Fecal DNA testing compared with conventional colorectal cancer screening methods: a decision analysis.

BACKGROUND & AIMS Fecal DNA testing is an emerging tool to detect colorectal cancer (CRC). Our aims were to estimate the clinical and economic consequences of fecal DNA testing vs. conventional CRC screening. METHODS Using a Markov model, we estimated CRC incidence, CRC mortality, and discounted cost/life-year gained for screening by fecal DNA testing (F-DNA), fecal occult blood testing (FOBT) and/or sigmoidoscopy, or colonoscopy (COLO) in persons at average CRC risk from age 50 to 80 years. RESULTS Compared with no screening, F-DNA at a screening interval of 5 years decreased CRC incidence by 35% and CRC mortality by 54% and gained 4560 life-years per 100,000 persons at USD $47,700/life-year gained in the base case. However, F-DNA gained fewer life-years and was more costly than conventional screening. The average number of colonoscopies per person was 3.8 with COLO and 0.8 with F-DNA. In most 1-way sensitivity analyses and Monte Carlo simulation iterations, F-DNA remained reasonably cost-effective compared with no screening, but COLO and FOBT dominated F-DNA. Assuming fecal DNA testing sensitivities of 65% for CRC and 40% for large polyp, and 95% specificity, a screening interval of 2 years and a test cost of USD $195 would be required to make F-DNA comparable with COLO. CONCLUSIONS Fecal DNA testing every 5 years appears effective and cost-effective compared with no screening, but inferior to other strategies such as FOBT and COLO. Fecal DNA testing could decrease the national CRC burden if it could improve adherence with screening, particularly where the capacity to perform screening colonoscopy is limited.

[1]  Brenda White,et al.  DEPARTMENT OF LABOR , 2006 .

[2]  W. Rosen Colorectal Cancer Screening , 2004 .

[3]  P. Pickhardt,et al.  Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. , 2003, The New England journal of medicine.

[4]  J. Yee,et al.  Computerized tomographic colonography: performance evaluation in a retrospective multicenter setting. , 2003, Gastroenterology.

[5]  C. Johnson,et al.  Prospective blinded evaluation of computed tomographic colonography for screen detection of colorectal polyps. , 2003, Gastroenterology.

[6]  Peter A Ubel,et al.  What is the price of life and why doesn't it increase at the rate of inflation? , 2003, Archives of internal medicine.

[7]  M. Lawson,et al.  Sensitivity and specificity of a stool DNA multitarget assay panel for the detection of advanced colorectal neoplasia. , 2003, Clinical colorectal cancer.

[8]  A. Fendrick,et al.  Potential effect of cyclooxygenase-2-specific inhibitors on the prevention of colorectal cancer: a cost-effectiveness analysis. , 2003, The American journal of medicine.

[9]  C. Willet,et al.  The loss of stool DNA mutation abnormalities in colorectal neoplasia after treatment , 2003 .

[10]  T. Heeren,et al.  A comparative study of patient perceptions and screening preferences for stool-based DNA testing (SBDNA), fecal occult blood testing (FOBT) or colonoscopy (CS) , 2003 .

[11]  D. Ransohoff Developing Molecular Biomarkers for Cancer , 2003, Science.

[12]  Susan Halabi,et al.  A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer. , 2003, The New England journal of medicine.

[13]  S. Woolf,et al.  Colorectal cancer screening and surveillance: clinical guidelines and rationale-Update based on new evidence. , 2003, Gastroenterology.

[14]  Alicia Samuels,et al.  Cancer Statistics, 2003 , 2003, CA: a cancer journal for clinicians.

[15]  B. Levin,et al.  Emerging Technologies in Screening for Colorectal Cancer: CT Colonography, Immunochemical Fecal Occult Blood Tests, and Stool Screening Using Molecular Markers , 2003, CA: a cancer journal for clinicians.

[16]  Robert A. Smith,et al.  American Cancer Society Guidelines for the Early Detection of Cancer, 2003 , 2003, CA: a cancer journal for clinicians.

[17]  David F Ransohoff,et al.  Challenges and opportunities in evaluating diagnostic tests. , 2002, Journal of clinical epidemiology.

[18]  Michael Pignone,et al.  Cost-Effectiveness Analyses of Colorectal Cancer Screening , 2002, Annals of Internal Medicine.

[19]  Michael Pignone,et al.  Screening for Colorectal Cancer in Adults at Average Risk: A Summary of the Evidence for the U.S. Preventive Services Task Force , 2002, Annals of Internal Medicine.

[20]  O. Kronborg,et al.  A randomised study of screening for colorectal cancer using faecal occult blood testing: results after 13 years and seven biennial screening rounds , 2002, Gut.

[21]  B. Levin,et al.  American Cancer Society Guidelines for the Early Detection of Cancer , 2002, CA: a cancer journal for clinicians.

[22]  R. Hayward,et al.  Which colon cancer screening test? A comparison of costs, effectiveness, and compliance. , 2001, The American journal of medicine.

[23]  Grace Huang,et al.  Aspirin as an Adjunct to Screening for Prevention of Sporadic Colorectal Cancer: A Cost-Effectiveness Analysis , 2001, Annals of Internal Medicine.

[24]  D. Lieberman,et al.  Feasibility of colonoscopy screening: discussion of issues and recommendations regarding implementation. , 2001, Gastrointestinal endoscopy.

[25]  S. Goodman,et al.  Detecting colorectal cancer in stool with the use of multiple genetic targets. , 2001, Journal of the National Cancer Institute.

