Application of a pharmacogenetic test adoption model to six oncology biomarkers

Personalized Medicine

Volumn 7, Issue 4, 2010, Pages 441-450

  Faruki, Hawazin ^a   Lai Goldman, Myla ^b  

^a LABORATORY CORPORATION OF AMERICA   (United States)

^b CancerGuide Diagnostics Inc   (United States)

Author keywords

BCRABL; CYP450; EGFR expression; HER2; KRAS; Oncology; Personalized medicine; Pharmacogenomic tests; Test adoption; UGT1A1 genotype

Indexed keywords

BCR ABL PROTEIN; CETUXIMAB; CLOPIDOGREL; CYTOCHROME P450 2D6; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GLUCURONOSYLTRANSFERASE 1A1; IMATINIB; IRINOTECAN; K RAS PROTEIN; PANITUMUMAB; PRASUGREL; TAMOXIFEN; TRASTUZUMAB;

BREAST CANCER; CHRONIC MYELOID LEUKEMIA; COLORECTAL CANCER; DRUG EXCRETION; DRUG METABOLISM; GENE EXPRESSION; GENE MUTATION; HUMAN; PHARMACOGENETICS; PRIORITY JOURNAL; REVIEW;

EID: 77956967099     PISSN: 17410541     EISSN: 1744828X     Source Type: Journal    
DOI: 10.2217/pme.10.37     Document Type: Review

References (48)

