Screening for Colorectal Cancer A 21st Century Challenge

1
Screening for Colorectal CancerA 21st Century
Challenge

• Thomas Weber MD FACS
• Associate Professor of Surgery Molecular
  Genetics
• Albert Einstein College of Medicine
• New York, New York

2
Colorectal CancerAn Ironic Tragedy in Three
Acts

• Act I
• A Nation Ravaged
• Act II
• Victory In Our Grasp
• Act III
• Paradise Lost

3
Colorectal CancerAct IA Nation Ravaged

• 148,000 cases anticipated for 2002
• 55,000 deaths
• 1 solid tumor killer after lung cancer
• 10,400 cases in NYS
• 4000 deaths in NYS
• ACS Cancer Statistics 2002

4
Colorectal CancerAct IA Nation Ravaged

• An equal opportunity killer
• Equal rates of death for women and men
• 1 in 20 Americans affected
• 1 in 10 with affected 1st degree relative
• ACS Cancer Statistics 2002

5
A Nation RavagedThe Devil IS in the Details
Colorectal Cancer Survival As A Function of
Stageat Diagnosis
6
(No Transcript)
7
NCDB Colon Cancer Survival
8
63 Stage III or IV55,000 Deaths
9
A Nation RavagedThe Devil IS in the Details
Distribution of Stage at Diagnosis

• Only 37 of Colorectal Cancers are diagnosed
  while still localized
• (node negative).
• 63 have regional or distant metastatic disease
  at the time of diagnosis.

10
Colorectal CancerAct IIVictory In Our Grasp

• Screening for colorectal cancer removes
  pre-malignant lesions, promotes early stage
  diagnosis and saves lives.
• Winawer et al. Gastroenterology 2003 124
• Selby et al. NEJM 1992 326653-657
• Winawer et al. NEJM 1993 3291977-81
• Newcomb et al. J Nat Can Inst 1992 841572-1575

11
Act IIVictory In Our Grasp

• Colorectal Cancer and Breast Cancer
• Two VERY different paradigms
• Mammography is principally directed at earliest
  stage INVASIVE lesions (DCIS aside).
• Endoscopic Colorectal surveillance REMOVES
  PREMALIGNANT LESIONS.

12
Act IIVictory In Our Grasp

• We have the tools!
• We have the case control and randomized evidence!
• Risk-benefit ratio is low!
• Cost is manageable!
• We have even achieved consensus!

13
An IRONIC Tragedy
14
Act III PARADISE LOST
15
Act IIIParadise Lost

• Based on data from the Behavioral Risk Factor
  Surveillance System fewer than one in five adults
  reported having had an FOBT in the previous year
  and only 9.5 of adults reported having had both
  an FOBT test and flexible sigmoidoscopy during an
  interval recommended by the ACS.
• CDC Morb Mortal Weekly Rep 199948116-121

16
Act IIIParadise Lost

• Despite a consensus among expert groups on the
  effectiveness of screening for colorectal cancer,
  screening rates remain low.
• Winawer et al. Gastroenterology February 2003
  124

17
Act ThreeParadise Lost

• Evidence Demonstrates that when a screening
  recommendation comes directly from the clinician,
  compliance with colorectal cancer screening can
  be quite high.
• CA Cancer Journal 2001 51 pg 49

18
Act ThreeParadise Lost

• Surveys of primary care providers and medical
  directors of managed care groups indicate a lack
  of preparedness to offer FOBT and flexible
  sigmoidoscopy
• A recent report indicated medical directors were
  more likely to regard flexible sigmoidoscopy as
  an unreasonable expectation in a capitated plan
• At this time economic and health care system
  disincentives to screening are impinging on CRC
  screeing efforts.
• CA Cancer Journal 2001 51 38-75 CANCER

19
Act ThreeParadise Lost

• A Summary of the Tragedy
• Improvement depends on changes in patients
  attitudes, physicians behaviors, insurance
  coverage, and the surveillance and reminder
  systems necessary to support screening programs
• Winawer et al. Gastroenterology February 2003
  124

20
Epilogue

• ?

21
We Write The Epilogue
22
What Is The Current State-of-the-Art for
Colorectal Cancer Screening?

• What is the best information that we have on this
  subject?

