Breast Cancer (Needle in Black Mass)

39 Breast Density on Mammography Summary Breast cancers (masses, calcs) are white Normal glandular breast tissue is white. Called dense breast tissue if it is white Dense breast tissue has nothing to do with how the breast feels to palpation, a dense breast can feel soft and a fatty breast can feel hard on physical examination Dense breast tissue can obscure cancers

40 California Law SB 1538 (2012) What is the Law and what does it say? Why did it come about? What is breast density? How do women approach the law? How high does heterogeneously dense or dense breast tissue raise the average woman s risk of breast cancer? Who should get supplemental screening and what kind?

41 California Breast Density Information Stanford University Debra M. Ikeda, MD Jafi A. Lipson, MD Bruce L. Daniel, MD Allison Kurian, MD MSc UC Davis Karen K. Lindfors, MD Jonathan Hargreaves, MD Donna D. Walgenbach, MS CGC Elyse Love, MS CGC UC Irvine Stephen Feig, MD UCLA Lawrence Bassett, MD Group (CBDIG) UC San Francisco Bonnie N. Joe, MD, PhD Edward A. Sickles, MD Elissa R. Price, MD Lauren Ryan, MS LCGC UC San Diego Haydee Ojeda-Fournier, MD Alta-Bates Summit Medical Center R. James Brenner, MD JD California Pacific Medical Center Jessica Leung, MD

42 California Breast Density Information Group (CBDIG) Academic and Private Practice Consortium formed in October 2012 Stanford University, UCSF, UC Davis, UC Irvine, UCLA, UCSD Alta Bates (Sutter), California Pacific Medical Center (CPMC) Breast Imaging/ Breast MRI/ Onocology physicians and Risk Assessment Specialists

43 The California Breast Density Information Group: A Collaborative Response to the Issues of Breast Density, Breast Cancer Risk, and Breast Density Notification Legislation Elissa R. Price, MD, Jonathan Hargreaves, MD, Jafi A. Lipson, MD, Edward A. Sickles, MD, R. James Brenner, MD, JD, Karen K. Lindfors, MD, MPH, Bonnie N. Joe, MD, PhD, Jessica W. T. Leung, MD, Stephen A. Feig, MD, Lawrence W. Bassett, MD, Haydee Ojeda-Fournier, MD, Bruce L. Daniel, MD, Allison W. Kurian, MD, MSc, Elyse Love, MS, CGC, Lauren Ryan, MS, LCGC, Donna D. Walgenbach, MS, CGC and Debra M. Ikeda, MD Radiology 2013; 269 (2)

44 California Breast Density Information Group (CBDIG) 6-Month Series of Conference Calls, ongoing now Developed Evidence- Based Approach to California Dense Breast Tissue Legislation Document addressing Breast Cancer risk, masking, screening options Creation of Breastdensity.info website Radiology publication

45 Who We Are FAQ Breastdensity.info For Health Care Providers ACR Brochure For Patients Breastdensity.info accessed 10/29/2013 Frequently Asked Questions About Breast Density, Breast Cancer Risk, and the Breast Density Notification Law in California: A Consensus Document Jafi A. Lipson, MD, Jonathan Hargreaves, MD, and Elissa R. Price, MD, on behalf of the California Breast Density Information Group (CBDIG) California breast density law»

46 California Law SB 1538 (2012) Raises Questions: How high does heterogeneously dense or dense breast tissue raise the average woman s risk of breast cancer?

47 Breast Density Higher risk of Breast Cancer As compared with women with density in less than 10% of the mammogram, women with density in 75% or more had an increased risk of breast cancer (odds ratio, 4.7; 95% confidence interval [CI], 3.0 to 7.4), whether detected by screening (odds ratio,3.5; 95% CI, 2.0 to 6.2) or less than 12 months after a negative screening examination (odds ratio, 17.8; 95% CI, 4.8 to 65.9). Increased risk of breast cancer, whether detected by screening or other means, persisted for at least 8 years after study entryand was greater in younger than in older women. For women younger than the median age of 56 years, 26% of all breast cancers and 50% of cancers detected less than12 months after a negative screening test were attributable to density in 50% or moreof the mammogram. Boyd et al. NEJM 2007;356:

48 California Law SB 1538 (2012) Raises 3 Questions: 1)How high does heterogeneously dense or dense breast tissue raise the average woman s risk of breast cancer? The risk of dense breast tissue conferring a risk of breast cancer is small especially compared to the risk of a significant family hx or genetic predisposition. Breastdensity.info accessed 10/29/2013

49 Breastdensity.info California breast density law» Breast density definitions» Breast density and risk» Masking» Importance of mammograms» Supplemental screening options: a riskbased approach» Breastdensity.info accessed Breastdensity.info accessed 10/29/2013

50 Breastdensity.info Supplemental screening options: a riskbased approach» Where did the Risk-Assessment Based Approach come from and what is the evidence that supports this approach?

