Paying for personalized care: Cancer biomarkers and comparative effectiveness

Molecular Oncology

Volumn 6, Issue 2, 2012, Pages 260-266

  Thariani, Rahber ^a   Veenstra, David L ^a   Carlson, Josh J ^a   Garrison, Louis P ^a   Ramsey, Scott ^b  

^a UNIVERSITY OF WASHINGTON   (United States)

^b Fred Hutchinson Cancer Research Center   (United States)

Author keywords

Comparative effectiveness; Diagnostics; Personalized genomics; Value

Indexed keywords

CETUXIMAB; ERLOTINIB; TRASTUZUMAB; TUMOR MARKER;

ARTICLE; BREAST CANCER; CANCER DIAGNOSIS; CANCER GENETICS; CANCER PROGNOSIS; CANCER SURVIVAL; CANCER THERAPY; COLORECTAL CANCER; COMPARATIVE EFFECTIVENESS; DECISION TREE; DIAGNOSTIC VALUE; FALSE NEGATIVE RESULT; FALSE POSITIVE RESULT; GENE MUTATION; HEALTH CARE COST; HUMAN; LUNG NON SMALL CELL CANCER; MEDICAL DECISION MAKING; NEOPLASM; OUTCOME ASSESSMENT; PATIENT CARE; PERSONALIZED MEDICINE; PRACTICE GUIDELINE; PREDICTIVE VALUE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY ADJUSTED LIFE YEAR; QUALITY OF LIFE; REIMBURSEMENT; RESOURCE ALLOCATION; SENSITIVITY AND SPECIFICITY; TREATMENT RESPONSE;

EID: 84860468495     PISSN: 15747891     EISSN: 18780261     Source Type: Journal    
DOI: 10.1016/j.molonc.2012.02.006     Document Type: Article

References (52)

