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Density matters: breast cancer screening guidelines November 23, 2019 Colin Mar BC Cancer Breast Screening
No disclosures
Objectives
1. To appreciate the risks associated with breast density, in the context of other breast cancer risks
2. To understand the background and current means of breast density notification in British Columbia
3. To appreciate the potential benefits and limitations of supplemental ultrasound in screening
What is BD?
• Non-dense – Fatty – Fat – Black
• Dense
– Glandular, ducts
– Fibrous, CT – White
What is BD?
• Non-dense – Fatty – Fat – Black
• Dense
– Glandular, ducts
– Fibrous, CT – White
What is BD?
• Non-dense – Fatty – Fat – Black
• Dense
– Glandular, ducts
– Fibrous, CT – White
How is BD measured?
BD measurement: BIRADS
A B C D
BD measurement: complete BIRADS
A
The breasts are almost entirely fatty
B
There are scattered areas of fibroglandular density
C
The breasts are heterogeneously dense, which may obscure small masses
D
The breasts are extremely dense, which lowers the sensitivity of mammography
Why does it matter?
Rationale for notification
• Patient autonomy and right to knowledge re personal health – Increased understanding of breast cancer risk Optimized informed decision making re breast health
Challenges of notification
• Potential confusion and anxiety • BD assessment variability and reproducibility • Interpretability for the patient • Question of supplemental
– Implications for future study
Keating NL, Pace LE. New federal requirements to inform patients about breast density; will they help patients? JAMA 2019;doi: 10.1001/jama.2019.5919
Background: USA
• 2005 Connecticut BD legislation mandating supplemental US for dense breasts
• Followed by BD notification laws in 38 states • 2016 USPSTF: insufficient evidence to assess balance
of benefits/harms of supplemental • Feb/2019 federal BD inform law • Heterogeneous use of US and MR
Siu 2016
Background: International
• Australia does not recommend routine notification, or supplemental screening
• UK Nat Screening Committee completed systematic review and does not recommend sUS
BreastScreen Australia (2016). Breast Density and Screening: Position Statement.
Background: International
• International Agency for Research on Cancer – Inadequate evidence that sUS reduces mortality
or interval cancers • European Society of Breast Imaging
– 1st priority is digital mammo adoption to optimize sensitivity
International Agency for Research on Cancer (IARC). (2016)
Background: BC
Fall 2016 • Use of BD in BC Cancer Breast Screening
– Dense Breasts Canada – US activity – Cdn environment
• No federal legislation • 7/12 programs notifying PCP; 1 to Pt
• BD available to Pt/PCP upon Pt request
2016 2017 2018
Background BC
Spring 2017 • Commissioned an External Review
– Andy Coldman, PhD – Published literature – Key informants – BC program data 2011 – 2014
2016 2017 2018
Background: BC
Aug 2017 • Quebec
– supplemental US “can also be useful” for very dense breasts (BI-RADS d) + family Hx
– Rad recommendation and breast cancer risk assessment followed by patient discussion
2016 2017 2018
Background: BC
Spring 2018 • External Review recommendations
1. Develop a plan to communicate breast density • Involve participants and primary care providers • Use BC data to develop risk info for BC population • Messages BD in context of other recognized risk
factors 2. Continue with BI-RADS, and monitor 3. Supplemental not recommended
2016 2017 2018
Background: BC
Fall 2018 • Began BD notification to Pts and PCP • CTFPHC
– Ltd evidence on patient-important outcomes of sUS
Klarenbach, S. et al. (2018). Recommendations on screening for breast cancer in women aged 40–74 years who are not at increased risk for breast cancer. Canadian Medical Association Journal, 190(49), E1441-E1451. DOI: 10.1503/cmaj.180463.
2016 2017 2018
Background: BC
Spring 2018 • External Review recommendations
1. Develop a plan to communicate breast density • Involve participants and primary care providers • Use BC data to develop risk info for BC population • Messages BD in context of other recognized risk
factors 2. Continue with BI-RADS, and monitor 3. Supplemental not recommended
2016 2017 2018
Markers of a successful screening test
• ↓Mortality • ↓Advanced cancers • ↑Sensitivity ↓Interval
cancers • ↑Cancer detection rate
• Abnormal call rate and false positives
• Overdiagnosis
RCT Data: J-START trial
• [M + CBE] vs [M + US + CBE] • 73K Japanese women 40-49 • 1st round only!
