Blog
FDA MQSA and DBI Europe Updates
It’s done! After multiple iterations and a great deal of useful input from many of you, DBI has submitted its comments to the FDA on the proposed MQSA amendment. Though the proposed amendment covers other topics, as the leading expert on density-inform law analysis, DBI comments (which can be viewed HERE are focused exclusively on the proposed density notification language and implementation.What’s next? The public comment period for this proposed rule ends on June 26, 2019. All comments will then be reviewed by the FDA and a final rule will be published. The amendment will become effective 18 months following finalization, likely in early 202. Prominent International Oncology Resource, ecancer.org, Highlights Importance of Breast Density Education:
Our thanks to ecancer.org for highlighting a piece on the importance of breast density education for women and the health care community. The article, Why Breast Density Matters, was authored by Cheryl Cruwys, DBI’s European Education Coordinator and founder of Breast Density Matters UK, who recently joined the ecancer.org editorial board.
Why Screening Before Age 45 Matters
DO I NEED A MAMMOGRAM BEFORE I TURN 45? YES.
- The entire reason we screen for breast cancer is to find it EARLY, when most treatable and survivable.
- Breast cancer is the number one cause of death in women aged 35 to 54 years.
- Mammography has been proven to reduce deaths due to breast cancer in women screened beginning at age 40.
- 25% of all years of life lost to breast cancer occur in women diagnosed before the age of 45.
- Women at “high risk” for breast cancer due to known or suspected disease-causing mutation (such as BRCA1 or BRCA2) should begin screening at least by age 30, to include MRI.
WHAT ABOUT FALSE ALARMS (KNOWN AS “FALSE POSITIVES”)?
- About 10% of women having a screening mammogram will be called back (recalled) for extra testing or views. THIS IS NORMAL. Among women called back, 95% do not have cancer. If a needle biopsy is necessary, even that is a simple test not much different from a dental filling.
- The newer technique of 3D-mammography (also known as tomosynthesis), is better able to show cancer AND results in fewer callbacks for extra testing.
WHAT ABOUT SCREENING IN DENSE BREASTS?
- Younger women are more likely to have dense breast tissue, that can hide cancer on mammography.
- In women who have breasts categorized as “dense” (heterogeneously dense or extremely dense), adding screening ultrasound after a mammogram can help find more breast cancers. However, ultrasound also finds areas/masses that are not cancer and increases the chance of needing a needle biopsy to determine if something detected is cancerous or not.
IS IT COVERED?
- Under the Affordable Care Act, insurance carriers are required to cover the full cost of screening mammography. If the screening is performed by 3D mammography (tomosynthesis), the full cost may not be covered by some insurance companies in some states.
- Diagnostic mammography is performed to evaluate abnormalities found on screening or when a woman has signs or symptoms of breast cancer. A deductible/co-pay will usually apply for diagnostic mammography.
Insurance coverage for additional screening tests, such as ultrasound or MRI, varies by state and by insurance company. Women should check with their insurance carriers to determine how additional tests will be covered. In women at high risk for breast cancer, most insurers will cover screening MRI (regardless of density) though a deductible/co-pay will typically apply and pre-authorization may be needed.
Screening in Women at Higher Than Average Risk
The American College of Radiology (ACR [1]) recommends all women, and especially black women and those of Ashkenazi Jewish descent, should undergo risk assessment by age 30 so that women at higher risk can be identified and begin earlier and more aggressive screening for breast cancer. In a separate recent analysis [2] from Harvard, black, Hispanic, and Asian women have peak incidence of breast cancer in their 40s and should begin screening at least by age 40.
The ACR reaffirmed recommendations for annual MRI in the following groups, with slight refinements:
- Women with known or disease-causing BRCA1 mutation (or their untested first-degree relatives) should begin annual MRI at age 25. If MRI is performed annually, there is emerging evidence that the benefit of mammography is relatively small in such women prior to the age of 40.
