Study: Should biannual MRIs replace annual mammograms in high-risk women?
Summary
The risk of breast cancer is exceptionally high in women who have a personal or family history of breast cancer or who carry a mutation in BRCA or certain other genes. More frequent screening is one strategy for early detection of breast cancer for these women. Study results presented at the 2017 San Antonio Breast Cancer Symposium suggest that MRI screening every 6 months may be more effective than the currently recommended annual breast MRI and annual mammogram in detecting early stage breast cancers-which are more treatable-in high-risk women. (2/1/18)
Relevance
This article is most relevant for Women at increased risk for breast cancer due to an inherited mutation
Relevance: High
Strength of Science: High
Research Timeline: Post Approval
Media Ratings
Who covered this study?
Breast Cancer News
Biannual MRI better than annual mammogram at detecting breast cancer in high-risk women, study finds
This article rates 4.0 out of 5 stars
Science Daily
For women with genetic risk, semi-annual MRI beats mammograms
This article rates 3.5 out of 5 stars
Contents
| At a glance | Questions for your doctor |
| Findings | In-depth |
| Clinical trials | Limitations |
| Guidelines | Resources |
STUDY AT A GLANCE
This study is about:
Whether women at high risk for breast cancer benefit from biannual breast screening.
Why is this study important?
The National Comprehensive Cancer Network and the American Cancer Society recommend a screening breast and a each year for high-risk women, typically starting at age 30. In studies of annual , the cancer detection rates are quite variable. In most studies of annual , only about half of the women in the study were diagnosed with small tumors (<1 cm) and some were diagnosed with lymph node positive tumors. Both the diagnosis of tumors larger than 1cm and lymph node positive tumors translates into more advanced disease.
Is the recommended screening regimen for high-risk women the best screening protocol? Questions remain, and many experts are concerned that the increased sensitivity of MRIs may result in false positives that require follow-up screening or biopsy, and increased psychosocial distress that may negatively impact a women’s quality of life. Three posters presented at the 2017 San Antonio Breast Cancer Symposium addressed these issues.
Study findings:
Between 2004 and 2016, researchers at the University of Chicago recruited high-risk women into a clinical trial to prospectively evaluate semiannual and annual . Eligible participants had a lifetime breast cancer risk greater than 20% and/or an in , , , , or other cancer susceptibility gene. (More than half of the enrolled women had a mutation in a high-risk gene.) The participants’ median age was 44 (ranging from 21-73).
The 295 enrolled women were given a clinical breast exam and an scan every 6 months, and a digital every 12 months:
- At a median follow-up of 3.3 years (range 0-12 years), 3 cases of and 13 cases of invasive breast cancers were detected:
- 14 in women with inherited mutations (11 , 2 , 1 ).
- Among all subjects, the annual incidence rate was 1.3%, but it was 3.5 % in carriers.
- correctly identified all 13 invasive cancers at a mean size of .61 cm, (about the size of a pea) (range .1-1.0 cm); none of the women had lymph node involvement.
- Semiannual breast demonstrated high sensitivity without substantially increasing recall rates or biopsy rates to an unacceptable value.
- Patients with mutations had the lowest biopsy rates needed to detect one cancer as well as higher cancer detection rates than non-BRCA1 carriers.
- Semiannual breast did not increase anxiety, depression or contribute to a decline in mental health over time.
What does this mean for me?
If you are at high risk for breast cancer, this study suggests that having an every 6 months may be more effective for detecting breast cancer than an annual and . In this study, the cancer detection rates are comparable to previous studies looking at . Where this study is unique and meaningful is that it was able to detect earlier cancers that are likely more curable and consequently may lead to improved survival in high-risk women.
This study also suggests that semiannual MRIs do not substantially increase recall or biopsy rates; nor do they increase anxiety or depression. This study also suggests that biannual may be an especially effective screening tool for mutation carriers. The study’s lead author, Olufunmilayo Olopade, MD, professor of medicine and human genetics and director of the University of Chicago's Center for Clinical Cancer Genetics was quoted in the media articles, saying " remain important for most women. But for women at high risk who are getting an every six months, annual could probably be eliminated."
Screening breast MRIs for women are not without controversy. Guidelines recommend that they be given with a contrast agent—an intravenous substance that enhances imaging and makes it easier to identify abnormalities. Most contrast agents used for include gadolinium, a metal-based chemical. Experts have expressed concern about the safety of gadolinium, primarily because it remains in patients’ brains and bodies for months to years. The required that labels for gadolinium-based contrast agents be updated to include a warning and safety measures that should be followed before the agents are given to patients.
