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Colorectal Cancer Screening and Surveillance FDA Advisory Committee March, 2002 PowerPoint Presentation
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Colorectal Cancer Screening and Surveillance FDA Advisory Committee March, 2002 David Lieberman MD Chief, Division of Gastroenterology Oregon Health Sciences University Preventing Cancer Normal Colon Advanced Adenoma Cancer Colon Cancer Prevention MD Colon Cancer Detection

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Colorectal Cancer Screening and Surveillance

FDA Advisory Committee

March, 2002

David Lieberman MD

Chief, Division of Gastroenterology

Oregon Health Sciences University

preventing cancer
Preventing Cancer

Normal Colon

Advanced

Adenoma

Cancer

raising the bar

Colon Cancer

Prevention

MD

Colon

Cancer

Detection

Raising the bar
colorectal cancer screening recommendations
Colorectal Cancer ScreeningRecommendations
  • FOBT annual
  • Sigmoidoscopy every 5 yrs
  • FOBT + Sigmoidoscopy
  • Barium Enema every 5-10 yrs
  • Colonoscopy every 10 yrs

U.S. Preventive

Services,1995

AHCPR

Multi-discipline

Panel, 1997

Am College Gastro

“Preferred option”,

2000

Am. Cancer

Society,2001

fecal occult blood test
Fecal Occult Blood Test
  • RCT demonstrate mortality reduction (15-33%)
  • Easy to perform
  • Can be completed by primary providers
fecal occult blood test6

Detection of Advanced Neoplasia

with one-time test: 24%

Fecal Occult Blood Test
  • Poor sensitivity for one-time test
  • Requires repeat testing
  • Compliance with repeat testing poor
  • Costs are deceptive
sigmoidoscopy
Sigmoidoscopy

Evidence:

Case-Control Studies:

60% reduction in CRC

mortality in the examined

portion of the colon

sigmoidoscopy8
Sigmoidoscopy

Advantages:

- Detects early

cancer or polyps

- Can be performed

by primary care

providers

Limitations:

- Examines 1/3

of colon

- Proximal lesions

may not be

detected

detection of advanced neoplasia va study data

A

NEJM 2001; 345:555-60

Detection of Advanced Neoplasia: VA Study Data

Sigmoidoscopy alone:

Detection: 70%

FOBT alone:

Detection: 24%

FOBT + Sigmoidoscopy:

Detection: 76%

barium enema
Barium Enema
  • No Data in screening populations
  • Miss rate for polyps > 1cm exceeds 50%(National Polyp Study)
virtual colon imaging
Attractive name

Sensitivity for largepolyps

Rapid exam

Cost-effectiveness uncertain

False positive rate increases cost

Some patient discomfort

Small polyp dilemma

Virtual Colon Imaging

Limitations

Advantages

screening with colonoscopy
Screening with Colonoscopy
  • Limitations
  • Risk
  • Costs
  • Resources
  • Advantages
  • Detection of early cancer and advanced adenomas
  • Indirect evidence for effectiveness
screening with colonoscopy15

NEJM 2000;343;162-8 & 169-174

Screening with Colonoscopy

Lieberman Imperiale

n = 3121 n = 1994

Age 62.9 yrs 58.9 yrs

% male 96.8% 58.9%

% of exams

complete 97.0% 97.0%

% with

Advanced

Neoplasia 10.6% 7.0%

screening with colonoscopy evidence for effectiveness
Screening with Colonoscopy Evidence for Effectiveness
  • National Polyp Study (1993):
  • Selby et al (1992):
  • Mandel et al (1993 and 2000):

- Polypectomy reduced cancer incidence

- Sigmoidoscopy reduced mortality…… in that portion of the colon examined

- FOBT screened patients had reduced mortality and incidence

summary
Summary

With increasing age:

  • prevalence of advanced neoplasia increases
  • prevalence of proximal advanced neoplasia increases
  • more patients with advanced neoplasia go undetected with FOBT and sigmoidoscopy
  • colonoscopy may be more effective screening test in men after age 60 yrs.
colon screening

Colonoscopy

Colon Screening

FOBT

Sigmoidoscopy

Colon Imaging

Fecal markers

Colonoscopy

Surveillance

Colonoscopy

screening issues
Screening Issues
  • Surveillance
  • Risk
  • Cost
  • Resources
colon surveillance recommendations

