Barriers to the use of personalized medicine in breast cancer

Journal of Oncology Practice

Volumn 8, Issue 4, 2012, Pages

  Weldon, Christine B ^a   Trosman, Julia R ^a   Gradishar, William J ^a   Benson III, Al B ^a   Schink, Julian C ^a  

^a NORTHWESTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BRCA1 PROTEIN; BRCA2 PROTEIN;

ARTICLE; BREAST CANCER; BREAST SURGERY; CANCER ADJUVANT THERAPY; CANCER RECURRENCE; CANCER SURVIVOR; GENE EXPRESSION PROFILING; GENE MUTATION; GENETIC SERVICE; HEALTH CARE COST; HEALTH CARE DELIVERY; HEALTH CARE POLICY; HUMAN; MOLECULAR DIAGNOSIS; ONCOGENE; PATIENT ADVOCACY; PERCEPTION; PERSONALIZED MEDICINE; QUALITATIVE RESEARCH; REIMBURSEMENT; THERAPY DELAY;

BRCA1 PROTEIN; BRCA2 PROTEIN; BREAST NEOPLASMS; DECISION MAKING; DELIVERY OF HEALTH CARE; FEMALE; GENE EXPRESSION PROFILING; HEALTH SERVICES ACCESSIBILITY; HUMANS; INDIVIDUALIZED MEDICINE; INSURANCE, HEALTH, REIMBURSEMENT; MOLECULAR DIAGNOSTIC TECHNIQUES; QUESTIONNAIRES;

EID: 84870377686     PISSN: 15547477     EISSN: 1935469X     Source Type: Journal    
DOI: 10.1200/JOP.2011.000448     Document Type: Article

References (58)

