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Study: Should biannual MRIs replace annual mammograms in high-risk women?

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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 inherited mutation 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 "Mammograms remain important for most women. But for women at high risk who are getting an every six months, annual mammograms 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.

NCCN Guidelines: Genetic/Familial High-Risk Assessment: Breast and Ovarian.
 

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

Breast cancer survivors

Women under 45

Women over 45

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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 mammograms (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) establishes guidelines for breast cancer screening and cancer care in the U.S. For women with increased risk (a lifetime risk for breast cancer of 20% 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
  • Obtain a referral to genetic counselor or similarly trained health care provider, if you haven’t already done so.
  • Start annual screening 10 years earlier than the age of the youngest family member who has been diagnosed with breast cancer, but not prior to age 30. Consider getting a 3-D .
  • Begin annual breast 10 years earlier than the age of the youngest family member who has been diagnosed with breast cancer, but not prior to age 25.
  • Consider recommended risk reduction strategies, such as preventive hormonal medications or risk-reducing surgeries that remove the breasts or ovaries.
  • Develop breast awareness and report any changes to your health care providers

 

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 look at your personal and family history of cancer and can help you to determine the best risk management plan. 

Screening for women:

  • Learn to be aware of changes in breasts beginning at age 18.
  • Clinical breast exam every 6-12 months beginning at age 25.
  • Annual breast  with contrast (or  if  is unavailable) beginning at age 25 and continuing until age 75.
  • Annual  at age 30 until age 75 (consider 3D  if available).
  • Screening after age 75 should be considered on an individual basis.

Risk reduction for women:

  • Women should have a discussion with their doctors about of the advantages and disadvantages of risk-reducing mastectomy.
    • Research has shown that risk-reducing mastectomy can lower the risk for breast cancer in high risk women by about 90%. Despite this, mastectomy has not been shown to help high risk women live longer.
    • Even after mastectomies, some breast tissue-and therefore some breast cancer risk remains. 
  • Women should have a conversation with their doctor about the possible benefits of tamoxifen or other estrogen-blocking drugs to reduce breast cancer risk in women with  mutations. Research on the benefit of these drugs to reduce breast cancer risk in women with  mutations has been mixed.

Risk management in men:

  • Breast self-exam training and education beginning at age 35.
  • Clinical breast exam every 12 months beginning at age 35.
  • In men with enlarged breasts, (gynecomastia) consider annual  in men with gynecomastia beginning at age 50 or 10 years younger then the earliest case of male breast cancer in the family (whichever comes first). 

Updated: 12/14/2021

Expert Guidelines
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 to determine the best risk management plan. 

or

  • Begin yearly mammograms at age 40, or earlier based on the family history of breast cancer.
  • Consider yearly with contrast beginning at age 30-35.

, or  

  • Beginning at age 40 (or earlier based on family history):
    • recommend yearly .
    • consider yearly breast  with contrast.

  • No specific breast cancer screening guidelines. Risk management should be based on 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 contrast.
    • discuss risk reducing mastectomy. 

  • Beginning at age 18, learn to be aware of changes in breasts.
  • Begining 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 30-35 (or 5-10 years earlier than the youngest breast cancer in the family).  

RAD51C/RAD51D

 

  • Yearly  beginning at age 40 or 5-10 years younger than the earliest age of diagnosis in the family (but no later than age 40).
  • Consider yearly breast with contrast beginning at age 40 or 5-10 years younger than the earliest age of diagnosis in the family.

  • Beginning at age 30:
    • clinical breast examination by a health care provider every 6 months starting at age 30.
    • recommend yearly .
    • recommend yearly  with contrast.

  • Beginning at age 18, learn to be aware of changes in breasts.
  • Beginning at age 20:
    • clinical breast examination by a health care provider every 6 months.
    • recommend yearly breast  with 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.

Updated: 09/22/2022

Expert Guidelines
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 3-D .
  • 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 inherited mutation. See our gene-by-gene listing to find specific risk-management guidelines for people with an inherited mutation linked to cancer.  

Updated: 03/28/2022

Questions To Ask Your Doctor
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
Open Clinical Trials

The following breast cancer screening clinical trials are currently enrolling participants:

Open Clinical Trials
Open Clinical Trials

The following are breast cancer screening or prevention studies enrolling people at high risk for breast cancer.   

Additional risk-management clinical trials for people at high risk for breast cancer may be found here.

Updated: 01/10/2023

Who covered this study?

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

How we rated the media

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