Cost effectiveness of pharmacogenetic testing for uridine diphosphate glucuronosyltransferase 1A1 before irinotecan administration for metastatic colorectal cancer

Cancer

Volumn 115, Issue 17, 2009, Pages 3858-3867

  Gold, Heather Taffet ^a   Hall, Michael J ^b   Blinder, Victoria ^c   Schackman, Bruce R ^a  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b FOX CHASE CANCER CENTER   (United States)

^c MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Colorectal cancer; Cost effectiveness analysis; Genotype testing; Irinotecan; UGT1A1

Indexed keywords

FLUOROURACIL; FOLINIC ACID; GLUCURONOSYLTRANSFERASE 1A1; IRINOTECAN;

ADVERSE DRUG REACTION; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; COLORECTAL CANCER; COST EFFECTIVENESS ANALYSIS; DRUG DOSE REGIMEN; DRUG EFFICACY; HOMOZYGOSITY; METASTASIS; NEUTROPENIA; PHARMACOGENETICS; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR;

CAMPTOTHECIN; COLORECTAL NEOPLASMS; COST-BENEFIT ANALYSIS; DECISION TREES; GENETIC SCREENING; GENETIC VARIATION; GLUCURONOSYLTRANSFERASE; HOMOZYGOTE; HUMANS; NEOPLASM METASTASIS; NEUTROPENIA; QUALITY OF LIFE;

EID: 69249104215     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.24428     Document Type: Article

References (51)

