The value of multigene predictors of clinical outcome in breast cancer: An analysis of the evidence

Expert Review of Molecular Diagnostics

Volumn 15, Issue 2, 2015, Pages 277-286

  Issa, Amalia M ^a   Chaudhari, Vivek S ^a   Marchant, Gary E ^b  

^a UNIVERSITY OF THE SCIENCES   (United States)

^b ARIZONA STATE UNIVERSITY   (United States)

Author keywords

breast cancer; Cox hazard ratios; gene expression profiling; meta analysis; multigene predictors; recurrence score

Indexed keywords

BREAST CANCER; CANCER RECURRENCE; GENE EXPRESSION ASSAY; HAZARD RATIO; HUMAN; MULTIGENE FAMILY; PREDICTION; PROPORTIONAL HAZARDS MODEL; REVIEW; BREAST NEOPLASMS; FEMALE; GENETICS; META ANALYSIS; METABOLISM; MOLECULAR DIAGNOSIS; MORTALITY; NEOPLASM RECURRENCE, LOCAL; TREATMENT OUTCOME;

TRANSCRIPTOME; TUMOR MARKER;

BREAST NEOPLASMS; FEMALE; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; NEOPLASM RECURRENCE, LOCAL; PROPORTIONAL HAZARDS MODELS; TRANSCRIPTOME; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 84921326144     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.2015.983476     Document Type: Review

References (74)

