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Colorectal Cancer Post-Treatment Surveillance

Colorectal Cancer Post-Treatment Surveillance . Robert Fry, MD Emilie & Roland deHellebranth Professor Chief, Division of Colon & Rectal Surgery Chairman, Department of Surgery Pennsylvania Hospital. Department of Surgery, University of Pennsylvania Health System.

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Colorectal Cancer Post-Treatment Surveillance

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  1. Colorectal Cancer Post-Treatment Surveillance Robert Fry, MD Emilie & Roland deHellebranth Professor Chief, Division of Colon & Rectal Surgery Chairman, Department of Surgery Pennsylvania Hospital Department of Surgery, University of Pennsylvania Health System

  2. Lifetime Probability of Developing Cancer, Women, USA, 2002-2004 Site Risk All sites† 1 in 3 Breast 1 in 8 Lung & bronchus 1 in 16 Colon & rectum 1 in 19 Uterine corpus 1 in 41 Non-Hodgkin lymphoma 1 in 53 Melanoma 1 in 61 Ovary 1 in 71 Pancreas 1 in 76 Urinary bladder‡ 1 in 85 Uterine cervix 1 in 142 Source: DevCan: Probability of Developing or Dying of Cancer Software, Version 6.2.1 Statistical Research and Applications Branch, NCI, 2007. http://srab.cancer.gov/devcan

  3. Lifetime Probability of Developing Cancer, Men, USA, 2002-2004 Site Risk All sites† 1 in 2 Prostate 1 in 6 Lung and bronchus 1 in 13 Colon and rectum 1 in 18 Urinary bladder‡ 1 in 27 Melanoma 1 in 41 Non-Hodgkin lymphoma 1 in 46 Kidney 1 in 59 Leukemia 1 in 67 Oral Cavity 1 in 71 Stomach 1 in 88 Source: DevCan: Probability of Developing or Dying of Cancer Software, Version 6.2.1 Statistical Research and Applications Branch, NCI, 2007. http://srab.cancer.gov/devcan

  4. Trends in Five-year Relative Survival (%) Rates, US, 1975-2003 Site 1975-1977 1984-1986 1996-2003 • All sites 50 54 66 • Breast (female) 75 79 89 • Colon 51 59 65 • Leukemia 35 42 50 • Lung and bronchus 13 13 16 • Melanoma 82 87 92 • Non-Hodgkin lymphoma 48 53 64 • Ovary 37 40 45 • Pancreas 2 3 5 • Prostate 69 76 99 • Rectum 49 57 66 • Urinary bladder 74 78 81

  5. Value of a Human Life • 1987: 21 states raised speed limits from 55 mph to 65 mph • Speeds increased 3.5% (2 mph) • Fatality rates increased 35% • 125,000 hours saved/life lost Orley Ashenfelter, Princeton University Michael Greenstone, University of Chicago April, 2002

  6. Value of a Human Life • Consider average hourly wage (1997$) • Dollars saved/lives lost = $1.54 M/life • $1,540,000.00* *Sampling error around 1/3 of this value Orley Ashenfelter, Princeton University Michael Greenstone, University of Chicago April, 2002

  7. Value of a Human Life: EPA • Earning ability or wealth not relevant • Two survey studies on avoiding risks • $8.8 M (Kip Viscusi, Vanderbilt University) • $2-3.3 M (Laura Taylor, N Carolina State U) • What people pay to avoid risk • How much extra employers pay to take on risk • Old value: $7.8 million • New value: $6.9 million Seth Borenstein, Associated Press, Jul 10, 2008

  8. Value of a Human Life: EPA • Hypothetical Regulation • $18 Billion to enforce • prevents 2,500 deaths • Worth it at $7.8 M (old figure) • $18 B/2500 = $7.2 M • Not cost effective at $6.9 M Seth Borenstein, Associated Press, Jul 10, 2008