23
Key Elements In Screening Average Risk
Individuals

• Consensus on the First Step
• Screening programs should begin by classifying
  the individual patients level of risk based on
  personal, family and medical history, which will
  determine the appropriate approach to screening
  that person
• Winawer et al. Gastroenterology February 2003
  124

24
Key Elements In Screening Average Risk
Individuals

• Men Women 50 Years and Older
• Stratify be Risk
• Provide Options
• Positive Screen gt COLONOSCOPY
• Cancer Detected gt Definitive Therapy
• Surveillance post polypectomy or surgery
• Winawer et al. Gastroenterology February 2003
  124

25
Why Is Risk Assessment So Important?
26
The Impact of Family History on Colorectal Cancer
Risk

• General population 6 1 in 16
• 1 first degree relative 2-3 X
• 2 first degree relatives 3-4 X
• 1st degree lt 50 years 3-4 X
• Multiple 1st degree 50
• Relative risk

27
The First StepRisk Assessment

• Three Questions for Every Patient
• History of CRC or Adenomatous Polyp
• Predisposing Illness? eg Ulcerative Colitis
• Family History CRC or Polyps
• How many?
• First degree?
• Age at diagnosis?

28
Application of Risk Stratification

• Three Questions for Every Patient
• History of CRC or Adenomatous Polyp
• Predisposing Illness? Eg Ulcerative Colitis
• Family History CRC or Polyps
• How many?
• First degree?
• Age at diagnosis?
• Answer is NO Average Risk

29
70-80 of Colorectal Cancer in the United States
Occurs Among Average Risk Individuals.
30
70-80 of Colorectal Cancer in the United States
Occurs Among Average Risk Individuals

• For up to 80 of the CRC deaths sustained every
  year there is NO known predisposition clue!
• Rigorous Systematic Screening Protocol is the
  ONLY way we will save lives

31
Outline

• Screening Recommendations and their scientific
  support for
• Average Risk
• Increased Risk
• High Risk

32
Screening RecommendationsAverage Risk Population

• Begin at age 50 for women and men
• Yearly FOBT
• Flexible sigmoidoscopy 5 year interval
• FOBT yearly, Flex Sig every 5 years
• Colonoscopy very 10 years
• Double-contrast every 5 years

33
Why Is There a Range of Options?

• No single test is of unequivocal superiority.
• Choice increases the likelihood that screening
  will in fact occur.

34
Yearly FOBTGuaiac based with diet restriction
or immunochemical with no restriction

• Rational and Evidence
• Testing of 2 samples from 3 consecutive stools
  has been shown in 3 randomized controlled trials
  to reduce the risk of death from CRC
• Repeated annual testing can detect as many as 92
  of cancers

35
WARNING!

• Only 1 in 3 individuals with a positive FOBT
  undergoes colonoscopy!

36
Flexible Sigmoidoscopy Every 5 Years

• Rational and Evidence
• 4 case-controlled studies have reported reduced
  CRC mortality using flexible sigmoidoscopy.
• In the strongest study this reduction was 2/3rds
  for lesions within reach of the exam.

37
Warning!

• There was no reduction in risk for lesions beyond
  the reach of the flex scope.
• 50 of patients with advanced proximal colonic
  cancers had NO distal (within flex sig range)
  colonic neoplasms.

38
Combined FOBT (yearly) and Flexible Sigmoidoscopy
(5yrs)

• The effectiveness of the combination strategy has
  never been tested directly in a randomized trial.
• FOBT should be done first to minimize risks
  associated with multiple invasive procedures.

39
Colonoscopy every 10 Years

• Rational and Evidence
• Several lines of evidence support screening
  colonoscopy.
• Colonoscopy integral part of the FOBT trials that
  demonstrated a reduction in CRC mortality.
• Colonoscopy is diagnostic AND therapeutic.

40
Colonoscopy every 10 Years

• Rational and Evidence
• There are no randomized controlled studies
  evaluating whether colonoscopy alone reduces CRC
  mortality among individuals at average risk.
• HOWEVER
• 50 of patients with advanced proximal colonic
  cancers had NO distal (within flex sig range)
  colonic neoplasms.