- Women with other known disease-causing mutations (or their untested first-degree relatives), and those with a calculated lifetime risk of 20% or more, should begin annual MRI between age 25 and 30. Annual mammography is of benefit in those with BRCA2 mutations.
- Women with prior chest/mantle radiation therapy (cumulative dose of ≥ 10 Gy) before age 30 should begin MRI and annual mammography at age 25 or at least 8 years after completion of radiation, whichever is latest.
- Women with a calculated lifetime risk of breast cancer of ≥ 20%. The Tyrer-Cuzick model was discussed as the most comprehensive and consistently accurate model for predicting risk and now includes breast density as a risk factor, though all models may over- or underestimate risk for a given individual.
The ACR newly endorses annual screening MRI in addition to annual mammography or tomosynthesis for women in the following situation (provided the patient has not had bilateral mastectomy):
- Women with a personal history of breast cancer and dense breasts.
- All women diagnosed by age 50. A personal history of breast cancer is not included in risk models, but all women diagnosed with breast cancer at or before age 50 and treated with breast-conserving therapy have a ≥ 20% risk for a new breast cancer.
The ACR suggests annual MRI be considered in addition to annual mammography or tomosynthesis in women with a history of LCIS or prior atypia (ADH, ALH, atypical papilloma), especially if other risk factors are present, though further study of the benefit of MRI is needed.
In women who meet guidelines for MRI screening but are unable to tolerate it and who have dense breasts, the ACR suggests ultrasound be considered in addition to annual mammography. Tomosynthesisis expected to reduce the benefit of supplemental screening ultrasound, depicting about half of the cancers that would have been seen only on ultrasound after 2D mammography, though further study is warranted. If MRI is performed, there is no benefit to screening ultrasound.
1. Monticciolo DL et al. J Am Coll Radiol. 2018 Mar;15(3 Pt A):408-414. doi: 10.1016/j.jacr.2017.11.034. Epub 2018 Jan 19.
2. Stapleton SM, Oseni TO, Bababekov YJ, Hung Y, Chang DC. Race/Ethnicity and Age Distribution of Breast Cancer Diagnosis in the United States. JAMA Surg. Published online March 07, 2018. doi:10.1001/jamasurg.2018.0035
Research Study in Western Pennsylvania
A trial evaluating screening ultrasound after tomosynthesis (3D mammography) is ongoing at the University of Pittsburgh School of Medicine/UPMC. The study is funded by the National Cancer Institute and the Pennsylvania Breast Cancer Coalition and will recruit 6,200 women. Participants will receive screening ultrasound each year for three years as part of the study provided 3D mammography is included as part of their usual breast screening. Results are expected in late 2021.
ASTOUND Study
ASTOUND is the first published prospective multicenter trial to directly compare cancer detection and “false positive” (false alarm) rates of ultrasound (sonogram) and tomosynthesis (a form of 3D mammography) in women with dense breasts after a standard (2D) mammogram. In over 3,000 women with dense breasts in Italy, it was found that adding tomosynthesis or physician-performed ultrasound detected an additional 24 cancers (23 invasive), though not at the same rate.
The additional screening tests found a total of 24 breast cancers missed by 2D mammography:
- 1 was detected only by 3-D mammogram
- 11 were detected only by ultrasound
- 12 were detected by both 3-D mammogram and ultrasound
Based on the number of women screened, tomosynthesis detected an additional four breast cancers per 1,000 women screened and ultrasound detected significantly more, an additional seven breast cancers per 1,000 women screened.
The study publication and accompanying editorial by Dr. Wendie A. Berg were featured in the Journal of Clinical Oncology , March 9, 2016. Dr. Berg addresses how the acceptably low and comparable false-positive rates found in the ASTOUND study (107 false-positive recalls, 53 for 3-D mammograms, 65 for ultrasound, with a total of 38 false positive biopsies, 22 for 3-D mammograms and 24 for ultrasound) have implications for new screening protocols.