1. Breast Cancer Screening Guidelines: Do They All Say the Same Thing?
Marilyn Kile MSN, APRN-NP, ANP-BC, AOCNP
Good Samaritan Hospital Cancer Center
Every Woman Matters
August 14, 2014

2. Find cancer before symptoms occur
What Makes a Good Screening Test? Screening Tests Are Helpful When They:
Find cancer before symptoms occur
Screen for a cancer that is easier to treat and cure when found early
Has few false-negative test results (sensitivity) and few false-positive test results (specificity)
Decreases the chance of dying from cancer
Cost is reasonable
National Cancer Institute, 2014

3. Who Publishes Cancer Screening Guidelines
American Cancer Society (ACS)
National Comprehensive Cancer Network (NCCN)
United States Preventive Services Task Force (USPSTF)
Professional Organizations (not inclusive list)
American College of Obstetricians and Gynecologists
The American Gastroenterology Association
American Family Physician
Who is the American Cancer Society?
The American Cancer Society is a nationwide, community-based voluntary health organization dedicated to eliminating cancer as a major health problem. They are an advocacy network. OTIS W. BRAWLEY, M.D. Is the chief medical officer for the American Cancer Society, is responsible for promoting the goals of cancer prevention, early detection, and quality treatment through cancer research and education. He is an acknowledged global leader in the field of health disparities research, Dr. Brawley is a key leader in the Society’s work to eliminate disparities in access to quality cancer care. Dr. Brawley currently serves as professor of hematology, oncology, medicine and epidemiology at Emory University. He has also previously served as a member of the Society’s Prostate Cancer Committee, co-chaired the U.S. Surgeon General’s Task Force on Cancer Health Disparities, and filled a variety of capacities at the National Cancer Institute (NCI), most recently serving as assistant director.
Who is the NCCN? The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 25 leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.
Who is the USPSTF? Created in 1984, the U.S. Preventive Services Task Force (USPSTF or Task Force) is an independent group of national experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services such as screenings, counseling services, or preventive medications. The USPSTF is made up of 16 volunteer members who come from the fields of preventive medicine and primary care, including internal medicine, family medicine, pediatrics, behavioral health, obstetrics/gynecology, and nursing. All members volunteer their time to serve on the USPSTF, and most are practicing clinicians.
Who are the ACOG and AGA? Professional organizations

4. Guidelines Should be Evidence Based: Levels of Evidence
Not all evidence is created equal
It tries to answer the question:
“How certain can you be that the stated evidence is a true measure of the benefits and harms of treatment?”
What is the strength of the evidence? Is it a case report or is it a systematic review?
Most “levels of evidence” are similar but not exactly the same
Not everyone publishes exactly what they use
Cochrane Consumer Network: Retrieved on 6/9/2014

5. ACS: Levels of Evidence
Exact breakdown of evidence not found on website or in journal
ACS revised its process for creating cancer screening guidelines
More consistent with the new Institute of Medicine (IOM) standards for trustworthy clinical guideline development
Created a Guideline Development Group for writing the guidelines, using independent systematic review of evidence, and requires clear articulation of the benefits, limitations, and harms associated with each screening test
Ongoing process for reviewing evidence, commitment to update guidelines every 5 years or sooner if evidence warrants
Smith et al., 2014

6. NCCN: Levels of Evidence
Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.
Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate.
All recommendations are category 2A unless otherwise noted
National Comprehensive Cancer Network, Retrieved on 6/9/214

7. USPSTF: Level of Certainty
Description
High
The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies.
Moderate
The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by such factors as:
The number, size, or quality of individual studies.
Inconsistency of findings across individual studies.
Limited generalizability of findings to routine primary care practice.
Lack of coherence in the chain of evidence.
As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.
Low
The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of: The limited number or size of studies.
Important flaws in study design or methods.
Gaps in the chain of evidence.
Findings not generalizable to routine primary care practice.
Lack of information on important health outcomes.
More information may allow estimation of effects on health outcomes.
USPSTF, 2012

8. USPSTF: Grading System for Recommendations
Grade
Definition
Suggestions for Practice A
The USPSTF recommends the service. There is high certainty that the net benefit is substantial.
Offer or provide this service. B
The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. C
The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small.
Offer or provide this service for selected patients depending on individual circumstances. D
The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.
Discourage the use of this service.
I Statement
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.
Read the clinical considerations section of USPSTF Recommendation Statement. If the service is offered, patients should understand the uncertainty about the balance of benefits and harms.
USPSTF, 2012

9. Breast Cancer Screening Guidelines Average Risk

10. ACS: Average Risk Breast Cancer Screening
Women Ages > 20 years
BSE
It is acceptable for women to choose to do or not do BSE regularly or irregularly. Women should be told about the benefits and limitations of BSE. Emphasize prompt reporting of new symptoms. If they perform BSE their technique should be evaluated.
CBE
For women in their 20s and 30s CBE should be part of a periodic health exam, preferably every 3 years. Asymptomatic women > 40 should receive CBE as part of periodic health exam, preferably annually. Annual CBE should be performed prior to mammogram.
Mammography
Begin annual mammography at age 40 years. The decision to stop screening should be individualized based on the benefits and harms of screening within the context of overall health status and estimated longevity.
Smith et al., 2014

11. NCCN: Average Risk Breast Cancer Screening
Women > 25 but < 40 years
CBE every 1 to 3 years
Breast Awareness – women should be aware of changes and report promptly. Periodic, consistent BSE may facilitate breast self awareness. Premenopausal women may find BSE most informative when performed at the end of menses.
Women > 40 years
Annual CBE
Annual Screening Mammogram - no upper age limit, consistent terminology with ACS recommendation
Breast Awareness – see above
NCCN, 2014

