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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
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
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 88Source: 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
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
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
Value of a Human Life
• Consider average hourly wage (1997$)
• Dollars saved/lives lost = $1.54 M/life
• $1,540,000.00*
Orley Ashenfelter, Princeton University Michael Greenstone, University of Chicago
April, 2002
*Sampling error around 1/3 of this value
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
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
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
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.
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
ASCO Outcomes That Justify Diagnostic Tests or Treatments
Outcomes that
justify use
Outcomes that do
not justify use
Improved overall survival Earlier knowledge about recurrence
Improved disease-free survival
Unproven hope that earlier detection leads to better care or palliation
Better quality of life Cost alone
Less toxicity
Improved cost-effectiveness
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
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.”
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.”
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
Jeffery M, Heckey BE, Hider PN. Follow-up strategies for patients treated for non-metastatic colorectal cancer. Cochrane Database of Systematic Reviews 2007, 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
Cochrane Review Conclusions
• Overall survival benefit!• Cannot determine the appropriate
– Clinic visits
– Blood tests
– Endoscopic procedures
– Radiological investigations
Methods of Follow-up
• History taking
• Abdominal & Rectal Exam
• Sigmoidoscopy (for rectal CA)
Clinical Examination
Signs/Symptoms would have (could have) indicated recurrence in 21-48% of patients.
Methods of Follow-up
• LFTs: worthless
• Hgb/Hct: pretty much worthless
• CEA: most cost effective test
Blood Tests
Methods of Follow-up
• 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
CEA
Cost per Recurrence
• CEA $5,696
• Physical Exam$418,615
Papagrigoriadia, S. International Journal of Surgery (2007) 5, 120-128.
Methods of Follow-up
• Colonoscopy (more for metachronous tumors)
• Sigmoidoscopy/Proctoscopy
Direct Imaging
Methods of Follow-up
• US: regular intervals 1st 2-3 years• CT scan (MRI)• Chest X-ray (not routine)• PET (not routine)
Radiology
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
325 Prospectively Randomized Follow-up for Colorectal Cancer
• 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
Standard Intensive
Schoemaker D, et al. Gastroenterology, 1998
325 Prospectively Randomized Follow-up for Colorectal Cancer
• Colonoscopy, CT, CXR have no survival benefit
• Do colonoscopy 5 years after operation• CXR & CT used to investigate symptoms
or LFT changes
Conclusions
Schoemaker D, et al. Gastroenterology, 1998
Mayo Clinic Calculator
Prognostic Factors 5-yr relapse-free survival
T3N0 (>10 nodes) 79%
T3N0 low grade 73%
T3N0 (< 10 nodes) 72%
T3N0 high grade 65%
T4N0 low grade 60%
T4N0 high grade 51%
T3N1 49%
T3N2 15%
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)
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 monthsJ Clin Oncol 23:8512-8519, 2005.
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.
Practice GuidelineASCO 2005 Update
3 meta-analyses demonstrate survival for CT or “liver imaging”
Why CT Scans?
J Clin Oncol 23:8512-8519, 2005.
25% decreased mortality with liver imaging compared to nonimaging strategies
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.
Practice GuidelineASCO 2005 Update
1. Detects largest number of resectable recurrences.
2. CEA elevation less likely with pulmonary metastases
3. Lung as common as liver mets in rectal cancer patients
4. Replaces Chest X-rays
Why Chest CT Scans?
J Clin Oncol 23:8512-8519, 2005.