1. Secretary's Advisory Committee on Genetics, Health, and Society: The integration of genetic technologies into health care and public health. http://oba.od.nih.gov/SACGHS/sacghs-documents.html
2. Collins FS: Research agenda. Opportunities for research and NIH. Science 327:36-37, 2010
3. President's Council of Advisors on Science and Technology: Priorities for personalized medicine. Washington DC, Executive Office of the President of the United States of America, 2008
4. Hamburg MA, Collins FS: The path to personalized medicine. N Engl J Med 363:301-304, 2010
5. Peppercorn JM, Smith TJ, Helft PR, et al: American Society of Clinical Oncology statement: Toward individualized care for patients with advanced cancer. J Clin Oncol 29:755-760, 2011
6. Harris L, Fritsche H, Mennel R, et al: American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol 25:5287-5312, 2007 (Pubitemid 350232263)
7. Robson ME, Storm CD, Weitzel J, et al: American Society of Clinical Oncology policy statement update: Genetic and genomic testing for cancer susceptibility. J Clin Oncol 28:893-901, 2010
8. Phillips KA: Closing the evidence gap in the use of emerging testing technologies in clinical practice. JAMA 300:2542-2544, 2008
9. Aspinall MG, Hamermesh RG: Realizing the promise of personalized medicine. Harv Bus Rev 85:108-117, 2007
10. Deverka PA, Doksum T, Carlson RJ: Integrating molecular medicine into the US health-care system: Opportunities, barriers, and policy challenges. Clin Pharmacol Ther 82:427-434, 2007 (Pubitemid 47414350)
11. Wideroff L, Phillips KA, Randhawa G, et al: A health services research agenda for cellular, molecular and genomic technologies in cancer care. Public Health Genomics 12:233-244, 2009
12. Secretary's Advisory Committee on Genetics, Health, and Society: Coverage and reimbursement of genetic tests and services. http://oba.od.nih.gov/oba/ sacghs/reports/CR-report.pdf
13. Centers for Medicare & Medicaid Services: Update on horizon scans of genetic tests currently available for clinical use in cancers. https://www.cms.gov/medicare-coverage-database/details/technology-assessments- details.aspx?TAId=81&bc=AAAQAAAAAAAA&
14. Miller FA, Krueger P, Christensen RJ, et al: Postal survey of physicians and laboratories: Practices and perceptions of molecular oncology testing. BMC Health Serv Res 9:131, 2009
15. Schwartz MD, Lerman C, Brogan B, et al: Utilization of BRCA1/BRCA2 mutation testing in newly diagnosed breast cancer patients. Cancer Epidemiol Biomarkers Prev 14:1003-1007, 2005 (Pubitemid 40478572)
16. Weitzel JN, McCaffrey SM, Nedelcu R, et al: Effect of genetic cancer risk assessment on surgical decisions at breast cancer diagnosis. Arch Surg 138:1323-1329, 2003 (Pubitemid 37499389)
17. National Comprehensive Cancer Network: NCCN Guidelines. Breast cancer. Version 2.2011. www.nccn.org/professionals/physician-gls/f-guidelines.asp
18. Levy DE, Byfield SD, Comstock CB, et al: Underutilization of BRCA1/2 testing to guide breast cancer treatment: Black and Hispanic women particularly at risk. Genet Med 13:349-355, 2011
19. Haas JS, Phillips KA, Liang SY, et al: Genomic testing and therapies for breast cancer in clinical practice. Am J Manag Care 17:e174-e181, 2011
20. Ritchie J, Lewis J: Qualitative Research Practice: A Guide for Social Science Students and Researchers. Thousand Oaks, CA, Sage, 2003
21. Meyer J: Qualitative research in health care. Using qualitative methods in health related action research. BMJ 320:178-181, 2000
22. Patton MQ: Qualitative Research and Evaluation Methods (ed 3). Thousand Oaks, CA, Sage, 2002
23. Pope C, Mays N: Qualitative Research in Health Care (ed 3). Malden, MA, Blackwell Publishing/BMJ Books, 2006
24. Pope C, Ziebland S, Mays N: Qualitative research in health care. Analysing qualitative data. BMJ 320:114-116, 2000
25. Haffty BG, Harrold E, Khan AJ, et al: Outcome of conservatively managed early-onset breast cancer by BRCA1/2 status. Lancet 359:1471-1477, 2002 (Pubitemid 34457765)
26. Metcalfe K, Lynch HT, Ghadirian P, et al: Contralateral breast cancer in BRCA1 and BRCA2 mutation carriers. J Clin Oncol 22:2328-2335, 2004 (Pubitemid 41115389)
27. Pierce LJ, Levin AM, Rebbeck TR, et al: Ten-year multi-institutional results of breast-conserving surgery and radiotherapy in BRCA1/2-associated stage I/II breast cancer. J Clin Oncol 24:2437-2443, 2006 (Pubitemid 46630619)
28. Graeser MK, Engel C, Rhiem K, et al: Contralateral breast cancer risk in BRCA1 and BRCA2 mutation carriers. J Clin Oncol 27:5887-5892, 2009
29. National Comprehensive Cancer Network: NCCN guidelines. Breast cancer risk reduction. Version 2.2011,
30. Palomares MR, Paz B, Weitzel JN: Genetic cancer risk assessment in the newly diagnosed breast cancer patient is useful and possible in practice. J Clin Oncol 23:3165-166; author reply 3166-3167, 2005
