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  1. 1. Screening for Colorectal Cancer A 21 st Century Challenge Thomas Weber MD FACS Associate Professor of Surgery & Molecular Genetics Albert Einstein College of Medicine New York, New York
  2. 2. “ Colorectal Cancer” An Ironic Tragedy in Three Acts <ul><li>Act I </li></ul><ul><li>“ A Nation Ravaged” </li></ul><ul><li>Act II </li></ul><ul><li>“ Victory In Our Grasp” </li></ul><ul><li>Act III </li></ul><ul><li>“ Paradise Lost” </li></ul>
  3. 3. Colorectal Cancer Act I “A Nation Ravaged” <ul><li>148,000 cases anticipated for 2002* </li></ul><ul><li>55,000 deaths </li></ul><ul><li>#1 solid tumor killer after lung cancer </li></ul><ul><li>10,400 cases in NYS </li></ul><ul><li>4000 deaths in NYS </li></ul><ul><li>*ACS Cancer Statistics 2002 </li></ul>
  4. 4. Colorectal Cancer Act I “A Nation Ravaged” <ul><li>An equal opportunity killer </li></ul><ul><li>Equal rates of death for women and men </li></ul><ul><li>1 in 20 Americans affected </li></ul><ul><li>1 in 10 with affected 1 st degree relative </li></ul><ul><li>*ACS Cancer Statistics 2002 </li></ul>
  5. 5. “ A Nation Ravaged” The Devil IS in the Details” Colorectal Cancer Survival As A Function of Stage at Diagnosis
  6. 7. NCDB Colon Cancer Survival
  7. 8. 63% Stage III or IV 55,000 Deaths
  8. 9. “ A Nation Ravaged” The Devil IS in the Details Distribution of Stage at Diagnosis <ul><li>Only 37% of Colorectal Cancers are diagnosed while still localized </li></ul><ul><li>(node negative). </li></ul><ul><li>63% have regional or distant metastatic disease at the time of diagnosis. </li></ul>
  9. 10. Colorectal Cancer Act II “Victory In Our Grasp” <ul><li>Screening for colorectal cancer removes pre-malignant lesions, promotes early stage diagnosis and saves lives.* </li></ul><ul><li>* Winawer et al. Gastroenterology 2003 124 </li></ul><ul><li>* Selby et al. NEJM 1992 326:653-657 </li></ul><ul><li>* Winawer et al. NEJM 1993 329:1977-81 </li></ul><ul><li>* Newcomb et al. J Nat Can Inst 1992 84:1572-1575 </li></ul>
  10. 11. Act II “Victory In Our Grasp” <ul><li>Colorectal Cancer and Breast Cancer </li></ul><ul><li>Two VERY different paradigms </li></ul><ul><li>Mammography is principally directed at earliest stage INVASIVE lesions (DCIS aside). </li></ul><ul><li>Endoscopic Colorectal surveillance REMOVES PREMALIGNANT LESIONS. </li></ul>
  11. 12. Act II “Victory In Our Grasp” <ul><li>We have the tools! </li></ul><ul><li>We have the case control and randomized evidence! </li></ul><ul><li>Risk-benefit ratio is low! </li></ul><ul><li>Cost is manageable! </li></ul><ul><li>We have even achieved consensus! </li></ul>
  12. 13. An IRONIC Tragedy
  13. 14. Act III PARADISE LOST
  14. 15. Act III Paradise Lost <ul><li>“ 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.”* </li></ul><ul><li>*CDC Morb Mortal Weekly Rep 1999;48:116-121 </li></ul>
  15. 16. Act III Paradise Lost <ul><li>“ Despite a consensus among expert groups on the effectiveness of screening for colorectal cancer, screening rates remain low.”* </li></ul><ul><li>* Winawer et al. Gastroenterology February 2003 124 </li></ul>
  16. 17. Act Three Paradise Lost <ul><li>“ Evidence Demonstrates that when a screening recommendation comes directly from the clinician, compliance with colorectal cancer screening can be quite high.”* </li></ul><ul><li>*CA Cancer Journal 2001 51: pg 49 </li></ul>