51 Screening US in Patients with Mammographically Dense Breasts: Initial Experience with Connecticut Public Act Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

52 Purpose of Study: To determine performance and utilization of screening breast ultrasound in women with dense breast tissue who underwent additional screening breast ultrasound in the 1 st year since implementation of Connecticut Public Act Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

53 Screening Breast Ultrasound Multiple studies have looked at supplemental screening breast ultrasound Generates incremental cancer detection at rate of cancers per 1000 women screened Limited by low positive perdictive value (PPV) compared with mammography No directly proven mortality benefit

54 Materials and Methods HIPAA compliant, IRB approved study Retrospective review of results of screening breast ultrasound preformed at the facility from Oct 1, 2009 to Sept 30, CT Public Act all mammographic reports notified patients of their breast density as of Oct 1, 2009

55 Subject Population 175 women underwnt a screening breast ultrasound at the same time as their diagnositic mammogram If a mass was found in the same quadrant as their mammgraphic of physical finding, they were excluded (n=52) Only regions of the breast with no US correlate to mammographic or physical exam findings were included in the study Had to have heterogenously dense or dense breasts, mammogram with 12 months prior Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

56 Results: Study Population Of the 935 women in study: patient risk factor for breast cancer were as follows: Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

57 Study Population Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

58 Cancer Detection Biopsy recommended for 55 lesions in 47 patients, classified as BIRADS 4 at initial screening us Of 54 lesions sampled: 46 US core, 3 surgical excision,5 cyst aspiration 3 cancers were found: one 5-mm DCIS and two invasive ductal carcinomas measuring 9mm and 5 mm All found in women with BIRADS 1 mammograms None of the cancers were able to be seen on retrospective review of mammograms Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

59 Cancer Detection Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

60 Cancer on Screening US Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

61 Cancer on Screening US Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

62 Results: Cancer Detection Overall PPV for all biopsies preformed on BI-RADS 4 lesions: 5.6% Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

63 Conclusions: Technologist preformed handheld screening breast US in women in the general population w/ dense breast tissue results in a cancer detection rate of 3.2 cancers per 1000 The 3 cancers that were detected on screening US were all smaller than 1 cm, highest risk had the highest PPV BIRADS 4 lesions may be assessed in 5.0% of screening breast US cases, with a PPV of 6.5% Limitation: FN rate yet to be assessed, only 420 patients underwent a 1 year follow up US Hooley RJ et al. Radiology: Volume 265: Number 1 October 2012

64 CBDIG Family History Risk- Assessment Based Approach Guidelines for Breast Cancer Screening are based on Risk Assessment based on Family History or Genetic Models American Cancer Society, National Conprehensive Cancer Network (NCCN), American College of Radiology Conn data (Hooley, Weigert) showed highest % cancers were found in high risk women on US, high FP

65 Risk-Models Largely Based on Family History National Conprehensive Cancer Network (NCCN Guidelines V ) Tyer-Cuzick Claus BRCAPRO BODICEA

66 Family History Risk Based Assessment MRI Recommended: BRCA mutation, or 1 st degree relative of BRCA carrier but untested Lifetime risk >20% or greater Chest radiation between years old Li-Fraumeni, Cowden and Bannayanriley-Ruvalcaba and 1 st degree relative National Conprehensive Cancer Network (NCCN Guidelines V ), ACS Saslow D 2007

67 Risk and Supplemental MRI Screening Insufficient Evidence for or against MRI: Lifetime risk 15-20%, LCIS, ALH, ADH, Hetero or Dense Breast Tissue, Personal Hx of Breast Cancer including DCIS Recommend Against MRI screening (based on expert opinion) Women at <15% lifetime risk National Conprehensive Cancer Network (NCCN Guidelines V ), ACS Saslow D 2007