Ohuci et al. Lancet 2016
RCT Data: J-START trial
Ohuci et al. Lancet 2016 Coldman 2018
Arm
Mode of Detection
TEST
Number of Cases
Stage 0 I II+
Intervention
Screen Detected
M or CBE 122* 45 (37%)
52 (43%)
25 (20%)
Screen Detected
US not M or CBE
59† 9 (15%)
39 (66%)
11 (19%)
Interval - 18 1 (6%)
8 (44%)
9 (50%)
TOTAL 199 55 (28%)
99 (50%)
45 (23%)
Control
Screen Detected
M or CBE 117 31 (26%)
48 (41%)
38 (32%)
Interval - 35 8 (23%)
17 (49%)
10 (29%)
TOTAL 152 39 (26%)
65 (43%)
48 (32%)
*1 case had missing stage and was omitted from this table †2 cases had missing stage and were omitted from this table
RCT Data: J-START trial
Ohuci et al. Lancet 2016 Coldman 2018
Arm
Mode of Detection
TEST
Number of Cases
Stage 0 I II+
Intervention
Screen Detected
M or CBE 122* 45 (37%)
52 (43%)
25 (20%)
Screen Detected
US not M or CBE
59† 9 (15%)
39 (66%)
11 (19%)
Interval - 18 1 (6%)
8 (44%)
9 (50%)
TOTAL 199 55 (28%)
99 (50%)
45 (23%)
Control
Screen Detected
M or CBE 117 31 (26%)
48 (41%)
38 (32%)
Interval - 35 8 (23%)
17 (49%)
10 (29%)
TOTAL 152 39 (26%)
65 (43%)
48 (32%)
*1 case had missing stage and was omitted from this table †2 cases had missing stage and were omitted from this table
55% ↑cancer detection
Modality Abnormal call rate (%) PPV (%)
Mammo 6.6 4.8
US (after M-) 5.7 3.6
RCT Data: J-START trial
• Subsequent abstract: – Similar proportional increase across all densities
• Awaiting publication of 2nd round data
Ohuci et al. Lancet 2016 Ohuci et al. 2019
RCT Data: J-START trial
Ohuci et al. Lancet 2016 Coldman 2018
Arm
Mode of Detection
TEST
Number of Cases
Stage 0 I II+
Intervention
Screen Detected
M or CBE 122* 45 (37%)
52 (43%)
25 (20%)
Screen Detected
US not M or CBE
59† 9 (15%)
39 (66%)
11 (19%)
Interval - 18 1 (6%)
8 (44%)
9 (50%)
TOTAL 199 55 (28%)
99 (50%)
45 (23%)
Control
Screen Detected
M or CBE 117 31 (26%)
48 (41%)
38 (32%)
Interval - 35 8 (23%)
17 (49%)
10 (29%)
TOTAL 152 39 (26%)
65 (43%)
48 (32%)
*1 case had missing stage and was omitted from this table †2 cases had missing stage and were omitted from this table
48% ↓Interval cancers
RCT Data: J-START trial
Ohuci et al. Lancet 2016 Coldman 2018
Arm
Mode of Detection
TEST
Number of Cases
Stage 0 I II+
Intervention
Screen Detected
M or CBE 122* 45 (37%)
52 (43%)
25 (20%)
Screen Detected
US not M or CBE
59† 9 (15%)
39 (66%)
11 (19%)
Interval - 18 1 (6%)
8 (44%)
9 (50%)
TOTAL 199 55 (28%)
99 (50%)
45 (23%)
Control
Screen Detected
M or CBE 117 31 (26%)
48 (41%)
38 (32%)
Interval - 35 8 (23%)
17 (49%)
10 (29%)
TOTAL 152 39 (26%)
65 (43%)
48 (32%)
*1 case had missing stage and was omitted from this table †2 cases had missing stage and were omitted from this table
↑Screen detected cancers > ↓Interval cancers • Future mammo interval cancers • Future mammo detectable cancers • Overdiagnosis
RCT Data: J-START trial
Ohuci et al. Lancet 2016 Coldman 2018
Arm
Mode of Detection
TEST
Number of Cases
Stage 0 I II+
Intervention
Screen Detected
M or CBE 122* 45 (37%)
52 (43%)
25 (20%)
Screen Detected
US, not M or CBE
59† 9 (15%)
39 (66%)
11 (19%)
Interval - 18 1 (6%)
8 (44%)
9 (50%)
TOTAL 199 55 (28%)
99 (50%)
45 (23%)
Control
Screen Detected
M or CBE 117 31 (26%)
48 (41%)
38 (32%)
Interval - 35 8 (23%)
17 (49%)
10 (29%)
TOTAL 152 39 (26%)
65 (43%)
48 (32%)
*1 case had missing stage and was omitted from this table †2 cases had missing stage and were omitted from this table
Lower stage of US detected
RCT Data: J-START trial
Ohuci et al. Lancet 2016 Coldman 2018
Arm
Mode of Detection
TEST
Number of Cases
Stage 0 I II+
Intervention
Screen Detected
M or CBE 122* 45 (37%)
52 (43%)
25 (20%)
Screen Detected
US not M or CBE
59† 9 (15%)
39 (66%)
11 (19%)
Interval - 18 1 (6%)
8 (44%)
9 (50%)
TOTAL 199 55 (28%)
99 (50%)
45 (23%)
Control
Screen Detected
M or CBE 117 31 (26%)
