[PDF] - Page 1 1 Origins of Breast Density Legislation Origins of Breast PDF Document

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Breast Density Notification Legislation, Supplemental Screening and Controversies

Amie Y. Lee, MD Assistant Professor, Breast Imaging University of California, San Francisco

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Message

The majority of states have enacted breast density notification legislation. A basic understanding of the implications of dense breast tissue and supplemental screening

ptions will allow you to better communicate

with your patients.

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Outline

Origins of breast density legislation and

current status.

What is breast density?
Why is it important?
What to do about it?

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Outline

Origins of breast density legislation and

current status.

What is breast density?
Why is it important?
What to do about it?

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http://areyoudense.org

In 2003, Nancy Capello had a

negative screening mammogram

6 weeks later, a palpable lump

was detected on CBE

– A 2.5 cm mass was found on US – Stage IIIC cancer with metastasis to 13 axillary lymph nodes

She learned for the first time that

she had dense breast tissue

Origins of Breast Density Legislation

Image use with permission by Dr. Nancy Capello

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Origins of Breast Density Legislation

She believed her cancer would have been diagnosed

earlier had she been informed of her breast density and undergone supplemental screening

Capello lobbied for state legislation to inform women of

dense breasts

– In 2009, the first breast density notification law passed in her state of CT

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Origins of Breast Density Legislation

She founded ‘Are You Dense Advocacy, Inc to advance

legislation in other states

Image use with permission by Dr. Nancy Capello (http://areyoudense.org)

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Origins of Breast Density Legislation

Her story and the issue of breast density has received widespread national attention

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2009: CT is the 1st state to pass breast density notification legislation

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2012: CA becomes the 5th state to pass breast density notification legislation

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2018: 35 states require breast density notification An additional 3 states recommend it

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Federal Efforts:

densebreast-info.org

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California Breast Density Legislation

Effective as of April 1, 2013
Exact wording specified by law
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California Breast Density Legislation

“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.”

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Outline

Origins of breast density legislation and

current status in the U.S.

What is breast density?
Why is it important?
What to do about it?

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Breast Density Assessment

Density = Relative amount of fibroglandular

tissue is within the breast

Based on qualitative visual assessment of

mammogram by the radiologist

– Indicate the relative possibility that a lesion could be obscured by normal tissue

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Four Breast Composition Categories ACR BI-RADS 5th ed. 2013

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

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(A) Fatty (B) Scattered (C) Heterogeneous

Breast Density Categories

(D) Extreme

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(A) Fatty (B) Scattered (D) Extreme

~50% have dense breast tissue

(C) Heterogeneous

Distribution of patients by density

Breast density policies impact approximately half the screening population à Wide ranging consequences

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Outline

Origins of breast density legislation and

current status in the U.S.

What is breast density?
Why is it important?
What to do about it?

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What is the Clinical Significance of Mammographic Breast Density?

Masking

– Dense tissue can mask cancers on mammography

Risk

– Presence of dense tissue is a risk factor for the development of breast cancer

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Masking

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Masking Associated with Breast Density

How much does dense breast tissue reduce the sensitivity

f mammography?
Overall ~ 10% decreased sensitivity

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Risk Associated with Breast Density

Risk of breast cancer increases with increasing breast

density

Average density at screening is between B & C

– RR for density C vs. “average”: 1.2 – RR for density D vs. “average”: 2.1

Women with density D have a 4-6 x increased risk of

breast cancer compared to women with density A

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Breast density is an independent risk factor but not a

major one.

densebreast-info.org

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Outline

Origins of breast density legislation and

current status in the U.S.

What is breast density?
Why is it important?
What to do about it?

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Key Point

Mammography is the only screening tool shown to reduce breast cancer mortality in randomized controlled trials

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Any supplementary screening is in addition to (not instead of) screening mammography Decision to pursue supplemental screening is an informed personal decision, including discussion of other risk factors

Imaging Options for Suppl Screening

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Breast MRI
Whole Breast Ultrasound

− Hand-held (HHUS) − Automated (ABUS)

Breast Tomosynthesis

Imaging Options for Suppl Screening

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Not limited by dense breast tissue
Most sensitive modality for detecting breast

cancer

Recommended for screening high risk

women (>20-25% lifetime risk)

Breast MRI

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Limitations:

Limited specificity (increased false positives)
Requires IV contrast
Length of exam
Expensive

Breast MRI

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Breast MRI

Small mass in dense breast tissue

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Spiculated enhancing mass

Invasive Ductal Carcinoma

Breast MRI 38

Finds additional cancers not seen at mammography
Well tolerated by patients
Less expensive, less invasive than MRI

Whole Breast Ultrasound

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Limitations:

Very poor specificity
Very high false positive recall and biopsy rate
>90% of biopsies are not malignant

Breast Ultrasound Screening

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Studies to date are promising

− Cancer detection similar to US, lower than MRI − Fewer false positives than US − Most studies: improved sensitivity + specificity

Breast Tomosynthesis (DBT)

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Limitations

Limited availability
Added time (but less than MRI and US)
Additional radiation (but within FDA limits)

Due to promising initial results, DBT is slowly being incorporated into the standard annual screening mammogram

Tomosynthesis (DBT)

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Screening

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Tomosynthesis (DBT)

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Breast Density Legislation: Problems

Insurance coverage for supplemental screening

not guaranteed

− < 10 states mandate insurance coverage

US and MRI increase false positives
No evidence of mortality benefit…yet

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Additional guidance?

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DenseBreast-info.org

Educational resource providing information on breast

density to patients and health care providers

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What do we offer at UCSF?

Screening mammography
Supplemental screening based on risk
If high risk (>20% lifetime risk), add MRI
US screening not offered at UCSF
DBT- Women may opt for this as part of routine

screening mammography exam

Supplemental screening: Insurance coverage is not

guaranteed

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Summary

~ 50% of women undergoing screening

mammography have dense breast tissue

Dense breast tissue decreases the sensitivity of

mammography by masking

Dense breast tissue is an independent cancer risk

factor

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Summary

No consensus for supplemental screening
Screening US improves cancer detection
MRI has the highest cancer detection
Both US and MRI have limited specificity
Initial data on the performance of DBT is