  17. 18. Act Three Paradise Lost <ul><li>“ Surveys of primary care providers and medical directors of managed care groups indicate a lack of preparedness to offer FOBT and flexible sigmoidoscopy”* </li></ul><ul><li>“ A recent report indicated medical directors were more likely to regard flexible sigmoidoscopy as an unreasonable expectation in a capitated plan“* </li></ul><ul><li>“ At this time economic and health care system disincentives to screening are impinging on CRC screeing efforts.* </li></ul><ul><li>*CA Cancer Journal 2001 51 38-75 CANCER </li></ul>
  18. 19. Act Three Paradise Lost <ul><li>A Summary of the Tragedy </li></ul><ul><li>“ Improvement depends on changes in patients attitudes, physicians behaviors, insurance coverage , and the surveillance and reminder systems necessary to support screening programs”* </li></ul><ul><li>* Winawer et al. Gastroenterology February 2003 124 </li></ul>
  19. 20. Epilogue <ul><li>? </li></ul>
  20. 21. We Write The Epilogue
  21. 22. What Is The Current State-of-the-Art for Colorectal Cancer Screening? <ul><li>What is the best information that we have on this subject? </li></ul>
  22. 23. Key Elements In Screening Average Risk Individuals* <ul><li>Consensus on the First Step </li></ul><ul><li>“ Screening programs should begin by classifying the individual patient’s level of risk based on personal, family and medical history, which will determine the appropriate approach to screening that person”* </li></ul><ul><li>* Winawer et al. Gastroenterology February 2003 124 </li></ul>
  23. 24. Key Elements In Screening Average Risk Individuals* <ul><li>Men & Women 50 Years and Older </li></ul><ul><li>Stratify be Risk </li></ul><ul><li>Provide Options </li></ul><ul><li>Positive Screen => COLONOSCOPY </li></ul><ul><li>Cancer Detected => Definitive Therapy </li></ul><ul><li>Surveillance post polypectomy or surgery </li></ul><ul><li>* Winawer et al. Gastroenterology February 2003 124 </li></ul>
  24. 25. Why Is Risk Assessment So Important?
  25. 26. The Impact of Family History on Colorectal Cancer Risk <ul><li>General population 6% 1 in 16 </li></ul><ul><li>1 first degree relative 2-3 X </li></ul><ul><li>2 first degree relatives 3-4 X </li></ul><ul><li>1 st degree < 50 years 3-4 X </li></ul><ul><li>Multiple 1 st degree 50%* </li></ul><ul><li>* Relative risk </li></ul>
  26. 27. The First Step: Risk Assessment <ul><li>Three Questions for Every Patient </li></ul><ul><li>History of CRC or Adenomatous Polyp </li></ul><ul><li>Predisposing Illness? eg Ulcerative Colitis </li></ul><ul><li>Family History: CRC or Polyps </li></ul><ul><li>How many? </li></ul><ul><li>First degree? </li></ul><ul><li>Age at diagnosis? </li></ul>
  27. 28. Application of Risk Stratification <ul><li>Three Questions for Every Patient </li></ul><ul><li>History of CRC or Adenomatous Polyp </li></ul><ul><li>Predisposing Illness? Eg Ulcerative Colitis </li></ul><ul><li>Family History: CRC or Polyps </li></ul><ul><li>How many? </li></ul><ul><li>First degree? </li></ul><ul><li>Age at diagnosis? </li></ul><ul><li>Answer is “NO” = Average Risk </li></ul>
  28. 29. 70-80% of Colorectal Cancer in the United States Occurs Among Average Risk Individuals.