48 (41%)
38 (32%)
Interval - 35 8 (23%)
17 (49%)
10 (29%)
TOTAL 152 39 (26%)
65 (43%)
48 (32%)
*1 case had missing stage and was omitted from this table †2 cases had missing stage and were omitted from this table
? ↓advanced interval cancers
Markers of a successful screening test
• ↓Mortality • ↓Advanced cancers • ↑Sensitivity ↓Interval
cancers • ↑Cancer detection rate
• Abnormal call rate and false positives
• Overdiagnosis
? ? ?
Background: BC
Spring 2018 • External Review recommendations
1. Develop a plan to communicate breast density • Involve participants and primary care providers • Use BC data to develop risk info for BC population • Messages BD in context of other recognized risk
factors 2. Continue with BI-RADS, and monitor 3. Supplemental not recommended
2016 2017 2018
Patient and Primary Care Engagement Committee Objectives and Representation
Pt/PCP Results Letters
Pt Brochure PCP Guide
3 Pt Reps
BC Divisions of Family Practice
BC Naturopathic Assoc
BC Cancer
Others Others • Dense Breasts Canada • Mammo technologist • BC Radiologic Society • First Nations Health
Authority • BC Ministry of Health
Focus Group Testing
• 250 random women 40-74 years – Geographic
– Various educational backgrounds
– Indigenous women
– ESL
• 14 Providers – Family Practice
– Radiology
– Mammography technologist
– Naturopathy
– Nurse Practitioner
BD Discussion Guide for Clinicians
• Can change; tending to decrease with age • Intro BI-RADS assessment of volume of dense tissue • “breast composition” = “breast density” • Intro masking/interval cancer and risk factor concepts • “dense breasts” = C/D vs spectrum: C vs D; B
Role of Mammography • Only means to know breast density • Continue regular mammo regardless of density • Proven mortality benefit, density aside • No screening test perfect, and density can mask • Any breast changes remain important, even if negative mammo
Updated Discussion Guide
“Understanding Breast Density as a Risk Factor” • Explain concept of Absolute Risk (“2y”) • Use 2 examples
“Additional Breast Cancer Risk Factors” • Overall risk is complex combination of: • Age, mutations, personal Hx, family Hx, Bx showing high risk lesion • Lifestyle choices: active, wt, EtOH, breastfeeding, hormone (“5+”) • Risk calculator links: NIH (-BD); BCSC (+BD)
“Relative Risk” explained
Updated Discussion Guide
Updated Discussion Guide “Supplemental Testing” (not “screening”) • Review purpose of screening: early cancer detection; not risk reduction • Insufficient evidence for recommendation of routine supplemental for dense • Does show additional cancer detection, including favourable stages • But unclear re overdiagnosis, proportion found at next screen, mortality • RCT for US ongoing, but need to discuss benefits vs limitations (FP, sensitivity) • Possible change in balance for density in combination with other risk factors
Objectives
1.To understand the background and current means of breast density notification in British Columbia
2.To appreciate the risks associated with breast density, in the context of other breast cancer risks
3.To appreciate the potential benefits and limitations of supplemental ultrasound in screening
Masking >> Carcinogenesis Must consider other risks, but relationship is unclear
False positives Uncertain benefit of additional cancers
Additional cancers ↓ Interval cancers
Acknowledgements
• Canadian Partnership Against Cancer
• Andy Coldman, PhD
• Javis Lui
References • Berg, W. A. et al. 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;307:1394–1404
• Berg WA, Mendelson EB. Technologist-performed Handheld Screening Breast US Imaging: How Is It Performed and What Are the Outcomes to Date? Radiology 2014;272:12-27
• BreastScreen Australia (2016). Breast Density and Screening: Position Statement.
