Transcript Durado_Brooks_Prostate and

Recommendations for
Preventing Cancer and Finding It
Early:
Prostate and Colorectal
UCAN Conference
May 14, 2015
Durado Brooks, MD, MPH
Director, Prostate and Colorectal Cancers
American Cancer Society
Prostate Cancer
2
USPSTF Recommendation on PCA
Screening with PSA
(May 2012)
“The U.S. Preventive Services Task Force (USPSTF)
recommends against prostate-specific antigen
(PSA)-based screening for prostate cancer...
This recommendation applies to men in the U.S.
population that do not have symptoms that are
highly suspicious for prostate cancer, regardless
of age, race, or family history. “
Guidelines from other organizations
Organization
Recommendation
American Cancer Society
(2010)
Shared Decision
Making
National Comprehensive Cancer
Network (2010)
Shared Decision
Making
American Society of Clinical
Oncology (2012)
Shared Decision
Making
American Urological Association
(2013)
Shared Decision
Making
What’s Different about Prostate Screening?
Compared to other recommended cancer screenings:
• Less scientific evidence that prostate cancer screening
saves lives
– Breast Cancer: 9 studies show mammograpy lowers deaths
– Prostate Cancer: 2 positive studies, and 1 in which screening
did not lower the risk of dying from prostate cancer
 Studies did not include significant numbers of African
American or other high risk men
• Available tests are less accurate
– False positives and false negatives very common
• More evidence of
– Overdiagnosis (~1 out of every 4 cases in African Americans)
– Major treatment side effects and complications
– Overtreatment (one-third to one-half of all treated men
would likely do well without treatment)
.
Limitations/Harms
False negative results
 PSA and DRE “normal”, but cancer is present
 May lead to false reassurance and delayed
diagnosis
Research has shown that no PSA level can
completely rule-out cancer
 Prostate Cancer Prevention Trial found cancer
in significant proportion of men with “normal”
PSA level
False Negative Results
Prostate Ca in Men with PSA < 4.0ng/ml
in the Prostate Cancer Prevention Trial
30
27
24
25
% with
Prostate
Cancers
(n=2956)
20
17
15
10
10
7
5
0
<0.6
0.6 - 1
1.1 - 2
2.1 - 3
PSA Level (ng/ml)
Adapted from Thompson I. N Engl J Med 2004;350:2239-46
3.1 - 4
False Negative PSA
4.0+
<4.0
PSA 4+
7.6%
Positive biopsy 25%
High grade
19%
“Normal” PSA 92.4%
Positive biopsy 15%
High grade
15%
PSA
Sources: SEER, PCAW, Prostate Cancer Prevention Trial Data
False Negative – Population Level
4.0+
<4.0
Screen 10,000 Men
PSA 4+
Positive biopsy
High grade
7.6%
25%
19%
“Normal” PSA 92.4%
Positive biopsy 15%
High grade
15%
PSA 4+
Cancer
High grade
760
190
36
PSA <4
9240
Cancer
1386
High grade 208
PSA
Sources: SEER, PCAW, Prostate Cancer Prevention Trial Data
False Positive Results
If 100 men in each age group are tested:
Age
(in years)
# With
PSA > 4.0*
50s
5
1–2
3–4
60s
15
3–5
10–12
70s
27
9
18
# With Cancer # False Positives
*Lowering the threshold PSA (e.g. to 2.5 ng/ml) will increase false
positives and resulting biopsies
False Positive PSA
False positive results may lead to:
• Anxiety and fear of a cancer
diagnosis
• Additional tests, with associated
costs and risk of complications
• Insurance implications*
 “pre-existing condition” exclusions
for health insurance
 Life insurance - high rates or
uninsurable
*A prostate cancer diagnosis carries similar implications
Overdiagnosis
Risk of Pca Diagnosis & Death during the next 15 years
(per 1000 men )
Age 50
Race/Ethnicity
Diagnosis
Age 65
Death
Diagnosis
Death
All
50
2
117
16
White
44
2
113
14
African American
76
5
163
34
.