1. American Cancer Society. Cancer Facts and Figures. Available at: http://www.cancer.org/docroot/stt/stt-0.asp. Accessed July 9, 2008.
2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer, version 1. Available at: http://www.nccn.org. Accessed July 9, 2008.
3. United States Food and Drug Administration. FDA approves Campostar for first line therapy in treatment of advanced colorectal cancer. Available at: http://www.fda.gov/bbs/topics/ANSWERS/ANS01011.html. Accessed July 29, 2007.
4. Iyer L, Das S, Janisch L, et al. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J. 2002;2:43-47.
5. Humerickhouse R, Lohrbach K, Li L, Bosron WF, Dolan ME. Characterization of CPT-11 hydrolysis by human liver carboxylesterase isoforms hCE-1 and hCE-2. Cancer Res. 2000;60:1189-1192.
6. Innocenti F, Undevia SD, Iyer L, et al. Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol. 2004;22:1382-1388.
7. Marcuello E, Altes A, Menoyo A, Del Rio E, Gomez-Pardo M, Baiget M. UGT1A1 gene variations and irinotecan treatment in patients with metastatic colorectal cancer. Br J Cancer. 2004;91:678-682.
8. Toffoli G, Cecchin E, Corona G, et al. The role of UGT1A1*28 polymorphism in the pharmacodynamics and pharmacokinetics of irinotecan in patients with metastatic colorectal cancer. J Clin Oncol. 2006;24:3061-3068.
9. Hoskins JM, Goldberg RM, Qu P, Ibrahim JG, McLeod HL. UGT1A1*28 genotype and irinotecan-induced neutropenia: dose matters. J Natl Cancer Inst. 2007;99:1290-1295.
10. Gupta E, Lestingi TM, Mick R, Ramirez J, Vokes EE, Ratain MJ. Metabolic fate of irinotecan in humans: correlation of glucuronidation with diarrhea. Cancer Res. 1994;54:3723-3725.
11. United States Food and Drug Administration. Invader UGT1A1 molecular assay, 510(k) summary. Available at: http://www.fda.gov/cdrh/pdf5/K051824.pdf. Accessed September 30, 2007.
12. United States Food and Drug Administration. Campostar (irinotecan HCl), hepatic dysfunction, pancreatitis, UGT1A1, July 21, 2005, final label. Available at: http://www.fda.gov/cder/foi/label/2005/020571s024,027,028lbl.pdf. Accessed on November 8, 2006.
13. Phillips KA, Van Bebber SL. A systematic review of cost-effectiveness analyses of pharmacogenomic interventions. Pharmacogenomics. 2004;5:1139-1149.
14. TreeAge Software, Inc. TreeAge Pro. Available at: http://www.treeage.com/ products/index.html. Accessed July 29, 2007.
15. Andre T, Louvet C, Maindrault-Goebel F, et al. CPT-11 (irinotecan) addition to bimonthly, high-dose leucovorin and bolus and continuous-infusion 5-fluorouracil (FOLFIRI) for pretreated metastatic colorectal cancer. GERCOR. Eur J Cancer. 1999;35:1343-1347.
16. Tournigand C, Andre T, Achille E, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004;22:229-237.
17. Kweekel DM, Gelderblom H, Van der Straaten T, Antonini NF, Punt CJA, Guchelaar H-J; Dutch Colorectal Cancer Group Study. UGT1A1*28 genotype and irinotecan dosage in patients with metastatic colorectal cancer: a Dutch Colorectal Cancer Group study. Br J Cancer. 2008;99:275-282.
18. Roth AD, Yan P, Dietrich D, et al. Does UGT1A1*28 homozygosity predict for severe toxicity in patients treated with 5-fluorouracil (5-FU)-irinotecan (IRI)? Results of the PETACC 3-EORTC 40993-SAKK 60/00 trial comparing IRI/5-FU/folinic acid (FA) to 5-FU/FA in stage II-III colon cancer. Paper presented at: ASCO 2008 Gastrointestinal Cancers Symposium; January 25-27, 2008; Orlando, Fla.
19. National Cancer Institute, Cancer Therapy Evaluation Program (CTEP). Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Available at: http://www.ctep.cancer.gov/forms/CTCAEv3.pdf. Accessed February 2008.
20. Rouits E, Boisdron-Celle M, Dumont A, Guerin O, Morel A, Gamelin E. Relevance of different UGT1A1 polymorphisms in irinotecan-induced toxicity: a molecular and clinical study of 75 patients. Clin Cancer Res. 2004;10:5151-5159.
21. Elting L, Lu C, Escalante CP, et al. Outcomes and cost of outpatient or inpatient management of 712 patients with febrile neutropenia. J Clin Oncol. 2008;26:606-610.
22. Rougier P, Van Cutsem E, Bajetta E, et al. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer [erratum appears in Lancet. 1998;352:1634]. Lancet. 1998;352:1407-1412.
23. Cunningham D, Pyrhonen S, James RD, et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet. 1998;352:1413-1418.
24. Fuchs CS, Moore MR, Harker G, Villa L, Rinaldi D, Hecht JR. Phase III comparison of 2 irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. J Clin Oncol. 2003;21:807-814.
25. Colucci G, Gebbia V, Paoletti G, et al. Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico Dell'Italia Meridionale. J Clin Oncol. 2005;23:4866-4875.
26. Souglakos J, Androulakis N, Syrigos K, et al. FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG). Br J Cancer. 2006;94:798-805.
27. Fuchs CS, Marshall J, Barrueco J. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: updated results from the BICC-C Study. J Clin Oncol. 2008;26:689-690.
28. Third Wave Products. Current products: advancing personalized medicine: the Invader UGT1A1 molecular assay. Available at: http://www.twt.com/company/ pressreleases/2006/fda-feb-06.htm. Accessed July 29, 2007.
29. United States Food and Drug Administration, Center for Drug Evaluation and Research. Table of valid genomic biomarkers in the context of approved drug labels. Available at: http://www.fda.gov/cder/genomics/genomic-biomarkers-table. htm. Accessed on June 6, 2007.
30. Lin J-P, O'Donnell CJ, Schwaiger JP, et al. Association between the UGT1A1*28 allele, bilirubin levels, and coronary heart disease in the Framingham Heart Study. Circulation. 2006;114:1476-1481.
31. Brown ML, Nayfield SG, Shibley LM. Adjuvant therapy for stage III colon cancer: economics returns to research and cost-effectiveness of treatment. J Natl Cancer Inst. 1994;86:424-430.
32. Brown RE, Hutton J. Cost-utility model comparing docetaxel and paclitaxel in advanced breast cancer patients. Anticancer Drugs. 1998;9:899-907.
33. Bonds DE, Freedberg KA. Combining utility measurements: exploring different approaches [serial online]. Dis Manage Health Outcomes. 2001;9:507-516.
34. Centers for Medicare and Medicaid Services, Department of Health and Human Services. Medicare laboratory fee schedule. Available at: http://www.cms.hhs.gov/. Accessed February 20, 2007.
35. Centers for Medicare and Medicaid Services, Department of Health and Human Services. Medicare Diagnosis-related Group weights. Available at: http://www.cms.hhs.gov/. Accessed February 20, 2007.
36. Centers for Medicare and Medicaid Services, Department of Health and Human Services. Medicare physician fee schedule, 2007. Available at: http://www.cms.hhs.gov. Accessed February 20, 2007.
37. Centers for Medicare and Medicaid Services, Department of Health and Human Services. Medicare drug acquisition price. Available at: http://www.cms.hhs.gov. Accessed February 20, 2007.
38. Gold M, Siegel J, Russell L, Weinstein M. Cost-Effectiveness in Health and Medicine. New York, NY: Oxford University Press; 1996.
39. Yabroff KR, Davis WW, Lamont EB, et al. Patient time costs associated with cancer care. J Natl Cancer Inst. 2007;99:14-23.
40. Ubel PA, Hirth RA, Chernew ME, Fendrick AM. What is the price of life and why doesn't it increase at the rate of inflation? Arch Intern Med. 2003;163:1637-1641, 2003.
41. Hunink M, Glasziou P, Siegel J, et al. Decision Making in Health and Medicine: Integrating Evidence and Values. Cambridge, United Kingdom: Cambridge University Press; 2001.
42. Briggs A, Sculpher M, Claxton K. Decision Modeling for Health Economic Evaluation. Oxford, United Kingdom: Oxford University Press; 2006.
43. National Cancer Institute. Surveillance Epidemiology and End Results data, 1973-2002. Available at: http://seer.cancer.gov/. Accessed March 2007.
44. Phillips KA, Van Bebber SL. Measuring the value of pharmacogenomics. Nat Rev Drug Discov. 2005;4:500-509.
45. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22:151-185.
46. Light DW, Warburton RN. Extraordinary claims require extraordinary evidence. J Health Econ. 2005;24:1030-1033, discussion 1034-1053.
47. Adams CP, Brantner VV. Estimating the cost of new drug development: is it really 802 million dollars? Health Affairs. 2006;25:420-428.
48. Green MD, Koelbl H, Baselga J, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003;14:29-34.
49. Cloughesy T, Filka E, Nelson G, et al. Irinotecan treatment for recurrent malignant glioma using an every-3-week regimen. Am J Clin Oncol. 2002;25:204-208.
50. Vredenburgh J, Desjardins A, Herndon JE 2nd, et al. Bevacizumab plus irinotecan in recurrent glioblastoma multiforme. J Clin Oncol. 2007;25:4722-4729.
51. Dank M, Zaluski J, Barone C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008;19:1450-1457.