[26]  S D Wall,et al.  Colorectal neoplasia: performance characteristics of CT colonography for detection in 300 patients. , 2001, Radiology.

[27]  L M Schuman,et al.  The effect of fecal occult-blood screening on the incidence of colorectal cancer. , 2000, The New England journal of medicine.

[28]  J. Bond Polyp Guideline: Diagnosis, Treatment, and Surveillance for Patients With Colorectal Polyps* , 2000 .

[29]  S. Thibodeau,et al.  Colorectal cancer screening by detection of altered human DNA in stool: feasibility of a multitarget assay panel. , 2000, Gastroenterology.

[30]  J. Bond Polyp guideline: diagnosis, treatment, and surveillance for patients with colorectal polyps , 2000, American Journal of Gastroenterology.

[31]  Graham A. Colditz,et al.  Cost-effectiveness of screening for colorectal cancer in the general population. , 2000, JAMA.

[32]  A. Sonnenberg,et al.  Cost-Effectiveness of Colonoscopy in Screening for Colorectal Cancer , 2000, Annals of Internal Medicine.

[33]  J. Bond,et al.  Clinical evidence for the adenoma-carcinoma sequence, and the management of patients with colorectal adenomas. , 2000, Seminars in gastrointestinal disease.

[34]  J. Mitchell,et al.  A DECISION MODEL AND COST-EFFECTIVENESS ANALYSIS OF COLORECTAL CANCER SCREENING AND SURVEILLANCE GUIDELINES FOR AVERAGE-RISK ADULTS , 2000, International Journal of Technology Assessment in Health Care.

[35]  B. Levin,et al.  The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis. , 2000, The New England journal of medicine.

[36]  E T Stewart,et al.  A comparison of colonoscopy and double-contrast barium enema for surveillance after polypectomy. National Polyp Study Work Group. , 2000, The New England journal of medicine.

[37]  R D Etzioni,et al.  Obtaining long-term disease specific costs of care: application to Medicare enrollees diagnosed with colorectal cancer. , 1999, Medical care.

[38]  J. Ferrucci,et al.  A comparison of virtual and conventional colonoscopy for the detection of colorectal polyps. , 1999, The New England journal of medicine.

[39]  C. Mulrow,et al.  Colorectal cancer screening: clinical guidelines and rationale. , 1997, Gastroenterology.

[40]  F T Bosman,et al.  Prevention of colorectal cancer. Costs and effectiveness of sigmoidoscopy. , 1997, Scandinavian journal of gastroenterology. Supplement.

[41]  C. Somkin,et al.  Cost of Care for Cancer in a Health Maintenance Organization , 1997, Health care financing review.

[42]  J. Olsen,et al.  Randomised study of screening for colorectal cancer with faecal-occult-blood test , 1996, The Lancet.

[43]  P. Glasziou,et al.  Cost‐effectiveness analysis of screening by faecal occult blood testing for colorectal cancer in Australia , 1996, Australian and New Zealand journal of public health.

[44]  S. Moss,et al.  Randomised controlled trial of faecal-occult-blood screening for colorectal cancer , 1989, The Lancet.

[45]  D. Lieberman,et al.  Cost-effectiveness model for colon cancer screening. , 1995, Gastroenterology.

[46]  Tammy O. Tengs,et al.  Five-hundred life-saving interventions and their cost-effectiveness. , 1995, Risk analysis : an official publication of the Society for Risk Analysis.

[47]  N Urban,et al.  Stage, age, comorbidity, and direct costs of colon, prostate, and breast cancer care. , 1995, Journal of the National Cancer Institute.

[48]  A. Zauber,et al.  Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. , 1993 .

[49]  L M Schuman,et al.  Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. , 1993, The New England journal of medicine.

[50]  A. Detsky,et al.  Tentative guidelines for using clinical and economic evaluations revisited. , 1993, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[51]  G. Friedman,et al.  A case-control study of screening sigmoidoscopy and mortality from colorectal cancer. , 1992, The New England journal of medicine.

[52]  A S Detsky,et al.  How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. , 1992, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[53]  R Levine,et al.  Prevention and early detection of colorectal cancer. , 1992, American family physician.

[54]  D. Eddy,et al.  Screening for colorectal cancer , 1992, The Lancet.

[55]  S. Winawer,et al.  Screening for colorectal cancer in a high-risk population. Results of a mathematical model. , 1987, Gastroenterology.

[56]  Yrjö Collan,et al.  Prevalence of polyps in an autopsy series from areas with varying incidence of large‐bowel cancer , 1985, International journal of cancer.

[57]  B C Morson,et al.  The evolution of colorectal carcinoma. , 1984, Clinical radiology.

[58]  D W Day,et al.  Polyps and cancer of the large bowel: a necropsy study in Liverpool. , 1982, Gut.

[59]  M. Vatn,et al.  The prevalence of polyps of the large intestine in Oslo: An autopsy study , 1982, Cancer.

[60]  E. C. Hammond,et al.  Adenomatous lesions of the large bowel: An autopsy survey , 1979, Cancer.

[61]  H. Enterline,et al.  Polyps and cancer of the large bowel. , 1976, Current topics in pathology. Ergebnisse der Pathologie.

[62]  T C ARMINSKI,et al.  Incidence and distribution of adenomatous polyps of the colon and rectum based on 1,000 autopsy examinations , 1964, Diseases of the colon and rectum.