Treatment Risks/Harms
Estimates from USPSTF review:
•90%
•
of diagnosed men choose active treatment
195,000 men each year
 38% radiation
 40% prostatectomy
•5/1000
men die within 30 day of prostatectomy
•200-300/1000
treated men experience
impotence, incontinence or both
These complications may be a worthwhile trade-off for men
whose lives are saved by treatment, but it is not clear how many
men fall into this category.
Balance of Benefits and Harms
Potential Benefits
Potential Harms
 PSA screening detects
cancers earlier.
 False negatives and false
positives are common.
 Treating PSA-detected
cancers may be more
effective, but this is
uncertain.
 Overdiagnosis and
overtreatment are
problems, but the
magnitude is uncertain.
 PSA may contribute to
the declining death rate,
but the extent is unclear
 Treatment-related
complications and side
effects can be significant.
ACS Guideline for the
Early Detection of Prostate Cancer
The American Cancer Society recommends that
asymptomatic men who have at least a 10-year life
expectancy have an opportunity to make an
informed decision with their health care provider
about whether to be screened for prostate cancer,
after receiving information about the uncertainties,
risks, and potential benefits associated with prostate
cancer screening.
Source: Wolf, et al. CA, 2010
ACS Guideline
Age to start the discussion depends on risk
Risk Group
Age
Average
(with life expectancy 10 years or more*)
50
Increased
(African American or family history)
45
Highest
(multiple family members)
40
*Men who have less than 10 year life expectancy (due
to age or health problems) should not be screened
ACS Guideline:
Emphasis on Informed Decision Making
Core elements of IDM discussion:
– Screening increases the chance of finding
prostate cancer at an earlier stage
– Screening might lower a man’s risk of dying
from prostate cancer – but this is not entirely
clear
– Screening gives many false negative and false
positive results
– Overdiagnosis and overtreatment are common
African American and men with PCa family hx
should be informed of their increased risk
ACS Decision Aids
Decision Aids:
Values and Preferences
ACS Guideline:
Supporting Materials and Information
• Materials for clinicians and patients are
available at www.cancer.org/prostatemd
– Patient Decision Aid “Should I Be Tested for Prostate
Cancer”
– Brochure “What You Should Know About Prostate
Cancer Testing”
– Links to videos for patients and clinicians
– Prostate Cancer Fact Sheet
– Cancer Facts for Men
– Links to decision aids from other organizations
Research Needs
 New screening paradigms
 Identifying higher risk men at earlier age
 New screening and diagnostic tools
 Detect men at risk of significant cancers
 Detect cancers but not benign disease
 Distinguish aggressive, dangerous prostate
cancers from slow-growing, low risk forms
 New Treatments
 lower risk of complications, side effects
Research Needs
 Optimal approaches to informed decisionmaking
 Screening
 Treatment
 Appropriate use of active surveillance
 Evaluation of AS factors and outcomes in African
American men
 High quality treatment for all who choose to be
treated
 Treatment disparities for African American men
well-documented
 Potential for improved access and outcomes
through ACA, health system restructuring
Colorectal Cancer
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Colorectal Cancer (CRC)
• 3rd most common cancer and the 2nd
deadliest in the U.S.
• 132,700 new cases in US in 2015
• More than 49,000 deaths
• Incidence and death rates falling steadily
over the past 20 years
• Treatment advances
• Screening --> prevention and early
detection
Colorectal Cancer Incidence, 1980-2008
Incidence Rate per 100,000
Utah DOH
Colorectal Cancer Mortality, 1980-2008
Age Adjusted Mortality Rate per
100,000
Utah DOH
Colorectal Cancer Deaths by Race, Utah
Utah DOH
Age: the most impactful risk factor
CRC usually
develops after
age 50.
The chances of
getting it
increases as
you get older.
http://science.education.nih.gov/supplements/nih1/cancer
/guide/pdfs/ACT3M.PDF.
