Breast Cancer Screening Guidelines: Do They All Say the Same Thing?

Marilyn Kile MSN, APRN-NP, ANP-BC, AOCNPGood Samaritan Hospital Cancer Center

Every Woman Matters August 14, 2014

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

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?”

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» 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 CertaintyLevel of Certainty*

Description

HighThe 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.

ModerateThe 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.

LowThe 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.• Inconsistency of findings across individual studies.• 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 RecommendationsGrade 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.

Offer or provide this service.

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 ScreeningWomen 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 40sUSPSTF» 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

ACS / NCCN» 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 ScreeningUSPSTF» 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

ACS / NCCN» 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 75USPSTF

» 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

ACS / NCCN» 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 RiskBreast 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]

• Annual screening mammogram + CBE every 6 to 12 months

• Breast awareness• Consider risk reduction strategies• 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• Breast awareness

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