Gene Expression Profiling for Guiding Adjuvant Chemotherapy Decisions in Women with Early Breast Cancer An Evidence-Based and Economic Analysis

Ontario Health Technology Assessment Series

Volumn 10, Issue 23, 2010, Pages 1-57

 

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

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85168679425     PISSN: 19157398     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (54)

1. Canadian Cancer Society's Steering Committee. Canadian cancer statistics 2009 [Internet]. Toronto: Canadian Cancer Society. 2009 Apr [cited: 2010 Mar 3]. 124 p. Available from: http://tinyurl.com/d885ah
2. Ghafoor A, Jemal A, Ward E, Cokkinides V, Smith R, Thun M. Trends in breast cancer by race and ethnicity. CA Cancer J Clin 2003; 53(6):342-55.
3. Fisher B, Jeong JH, Bryant J, Anderson S, Dignam J, Fisher ER et al. Treatment of lymph-node- negative, oestrogen-receptor-positive breast cancer: long-term findings from National Surgical Adjuvant Breast and Bowel Project randomised clinical trials. Lancet 2004; 364(9437):858-68.
4. Marchionni L, Wilson RF, Marinopoulos SS, Wolff AC, Parmigiani G, Bass EB et al. Impact of gene expression profiling tests on breast cancer outcomes. Evid Rep Technol Assess (Full Rep) 2007;(160): 1-105.
5. Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004; 351(27):2817-26.
6. Akashi TS, Shimizu C, Ando M, Shibata T, Katsumata N, Kouno T et al. 21-Gene expression profile assay on core needle biopsies predicts responses to neoadjuvant endocrine therapy in breast cancer patients. Breast 2009; 18:171-4.
7. Mina L, Soule SE, Badve S, Baehner FL, Baker J, Cronin M et al. Predicting response to primary chemotherapy: gene expression profiling of paraffin-embedded core biopsy tissue. Breast Cancer Res Treat 2007; 103(2): 197-208.
8. Gianni L, Zambetti M, Clark K, Baker J, Cronin M, Wu J 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 2005; 23(29):7265-77.
9. Chang JC, Makris A, Gutierrez MC, Hilsenbeck SG, Hackett JR, Jeong J et al. Gene expression patterns in formalin-fixed, paraffin-embedded core biopsies predict docetaxel chemosensitivity in breast cancer patients. Breast Cancer Res Treat 2008; 108(2):233-40.
10. Kok M, Linn SC, Van Laar RK, Jansen MP, van den Berg TM, Delahaye LJ et al. Comparison of gene expression profiles predicting progression in breast cancer patients treated with tamoxifen. Breast Cancer Res Treat 2009; 113(2):275-83.
11. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, onso-Coello P et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336(7650):924-6.
12. Cronin M, Sangli C, Liu ML, Pho M, Dutta D, Nguyen A et al. Analytical validation of the Oncotype DX genomic diagnostic test for recurrence prognosis and therapeutic response prediction in node-negative, estrogen receptor-positive breast cancer. Clin Chem 2007; 53(6): 1084-91.
13. Lyman GH, Cosler LE, Kuderer NM, Hornberger J. 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 2007; 109(6): 1011-8.
14. Habel LA, Shak S, Jacobs MK, Capra A, Alexander C, Pho M et al. A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. Breast Cancer Res 2006; 8(3):R25.
15. Paik S, Tang G, Shak S, Kim C, Baker J, Kim W et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 2006; 24(23):3726-34.
16. Oratz R, Paul D, Cohn AL, Sedlacek SM. Impact of a commercial reference laboratory test recurrence score on decision making in early-stage breast cancer. J Oncol Pract 2007; 3(4): 182-8.
17. Hornberger J, Cosler LE, Lyman GH. 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 2005; 11(5):313-24.
18. Esteva FJ, Sahin AA, Cristofanilli M, Coombes K, Lee SJ, Baker J 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 2005; 11(9):3315-9.
19. Cobleigh MA, Tabesh B, Bitterman P, Baker J, Cronin M, Liu ML et al. Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes. Clin Cancer Res 2005; 11(24 Pt 1):8623-31.
20. Cronin M, Pho M, Dutta D, Stephans JC, Shak S, Kiefer MC et al. Measurement of gene expression in archival paraffin-embedded tissues: development and performance of a 92-gene reverse transcriptase-polymerase chain reaction assay. Am J Pathol 2004; 164(1):35-42.
21. Bryant J. Toward a more rational selection of tailored adjuvant therapy data from the National Surgical Adjuvant Breast and Bowel Project. 2005 St. Gallen Breast Cancer Symposium. [Complete slide presentation via Genomic Health]. 2005
22. Asad J, Jacobson AF, Estabrook A, Smith SR, Boolbol SK, Feldman SM et al. Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer? Am J Surg 2008; 196(4):527-9.
23. Fan C, Oh DS, Wessels L, Weigelt B, Nuyten DS, Nobel AB et al. Concordance among gene- expression-based predictors for breast cancer. N Engl J Med 2006; 355(6):560-9.
24. Geffen DB, Amir N, Sion-Vardy N, Ariad S, Kachko L, Bayme M et al. Stage I breast cancer in a regional oncology practice in Israel 2002-2006: clinicopathologic features, risk estimation and planned therapy of 328 consecutive patients. Breast 2009; 18(5):316-21.
25. Goldstein LJ, Gray R, Badve S, Childs BH, Yoshizawa C, Rowley S et al. Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features. J Clin Oncol 2008; 26:4063-71.
26. Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT et al. 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 2010; 11(1):55-65.