CRC screening should begin at age 50 for
most people, earlier for those with a family history.
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Why Screen for CRC?
There are two aims of screening:
1. Prevention
2. Early Detection
Find and remove polyps
to prevent cancer
Find cancer in the early stages,
when best chance for a cure
Risk factor - polyps
Different types of polyps:
 Hyperplastic
 Low risk: very small
chance they’ll grow
into cancer
 Adenomas
 About 9 out of 10
colon and rectal
cancers start as
adenomas
Usually takes 10 or more years for polyp to become cancer
Benefits of Screening
Survival Rates by Disease Stage*
5-yr
Survival
100
90
80
70
60
50
40
30
20
10
0
89.8%
67.7%
10.3%
Lo cal
Reg io n al
Distan t
St age of Det ect ion
*1996 - 2003
CRC mortality under 2 screening scenarios
80% screening rate by 2018 yields:
• 43,000 averted cases and 21,000 averted cancer deaths/yr
• 277,000 cases averted and 203,000 total averted deaths
from 2013 through 2030
80% Colon Cancer
Screening Rate By 2018
http://nccrt.org/tools/80-percent-by-2018/
http://nccrt.org/tools/80-percent-by-2018/
Recommended Screening Tests
ACS and USPSTF
 Colonoscopy
 High Sensitivity Fecal Occult Blood Testing
 Guaiac
 Immunochemical
 Flexible Sigmoidoscopy (FSIG)
 Recent studies support efficacy
 Availability extremely limited in U.S.
CRC Screening: National Rates
In 2012, 65.1% of US
adults were up to date with
screening.
• The percentages of blacks
and whites up-to-date with
screening were equivalent.
• Lower rates for Hispanics
and Native Americans
• Lowest rates among the
uninsured
CRC Screening: Utah
In 2012, 70.2% of
Utah adults were up to
date with screening.
• Significant differences
by race/ethnicity, as
well as by education
and income
CRC Screening by Race, Utah 2012-2013
Utah DOH
©2010 American Cancer Society, Inc. No.0052.19
CRC Screening by Ethnicity, Utah 2012-2013
Utah DOH
©2010 American Cancer Society, Inc. No.0052.19
CRC Screening by Education, Utah 2012-2013
Utah DOH
©2010 American Cancer Society, Inc. No.0052.19
CRC Screening by Education, Utah 2012-2013
Utah DOH
©2010 American Cancer Society, Inc. No.0052.19
What’s the Problem?
• Medical practice is demand (patient) driven
• Practice demands are numerous/diverse
• Few practices currently have mechanisms
to assure that every eligible patient gets an
appropriate recommendation for screening.
• Opportunistic vs organized screening
©2009 American Cancer Society, Inc. No.0052.19
“Action Plan” Toolkit Version
 Eight page guide introduces
clinicians and staff to concepts
and tools provided in the full
Toolkit
 Contains links to the full Toolkit,
tools and resources
 Not colorectal-specific; practical,
action-oriented assistance that
can be used in the office to
improve screening rates for
multiple cancer sites (colorectal,
breast and cervical)
Available at
http://nccrt.org/about/providereducation/crc-clinician-guide/
Staff Involvement
• Key Point…..the clinicians cannot do it all!
• Time that patients spend with non-clinician staff is
underutilized
• Standing orders can empower nurses, intake staff, etc.
to distribute educational materials, schedule
appointments, etc.
• Involve staff in meetings to discuss progress
in achieving office goals for improving the
delivery of preventive services
Communication
http://nccrt.org/about/provider-education/manual-for-community-health-centers-2/
Step #1 Make A Plan
Determine Baseline
Screening Rates
• Identify your
patients due for
screening
• Identify patients
who received
screening
• Calculate the
baseline screening
rate
• Improve the
accuracy of the
baseline screening
rate
Design Your
Practice's Screening
Strategy
• Choose a
screening method
• Use a high
sensitivity stoolbased test
• Understand
insurance
complexities.