FINDING INTERVAL

Adenoma >1cm 3 yrs

Multiple adenomas 3 yrs

1-2 tub. Adenoma < 1cm 3-5 yrs

Colon Surveillance:Recommendations

Surveillance accounts for 20-50%

of cost of colon screening programs

neoplasia in asymptomatic men

N Engl J Med 2000; 343: 162

Neoplasia in Asymptomatic Men

%

  • Tubular adenoma <1cm 27.0
  • Tubular adenoma >10mm 5.0
  • Mixed/Villous 3.0
  • High-grade dysplasia 1.6
  • Invasive Cancer 1.0

ADVANCED

10.6%

Among patients with neoplasia,

72% had only Tub. Adenomas < 1cm

surveillance
Surveillance
  • Impact on cost of screening program
  • Impact on available resources for screening
  • Risk Management
    • Risk may be low for patients with small adenomas
    • Could be reduced with chemoprevention
risks of screening colonoscopy

Gastrointest Endosc 2002; 55: 307-14

Risks of Screening Colonoscopy
  • VA Cooperative Study:
    • n = 3196 exams
    • mean age = 63.0 yrs
    • Gender (% male) = 96.8
risk of screening colonoscopy

Gastrointest Endosc 2002; 55: 307-14: VA Coop Study

Risk of Screening Colonoscopy

Major Complications (Definite)

GI bleed

+ hosp. or transfusion 7 (6) 0.22%

Perforation 0

New Atrial Fib 1

MI or CVA 4 (2) 0.12%

Venous Thrombosis 1 (1)

Other 4

ALL Definite 9/3196 0.3%

For Diagnostic only 2/1435 0.1%

All complications 17 0.53%

risk of colonoscopy
Risk of Colonoscopy
  • Significant Bleed
    • Prior studies 0.2-1.0%
    • VA Coop 0.22 (all therapeutic)
  • Perforation
    • Prior studies 0 - 0.2%
    • VA Coop 0

Controlling Risk:

- Training

- Quality improvement

colon screening26
Colon Screening

Can we afford it ?

cost of not screening
Cost of not screening

Cost of Cancer Care

Emotional Costs

Missed opportunity for prevention

cost of colon cancer screening
Cost of Colon Cancer Screening

Cost ($)

per

added

year

of life

(x 1000)

Colon Hypertension Mammography Cholesterol

Screening

resources supply and demand
Resources: Supply and Demand

Capacity

Colon

New Demand

Screening

colonoscopy indications

CORI: National Endoscopic Database 2000-2001

Colonoscopy: Indications

Current Screening

BRBPR

Pain

Polyp-Surv

+FOBT

Diarrhea

Screen

Cancer

Surv

Constip.

+FHx

Anemia

FS/BaE

IBD

shifting resources surveillance

N Engl J Med 2000; 343:162-8: VA Coop

Shifting Resources: Surveillance

72% of asymp. men with

neoplasia had only

small tubular adenomas

Can we shift

resources from

surveillance to

screening ?

Low Risk of Cancer

supply and demand
Supply and Demand

Demand

Capacity

New Demand

Increased capacity:

- shift resources

- improve efficiency

summary of screening guidelines
Summary of Screening Guidelines

Potential

Strategy Evidence Mortality Limitations

FOBT RCT 20-50% - Need for repeat testing

- Poor detection of

advanced adenomas

Flexible Case- 50-55% - Miss-rate for

Sigmoid (FS) Control proximal neoplasia

Barium/ none ?? 50-60% - False (+) rates

Imaging - Poor sensitivity

Colonoscopy Indirect 70-80% - Invasive, higher risk

intervention

Chemo-

Prevention

Adenoma

Possible role of

chemo-prevention

Intervention

Recurrence

Surveillance

Recurrence

Cancer

Advanced Adenoma

summary of screening guidelines35
Summary of Screening Guidelines
  • Effectiveness of any screening program depends on patient compliance
    • In 1999, only 44% of adults aged 50 and older had at least one recommended test at appropriate interval (MMWR, 2001)
  • There are many obstacles to colon screening that reduce compliance
challenges for the future
Challenges for the Future
  • Identify risk factors for colorectal cancer
    • Stratify higher risk patients
    • Develop risk-reduction strategies
  • Develop new tools to find high-risk patients
    • Genetic markers ( in blood or stool )
    • Circulating proteins
    • New imaging modalities
  • Improve patient compliance