  29. 30. 70-80% of Colorectal Cancer in the United States Occurs Among Average Risk Individuals <ul><li>For up to 80% of the CRC deaths sustained every year there is NO known predisposition clue! </li></ul><ul><li>Rigorous Systematic Screening Protocol is the ONLY way we will save lives </li></ul>
  30. 31. Outline <ul><li>Screening Recommendations and their scientific support for: </li></ul><ul><li>Average Risk </li></ul><ul><li>Increased Risk </li></ul><ul><li>High Risk </li></ul>
  31. 32. Screening Recommendations Average Risk Population <ul><li>Begin at age 50 for women and men </li></ul><ul><li>Yearly FOBT </li></ul><ul><li>Flexible sigmoidoscopy 5 year interval </li></ul><ul><li>FOBT yearly, Flex Sig every 5 years </li></ul><ul><li>Colonoscopy very 10 years </li></ul><ul><li>Double-contrast every 5 years </li></ul>
  32. 33. Why Is There a Range of Options? <ul><li>No single test is of unequivocal superiority. </li></ul><ul><li>Choice increases the likelihood that screening will in fact occur. </li></ul>
  33. 34. Yearly FOBT : Guaiac based with diet restriction or immunochemical with no restriction <ul><li>Rational and Evidence </li></ul><ul><li>Testing of 2 samples from 3 consecutive stools has been shown in 3 randomized controlled trials to reduce the risk of death from CRC </li></ul><ul><li>Repeated annual testing can detect as many as 92% of cancers </li></ul>
  34. 35. WARNING! <ul><li>Only 1 in 3 individuals with a positive FOBT undergoes colonoscopy! </li></ul>
  35. 36. Flexible Sigmoidoscopy Every 5 Years <ul><li>Rational and Evidence </li></ul><ul><li>4 case-controlled studies have reported reduced CRC mortality using flexible sigmoidoscopy. </li></ul><ul><li>In the strongest study this reduction was 2/3rds for lesions within reach of the exam. </li></ul>
  36. 37. Warning! <ul><li>There was no reduction in risk for lesions beyond the reach of the flex scope. </li></ul><ul><li>50 % of patients with advanced proximal colonic cancers had NO distal (within flex sig range) colonic neoplasms. </li></ul>
  37. 38. Combined FOBT (yearly) and Flexible Sigmoidoscopy (5yrs) <ul><li>The effectiveness of the combination strategy has never been tested directly in a randomized trial. </li></ul><ul><li>FOBT should be done first to minimize risks associated with multiple invasive procedures. </li></ul>
  38. 39. Colonoscopy every 10 Years <ul><li>Rational and Evidence </li></ul><ul><li>Several lines of evidence support screening colonoscopy. </li></ul><ul><li>Colonoscopy integral part of the FOBT trials that demonstrated a reduction in CRC mortality. </li></ul><ul><li>Colonoscopy is diagnostic AND therapeutic. </li></ul>
  39. 40. Colonoscopy every 10 Years <ul><li>Rational and Evidence </li></ul><ul><li>There are no randomized controlled studies evaluating whether colonoscopy alone reduces CRC mortality among individuals at average risk. </li></ul><ul><li>HOWEVER </li></ul><ul><li>50 % of patients with advanced proximal colonic cancers had NO distal (within flex sig range) colonic neoplasms. </li></ul>
  40. 41. Double Contrast Barium Enema Every 5 Years <ul><li>Rational and Evidence </li></ul><ul><li>There are no randomized controlled trials evaluating the impact of DCBE on CRC mortality. </li></ul><ul><li>DCBE sensitivity is significantly less than colonoscopy </li></ul><ul><li>DCBE has no therapeutic option </li></ul>
  41. 42. Outline <ul><li>Screening Recommendations and their scientific support for: </li></ul><ul><li>Average Risk </li></ul><ul><li>Increased Risk </li></ul><ul><li>High Risk </li></ul>
  42. 43. CRC Screening for Individuals at Increased Risk <ul><li>People with a first-degree relative with colon cancer or adenomatous polyps diagnosed < 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. </li></ul>
  43. 44. CRC Screening for Individuals at Increased Risk <ul><li>People with a first-degree relative with colon cancer or adenomatous polyps diagnosed > 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 . </li></ul>
  44. 45. CRC Screening for Individuals at Increased Risk <ul><li>Rational and Evidence </li></ul><ul><li>Screening recommendations for increased risk individuals are based on the known effectiveness of available screening procedures and the observed increased risk among affected relatives. </li></ul>