• Calculate the
clinic's need for
colonoscopy
• Consider a direct
endoscopy referral
system
Step #2 Assemble A
Team
Form An Internal
CHC Leadership
Team
• Identify an
internal champion
• Define roles of
internal
champions
• Utilize patient
navigators
• Define roles of
patient navigators
• Agree on team
tasks
Partner with
Colonoscopists
• Identify a
physician
champion
Step #3 Get
Patients Screened
Prepare The Clinic
• Conduct a risk
assessment
Prepare The Patient
• Provide patient
education
materials
Step #4 Coordinate
Care Across The
Continuum
Coordinate
Follow-Up After
Colonoscopy
• Establish a
medical
neighborhood
Make A
Recommendation
• Convince
reluctant patients
to get screened
Ensure Quality
Screening for StoolBased Screening
Program
Track Return Rates
and Follow-Up
Measure and
Improve
Performance
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http://nccrt.org
Who’s Not Screened?
51
Address Potential Barriers to Screening*
#1:
Affordability
#2: Lack of
symptoms
#3: No family
history of colon
cancer
• “I do not have health insurance
and would not be able to afford
this test. I do not feel the need
to have it done.”
• “Doctors are seen when the
symptoms are evidently
presumed, not before.”
• “Never had any problems and
my family had no problems, so
felt it wasn't really necessary.”
*Based on 2014 consumer surveys
#1 reason
among 50-64
year olds &
Hispanics
Nearly ½
uninsured
#1 reason
among 65+
year olds
Address Potential Barriers to Screening*
#4: Perceptions
about the
unpleasantness
of the test
• “I do not think it is a good idea
to stick something where the
sun don’t shine. The yellow
Gatorade I cannot stomach.”
#5: Doctor did
not
recommend it
• “I fear it will be uncomfortable.
My doctor has never mentioned
it to me, so I just let it go.”
#6: Priority of
other health
issues
• “I just turned 50 and I am
dealing with another health
issue, so it's on the back
burner.”
*Based on 2014 consumer surveys
#1 reason
among
Black/African
Americans;
#3 reason
among
Hispanics
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Activating Messages that Motivate
 Most successful communications campaigns relay 3 messages to
allow consumers to comprehend what is being asked to motivate
action.
 We recommend utilizing these messages, or similar messaging, to
educate your constituents around options to help achieve our goal.
There are several screening options available, including simple take home
options. Talk to your doctor about getting screened.
Colon cancer is the second leading cause of cancer deaths in the U.S.,
when men and women are combined, yet it can be prevented or detected
at an early stage.
Preventing colon cancer, or finding it early, doesn’t have to be expensive.
There are simple, affordable tests available. Get screened! Call your
doctor today.
High Quality Stool Testing
Clinicians Reference: FOBT
One page document designed
to educate clinicians about
important elements of colorectal
cancer screening using fecal
occult blood tests (FOBT).
Provides state-of-the-science
information about guaiac and
immunochemical FOBT, test
performance and characteristics
of high quality screening
programs.
Available at
www.cancer.org/colonmd
New CDC Resource
 A new CDC-sponsored
program to provide guidance
and tools for clinicians on the
best ways to implement
screening for colorectal cancer.
 Two versions: one for primary
care providers and one for
clinicians who perform
colonoscopy procedures.
 Continuing education credits
are available at no cost for
physicians, nurses, and other
health professionals.
http://www.cdc.gov/cancer/colorectal/quality
www.cancer.org/colonmd
www.cancer.org/professionals
Cancer Resource Network
The American Cancer Society is available
24 hours a day, 7 days a week, to help
guide you through every step of a
cancer experience.
1-800-227-2345
cancer.org
Easy to understand information to help you make
decisions about your care.
Referral for day-to-day questions such as
financial, insurance, transportation, and lodging.
Connection to others who have been there for
emotional support.