Posted 2/1/18
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References
Whitaker K, Guindalini R, Abe H, Huo D, Hong S, Churepek J, Verp M, Obeid E, Zheng Y, Amico A, Yoshimatsu T, Olopade O. “Breast cancer surveillance in high-risk women with dynamic contrast-enhanced magnetic resonance imaging every 6 months: Results from a single institution study.” Poster presented at San Antonio Breast Cancer Symposium, December 8, 2017.
Whitaker K, Abe H, Sheth D, Huo D, Yoshimatsu TF, Zheng Y, Karczmar G, Guindalini R, Olopade O. “Recall rates during breast cancer surveillance in high-risk women with dynamic contrast-enhanced magnetic resonance imaging every 6 months: Results from a singl institution study”. Poster presented at San Antonio Breast Cancer Symposium, December 8, 2017.
Amico A, Fang R, Raoul A, Wroblewski K, Nielsen S, Weipert C, Abe H, Sheth D, Romero I, Kulkarni K, Schacht D, Patrick-Miller L, Verp M, Bradbury AR, Hlubocky F, Olopade O. “Psychosocial impact of a multi-modality surveillance program for women at high-risk for breast cancer”. Poster presented at San Antonio Breast Cancer Symposium, December 8, 2017.
Disclosure
FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
This article is relevant for:
Women at increased risk for breast cancer due to an inherited mutation
This article is also relevant for:
previvors
people with a genetic mutation linked to cancer risk
people with breast cancer
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IN-DEPTH REVIEW OF RESEARCH
Study background:
Women with a personal or family history of breast cancer or a mutation in , or certain other genes have a higher-than-normal risk of breast cancer. An intensified screening regimen—annual and annual –is currently recommended as an early detection strategy for these high-risk women. However, experts still have questions regarding the type and frequency of screening that is best for high-risk women.
Researchers of this study wanted to know:
Whether women at high risk for breast cancer benefit from biannual breast screening.
Population(s) in the study:
Women enrolled in the study had mutations in one of 11 known breast cancer-related genes, a diagnosis of breast cancer or carcinoma in situ before age 35, or a mother or sister who was diagnosed with breast cancer before age 50 (before age 40 for African Americans). The mean age at participation was 43.3 years.
Participants had semiannual breast and annual . During the study, researchers performed 2,111 MRIs (averaging about 7 per participant) and 1,223 (4 per participant). Biopsy was recommended when results were categorized as suspicious or highly suspicious. Further imaging was recommended and biopsy was performed if clinically indicated when results were incomplete and was suspicious or highly suspicious. Patients also completed psychosocial assessments when they began the study and at subsequent 6-month visits; psychosocial assessments were completed for 232 of 295 (79%) participants.
All study subjects were tested for inherited mutations in 12 genes that are associated with increased breast cancer risk via panel testing. Women with high-risk mutations who completed 5 years of the study protocol were offered continued screening.
Study findings:
- At a median follow-up of 3.3 years (range 0-12 years), 3 cases of and 13 cases of , invasive breast cancers were detected:
- 14 cases were in subjects with inherited mutations (11 , 2 , 1 ).
- Among all subjects, the annual incidence rate was 1.3%, but it was 3.5 % in carriers.
- None of the 16 diagnosed patients had lymph node involvement.
- 13 invasive cancers were detected (mean size of 0.61 cm, range 0.1-1.0 cm).
- 7 breast cancers were identified by at the 6-month screening interval.
- Semiannual breast did not cause elevated states of anxiety or depression or a decline in mental health over time.
- Participants had no significant demographic differences (age, race, income, mutation, and cancer type or cancer history) or psychosocial factors (baseline anxiety, depression or quality-of-life measures.
- Semiannual breast demonstrated high sensitivity (correctly identified breast cancers) and specificity (correctly identified the absence of breast cancer) without increasing rates of recall (being called back for an additional screening) and biopsy beyond an acceptable threshold.
- sensitivity and specificity was 93.7% and 96.6%, respectively
- sensitivity and specificity was 50% and 97.7%, respectively
- The recall rate was 4.2% for and 2.6% for .
- 89 women had 106 recalls: 74 from imaging alone, 18 from and 14 from combined and .
- 56 biopsies were performed, resulting in the diagnosis of 3 and 13 invasive breast cancers.
