Comparative Economics of a 12-Gene Assay for Predicting Risk of Recurrence in Stage II Colon Cancer

PharmacoEconomics

Volumn 32, Issue 12, 2014, Pages 1231-1243

  Alberts, Steven R ^a   Yu, Tiffany M ^b   Behrens, Robert J ^c   Renfro, Lindsay A ^a   Srivastava, Geetika ^a   Soori, Gamini S ^d   Dakhil, Shaker R ^e   Mowat, Rex B ^f   Kuebler, John P ^g   Kim, George P ^h   Mazurczak, Miroslaw A ⁱ   Hornberger, John ^b,j  

^a MAYO CLINIC   (United States)

^b Cedar Associates LLC   (United States)

^c Medical Oncology and Hematology Associates   (United States)

^d Department of Cardiothoracic and Vascular Surgery   (United States)

^e Cancer Center of Kansas   (United States)

^f Toledo Clinic   (United States)

^g Department of Pharmacy   (United States)

^h MAYO CLINIC   (United States)

ⁱ Sanford Children's Hospital   (United States)

^j STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; FLUOROPYRIMIDINE; FLUOROURACIL; FOLINIC ACID; OXALIPLATIN;

12 GENE ASSAY; ADULT; ARTICLE; ASSAY; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER RECURRENCE; CANCER RISK; COLON CANCER; COMPARATIVE ECONOMICS; CONTROLLED STUDY; DRUG COST; ECONOMICS; FEMALE; GENE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICARE; MIDDLE AGED; MONOTHERAPY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PHYSICIAN; QUALITY ADJUSTED LIFE YEAR; UNSPECIFIED SIDE EFFECT; VALIDITY; WELLBEING; ADJUVANT CHEMOTHERAPY; COLONIC NEOPLASMS; COMPARATIVE STUDY; COST BENEFIT ANALYSIS; GENETIC PREDISPOSITION; GENETIC SCREENING; GENETICS; HEALTH CARE COST; TUMOR RECURRENCE;

ADULT; CHEMOTHERAPY, ADJUVANT; COLONIC NEOPLASMS; COST-BENEFIT ANALYSIS; DRUG COSTS; FEMALE; GENETIC PREDISPOSITION TO DISEASE; GENETIC TESTING; HEALTH CARE COSTS; HUMANS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; QUALITY-ADJUSTED LIFE YEARS;

EID: 84912117497     PISSN: 11707690     EISSN: 11792027     Source Type: Journal    
DOI: 10.1007/s40273-014-0207-1     Document Type: Article

References (52)