1. Aspinall M.G., Hamermesh R.G. Realizing the promise of personalized medicine. Harvard Business Review 2007, 85(10):108.
2. Blank P.R., et al. KRAS and BRAF mutation analysis in metastatic colorectal cancer: a cost-effectiveness analysis from a Swiss perspective. Clinical Cancer Research: An Official Journal of the American Association for Cancer Research 2011.
3. Bonanno L., et al. Prognostic and predictive implications of EGFR mutations, EGFR copy number and KRAS mutations in advanced stage lung adenocarcinoma. Anticancer Research 2010, 30(12):5121-5128.
4. Braithwaite R.S., et al. What does the value of modern medicine say about the $50,000 per quality-adjusted life-year decision rule?. Medical Care 2008, 46(4):349-356.
5. Camajova J., et al. Variability in the use of CE-marked assays for in vitro diagnostics of CFTR gene mutations in European genetic testing laboratories. European Journal of Human Genetics: EJHG 2009, 17(4):537-540.
6. Cappuzzo F., et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. The Lancet Oncology 2010, 11(6):521-529.
7. Chakravarti A. To a future of genetic medicine. Nature 2001, 409(6822):822-823.
8. Concato J., Shah N., Horwitz R.I. Randomized, controlled trials, observational studies, and the hierarchy of research designs. The New England Journal of Medicine 2000, 342(25):1887-1892.
9. De Roock W., et al. KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Annals of Oncology: Official Journal of the European Society for Medical Oncology/ESMO 2008, 19(3):508-515.
10. Dowsett M., et al. Correlation between immunohistochemistry (Hercep Test) and fluorescence in situ hybridization (FISH) for HER-2 in 426 breast carcinomas from 37 centres. The Journal of Pathology 2003, 199(4):418-423.
11. Eberhard D.A., Giaccone G., Johnson B.E. Biomarkers of response to epidermal growth factor receptor inhibitors in Non-Small-Cell Lung Cancer Working Group: standardization for use in the clinical trial setting. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 2008, 26(6):983-994.
12. Elkin E.B., et al. HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost-effectiveness analysis. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 2004, 22(5):854-863.
13. Ford D., et al. Genetic heterogeneity and penetrance analysis of the BRCA1 and BRCA2 genes in breast cancer families. The Breast Cancer Linkage Consortium. American Journal of Human Genetics 1998, 62(3):676-689.
14. Garrison L.P., Austin M.J. Linking pharmacogenetics-based diagnostics and drugs for personalized medicine. Health Affairs 2006, 25(5):1281-1290.
15. Gerber D.E. Targeted therapies: a new generation of cancer treatments. American Family Physician 2008, 77(3):311-319.
16. Grosse S.D., Khoury M.J. What is the clinical utility of genetic testing?. Genetics in Medicine: Official Journal of the American College of Medical Genetics 2006, 8(7):448-450.
17. Health, G., 2010. Annual Report.
18. Helms P.J. 'Real world' pragmatic clinical trials: what are they and what do they tell us?. Pediatric Allergy and Immunology: Official Publication of the European Society of Pediatric Allergy and Immunology 2002, 13(1):4-9.
19. Herbst R.S., Lippman S.M. Molecular signatures of lung cancer-toward personalized therapy. The New England Journal of Medicine 2007, 356(1):76-78.
20. Hofmann M., et al. Central HER2 IHC and FISH analysis in a trastuzumab (Herceptin) phase II monotherapy study: assessment of test sensitivity and impact of chromosome 17 polysomy. Journal of Clinical Pathology 2008, 61(1):89-94.
21. Hornberger J., Cosler L.E., Lyman G.H. Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer. The American Journal of Managed Care 2005, 11(5):313-324.
22. Jackman D.M., et al. Impact of epidermal growth factor receptor and KRAS mutations on clinical outcomes in previously untreated non-small cell lung cancer patients: results of an online tumor registry of clinical trials. Clinical Cancer Research: an Official Journal of the American Association for Cancer Research 2009, 15(16):5267-5273.
23. Khoury M.J. Genetics and genomics in practice: the continuum from genetic disease to genetic information in health and disease. Genetics in Medicine: Official Journal of the American College of Medical Genetics 2003, 5(4):261-268.
24. Lecomte T., et al. Thymidylate synthase gene polymorphism predicts toxicity in colorectal cancer patients receiving 5-fluorouracil-based chemotherapy. Clinical Cancer Research: an Official Journal of the American Association for Cancer Research 2004, 10(17):5880-5888.
25. Lilja H., Ulmert D., Vickers A.J. Prostate-specific antigen and prostate cancer: prediction, detection and monitoring. Nature reviews. Cancer 2008, 8(4):268-278.
26. Lin K., et al. Benefits and harms of prostate-specific antigen screening for prostate cancer: an evidence update for the U.S. Preventive Services Task Force. Annals of Internal Medicine 2008, 149(3):192-199.
27. Luce B.R., et al. Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Annals of Internal Medicine 2009, 151(3):206-209.
28. Macpherson H. Pragmatic clinical trials. Complementary Therapies in Medicine 2004, 12(2-3):136-140.
29. Marthe R., Gold J.E.S., Russell Louise B., Weinstein Milton C. Cost-effectiveness in Health and Medicine 1996.
30. Medicine, I.O., 2009. Initial National Priorities for Comparative Effectiveness Research.
31. Mino-Kenudson M., Mark E.J. Reflex testing for epidermal growth factor receptor mutation and anaplastic lymphoma kinase fluorescence in situ hybridization in non-small cell lung cancer. Archives of Pathology & Laboratory Medicine 2011, 135(5):655-664.
32. Nadler E., Eckert B., Neumann P.J. Do oncologists believe new cancer drugs offer good value?. The Oncologist 2006, 11(2):90-95.
33. Neumann P.J., et al. Are pharmaceuticals cost-effective? A review of the evidence. Health Affairs 2000, 19(2):92-109.
34. Oncology Times, R.S.T. Two weeks, two drugs, two companion diagnostics - A growing theme. But at What Cost? August 30, 2011.
35. Pharoah P.D., et al. Polygenes, risk prediction, and targeted prevention of breast cancer. The New England Journal of Medicine 2008, 358(26):2796-2803.
36. Popat S., Hubner R., Houlston R.S. Systematic review of microsatellite instability and colorectal cancer prognosis. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 2005, 23(3):609-618.
37. Ramsey S.D. Personal Communication with Oncology Experts 2011.
38. Ramsey S.D.G., et al. Genomic Testing Patterns and Preferences in Advanced Nonsmall Cell Lung Cancer 2011.
39. Ramsey S.D., et al. Toward evidence-based assessment for coverage and reimbursement of laboratory-based diagnostic and genetic tests. American Journal of Managed Care 2006, 12(4):197-202.
40. Seidman A.D., et al. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. Journal of Clinical Oncology 2001, 19(10):2587-2595.
41. Shankaran, V., Bentrem, D.J., Mulcahy, M.F., Bennett, C.L., Benson, A.B.III. Economic Implications of Kras Testing in Metastatic Colorectal Cancer (mCRC). In 2009 Gastrointestinal Cancers Symposium 2009.
42. Sox H.C., Greenfield S. Comparative effectiveness research: a report from the Institute of Medicine. Annals of Internal Medicine 2009, 151(3):203-205.
43. Sullivan S.D., et al. Health technology assessment in health-care decisions in the United States. Value in Health: The Journal of the International Society for Pharmacoeconomics and Outcomes Research 2009, 12(Suppl. 2):S39-S44.
44. Thariani, R.E.A., Prioritization in cancer genomics: the CANCERGEN experience. Medical Care (Accepted), 2011.
45. Tsoi D.T., et al. Cost-effectiveness analysis of recurrence score-guided treatment using a 21-gene assay in early breast cancer. The Oncologist 2010, 15(5):457-465.
46. Varella-Garcia M., et al. EGFR fluorescence in situ hybridisation assay: guidelines for application to non-small-cell lung cancer. Journal of Clinical Pathology 2009, 62(11):970-977.
47. Veenstra D.G.L., Ramsey S. Economic issues and genomic medicine. Essentials of Genomic and Personalized Medicine 2009, Academic Press, New York. H.W. Geoffrey Ginsburg (Ed.).
48. Walther A., et al. Genetic prognostic and predictive markers in colorectal cancer. Nature reviews. Cancer 2009, 9(7):489-499.
49. Weinstein M.C., Skinner J.A. Comparative effectiveness and health care spending - Implications for reform. New England Journal of Medicine 2010, 362(5):460-465.
50. Willan A.R., Pinto E.M. The value of information and optimal clinical trial design. Statistics in Medicine 2005, 24(12):1791-1806.
51. Willard H.F., Angrist M., Ginsburg G.S. Genomic medicine: genetic variation and its impact on the future of health care. Philosophical transactions of the Royal Society of London. Series B, Biological Sciences 2005, 360(1460):1543-1550.
52. Zhou C., et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. The Lancet Oncology 2011, 12(8):735-742.