• Brem, R. F. et al. Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: the SomoInsight Study. Radiology 2015;274:663–673
• Coldman A. Report on Breast Density. Vancouver, BC: BC Cancer 2018.
• International Agency for Research on Cancer (IARC). (2016). Breast Cancer Screening, Volume 15: IARC Handbooks for Cancer Prevention. Lyon, France
• Keating NL, Pace LE. New federal requirements to inform patients about breast density; will they help patients? JAMA 2019;doi: 10.1001/jama.2019.5919
• Ohuci N et al. Sensitivity and specifi city 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 2016; 387: 341–48
• Ohuchi N, Suzuki A, Harada Y, Zheng Y, Ishida T. Balance of mammography in conjunction with ultrasonography for breast cancer screening according to breast density: Japan Strategic Anti-cancer Randomized Trial, J-Start. International Cancer Screening Network Meeting, Rotterdam 2019.
• Rebolj M et al. Addition of ultrasound to mammography in the case of dense breast tissue: systematic review and meta-analysis. British Journal of Cancer https://doi.org/10.1038/s41416-018-0080-3
• Sardanelli, F., Aase, H. S., Álvarez, M., Azavedo, E., Baarslag, H. J., Balleyguier, C., ... Forrai, G. (2017). Position paper on screening for breast cancer by the European Society of Breast Imaging (EUSOBI) and 30 national breast radiology bodies from Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Israel, Lithuania, Moldova, The Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland and Turkey. European Radiology, 27(7), 2737-2743. DOI: 10.1007/s00330-016-4612-z
• Saraiya et al. Breast density notification letter and websites: are they too “dense”? J Am Coll Radiol 2019;16:717-723
• Siu AL, on behalf of the U.S. Preventive Services Task Force. Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2016;164:279–296. doi: 10.7326/M15-2886.
• Wilczek, B., Wilczek, H. E., Rasouliyan, L. & Leifland, K. Adding 3D automated breast ultrasound to mammography screening in women with heterogeneously and extremely dense breasts: report from a hospital-based, high-volume, single-center breast cancer screening program. Eur. J. Radiol. 2016;85:1554–1563
BI-RADS A/B Results Letter
“no sign of breast cancer”
Symptoms + Normal screen
BI-RADS letter + paraphrase
• Do not have “dense breasts” • Refer to brochure
Encourage complete discussion of risk and modifiable factors
BI-RADS C/D Results Letter
“no sign of breast cancer”
Symptoms + Normal screen
• At least some dense tissue • Common and normal • Masking and Inc’d Risk • Refer to brochure
Encourage complete discussion of risk and modifiable factors
BI-RADS letter + paraphrase
Updated Patient Brochure
What is breast density? • Comparison of 2 tissue types • Normal, common
How do I know how much dense tissue I have? • Introduce BI-RADS assessment
BI-RADS composition categories • Had to paraphrase
Other important concepts • Based on mammo, not clinical • Can change, particularly with age
Why should I know my breast density? 1. Increased risk, but small impact on overall 2. Masking, so any symptoms still important
Graphic demonstration of density • Combined with masking demonstration
What you can do Are there additional screening tests available for those with dense breasts? • Evidence limitations precluding definitive
recommendation • Other tests may find additional cancers • Explain false positive risk
Updated Patient Brochure
Grade 6/7 reading level
Saraiya et al. Breast density notification letter and websites: are they too “dense”? J Am Coll Radiol 2019;16:717-723
Updated Patient Brochure
Updated Patient Brochure
“What you can do” continued:
• “If I have dense breasts, do I still need a mammogram?”
• “Besides getting regular mammograms, what else can I do? – “Be familiar with your breasts”
– “Understand your overall risk for breast cancer” (≠ “high” risk)
– “Make positive lifestyle choices” (5-plus)
“What else determines my risk for breast cancer?” – Age
– Personal Hx of breast cancer
– Family Hx of breast cancer
– Inherited gene mutations