12. USPSTF: Breast Cancer Screening Recommendations
Recommends biennial screening mammography for women aged 50 to 74 years. Grade: B recommendation
The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms. Grade: C recommendation
Concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. Grade: I Statement
USPSTF, 2009

13. USPSTF: Breast Cancer Screening Recommendations
Recommends against teaching BSE. Grade: D recommendation
Concludes that the current evidence is insufficient to assess the additional benefits and harms of CBE beyond screening mammography in women 40 years or older. Grade: I Statement
Concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer. Grade: I Statement
USPSTF, 2009

14. What are the differences?

15. Difference in Recommendations
Minimal difference between ACS and NCCN
Variation between USPSTF & ACS / NCCN
Mammography for women 40 to <50 years
Biennial versus annual screening
Screening women after the age of 75
CBE

16. Screening Women in 40s USPSTF ACS / NCCN
Lower breast cancer incidence in younger women – have to screen more women to prevent one death
Initiation of screening younger women leads to higher cumulative rates of false-positive results and associated potential harms (biopsies) and this alters the risk/ benefit ratio of screening this age group
Meta – analysis supports screening at age 40
Benefit of early detection includes less aggressive treatment and a wide range of treatment options
Benefits versus risk strongly supports the value of screening and the importance of adhering to a schedule of regular mammograms
Pace et al., 2013; NCCN, 2014; Smith et al., 2014

17. Biennial Screening USPSTF ACS / NCCN
A large proportion of the benefit of screening mammography is maintained by biennial screening
Changing from annual to biennial screening is likely to reduce the harms of mammography screening by nearly half
At the same time, benefit may be reduced when extending the interval beyond 24 months
Acknowledges the controversy
Believes evidence supports the benefit of annual mammogram outweighs the risk of the procedure as breast cancer mortality is lower with annual screening
USPSTF, 2009; NCCN, 2014; Smith, 2014

18. Screening After Age 75 USPSTF ACS / NCCN
No women > 75 years have been included in the randomized clinical trials
The benefits of screening occur only several years after the actual screening test, whereas the percentage of women who survive long enough to benefit decreases with age
Most breast cancer detected in this age group is estrogen receptor-positive type
Women of this age are at greater risk for dying of other conditions
Acknowledge there is limited data
High incidence of breast cancer in elderly women
Clinicians should use judgment when applying screening guidelines
USPSTF, 2009; NCCN, 2014; Smith, 2014

19. CBE
USPSTF: Insufficient evidence to assess the additional benefits and harms of CBE beyond screening mammography; ACS / NCCN Recommend
Variation in how providers conduct a CBE
NCCN defines adequate breast exam as including “upright and supine position during exam, appearance of breast and palpation of all components of the breast”
No disagreement that mammography can detect breast cancer up to two years before it could be detected by CBE
USPSTF, 2009; NCCN, 2014

20. Trends in Average Risk Breast Cancer Screening
The Affordable Care Act requires insurers to cover mammography, with no cost-sharing, every one to two years for women starting at age 40; Medicare fully pays for mammograms once every 12 months with no upper age limit
One study observed no decrease in mammography rates for women age >40 (in any age group) following publication of the USPSTF recommendations
There are programs that utilize USPSTF recommendations
Pace et al., 2013; Factcheck.org, 2013

21. Future Needs in Breast Cancer Screening
Stratify risk
Calls for more research
Calls for objectivity when evaluating the evidence
A need to have better communication of the risks and benefits

22. Do we have guidelines that stratify risk for breast cancer screening?

23. Increased Risk Screening for Breast Cancer
Women > 35 years with 5 year risk of invasive breast cancer > 1.7% [Gail Model]
Lobular carcinoma in situ (begin screening at dx)
Atypical ductal hyperplasia / Atypical lobular hyperplasia
Annual screening mammogram + CBE every 6 to 12 months
Breast awareness
Consider risk reduction strategies
Women who have a lifetime risk >20% as defined by models that are largely dependent on family history [BRACAPRO, BOADICEA or Tyrer Cuzick models]
Recommend annual breast MRI beginning at age 30 y (performed preferably days 7 – 15 of menstrual cycle)
Referral to genetic counselor
NCCN, 2014

24. Increased Risk Screening for Breast Cancer
Prior thoracic radiation therapy between the ages of 10 and 30 years
Age <25
Annual CBE beginning 8 to 10 years after radiation therapy
Breast awareness
Age >25
Annual screening mammogram + CBE every 6 to 12 months beginning 8 to 10 years after radiation therapy or at age 40 whichever comes first
Recommend breast MRI
NCCN, 2014

25. High Risk Screening for Breast Cancer
NCCN Guidelines address the following situations
Individuals who test positive for deleterious mutation
Individuals where there is a known mutation in the family but have not tested for the mutation
Individuals where there is a known mutation in the family but have tested negative
Individuals with strong family history suggestive of hereditary syndrome not undergoing genetic testing or when no mutation is found
Individuals with strong family history undergoing genetic testing with finding of variant of unknown significance
NCCN, 2014

26. High Risk Screening for Breast Cancer
Breast cancer awareness starting at age 18
CBE every 6 to 12 months starting at age 25
Breast screening
Age 25 to 29, annual breast MRI screening (preferred) or mammogram if MRI is unavailable or individualized based on the earliest age of onset in the family
Age >30 to 75, annual mammogram and breast MRI screening
Age >75 years, management should be considered on an individual basis
Risk reducing measures
Investigative imaging and screening studies
NCCN, 2014