68 Risk and Supplemental Screening Dense breasts are associated with an increased risk for breast cancer, but there is insufficient evidence to support routine supplemental screening in women with dense breasts and no other risk factors National Conprehensive Cancer Network (NCCN Guidelines V ), ACS Saslow D 2007 Breastdensity.info accessed 10/29/2013

69 High Risk Definition is > 20% Lifetime Risk BRCA1/BRCA2 genetic mutation Strong family history of first degree relative with premenopausal onset of cancer Definitions fit most published series of screening MRI in high risk women populations (test fit models)

70 American Cancer Society definitions not considered High Risk Normal general population Age 50 = 2% lifetime risk Age 85 = 14% lifetime risk; or 1 in 7 Slightly higher risk but still not high risk Personal history of breast cancer = 2-3x normal risk

71 Breastdensity.info For patients who are interested in additional screening options, a breast cancer risk assessment may be appropriate. It is a good starting point in the discussion of whether supplemental tests will be beneficial and what tests, if any, to order. Breastdensity.info accessed 10/29/2013

72 Dense Breast Tissue and Risk Assessment Determine if the woman is at high risk based on family history- If No -> routine mammography, shared decision making w/ referring If Yes or Possibly Yes -> Refer to risk assessment specialist for detailed family history See high risk algorithms for supplemental screening Breastdensity.info accessed 10/29/2013

73 California Law SB 1538 (2012) Raises Questions: How high does heterogeneously dense or dense breast tissue raise the average woman s risk of breast cancer? Who should get supplemental screening and what kind?

74 Breastdensity.info Take home points: The recommendations for screening mammography are exactly the same for women with dense breasts as for the rest of the population. Mammography is the only screening modality that has undergone randomized controlled trials demonstrating a reduction in breast cancer mortality. There is no recommendation that it be replaced with another test in any subset of the population. Breastdensity.info accessed 10/29/2013

75 EVA TRIAL : HIGH RISK SCREENING FOR BREAST CA 687 High Risk women, 1,679 screening rounds CBE, mammo, US, MRI 371/687 also had 6 mo US and CBE F/U 29 months 27 cancers 11 DCIS (41%) and 16 invasive (59%), 3 (11%) node positive Kuhl CK et al. J Clin Oncol 2010; Mar 20; 28(9):

76 EVA TRIAL : HIGH RISK SCREENING FOR BREAST CA Cancer Yield Mammo 5.4/1000 PPV=39% US 6/1000 PPV=36% M +US 7.7/1000 MRI 14.9/1000 PPV=48% MRI +M 16/1000 MRI+US 14.9/1000 Kuhl CK et al. J Clin Oncol 2010; Mar 20; 28(9):

77 Multicenter Surveillance of Women at High Genetic Breast Cancer Risk Using Mammography, Ultrasonography, and Contrast-Enhanced Magnetic Resonance Imaging (the High Breast Cancer Risk Italian 1 Study) Sardenelli, et. al. Invest Radiol 2011;46:

78 Sardenelli, et. al. High Risk Italian 1 Trial Invest Radiol 2011;46: MRI was more sensitive (91%) than clinical breast examination (18%), mammography (50%), ultrasonography (52%), or mammography plus ultrasonography (63%) (P 0.001). Specificity ranged 96% to 99%, positive predictive value 53% to 71%, positive likelihood ratio 24 to 52 (P not significant).

79 Sardenelli, et. al. High Risk Italian 1 Trial Invest Radiol 2011;46: Of 52 cancers, 16 (31%) were diagnosed only by MRI, 8 of 21 (38%) in women 50, and 8 of 31 (26%) in women 50 years of age. Conclusion: MRI largely outperformed mammography, ultrasonography, and their combination for screening highrisk women below and over 50.