  9. Value of a Human Life: EPA • An ever changing value • Decreasing value of the dollar implies decreasing value of life • 2002: EPA decided value of elderly people to be 38% less than people younger than 70 • Decision reversed after it became public Seth Borenstein, Associated Press, Jul 10, 2008

  10. Cost Utility Analysis (CUA) A type of cost-effectiveness study that combines mortality and morbidity data into a single multidimensional measure: QALY (the quality-adjusted life year) Canadians: $20,000 (Can 1992)/QALY definitely cost effective $20K to $100K (Can 1992)/QALY only possibly cost-effective Americans: $50,000 (U.S. 1992)/QALY* *Cost of end-stage renal dialysis, from 1973 Earle CC, Chapman RH, Baker CS, et al: Systematic overview of cost-utility assessments in oncology. J Clin Oncol 18:3302-3317, 2000.

  11. Value of a Human Life • In theory: Priceless • In traditional reality: $50,000/year • In U.S. today: $129,000/year • Stafanos Zenios et al, Stanford Graduate School of Business • Computer analysis of 500,000 dialysis patients, comparing costs to outcomes Kingsbury, K. Time/CNN, May 20, 2008

  12. ASCO Outcomes That Justify Diagnostic Tests or Treatments

  13. Cost of Patient Follow-up for Five Years after Potentially Curative Colorectal Cancer Treatment Low: $910.00 High: $26,717.00 Indications that High-cost Strategy Saves lives: Nill. Virgo KS, Vernava AM, Longo WE, McKirgan LW, Johnson FE, JAMA 273:1837-1841, 1995. Department of Surgery, University of Pennsylvania Health System

  14. Secco GB, Fardelli R, Gianquinto D, Bonfante P, Baldi E, Ravera G, et al: Efficacy and cost of risk adapted follow-up inpatients after colorectal cancer surgery: a prospective, randomized and controlled trial. European Journal of Surgical Oncology 2002;28:418-423. “The annual and total costs (euros) of risk-adapted follow-up over a period of 5 years were calculated as the sums of the cost of each diagnostic test considering the costs of materials, of depreciation of equipment and the cost of medical personnel, technicians and nursing staff per minute.”

  15. Secco GB, Fardelli R, Gianquinto D, Bonfante P, Baldi E, Ravera G, et al: Efficacy and cost of risk adapted follow-up inpatients after colorectal cancer surgery: a prospective, randomized and controlled trial. European Journal of Surgical Oncology 2002;28:418-423. “Risk-adapted follow-up reduced the costs of disease-free patients in the relaxed follow-up group as compared with the intensive follow-up patients.”

  16. Secco GB, Fardelli R, Gianquinto D, Bonfante P, Baldi E, Ravera G, et al: Efficacy and cost of risk adapted follow-up inpatients after colorectal cancer surgery: a prospective, randomized and controlled trial. European Journal of Surgical Oncology 2002;28:418-423. “Risk-adapted follow-up reduced the costs of disease-free patients in the relaxed follow-up group as compared with the intensive follow-up patients.” DOH! Homer Simpson

  17. Jeffery M, Heckey BE, Hider PN. Follow-up strategies for patients treated for non-metastatic colorectal cancer. Cochrane Database of Systematic Reviews2007, Issue 1. Oxford, United Kingdom, Cochrane Library, CD002200. • Review evidence concerning benefits of intensive follow up with respect to survival • Secondary endpoints • Time to dx of recurrence • Quality of life • Harms • Costs • 8 Randomized Controlled Trials

  18. Cochrane Review Conclusions • Overall survival benefit! • Cannot determine the appropriate • Clinic visits • Blood tests • Endoscopic procedures • Radiological investigations

  19. Cochrane Review Conclusions • Overall survival benefit! • Cannot estimate • Potential harms • Costs

  20. Methods of Follow-up Clinical Examination • History taking • Abdominal & Rectal Exam • Sigmoidoscopy (for rectal CA) Signs/Symptoms would have (could have) indicated recurrence in 21-48% of patients.