1. Eheman C, Henley SJ, Ballard-Barbash R, Jacobs EJ, Schymura MJ, Noone AM, et al. Annual Report to the Nation on the status of cancer, 1975–2008, featuring cancers associated with excess weight and lack of sufficient physical activity. Cancer. 2012;118(9):2338–66. doi:10.1002/cncr.27514.
2. American Cancer Society. Colorectal cancer facts and figures 2014–2016. American Cancer Society, Atlanta; 2014. http://www.cancer.org/acs/groups/content/documents/document/acspc-042280.pdf. Accessed April 11 2014.
3. American Joint Committee on Cancer. AJCC cancer staging manual, 7th edition: colon and rectum cancer staging. http://www.cancerstaging.org/staging/posters/colon8.5x11.pdf. Accessed November 29 2011.
4. National Cancer Institute. Surveillance epidemiology and end results SEER*Stat Software Version 8.1.5. 2014. http://seer.cancer.gov/seerstat/. Accessed June 18 2014.
5. United States Census Bureau. National population projections: middle series. 2012. http://www.census.gov/population/projections/data/national/2012/downloadablefiles.html. Accessed June 18 2014.
6. Gunderson LL, Jessup JM, Sargent DJ, Greene FL, Stewart AK. Revised TN categorization for colon cancer based on national survival outcomes data. J Clin Oncol. 2010;28(2):264–71. doi:10.1200/jco.2009.24.0952.
7. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: colon cancer version 3.2013. 2013. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed June 26 2013.
8. Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007;370(9604):2020–9. doi:10.1016/s0140-6736(07)61866-2.
9. Benson AB 3rd, Schrag D, Somerfield MR, Cohen AM, Figueredo AT, Flynn PJ, et al. American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J Clin Oncol. 2004;22(16):3408–19. doi:10.1200/jco.2004.05.063.
10. Twelves C, Wong A, Nowacki MP, Abt M, Burris H 3rd, Carrato A, et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 2005;352(26):2696–704. doi:10.1056/NEJMoa043116.
11. Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009;27(19):3109–16. doi:10.1200/jco.2008.20.6771.
12. Yothers G, O’Connell MJ, Allegra CJ, Kuebler JP, Colangelo LH, Petrelli NJ, et al. Oxaliplatin as adjuvant therapy for colon cancer: updated results of NSABP C-07 trial, including survival and subset analyses. J Clin Oncol. 2011;29(28):3768–74. doi:10.1200/jco.2011.36.4539.
13. Gray RG, Quirke P, Handley K, Lopatin M, Magill L, Baehner FL, et al. Validation study of a quantitative multigene reverse transcriptase-polymerase chain reaction assay for assessment of recurrence risk in patients with stage II colon cancer. J Clin Oncol. 2011;29(35):4611–9. doi:10.1200/jco.2010.32.8732.
14. Venook AP, Niedzwiecki D, Lopatin M, Ye X, Lee M, Friedman PN, et al. Biologic determinants of tumor recurrence in stage II colon cancer: validation study of the 12-gene recurrence score in cancer and leukemia group B (CALGB) 9581. J Clin Oncol. 2013;31(14):1775–81. doi:10.1200/jco.2012.45.1096.
15. Srivastava G, Renfro LA, Behrens RJ, Lopatin M, Chao C, Soori GS, et al. Prospective multicenter study of the impact of oncotype DX colon cancer assay results on treatment recommendations in stage II colon cancer patients. Oncologist. 2014;19(5):492–7. doi:10.1634/theoncologist.2013-0401.
16. Hornberger J, Lyman GH, Chien R, Meropol NJ. A multigene prognostic assay for selection of adjuvant chemotherapy in patients with T3, stage II colon cancer: impact on quality-adjusted life expectancy and costs. Value Health. 2012;15(8):1014–21. doi:10.1016/j.jval.2012.07.012.
17. Interactive Clinical Intelligence. OncoReport: Medical Oncology, 3rd Trimester. 2010.
18. Briggs AH, Weinstein MC, Fenwick EA, Karnon J, Sculpher MJ, Paltiel AD. Model parameter estimation and uncertainty: a report of the ISPOR-SMDM modeling good research practices task force–6. Value Health. 2012;15(6):835–42. doi:10.1016/j.jval.2012.04.014.
19. Caro JJ, Briggs AH, Siebert U, Kuntz KM. Modeling good research practices–overview: a report of the ISPOR-SMDM modeling good research practices task force–1. Value Health. 2012;15(6):796–803. doi:10.1016/j.jval.2012.06.012.
20. Eddy DM, Hollingworth W, Caro JJ, Tsevat J, McDonald KM, Wong JB. Model transparency and validation: a report of the ISPOR-SMDM modeling good research practices task force–7. Value Health. 2012;15(6):843–50. doi:10.1016/j.jval.2012.04.012.
21. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated health economic evaluation reporting standards (CHEERS)-explanation and elaboration: a report of the ISPOR health economic evaluation publication guidelines good reporting practices task force. Value Health. 2013;16(2):231–50. doi:10.1016/j.jval.2013.02.002.
22. Karnon J, Stahl J, Brennan A, Caro JJ, Mar J, Moller J. Modeling using discrete event simulation: a report of the ISPOR-SMDM modeling good research practices task force–4. Value Health. 2012;15(6):821–7. doi:10.1016/j.jval.2012.04.013.
23. Pitman R, Fisman D, Zaric GS, Postma M, Kretzschmar M, Edmunds J, et al. Dynamic transmission modeling: a report of the ISPOR-SMDM modeling good research practices task force–5. Value Health. 2012;15(6):828–34. doi:10.1016/j.jval.2012.06.011.
24. Roberts M, Russell LB, Paltiel AD, Chambers M, McEwan P, Krahn M. Conceptualizing a model: a report of the ISPOR-SMDM modeling good research practices task force–2. Value Health. 2012;15(6):804–11. doi:10.1016/j.jval.2012.06.016.
25. Siebert U, Alagoz O, Bayoumi AM, Jahn B, Owens DK, Cohen DJ, et al. State-transition modeling: a report of the ISPOR-SMDM modeling good research practices task force–3. Value Health. 2012;15(6):812–20. doi:10.1016/j.jval.2012.06.014.
