Cost-effectiveness of the 21-gene assay for guiding adjuvant chemotherapy decisions in early breast cancer

Value in Health

Volumn 16, Issue 5, 2013, Pages 729-739

  Paulden, Mike ^a   Franek, Jacob ^b   Pham, Ba' ^a   Bedard, Philippe L ^c,d   Trudeau, Maureen ^d,e   Krahn, Murray ^a  

^a UNIVERSITY OF TORONTO   (Canada)

^b ONTARIO MINISTRY OF HEALTH AND LONG TERM CARE   (Canada)

^c PRINCESS MARGARET HOSPITAL   (Canada)

^d UNIVERSITY OF TORONTO   (Canada)

^e DEPARTMENT OF RADIATION ONCOLOGY   (Canada)

Author keywords

breast cancer; chemotherapy; cost effectiveness analysis; decision making; pharmacogenetics

Indexed keywords

ANTINEOPLASTIC AGENT; CYCLOPHOSPHAMIDE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; ESTROGEN RECEPTOR; FLUOROURACIL; METHOTREXATE; PROGESTERONE RECEPTOR; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; TAMOXIFEN;

ADJUVANT CHEMOTHERAPY; ARTICLE; ASSAY; BREAST CANCER; CANCER PATIENT; COST EFFECTIVENESS ANALYSIS; DECISION MAKING; ESTROGEN RECEPTOR POSITIVE BREAST CANCER; GENE; HEALTH CARE COST; HUMAN; LIFESPAN; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; RISK ASSESSMENT;

BREAST CANCER; CHEMOTHERAPY; COST-EFFECTIVENESS ANALYSIS; DECISION MAKING; PHARMACOGENETICS;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; COST-BENEFIT ANALYSIS; DECISION SUPPORT TECHNIQUES; FEMALE; HUMANS; MARKOV CHAINS; MIDDLE AGED; MODELS, ECONOMIC; PRACTICE GUIDELINES AS TOPIC; QUALITY-ADJUSTED LIFE YEARS; RISK ASSESSMENT; TRANSCRIPTOME;

EID: 84881666232     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2013.03.1625     Document Type: Article

References (50)