80 Detection of Breast Cancer With Addition of Annual Screening Ultrasound or a Single Screening MRI to Mammography in Women With Elevated Breast Cancer Risk Berg, et. al. JAMA, April 4, 2012 Vol 307, No.13

81 Berg et al. JAMA 2012

82 Statistics Supplemental US increased cancer detection beyond screening mammography alone by finding an additional 5.3 cancers per 1000 women (1 st year), 3.7 per 1000 (2 nd and 3 rd years) (P <.001) MRI screening detected an additional 14.7 cancers per 1000 women (P=.004) Berg, et. al. JAMA, April 4, 2012

83 Breastdensity.info The other breast imaging "screening options" include screening MRI, ultrasound and tomosynthesis ("3D mammography"). Screening breast MRI has been shown to substantially increase the rate of cancer detection. It is recommended in patients who are at very high risk (>20% lifetime risk) based on American Cancer Society guidelines. Breastdensity.info accessed 10/29/2013

84 Breastdensity.info For patients at "intermediate risk," such as those with a personal history of breast cancer or a prior biopsy diagnosis of atypia (equivalent to a 15% to 20% lifetime risk), a patient-centered shared decision-making approach is recommended Breastdensity.info accessed 10/29/2013

85 Breastdensity.info Screening breast ultrasound is not offered at many centers and may entail an out of pocket charge to patients. Small studies have shown a modest increase in cancer detection, but also a high rate of false positives resulting in benign biopsies. The choice to have this test should be made on an individual basis after a discussion of these risks, benefits, and costs. Breastdensity.info accessed 10/29/2013

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87 Breastdensity.info Breast tomosynthesis ("3D mammography") is being offered in addition to screening mammography in some centers. Thus far, we have preliminary encouraging data on the performance of tomosynthesis in women with dense tissue. Breastdensity.info accessed 10/29/2013

88 Comparison of Digital Mammography Alone and Digital Mammography Plus Tomosynthesis in a Population-based Screening Program. Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Department of Radiology, Oslo, Norway; University of Pittsburgh, Pittsburgh, Pa; Department of Radiology, Oslo University Hospital, Oslo, Norway; Curato Roentgen Institute, Oslo, Norway; Hologic, Bedford, Mass Radiology Jan 7. [Epub ahead of print]

89 Oslo Breast Tomosynthesis Screening Trial 12,631 exams of FFDM and BT Nov 22, 2010 through December 31, 2011 Cancer detection: 6.1 cancers/1000 FFDM, 8 cancers/1000 FFDM + BT (27% increase, P =.001) Recalls: FP 61.1/100 FFDM, 53.1/1000 FFDM + BT (15% decrease, P <.001) PPV FFDM 29.1% vs FFDM + BT 28.5% P =.72 Skaane P. et al. Radiology 2013

90 Oslo Breast Tomosynthesis Screening Trial 25 additional invasive cancers found by FFDM + BT (40% increase, P <.001) Interpretation time: 45 seconds FFDM 91 seconds FFDM + BT Mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers Skaane P. et al. Radiology 2013

91 Integration of 3D Digital Mammography with Tomosynthesis for Population breast cancer Screening (STORM): a prospective comparison Study Ciatto S, Houssami N, Bernardi D et al. Azienda Provinciale Servizi Sanitari, Trento, Italy Radiology Jan 7. [Epub ahead of print]

92 STORM Breast Tomosynthesis Screening Trial 7,292 women were screened using both 2D and integrated 2D and 3D methods from August, 2011, to June, 2012 Cancer detection: 5.3 cancers per 1000 screens (95% CI ) for 2D only, 8.1cancers per 1000 screens ( ) for integrated 2D and 3D screening, The incremental cancer detection rate for integrated 2D and 3D mammography: 2.7 cancers per 1000 screens ( ) Recalls: 395 screens (5.5%; 95% CI ) resulted in false positive recalls: 181 at both screen reads, and 141 with 2D only versus 73 with integrated 2D and 3D screening (p<0.0001). Ciatto S. et al. The Lancet Oncology 2013

93 STORM Breast Tomosynthesis Conclusions: Screening Trial Integrated 2D and 3D mammography improves breast-cancer detection and has the potential to reduce false positive recalls. conditional recall (positive integrated 2D and 3D mammography as a condition to recall) could have reduced false positive recalls by 17.2% (95% CI ) without missing any of the cancers detected in the study population Ciatto S. et al. The Lancet Oncology 2013

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95 Understanding Breast Density Legislation Breast Density is a measure of how white the breast appears on a mammogram About 50% of women are heterogeneously dense or dense, so it is commen The risk of developing breast cancer due to dense tissue is small, the risk based on family history is much larger Supplemental screens based on FH + SDM Breastdensity.info website for information

96 Thank You!