- On average, caused more recalls and follow-up per diagnosis than mammography: statistically, almost 6 women were recalled with 3.3 biopsies per diagnosis, compared to 4 women recalled with 2.1 biopsies per diagnosis, respectively.
Limitations:
This single-institution research shows bi-annual breast MRIs, radiology reader expertise, careful clinical decision making, and improved technology at the University of Chicago can detect breast cancer more effectively than an annual and . Other institutions with different cohorts of women may observe varying rates of success with biannual screening. In addition, this study involved a relatively small sample size: only 295 women. Thus, this innovative screening approach needs to be further evaluated to refine and personalize breast cancer risk assessment and prevention.
Conclusions:
In this study, biannual breast accomplished the ultimate goal of breast cancer screening—detecting node-negative, invasive tumors smaller than 1 cm. Semiannual performed especially well in mutation carriers who are at increased risk for the most aggressive subtype of breast cancer. Bi-annual did not cause a significantly elevated state of depression or anxiety or a significant decline in mental health over time, regardless of cancer history or genetic mutation status. Finally, this single institution protocol achieved recall rates lower than those considered acceptable for annual or .
Study co-author, Mary-Claire King, PhD said, "The central goal of our study was to understand the needs of the highest risk women. My concern is that and be used in ways that make sense given a woman's personal genetics. Women with mutations in or have very different needs for surveillance for breast disease than do women with no mutations in these genes. This is particularly true for healthy young women with mutations. It's truly critical to offer intensive surveillance to still-healthy women with or mutations."
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Posted 2/1/18
Expert Guidelines
Expert Guidelines
The National Comprehensive Cancer Network (NCCN) provides breast cancer risk-management guidelines for people with and mutations. We recommend that you speak with a genetics expert who can review your personal and family history of cancer and help you to determine the best risk management plan. Note that our use of "men" and "women" refers to the sex you were assigned at birth.
Recommended screening for women with mutations:
- Beginning at age 18, be aware of how your breasts normally look and feel. Tell your doctor about any breast changes.
- Beginning at age 25, have a doctor examine your breasts every 6-12 months.
- Beginning at age 25, have an annual breast with contrast (or if is unavailable).
- Beginning at age 30 and continuing until age 75, have an annual and an annual breast with contrast.
- After age 75, speak with your doctor about the benefits and risks of screening.
Risk reduction for women:
- Speak with your doctor about the advantages and disadvantages of risk-reducing mastectomy.
- Research shows that risk-reducing mastectomy can lower the chance of developing breast cancer in high-risk women by about 90 percent. Mastectomy has not been shown to help high-risk women live longer.
- Because some breast tissue remains after mastectomy, some breast cancer risk also remains.
- Speak with your doctor about the benefits and risks of tamoxifen or other estrogen-blocking drugs to reduce your breast cancer risk. The benefits and risks may be different for women with or mutations. Research on the benefit of these drugs to reduce breast cancer risk in women with mutations has been mixed.
Risk management for men:
- Beginning at age 35, learn how to do breast self-exams to check for breast changes.
- Beginning at age 35, have a doctor examine your chest every 12 months.
- Beginning at age 50, consider an annual (especially for men with mutations).
Updated: 06/21/2024
Expert Guidelines
The National Comprehensive Cancer Network (NCCN) provides guidelines for management of breast cancer risk in people with inherited mutations linked to breast cancer. We recommend that you speak with a genetics expert who can look at your personal and family history of cancer and help you determine the best risk management plan.
or
- Beginning at age 40 (or earlier based on your family history of breast cancer)
- recommend yearly
- Beginning at age 30-35
- consider yearly with and without contrast
, or
- Beginning at age 40 (or earlier based on family history):
- recommend yearly
- consider yearly breast with and without contrast
- No specific breast cancer screening guidelines. Risk management should be based on your family history of cancer.
- Beginning at age 30 (or earlier based on family history):
- recommend yearly
- consider yearly breast with contrast
- discuss risk-reducing mastectomy
- Beginning at age 30 (or earlier based on family history):
- recommend yearly
- recommend yearly breast with and without contrast
- discuss risk-reducing mastectomy with your doctor
- Beginning at age 18, learn to be aware of changes in breasts.