  21. Methods of Follow-up Blood Tests • LFTs: worthless • Hgb/Hct: pretty much worthless • CEA: most cost effective test

  22. Methods of Follow-up CEA • 1st indication of recurrence in 60% • Sensitivity about 80% • 30% do not express antigen • False positive 5 – 15% • Better for distant recurrence • Median lead time: 6 months

  23. Cost per Recurrence • CEA $5,696 • Physical Exam $418,615 Papagrigoriadia, S. International Journal of Surgery (2007) 5, 120-128.

  24. Methods of Follow-up Direct Imaging • Colonoscopy (more for metachronous tumors) • Sigmoidoscopy/Proctoscopy

  25. Methods of Follow-up Radiology • US: regular intervals 1st 2-3 years • CT scan (MRI) • Chest X-ray (not routine) • PET (not routine)

  26. Follow-up for Colorectal Cancer:Ideal Combination of Tests • High diagnostic accuracy • Minimally invasive • Not affect quality of life • Cost-efficient Papagrigoriadia S. International Journal of Surgery 2007

  27. Q 3 months for 2 yrs: Symptoms and Signs CBC, LFTs, CEA Fecal occult blood Then Q 6 months Q 3 months for 2 yrs: Symptoms and Signs CBC, LFTs, CEA Fecal occult blood and YEARLY CXR CT of liver Colonoscopy 325 Prospectively Randomized Follow-up for Colorectal Cancer Intensive Standard Schoemaker D, et al. Gastroenterology, 1998

  28. Colonoscopy, CT, CXR have no survival benefit Do colonoscopy 5 years after operation CXR & CT used to investigate symptoms or LFT changes 325 Prospectively Randomized Follow-up for Colorectal Cancer Conclusions Schoemaker D, et al. Gastroenterology, 1998

  29. Mayo Clinic Calculator

  30. Individual patient data from 12,915 patients on 15 randomized trials: 85% of colon cancer recurrences are diagnosed with 3 years of resection. Sargent DJ, Wieand S, Benedetti J, et al: J Clin Oncol 22: 2004 (abstr 3502)

  31. Practice GuidelineASCO 2005 Update • Office visits q 3 – 6 months for 3 years, then decreased frequency • CEA q 3 months for Stage II or III initiate after adjuvant therapy completed • CT of chest and abd yearly for 3 years • CT of pelvis for rectal cancer patients • Colonoscopy: perioperative and at 3 years • Procto: for rectal ca without RT q 6 months J Clin Oncol 23:8512-8519, 2005.

  32. Practice GuidelineASCO 2005 Update • CBC and LFT • Fecal occult blood test • Yearly chest xrays • Molecular or cellular markers NOT RECOMMENDED: J Clin Oncol 23:8512-8519, 2005.

  33. Practice GuidelineASCO 2005 Update 3 meta-analyses demonstrate survival for CT or “liver imaging” Why CT Scans? 25% decreased mortality with liver imaging compared to nonimaging strategies J Clin Oncol 23:8512-8519, 2005.

  34. Practice GuidelineASCO 2005 Update • 530 patients, Stage II and III • CEA: 45 relapses • CT: 49 relapses • Both: 14 • Relapses detected by either had improved survival compared to those detected by symptoms Why CT Scans? Chau I, Allen MJ, et al: J Clin Oncol 22, 2004.

  35. Practice GuidelineASCO 2005 Update • Detects largest number of resectable recurrences. • CEA elevation less likely with pulmonary metastases • Lung as common as liver mets in rectal cancer patients • Replaces Chest X-rays Why Chest CT Scans? J Clin Oncol 23:8512-8519, 2005.

  36. Unanswered Questions • Two tiered follow-up? • More intense for more aggressive tumors? • PET scans? • Molecular markers?

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