41
Double Contrast Barium EnemaEvery 5 Years

• Rational and Evidence
• There are no randomized controlled trials
  evaluating the impact of DCBE on CRC mortality.
• DCBE sensitivity is significantly less than
  colonoscopy
• DCBE has no therapeutic option

42
Outline

• Screening Recommendations and their scientific
  support for
• Average Risk
• Increased Risk
• High Risk

43
CRC Screening for Individuals at Increased Risk

• People with a first-degree relative with colon
  cancer or adenomatous polyps diagnosed lt 60 years
  or 2 first degree relatives at any age should be
  advised to have screening colonoscopy at age 40
  or 10 years earlier than the first CRC diagnosis,
  and repeat every 5 years.

44
CRC Screening for Individuals at Increased Risk

• People with a first-degree relative with colon
  cancer or adenomatous polyps diagnosed gt 60 years
  or 2 second degree relatives at any age should be
  advised to utilize same options as for average
  risk but begin at age 40.

45
CRC Screening for Individuals at Increased Risk

• Rational and Evidence
• Screening recommendations for increased risk
  individuals are based on the known effectiveness
  of available screening procedures and the
  observed increased risk among affected relatives.

46
Outline

• Screening Recommendations and their scientific
  support for
• Average Risk
• Increased Risk
• High Risk

47
High RiskFamilial Adenomatous PolyposisFAP

• 100 CRC cancer risk.
• Flexible sigmoidoscopy at age 10-12.
• Genetic counseling testing.
• Prophylactic surgery performed by an experienced
  provider team.

48
High RiskHereditary Non-polyposis Colorectal
Cancer HNPCC

• Colonoscopy every 1-2 years, beginning at age
  20-25 years or 10 years younger than the
  earliest case in the family, whichever comes
  first.
• Supported by trials from the Netherlands and
  Finland by Vasen and Jarvinin respectively
  (Gastroenterology 2000 118829-834).

49

• What Now?

50
Act IIIParadise Lost

• Despite a consensus among expert groups on the
  effectiveness of screening for colorectal cancer,
  screening rates remain low.
• Winawer et al. Gastroenterology February 2003
  124

51
Elements Required for Improvement

• Patient attitudes
• Physician behavior
• Insurance coverage
• Surveillance and Reminder systems
• Winawer et al. Gastroenterolgy 2003 124 2

52
Our Approach

• Partners in Prevention

53
Partners in Preventionof Colorectal Cancer

• Taking the initiative in mobilizing all of the
  components required for success.
• Patients
• Physicians
• Support systems
• Research

54
Partners in Preventionof Colorectal Cancer

• Taking the initiative in mobilizing all of the
  components required for success.
• Patients gt Risk Assessment
• Physicians gt Guideline Clarification
• Support gt Reminders
• Research gt NIH ACS

55
Partners in PreventionStrategy

• Risk Assessment
• Appropriate Screening
• Follow-up Reminders

56
Partners in PreventionStrategy

• General population outreach
• Advertising
• Events
• Advocacy groups
• Academic medical provider groups
• Insurers
• Employers
• Trade Unions

57
Patient Provider Priority Number OneRisk
Assessment
58
How Does The Registry Work?

• We assess personal and family history of
  colorectal cancer AND adenomatous polyps
• RISK Assessment (ACS Guidelines)
• Screening Recommendations
• Identify PROVIDER
• Access to research protocols

59
Familial CRC RegistryObjectives

• Public Health
• Secure higher rates of screening
• Especially increased risk groups
• Population Genomics
• Study populations for the next generation of
  studies.

60
Registry Population Accrual Strategy

• Medical record retrospective review
• Prospective
• Surgical Admissions, Clinics, Admitting
• etc
• Partners in Prevention
• Employee Health
• Trade Unions
• Faith Based Organizations

61
The Future?
62
Identifying Who is at RiskAmong the Negative
History Population?

• Selected Genetic Polymorphisms
• Predisposition Haplotypes SNPS
• Novel gene discovery

63
Partners is looking for Partners!

• NYS NYC DOH
• NYC HH
• Insurers
• Employee Health
• Trade Union

64
Summary

• Colorectal Cancer remains a major public health
  challenge.
• We write the epilogue.
• Insurance industry support is crucial.
• Partners in Prevention is part of the solution.

65
Thank You!