  45. 46. Outline <ul><li>Screening Recommendations and their scientific support for: </li></ul><ul><li>Average Risk </li></ul><ul><li>Increased Risk </li></ul><ul><li>High Risk </li></ul>
  46. 47. High Risk: Familial Adenomatous Polyposis: FAP <ul><li>100% CRC cancer risk. </li></ul><ul><li>Flexible sigmoidoscopy at age 10-12. </li></ul><ul><li>Genetic counseling & testing. </li></ul><ul><li>Prophylactic surgery performed by an experienced provider team. </li></ul>
  47. 48. High Risk Hereditary Non-polyposis Colorectal Cancer: HNPCC <ul><li>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. </li></ul><ul><li>Supported by trials from the Netherlands and Finland by Vasen and Jarvinin respectively (Gastroenterology 2000; 118:829-834). </li></ul>
  48. 49. <ul><li>What Now? </li></ul>
  49. 50. Act III Paradise Lost <ul><li>“ Despite a consensus among expert groups on the effectiveness of screening for colorectal cancer, screening rates remain low.”* </li></ul><ul><li>* Winawer et al. Gastroenterology February 2003 124 </li></ul>
  50. 51. Elements Required for Improvement* <ul><li>Patient attitudes </li></ul><ul><li>Physician behavior </li></ul><ul><li>Insurance coverage </li></ul><ul><li>Surveillance and Reminder systems </li></ul><ul><li>* Winawer et al. Gastroenterolgy 2003 124 #2 </li></ul>
  51. 52. Our Approach <ul><li>“ Partners in Prevention” </li></ul>
  52. 53. Partners in Prevention of Colorectal Cancer <ul><li>Taking the initiative in mobilizing all of the components required for success. </li></ul><ul><li>Patients </li></ul><ul><li>Physicians </li></ul><ul><li>Support systems </li></ul><ul><li>Research </li></ul>
  53. 54. Partners in Prevention of Colorectal Cancer <ul><li>Taking the initiative in mobilizing all of the components required for success. </li></ul><ul><li>Patients > Risk Assessment </li></ul><ul><li>Physicians > Guideline Clarification </li></ul><ul><li>Support > Reminders </li></ul><ul><li>Research > NIH & ACS </li></ul>
  54. 55. Partners in Prevention Strategy <ul><li>Risk Assessment </li></ul><ul><li>Appropriate Screening </li></ul><ul><li>Follow-up & Reminders </li></ul>
  55. 56. Partners in Prevention Strategy <ul><li>General population outreach: </li></ul><ul><li>Advertising </li></ul><ul><li>Events </li></ul><ul><li>Advocacy groups </li></ul><ul><li>Academic medical & provider groups </li></ul><ul><li>Insurers </li></ul><ul><li>Employers </li></ul><ul><li>Trade Unions </li></ul>
  56. 57. Patient & Provider Priority Number One: Risk Assessment Early Age Risk Assessment Average Risk Increased Risk High Risk
  57. 58. How Does The Registry Work? <ul><li>We assess personal and family history of colorectal cancer AND adenomatous polyps </li></ul><ul><li>RISK Assessment (ACS Guidelines) </li></ul><ul><li>Screening & Recommendations </li></ul><ul><li>Identify PROVIDER </li></ul><ul><li>Access to research protocols </li></ul>
  58. 59. Familial CRC Registry Objectives <ul><li>Public Health </li></ul><ul><li>Secure higher rates of screening </li></ul><ul><li>Especially increased risk groups </li></ul><ul><li>Population Genomics </li></ul><ul><li>Study populations for the next generation of studies. </li></ul>
  59. 60. Registry Population Accrual Strategy <ul><li>Medical record retrospective review </li></ul><ul><li>Prospective </li></ul><ul><li>Surgical Admissions, Clinics, Admitting </li></ul><ul><li>etc </li></ul><ul><li>“ Partners in Prevention” </li></ul><ul><li>Employee Health </li></ul><ul><li>Trade Unions </li></ul><ul><li>Faith Based Organizations </li></ul>
  60. 61. The Future?
  61. 62. Identifying Who is at Risk Among the Negative History Population? <ul><li>Selected Genetic Polymorphisms </li></ul><ul><li>Predisposition Haplotypes & SNPS </li></ul><ul><li>Novel gene discovery </li></ul>
  62. 63. Partners is looking for Partners! <ul><li>NYS & NYC DOH </li></ul><ul><li>NYC H&H </li></ul><ul><li>Insurers </li></ul><ul><li>Employee Health </li></ul><ul><li>Trade Union </li></ul>
  63. 64. Summary <ul><li>Colorectal Cancer remains a major public health challenge. </li></ul><ul><li>We write the epilogue. </li></ul><ul><li>Insurance industry support is crucial. </li></ul><ul><li>Partners in Prevention is part of the solution. </li></ul>
  64. 65. Thank You!

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