26. Kerr D, Gray R, Quirke P, Watson D, Yothers G, Lavery I, et al. A quantitative multi-gene RT-PCR assay for prediction of recurrence in stage II colon cancer: selection of the genes in 4 large studies and results of the independent, prospectively-designed QUASAR validation study. J Clin Oncol. 2009;27(15s):suppl; abstr 4000.
27. Arias E. National Vital Statistics Reports Volume 61, Number 3: United States Life Tables, 2008. 2012. http://www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_03.pdf. Accessed November 8 2012.
28. Hendifar A, Yang D, Lenz F, Lurje G, Pohl A, Lenz C, et al. Gender disparities in metastatic colorectal cancer survival. Clin Cancer Res. 2009;15(20):6391–7. doi:10.1158/1078-0432.ccr-09-0877.
29. United States Department of Labor, Bureau of Labor Statistics. Consumer price index—all urban consumers, medical care. 2014. http://www.bls.gov/data/. Accessed April 29 2014.
30. Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA task force report. Value Health. 2005;8(5):521–33. doi:10.1111/j.1524-4733.2005.00045.x.
31. Parman C. Coding: the 7 deadly sins of infusion center documentation. In: Oncology Issues. 2010. http://www.accc-cancer.org/education/pdf/FILN/FILN-4-The-7-Deadly-Sins-of-Infusion-Center-Documentation.pdf.
32. Centers for Medicare and Medicaid Services. Payment Allowance Limits for Medicare Part B Drugs, Effective April 1, 2014 through June 30, 2014. 2014. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2014ASPFiles.html. Accessed April 29 2014.
33. Centers for Medicare and Medicaid Services. Medicare part B drug average sales price. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/. Accessed June 30 2014.
34. Centers for Medicare and Medicaid Services. Physician fee schedule. 2014. http://www.cms.gov/apps/physician-fee-schedule/. Accessed April 29 2014.
35. Chapuis PH, Bokey EL, Clarke S, Beale P, Dent OF. Adjuvant chemotherapy for stage C colonic cancer in a multidisciplinary setting. ANZ J Surg. 2009;79(10):685–92. doi:10.1111/j.1445-2197.2009.05052.x.
36. Dobie SA, Baldwin LM, Dominitz JA, Matthews B, Billingsley K, Barlow W. Completion of therapy by medicare patients with stage III colon cancer. J Natl Cancer Inst. 2006;98(9):610–9. doi:10.1093/jnci/djj159.
37. Gibbs P, McLaughlin S, Skinner I, Jones I, Hayes I, Chapman M, et al. Re: completion of therapy by medicare patients with stage III colon cancer. J Natl Cancer Inst. 2006;98(21):1582. doi:10.1093/jnci/djj416.
38. Callaghan B, McCammon R, Kerber K, Xu X, Langa KM, Feldman E. Tests and expenditures in the initial evaluation of peripheral neuropathy. Arch Intern Med. 2012;172(2):127–32. doi:10.1001/archinternmed.2011.1032.
39. Chu E, Schulman KL, Zelt S, Song X. Costs associated with complications are lower with capecitabine than with 5-fluorouracil in patients with colorectal cancer. Cancer. 2009;115(7):1412–23. doi:10.1002/cncr.24131.
40. Lansdorp-Vogelaar I, van Ballegooijen M, Zauber AG, Habbema JD, Kuipers EJ. Effect of rising chemotherapy costs on the cost savings of colorectal cancer screening. J Natl Cancer Inst. 2009;101(20):1412–22. doi:10.1093/jnci/djp319.
41. Centers for Medicare and Medicaid Services. Payment allowance limits for medicare part B drugs, effective January 1, 2008 through March 31, 2008. 2008. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/01a_2008aspfiles.html. Accessed April 29 2014.
42. Song X, Zhao Z, Barber B, Gregory C, Cao Z, Gao S. Cost of illness in patients with metastatic colorectal cancer. J Med Econ. 2011;14(1):1–9. doi:10.3111/13696998.2010.536870.
43. Best JH, Garrison LP, Hollingworth W, Ramsey SD, Veenstra DL. Preference values associated with stage III colon cancer and adjuvant chemotherapy. Qual Life Res. 2010;19(3):391–400. doi:10.1007/s11136-010-9589-5.
44. Blinman P, Duric V, Nowak AK, Beale P, Clarke S, Briscoe K, et al. Adjuvant chemotherapy for early colon cancer: what survival benefits make it worthwhile? Eur J Cancer. 2010;46(10):1800–7. doi:10.1016/j.ejca.2009.12.032.
45. Aballea S, Chancellor JV, Raikou M, Drummond MF, Weinstein MC, Jourdan S, et al. Cost-effectiveness analysis of oxaliplatin compared with 5-fluorouracil/leucovorin in adjuvant treatment of stage III colon cancer in the US. Cancer. 2007;109(6):1082–9. doi:10.1002/cncr.22512.
46. Cook J, Richardson J, Street A. A cost utility analysis of treatment options for gallstone disease: methodological issues and results. Health Econ. 1994;3(3):157–68.
47. Grunberg SM, Srivastava A, Grunberg KJ, Weeks J. Intensity of chemotherapy-induced emesis and overall survival as determinants of a global utility score. Support Care Cancer. 2002;10(8):624–9. doi:10.1007/s00520-002-0381-0.
48. Briggs A, Claxton K, Sculpher M. Decision modelling for health economic evaluation. Handbooks in health economic evaluation series. Oxford: Oxford University Press; 2006.
49. Severens JL, Brunenberg DE, Fenwick EA, O’Brien B, Joore MA. Cost-effectiveness acceptability curves and a reluctance to lose. Pharmacoeconomics. 2005;23(12):1207–14.
50. Centers for Medicare and Medicaid Services. Payment allowance limits for medicare part B drugs, effective October 1, 2012 through December 31, 2012. 2012. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2012ASPFiles.html. Accessed November 8 2012.
51. Centers for Medicare and Medicaid Services. Payment allowance limits for medicare part B drugs, effective October 1, 2013 through December 31, 2013. 2013. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2013ASPFiles.html. Accessed October 9 2013.
52. O’Brien BJ, Gertsen K, Willan AR, Faulkner LA. Is there a kink in consumers’ threshold value for cost-effectiveness in health care? Health Econ. 2002;11(2):175–80.