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

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

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

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

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

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

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

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

Breast Cancer Screening Guidelines Average Risk

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

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

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

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

What are the differences?

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

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

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

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

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

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

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

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

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

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

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

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