Transcript Breast Cancer Screening Guidelines

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
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 Certainty
Level of
Certainty*
High
Moderate
Low
Description
The available evidence usually includes consistent results from well-designed, wellconducted 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.
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.
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.
•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 Recommendations
Grade
Definition
Suggestions for Practice
A
The USPSTF recommends the service. There is high Offer or provide this service.
certainty that the net benefit is substantial.
B
The USPSTF recommends the service. There is high Offer or provide this service.
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.
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.
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.
Offer or provide this service for selected
patients depending on individual
circumstances.
Discourage the use of this service.
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.
Mammograp
hy
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
» Acknowledge there
included in the randomized clinical
is limited data
trials
» High incidence of
» The benefits of screening occur only
breast cancer in
several years after the actual
elderly women
screening test, whereas the percentage
» Clinicians should
of women who survive long enough to
use judgment when
benefit decreases with age
applying screening
» Most breast cancer detected in this age
guidelines
group is estrogen receptor-positive
type
» Women of this age are at greater risk
for dying of other conditions
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
• Annual screening mammogram + CBE
year risk of invasive breast
every 6 to 12 months
cancer > 1.7% [Gail Model] • Breast awareness
• Lobular carcinoma in situ
• Consider risk reduction strategies
(begin screening at dx)
• Atypical ductal hyperplasia /
Atypical lobular hyperplasia
• 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