- Beginning at age 25:
- clinical breast exam every 6-12 months beginning at age 25 or 10 years earlier than the youngest age of onset in the family
- Beginning at age 30:
- yearly and breast with contrast beginning at age 30 or earlier based on the youngest breast cancer in the family
- discuss risk-reducing mastectomy with your doctor
- After age 75
- discuss benefits and limitations of continued screening with your doctor
- Beginning at age 30:
- clinical breast examination by a health care provider every 6 months starting at age 30
- recommend yearly
- recommend yearly with and without contrast
- discuss risk-reducing mastectomy with your doctor
- Beginning at age 18, learn to be aware of changes in your breasts.
- Beginning at age 20:
- clinical breast examination by a healthcare provider every 6 months
- recommend yearly breast with and without contrast beginning at age 20 or at the age of earliest breast cancer diagnosis if there is a history of breast cancer before age 20 in family
- Beginning at age 30
- recommend yearly
- Consider risk reducing mastectomy.
- After age 75
- discuss benefits and limitations of continued screening with your doctor
Updated: 12/17/2023
Expert Guidelines
The National Comprehensive Cancer Network (NCCN) establishes guidelines for women with increased risk (a lifetime risk for breast cancer of 20 percent or more). The guidelines recommend the following screening:
- Have clinical exams every 6–12 months, starting when you are identified as being at increased risk, but not before age 21.
- Consider consulting with a genetic counselor or similarly trained health care provider, if you haven’t already done so.
- Consider consulting with a breast surgeon.
- Start annual screening at age 40 or 10 years earlier than the age of the youngest family member who has been diagnosed with breast cancer, but not before age 30. Consider getting a .
- Begin annual breast at age 40 or 10 years earlier than the age of the youngest family member who has been diagnosed with breast cancer, but not before age 25.
- Consider recommended risk reduction strategies, such as preventive hormonal medications.
- Develop breast awareness and report any changes to your health care providers.
NCCN has separate guidelines for breast screening in women with an . See our gene-by-gene listing to find specific risk-management guidelines for people with an linked to cancer.
Updated: 03/28/2022
Questions To Ask Your Doctor
- How often and with what method should I be screened for breast cancer?
- Will my include contrast with a gadolinium-based agent? If so, what health risks are associated with this contrast agent?
- Are there any other health risks associated with getting an every 6 months instead of annually?
- Do I still need an annual if I have an every 6 months?
- Will my insurance cover more frequent screenings?
Open Clinical Trials
The following are breast cancer screening or prevention studies enrolling people at high risk for breast cancer.
- NCT04067726: Denosumab and Mammographic Density in Premenopausal Women With Dense Breasts (TRIDENT). This study is looking at the drug denosumab to learn if it can reduce breast density in high-risk premenopausal women who have dense breasts.
- The Risk Factor Analysis of Hereditary Breast and Ovarian Cancer In Women with , or Mutations. This study seeks to improve researchers’ understanding of how hormonal, reproductive and lifestyle factors may be associated with cancer in high-risk people.
- NCT02620852: Women Informed to Screen Depending on Measures of Risk (WISDOM) study. The goal of this study is to determine if breast cancer screening can be improved by personalizing each woman’s schedule, compared to the current one-size-fits-all annual approach.
-
NCT04674306: Therapy With an Alpha-lactalbumin Vaccine in . This study is testing a new vaccine to lower the risk of breast cancer in high-risk women with an in , or .
Additional risk-management clinical trials for people at high risk for breast cancer may be found here.
Updated: 11/21/2024
Related Resources
The following organizations have breast cancer screening resources.
- FORCE resources:
- Information: Breast Cancer Screening
- Information: on Insurance Coverage for Breast Cancer Screening
- XRAY category: Breast Cancer Screening
- National Breast and Cervical Cancer Early Detection Program (NBCCEDP) provides low-income, uninsured and underinsured women with access to breast screenings (including MRIs for high-risk women in some states) and diagnostic services.
- American Breast Cancer Foundation’s Breast Cancer Assistance Program provides aid for breast cancer screenings and diagnostic tests for uninsured and underserved individuals, regardless of age or gender.
- The website www.densebreast-info.org offers information on breast density.
Updated: 09/27/2024
Who covered this study?
Breast Cancer News
Biannual MRI better than annual mammogram at detecting breast cancer in high-risk women, study finds
This article rates 4.0 out of 5 stars
Science Daily
For women with genetic risk, semi-annual MRI beats mammograms
This article rates 3.5 out of 5 stars
News18.com
Bi-annual MRIs helps high risk breast cancer patients
This article rates 1.0 out of 5 stars