31. Daly MB: Tailoring breast cancer treatment to genetic status: The challenges ahead. J Clin Oncol 22:1776-1777, 2004
32. Garber JE, Golshan M: Contralateral breast cancer in BRCA1/BRCA2 mutation carriers: The story of the other side. J Clin Oncol 27:5862-5864, 2009
33. Schwartz MD, Lerman C, Brogan B, et al: Impact of BRCA1/BRCA2 counseling and testing on newly diagnosed breast cancer patients. J Clin Oncol 22:1823-1829, 2004 (Pubitemid 41095172)
34. Myriad Genetics: BRACAnalysis questions and answers. https://www. myriadpro.com/node/109/anchor
35. Marchionni L, Wilson RF, Wolff AC, et al: Systematic review: Gene expression profiling assays in early-stage breast cancer. Ann Intern Med 148:358-369, 2008 (Pubitemid 351665467)
36. Paik S, Shak S, Tang G, et al: A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 351:2817-2826, 2004 (Pubitemid 40051905)
37. Paik S, Tang G, Shak S, et al: Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 24:3726-3734, 2006 (Pubitemid 46622311)
38. Habel LA, Shak S, Jacobs MK, et al: A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. Breast Cancer Res 8:R25, 2006
39. Esteva FJ, Sahin AA, Cristofanilli M, et al: Prognostic role of a multigene reverse transcriptase-PCR assay in patients with node-negative breast cancer not receiving adjuvant systemic therapy. Clin Cancer Res 11:3315-3319, 2005 (Pubitemid 40627881)
40. Gianni L, Zambetti M, Clark K, et al: Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer. J Clin Oncol 23:7265-7277, 2005 (Pubitemid 46202341)
41. Mina L, Soule SE, Badve S, et al: Predicting response to primary chemotherapy: Gene expression profiling of paraffin-embedded core biopsy tissue. Breast Cancer Res Treat 103:197-208, 2007 (Pubitemid 46789142)
42. Genomic Health: Oncotype DX breast cancer assay. Frequently asked questions. www.oncotypedx.com/en-US/Breast/PatientCaregiver/FAQs.aspx#7
43. Myriad to conduct BRCA mutation testing for Abbott's phase III study. Genetic Engineering and Biotechnology News. www.genengnews.com/gen-news- highlights/myriad-to-conduct-brca-mutation-testing-for-abbott-s-phase-iii-study/ 81244135/
44. Oratz R, Kim B, Chao C: Physician survey of the effect of the 21-gene recurrence score assay results on treatment recommendations for patients with lymph node-positive, estrogen receptor-positive breast cancer. J Oncol Pract 7:5, 2011
45. Ademuyiwa FO, Miller A, O'Connor T, et al: The effects of oncotype DX recurrence scores on chemotherapy utilization in a multi-institutional breast cancer cohort. Breast Cancer Res Treat 126:797-802, 2011
46. Hornberger J, Chien R, Krebs K, et al: US insurance program's experience with a multigene assay for early-stage breast cancer. Am J Manag Care 17:e194-e202, 2011
47. Jacobson M, O'Malley AJ, Earle CC, et al: Does reimbursement influence chemotherapy treatment for cancer patients? Health Aff (Millwood) 25:437-443, 2006 (Pubitemid 43529552)
48. Jacobson M, Earle CC, Price M, et al: How Medicare's payment cuts for cancer chemotherapy drugs changed patterns of treatment. Health Aff (Millwood) 29:1391-1399, 2010
49. Patient Protection and Affordable Care Act, Pub L No. 111-148, 124 Stat 727, §6301
50. Clauser SB, Wagner EH, Aiello Bowles EJ, et al: Improving modern cancer care through information technology. Am J Prev Med 40:S198-S207, 2011
51. Galligioni E, Berloffa F, Caffo O, et al: Development and daily use of an electronic oncological patient record for the total management of cancer patients: 7 years' experience. Ann Oncol 20:349-352, 2009
52. Reid PR, Compton WD, Grossman JH, et al: Building a better delivery system: A new engineering/health care partnership. Washington, DC, National Academies Press, 2005
53. Krist AH, Woolf SH: A vision for patient-centered health information systems. JAMA 305:300-301, 2011
54. Elkin EB, Bach PB: Cancer's next frontier: Addressing high and increasing costs. JAMA 303:1086-1087, 2010
55. Bach PB, Mirkin JN, Luke JJ: Episode-based payment for cancer care: A proposed pilot for Medicare. Health Aff (Millwood) 30:500-509, 2011
56. Newcomer L: Three changes for affordable care: One payer's wish list. J Oncol Pract 5:219-221, 2009
57. Doll KM, Weldon CB, Trosman JR, et al: BRCA+ test result impact and timing on surgical treatment decisions for patients with breast cancer. J Clin Oncol 29:76s, 2011 (suppl; abstr 626)
58. Weldon CB, Trosman JR, Dupuy DM, et al: Are breast cancer screening patients with family cancer history directed to genetic counseling/testing? Presented at the American Association of Cancer Research Fourth Conference on the Science of Cancer Health Disparities, Washington DC, September 18-21, 2011 (abstr A38) www.aacr.org/Uploads/DocumentRepository/2011-conf/CHD2011-abstracts- posterA.pdf, 2011