1. Adjuvant! Inc. Adjuvant! Online. 2011. Available from: http://www.adjuvantonline.com/index.jsp. [Accessed December 2, 2011].
2. Adjuvant! Inc. Comments on definition of relapse. 2011. Available from: http://www.adjuvantonline.com/breasthelp0306/CommentsOfDefinitionOfRelapse.html. [Accessed December 2, 2011].
3. Bryant J. Toward a more rational selection of tailored adjuvant therapy: data from the National Surgical Adjuvant Breast and Bowel Project. Presented at: 9th International Conference on Primary Therapy of Breast Cancer; January 26-29, 2005; St. Gallen, Switzerland.
4. I.A. Olivotto, C.D. Bajdik, and P.M. Ravdin Population-based validation of the prognostic model ADJUVANT! for early breast cancer J Clin Oncol 23 2005 2716 2725
5. I. Genomic Health. Oncotype DX: clinical summary. 2011. Available from: http://www.oncotypedx.com/en-US/Breast/HealthcareProfessional/ClinicalSummary. aspx. [Accessed December 2, 2011].
6. S. Paik, S. Shak, and G. Tang A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer N Engl J Med 351 2004 2817 2826
7. S. Paik, G. Tang, and S. Shak Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer J Clin Oncol 24 2006 3726 3734
8. K.S. Albain, W.B. Barlow, and S. Shak Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial Lancet Oncol 11 2010 55 65
9. M. Dowsett, J. Cuzick, and C. Wale Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study J Clin Oncol 28 2010 1829 1834
10. I. Genomic Health. Quarterly report, 8 November 2011. 2011. Available from: http://biz.yahoo.com/e/111108/ghdx10-q.html. [Accessed December 2, 2011].
11. J.A. Sparano TAILORx: trial assigning individualized options for treatment (Rx) Clin Breast Cancer 7 2006 347 350
12. J.A. Zujewski, and L. Kamin Trial assessing individualized options for treatment for breast cancer: the TAILORx trial Future Oncol 4 2008 603 610
13. Medical Advisory Secretariat of the Ontario Ministry of Health and Long-Term Care. Gene expression profiling for guiding adjuvant chemotherapy decisions in women with early breast cancer. 2010. Available from: http://www.health.gov.on.ca/english/providers/program/mas/tech/ohtas/ tech-gep-20101213.html. [Accessed December 2, 2011].
14. Canadian Agency for Drugs and Technologies in Health. Guidelines for the Economic Evaluation of Health Technologies: Canada. Ottawa, Canada: the Canadian Agency for Drugs and Technologies in Health (CADTH), 2006.
15. O. I. for C. Research. Evaluating pharmacogenetic tests. 2010. Available from: http://oicr.on.ca/report/evaluating-pharmacogenetic-tests. [Accessed December 2, 2011].
16. D.T. Tsoi, M. Inoue, and C.M. Kelly Cost-effectiveness analysis of recurrence score-guided treatment using a 21-gene assay in early breast cancer Oncologist 15 2010 457 465
17. Lo SS, Mumby PB, Norton J, et al. Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol 2010;28:1671-76.
18. Canadian Institute for Health Information. Available from: http://www.cihi.ca. [Accessed February 27, 2013].
19. S. Jones, F.A. Holmes, and J. O'Shaughnessy Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of US oncology research trial 9735 J Clin Oncol 27 2009 1177 1183
20. Roché H, Fumoleau P, Spielmann M, et al. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol;24:5664-71.
21. French Adjuvant Study Group Benefit of a high-dose epirubicin regimen in adjuvant chemotherapy for node-positive breast cancer patients with poor prognostic factors: 5-year follow-up results of French Adjuvant Study Group 05 randomized trial J Clin Oncol 19 2001 602 611
22. B. Fisher, A.M. Brown, and N.V. Dimitrov Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15 J Clin Oncol 8 1990 1483 1496
23. R.C. Coombes, J.M. Bliss, and J. Wils Adjuvant cyclophosphamide, methotrexate, and fluorouracil versus fluorouracil, epirubicin, and cyclophosphamide chemotherapy in premenopausal women with axillary node-positive operable breast cancer: results of a randomized trial J Clin Oncol 14 1 1996 35 45
24. Ludwig Breast Cancer Study Group Prolonged disease-free survival after one course of perioperative adjuvant chemotherapy for node-negative breast cancer N Engl J Med 320 1989 491 496
25. J. Chang, G.M. Clark, and D.C. Allred Survival of patients with metastatic breast carcinoma: importance of prognostic markers of the primary tumor Cancer 97 2003 545 553
26. Statistics Canada. Complete life table, Ontario, 2000 to 2002: females. 2002. Available from: http://www.statcan.gc.ca/pub/84-537-x/4064441-eng.htm. [Accessed December 2, 2011].