27. Lo SS, Mumby PB, Norton J, Rychlik K, Smerage J, Kash 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(10): 1671-6.
28. Espinosa E, Sanchez-Navarro I, Gamez-Pozo A, Marin AP, Hardisson D, Madero R et al. Comparison of prognostic gene profiles using qRT-PCR in paraffin samples: a retrospective study in patients with early breast cancer. PLoS One 2009; 4(6):e5911.
29. Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J et al. 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 2010; 28(11):1829-34.
30. Wolf I, Ben-Baruch N, Shapira-Frommer R, Rizel S, Goldberg H, Yaal-Hahoshen N et al. Association between standard clinical and pathologic characteristics and the 21-gene recurrence score in breast cancer patients: a population-based study. Cancer 2008; 112(4):731-6.
31. Toi M, Iwata H, Yamanaka T, Masuda N, Ohno S, Nakamura S et al. Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population. Cancer 2010; 116(13):3112-8.
32. Mamounas EP, Tang G, Fisher B, Paik S, Shak S, Costantino JP et al. Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20. J Clin Oncol 2010; 28(10): 1677-83.
33. Flanagan MB, Dabbs DJ, Brufsky AM, Beriwal S, Bhargava R. Histopathologic variables predict Oncotype DX recurrence score. Mod Pathol 2008; 21(10): 1255-61.
34. Geradts J, Bean SM, Bentley RC, Barry WT. The oncotype DX recurrence score is correlated with a composite index including routinely reported pathobiologic features. Cancer Invest 2010; 28(9):969-77.
35. Gwin K, Pinto M, Tavassoli FA. Complementary value of the Ki-67 proliferation index to the oncotype DX recurrence score. Int J Surg Pathol 2009; 17(4):303-10.
36. Fisher B, Dignam J, Wolmark N, DeCillis A, Emir B, Wickerham DL et al. Tamoxifen and chemotherapy for lymph node-negative, estrogen receptor-positive breast cancer. J Natl Cancer Inst 1997; 89(22):1673-82.
37. Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M et al. Multie-gene RT-PCR assay for predicting recurrence in node negative breast cancer patients - NSABP studies B-20 and B-14 [Abstract]. Breast Cancer Res Treat 2003; 82:A16.
38. Albain KS, Barlow WE, Ravdin PM, Farrar WB, Burton GV, Ketchel SJ et al. Adjuvant chemotherapy and timing of tamoxifen in postmenopausal patients with endocrine-responsive, node-positive breast cancer: a phase 3, open-label, randomised controlled trial. Lancet 2009; 374(9707):2055-63.
39. Giacomini M, Abelson J, Goldsmith L, Levin L, DeJean D, Smith A. Social values and health technology policy analysis: the role for qualitative social science and humanities research evidence. Canadian Agency for Drugs and Technology in Health (CADTH) Annual Symposium; April 19, 2010; Halifax, Nova Scotia. Giacomini M, Abelson J, Goldsmith L, Levin L, DeJean D, Smith A. Social Values and Health Technology Policy Analysis: The Role for Qualitative Social Science and Humanities Research Evidence. Canadian Agency for Drugs and Technology in Health (CADTH) Annual Symposium; April 19, 2010; Halifax, Nova Scotia.
40. Sun X, Briel M, Walter SD, Guyatt GH. Is a subgroup effect believable? Updating criteria to evaluate the credibility of subgroup analyses. BMJ 2010; 340:c117.
41. Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S et al. Grading quality of evidence and strength of recommendations. BMJ 2004; 328(7454): 1490.
42. Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst 2009; 101(21): 1446-52.
43. Mandrekar SJ, Sargent DJ. Predictive biomarker validation in practice: lessons from real trials. Clin Trials 2010; 7(5):567-73.
44. Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol 2009; 27(24):4027-34.
45. Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: one size does not fit all. J Biopharm Stat 2009; 19(3):530-42.
46. Mandrekar SJ, Grothey A, Goetz MP, Sargent DJ. Clinical trial designs for prospective validation of biomarkers. Am J Pharmacogenomics 2005; 5(5):317-25.
47. Hornberger J, Cosler LE, Lyman GH. 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 2005; 11(5):313-24.
48. Marchionni L, Wilson RF, Wolff AC, Marinopoulos S, Parmigiani G, Bass EB et al. Systematic review: gene expression profiling assays in early-stage breast cancer. Ann Intern Med 2008; 148(5):358-69.
49. Lyman GH, Cosler LE, Kuderer NM, Hornberger J. 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 2007; 109(6): 1011-8.
50. Tsoi DT, Inoue M, Kelly CM, Verma S, Pritchard KI. Cost-effectiveness analysis of recurrence score-guided treatment using a 21-gene assay in early breast cancer. Oncologist 2010; 15(5):457- 65.
51. Canadian Agency for Drugs and Technologies in Health. Guidelines for the economic evaluation of health technologies: Canada [3rd Edition]. Ottawa: Canadian Agency for Drugs and Technologies in Health. 2006 Mar 74 p. Available from: http://www.cadth.ca/media/pdf/186EconomicGuidelinese.pdf
52. Statistics Canada. Consumer Price Index, health and personal care, by province [Internet]. [updated 2010 Sep 27; cited 2010 Nov 29]. Available from: http://www40.statcan.ac.ca/l01/cst01/econ161a-ena.htm
53. John B. Bryant J. Toward a more rational selection of tailored adjuvant therapy [Poster presentation]. Poster presented at the 9th International St. Gallen Oncology Conference on Primary Therapy of Early Breast Cancer, 26-29 January 2005, St. Gallen, Switzerland.
54. Paik S, Tang G, Shak S, Kim C, Baker J, Kim W et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 2006; 24(23):3726-34.