1. Lai-Goldman M, Faruki H: Abacavir hypersensitivity: a model system for pharmacogenetic test adoption. Genet. Med. 10(12), 874-878 (2008).
2. Slamon DJ, Godolphin W, Jones LA et al.: Studies of the Her-2/neu proto-oncogene in human breast and ovarian cancer. Science 244, 707-712 (1989).
3. Paik S, Bryant J, Tau Chiu E et al.: Real-world performance of HER2 testing-national surgical adjuvant breast and bowel project experience. J. Natl Cancer Inst. 94, 852-854 (2002).
4. Roche PC, Suman VJ, Jenkins RB et al.: Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J. Natl Cancer Inst. 94, 855-857 (2002).
5. Wolff AC, Hammond EH, Schwartz JN et al.: American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J. Clin. Oncol. 25(1), 118-145 (2007).
6. Desmedt C, Sperinde J, Piette F et al.: Quantitation of HER2 expression or HER2:HER2 dimers and differential survival in a cohort of metastatic breast cancer patients carefully selected for trastuzumab treatment primarily by FISH. Diag. Molec. Pathol. 18(1), 22-29 (2009).
7. Hughes TP, Kaeda J, Branford S et al.: Frequency of major molecular responses to imatinib or interferon a plus cytarabine in newly diagnosed chronic myeloid leukemia. N. Engl. J. Med. 349(15), 1423-1432 (2003).
8. Hughes T, Branford S: Molecular monitoring of chronic myeloid leukemia. Seminars Hematol. 40(2 Suppl. 2), 62-68 (2003).
9. National Comprehensive Cancer Network: Chronic Myelogenous Leukemia. Clinical Practice Guidelines in Oncology - version 1.2004. National Comprehensive Cancer Network, Inc., PA, USA, Section CML-3 (2004).
10. Hughes T, Deninger M, Hochhaus A et al.: Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results. Blood 108(1), 28-37 (2006).
11. Lievre A, Bachet JB, LeCorre D et al.: KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res. 66(8), 3992-12995 (2006).
12. DiFiore F, Blanchard F, Charbonnier F et al.: Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by cetuximab plus chemotherapy. Br. J. Cancer 96(8), 1166-1169 (2007).
13. DeRoock W, Piessevaux H, deSchutter J et al.: KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Ann. Oncol. 19(3), 508-515 (2008).
14. Goncalves A, Esteyries S, Taylor-Smedra B et al.: A polymorphism of EGFR extracellular domain is associated with progression free-survival in metastatic colorectal cancer patients receiving cetuximab-based treatment. BMC Cancer 8, 169 (2008).
15. Van Cutsem E, Lang I, Dhaens G et al.: KRAS status and efficacy in the first-line treatment of patients with metastatic colorectal cancer (mCRC) treated with FOLFIRI with or without cetuximab: the CRYSTAL experience. J. Clin. Oncol. 26(Suppl.) (2008) (Abstract 2).
16. Bokemeyer C, Bondarenko I, Hartmann J et al.: KRAS status and efficiency of first-line treatment of patients with metastatic colorectal cancer (mCRC) with FOLFOX with or without cetuximab: the OPUS experience. J. Clin. Oncol. 26(Suppl.) (2008) (Abstract 4000).
17. BlueCross BlueShield Association: Technology Evaluation Center: KRAS Mutations and Epidermal Growth Factor Receptor Inhibitor Therapy in Metastatic Colorectal Cancer. TEC assessments (Volume 23, No.6). BlueCross BlueShield Association, IL, USA (2009).
18. Allegra CJ, Jessup JM, Somerfield MR et al.: American Society of Clinical Oncology provisional clinical opinion: testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy. J. Clin. Oncol. 27, 2091-2096 (2009).
19. College of American Pathologists Techology Assessment Committee (TAC): Perspectives on Emerging Technology: KRAS Mutation Testing for Colorectal Cancer. College of American Pathologists, IL, USA (2009).
20. Jin Y, Zeruesenay D, Stearns V et al.: CYP2D6 genotype, antidepressant use and tamoxifen metabolism during adjuvant breast cancer treatment. J. Natl Cancer Inst. 97(1), 30-39 (2005).
21. Borges S, Desta Z, Li L et al.: Quantitative effect of CYP2D6 genotype and inhibitors on tamoxifen metabolism: implication for optimization of breast cancer treatment. Clin. Pharmacol. Ther. 80, 61-74 (2006).
22. Goetz MP, Rae JM, Suman VJ et al.: Pharmacogenetics of tamoxifen biotransformation is associated with clinical outcomes of efficacy and hot flashes. J. Clin. Oncol. 23(36), 9312-9318 (2005).
23. Schroth W, Antoniadou L, Fritz P et al.: Breast cancer treatment outcomes with adjuvant tamoxifen relative to patient CYP2D6 and CYP2C19 genotypes. J. Clin. Oncol. 25(33), 5187-5193 (2007).
24. Stearns V, Johnson MD, Rae JM et al.: Active tamoxifen metabolite plasma concentrations after coadministration of tamoxifen and the selective serotonin reuptake inhibitor paroxetine. J. Natl Cancer Inst. 95(23), 1758-1764 (2003).
25. Goetz MP, Knox SK, Suman V et al.: The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant tamoxifen. Breast Cancer Res. Treat. 101, 113-121 (2007).
26. Hartman AR, Helft P: The ethics of CYP2D6 testing for patients considering tamoxifen. Breast Cancer Res. 9, 103 (2007).
27. 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. 22, 1382-1388 (2004).
28. Iyer L, Das S, Janisch L et al.: UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics 2, 43-47 (2002).
29. Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group: Recommendations from the EGAPP Working Group: can UGT1A1 genotyping reduce morbidity and mortality in patients with metastatic colorectal cancer treated with irinotecan? Genet. Med. 11(1), 15-20 (2009).
30. Simon T, Vertuyft C, Mary-Krause M et al.: Genetic determinants of response to clopidogrel and cardiovascular events. N. Engl. J. Med. 360(4), 363-375 (2009).
31. Freedman JE, Hylek EM. Clopidogrel, genetics, and drug responsiveness. N. Engl. J. Med. 360(4), 411-413 (2009).
32. Cunningham D, Humblet Y, Siena S et al.: Cetuximab with monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N. Engl. J. Med. 351(4), 337-345 (2004).
33. Chung KY, Shia J, Kemeny NE et al.: Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J. Clin. Oncol. 23(9), 1803-1810 (2005).
34. National Comprehensive Cancer Network: Clinical Practice Guidelines in Oncology: Colon Cancer (Version 1.2010): Chemotherapy for Advanced or Metastatic Disease (COL-C), page 3 (footnote 15). National Comprehensive Cancer Network, Inc., PA, USA, Section CML-3 (2004).
35. National Public Radio, Weekend Edition: Interview of Dr Francis Collins. 2 January (2010).
36. Table of valid genomic biomarkers in the context of approved drug labels www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm (Accessed 25 March 2010)
37. National Comprehensive Cancer Network: Updates guidelines for colorectal cancer www.nccn.org/about/news/newsinfo. asp?NewsID=194 (Accessed 27 November 2009)
38. Class labeling changes to anti-EGFR monoclonal antibodies, cetuximab (Erbitux®) and panitumumab (Vectibix®): KRAS mutations www.fda.gov/AboutFDA/CentersOffices/CDER/ucm172905.htm (Accessed 27 November 2009)
39. Cetuximab (Erbitux®) prescribing information www.accessdata.fda.gov/ drugsatfda-docs/label/2009/125084s168lbl.pdf (Accessed 23 November 2009)
40. Panitumumab (Vectibix®) prescribing information www.accessdata.fda. gov/drugsatfda-docs/label/2009/125147s080lbl.pdf (Accessed 23 November 2009)
41. FDA Advisory Committee for Pharmaceutical Science: Clinical Pharmacology Subcommittee Meeting Minutes, 18-19 October (2006) www.fda.gov/ohrms/dockets/ac/ 06/transcripts/2006-4248t1-01.pdf (Accessed 30 March 2010)
42. Center for Medicare and Medicaid Services Office of Clinical Standards and Quality Coverage and Analysis Group: Summary of Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) 27 January (2010) http://oba.od.nih.gov/oba/SACGHS/meetings/feb2010/Roche-Slides.pdf (Accessed 26 March 2010)
43. BlueCross BlueShield Association (BCBSA) Technology Evaluation Center (TEC) CYP2D6 pharmacogenomics of tamoxifen treatment. TEC Assessment Program www.bcbs.com/blueresources/tec/vols/23/cyp2d6-pharmacogenomics-of.html (Accessed 26 March 2010)
44. Aetna Clinical Policy Bulletin: Pharmacogenetic testing www.aetna.com/cpb/medical/data/700-799/0715.html (Accessed 26 March 2010)
45. Cigna Medical Coverage policy: Drug metabolizing enzyme genotype systems (AmpliChip®, Invader®) www.cigna.ca/customer-care/healthcare- professional/coverage-positions/medical/mm-0381-coveragepositioncriteria- AmpliChip.pdf (Accessed 26 March 2010)
46. Camptosar® prescribing information www.pfizer.com/files/products/ uspi- camptosar.pdf (Accessed 26 March 2010)
47. UGT1A1 510(k) Substantial Equivalence determination decision summary www.accessdata.fda.gov/cdrh-docs/reviews/K051824.pdf (Accessed 26 March 2010)
48. EGFR pharmDx, package insert. Dako, Glostrup, Denmark http://pri.dako.com/08052-egfr- pharmdx-interpretation-manual.pdf (Accessed 27 March 2010)