27. Bank of Canada. USD/CAD closing rate summary. 2011. Available from: http://www.bankofcanada.ca/rates/exchange/us-can-summary/. [Accessed November 21, 2011].
28. B.P. Will, J.M. Berthelot, and C. Le Petit Estimates of the lifetime costs of breast cancer treatment in Canada Eur J Can 36 2000 724 735
29. Ontario Case Costing Initiative. 2011. Available from: http://www.occp.com/. [Accessed December 2, 2011].
30. M. Lidgren, N. Wilking, B. Jönsson, and C. Rehnberg Health related quality of life in different states of breast cancer Qual Life Res 16 2007 1073 1081
31. A. Briggs, K. Claxton, and M. Sculpher Decision Modelling for Health Economic Evaluation 2006 Oxford University Press Oxford, UK
32. J. Albanell, A. González, and M. Ruiz-Borrego Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer Ann Oncol 23 3 2012 625 631
33. J. Asad, A.F. Jacobson, and A. Estabrook Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer? Am J Surg 196 2008 527 529
34. L.R. Henry, A. Stojadinovic, and S.M. Swain The influence of a gene expression profile on breast cancer decisions J Surg Oncol 99 2009 319 323
35. R. Oratz, D. Paul, and A.L. Cohn Impact of a commercial reference laboratory test recurrence score on decision making in early-stage breast cancer J Oncol Pract Am Soc Clin Oncol 3 2007 182 186
36. T. Vandenberg, J. Younus, and S. Al-Khayyat Febrile neutropenia rates with adjuvant docetaxel and cyclophosphamide chemotherapy in early breast cancer: discrepancy between published reports and community practice - a retrospective analysis Curr Oncol 17 2010 2 3
37. Y. Younis, D. Rayson, and K. Thompson Primary G-CSF prophylaxis for adjuvant TC or FEC-D chemotherapy outside of clinical trial settings: a systematic review and meta-analysis Support Care Cancer 20 10 2012 2523 2530
38. Statistics Canada. Consumer price index, health and personal care: Ontario. 2011. Available from: http://www.statcan.gc.ca. [Accessed December 2, 2011].
39. J. Hornberger, L.E. Cosler, and G.H. Lyman Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer Am J Manag Care 11 2005 313 324
40. G.H. Lyman, L.E. Cosler, N.M. Kuderer, and J. Hornberger Impact of a 21-gene RT-PCR assay on treatment decisions in early-stage breast cancer: an economic analysis based on prognostic and predictive validation studies Cancer 109 2007 1011 1018
41. S. Kondo, L. Hoshi, and H. Ishiguro Economic evaluation of 21-gene reverse transcriptase-polymerase chain reaction assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer in Japan Breast Can Res Treat 112 2008 175 187
42. M. Kondo, S.L. Hoshi, and T. Yamanaka Economic evaluation of the 21-gene signature (Oncotype DX) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03) Breast Can Res Treat 127 2011 739 749
43. S.H. Klang, A. Hammerman, and N. Liebermann Economic implications of 21-gene breast cancer risk assay from the perspective of an Israeli-managed health-care organization Value Health 13 2010 381 387
44. S.D. Reed, M. Dinan, K. Schulman, and G.H. Lyman Cost-effectiveness of the 21-gene recurrence score assay in the context of multifactorial decision making to guide chemotherapy for early-stage breast cancer Genet Med 15 2013 203 211
45. Breastcancer.org. Oncotype DX test. Available from: http://www. breastcancer.org/symptoms/testing/types/oncotype-dx.jsp#insurance. [Accessed February 27, 2013].
46. National Institute for Health and Clinical Excellence. Diagnostics consultation document - Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat. London, UK: National Institute for Health and Clinical Excellence (NICE), February, 2013.
47. OHTAC. OHTAC Recommendation: Multi-Gene Expression Profiling for Guiding Adjuvant Chemotherapy Decisions in Women with Early Breast Cancer. Toronto, ON, Canada: the Ontario Health Technology Advisory Committee (OHTAC), December, 2010.
48. E.A. Slodkowska, and J.S. Ross MammaPrint 70-gene signature: another milestone in personalized medical care for breast cancer patients Expert Rev Molec Diag 9 2009 417 422
49. J. Bartlett, J. Thomas, and D.T. Ross Mammostrat® as a tool to stratify breast cancer patients at risk of recurrence during endocrine therapy BCR 12 2010 R47
50. J. Cuzick, M. Dowsett, and S. Pineda Prognostic value of a combined estrogen receptor, progesterone receptor, Ki-67, and human epidermal growth factor receptor 2 immunohistochemical score and comparison with the genomic health recurrence score in early breast cancer J Clin Oncol 29 2011 4273 4278