1. Siegel R, Ma J, Zou Z, et al. Cancer statistics, 2014. CA Cancer J Clin 2014; 64(1):9-29
2. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: breast cancer. Version 2. 2011. March 2011 update
3. Zeng YC. Chemotherapy in older women with breast cancer. N Engl J Med 2009; 361(10):1023-4
4. Colleoni M, Gelber RD. Time to initiation of adjuvant chemotherapy for early breast cancer and outcome: the earlier, the better?. J Clin Oncol 2014;32(8):717-19
5. Adjuvant! Online. Available from: www.adjuvantonline.com
6. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)-. Version 3. 2013. 05/03/.2013- National Comprehensive Cancer Network, Inc; 2013
7. Goldhirsch A, Winer EP, Coates AS, et al. Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International expert consensus on the primary therapy of early breast cancer 2013. Ann Oncol 2013;24(9):2206-23
8. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology (NCCN Guidelines)-. version I.2014.-. National Comprehensive Cancer Network, Inc; 2014
9. Sinn P, Aulmann S, Wirtz R, et al. Multigene assays for classification, prognosis, and prediction in breast cancer: a critical review on the background and clinical utility. Geburtshilfe Frauenheilkd 2013;73(9):932-40
10. Marchant GE, Lindor RA. Personalized medicine and genetic malpractice. Genet Med 2013;15(12):921-2
11. Marchant GE, Lindor RA. Prudent precaution in clinical trials of nanomedicines. J Law Med Ethics 2012; 40(4):831-40
12. Milburn M, Rosman M, Mylander C, et al. Is oncotype DX recurrence score (RS) of prognostic value once HER2-positive and low-ER expression patients are removed?. Breast J 2013;19(4):357-64
13. Cobleigh MA, Tabesh B, Bitterman P, 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
14. Bartlett JMS, Bloom KJ, Piper T, et al. Mammostrat as an immunohistochemical multigene assay for prediction of early relapse risk in the tamoxifen versus exemestane adjuvant multicenter trial pathology study. J Clin Oncol 2012;30(36): 4477-84
15. Chen BC, Dhanda R, Tseng W, et al. Evaluating use characteristics for the Oncotype Dx 21-gene recurrence score and concordance with chemotherapy use in early-Stage breast cancer. J Oncol Pract 2013;9(4):182-7
16. Toole MJ, Kidwell KM, Poznak C. Van. Breast Cancer: basic and Clinical Research Oncotype Dx Results in Multiple Primary Breast Cancers. Breast Cancer (Auckl) 2014;8:1-6
17. Hassett MJ, Silver SM, Hughes ME, et al. Adoption of gene expression profile testing and association with use of chemotherapy among women with breast cancer. J Clin Oncol 2012;30(18):2218-26
18. Kamal AH, Loprinzi CL, Reynolds C, et al. Breast medical oncologists' use of standard prognostic factors to predict a 21-gene recurrence score. Oncologist 2011;16(10): 1359-66
19. Partin JF, Mamounas EP. Impact of the 21-gene recurrence score assay compared with standard clinicopathologic guidelines in adjuvant therapy selection for node-negative, estrogen receptor-positive breast cancer. Ann Surg Oncol 2011;18(12):3399-406
20. Arpino G, Generali D, Sapino A, et al. Gene expression profiling in breast cancer: a clinical perspective. Breast 2013;22(2): 109-20
21. Desmedt C, Haibe-Kains B, Wirapati P, et al. Biological processes associated with breast cancer clinical outcome depend on the molecular subtypes. Clin Cancer Res 2008;14(16):5158-65
22. Tang G, Shak S, Paik S, et al. Comparison of the prognostic and predictive utilities of the 21-gene Recurrence Score assay and Adjuvant! for women with node-negative, ER-positive breast cancer: results from NSABP B-14 and NSABP B-20. Breast Cancer Res Treat 2011;127(1):133-42
23. Ishibe N, Schully S, Freedman A, et al. Use of Oncotype DX in Women with Node-Positive Breast Cancer. PLoS Curr 2011;3:RRN1249
24. de Boer RH, Baker C, Speakman D, et al. The impact of a genomic assay (Oncotype DX) on adjuvant treatment recommendations in early breast cancer. Med J Aust 2013;199(3):205-8
25. Eiermann W, Rezai M, Kümmel S, et al. The 21-gene recurrence score assay impacts adjuvant therapy recommendations for ER-positive, node-negative and node-positive early breast cancer resulting in a risk-Adapted change in chemotherapy use. Ann Oncol 2013;24(3):618-24
26. 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(10):1671-6
27. Albanell J, González A, Ruiz-Borrego M, et al. Prospective trans GEICAM 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 2012;23(3):625-31
28. Esteva FJ, Hortobagyi GN. Integration of systemic chemotherapy in the management of primary breast cancer. Oncologist 1998; 3(5):300-13
29. Schneider JG, Khalil DN. Why does Oncotype DX recurrence score reduce adjuvant chemotherapy use?. Breast Cancer Res Treat 2012;134(3):1125-32
30. Haas JS, Liang SY, Hassett MJ, et al. Gene expression profile testing for breast cancer and the use of chemotherapy, serious adverse effects, and costs of care. Breast Cancer Res Treat 2011;130(2):619-26
31. Marchionni L, Wilson RF, Wolff AC. Systematic review: gene expression profiling assays in early-stage breast cancer. Ann Intern Med 2008;148(5):358-69
32. Kok M, Linn SC, Van Laar RK, 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
33. Carlson JJ, Roth JA. The impact of the Oncotype Dx breast cancer assay in clinical practice: a systematic review and meta-Analysis. Breast Cancer Res Treat 2013;141(1):13-22
34. Mamounas EP, Tang G, Paik S, et al. Prognostic impact of the 21-gene recurrence score on disease-free and overall survival of node positive, ER-positive patients with breast cancer treated with adjuvant chemotherapy: Results from NSABP B-28. Presented at 2012 Breast Cancer Symposium; 13-15 September; San Francsco, CA, USA. 2012
35. Drukker CA, Bueno-de-Mesquita JM, Retèl VP, et al. A prospective evaluation of a breast cancer prognosis signature in the observational RASTER study. Int J Cancer 2013;133(4):929-36
36. Stemmer SM, Klang SH, Ben-Baruch N, et al. The impact of the 21-gene Recurrence Score assay on clinical decision-making in node-positive (up to 3 positive nodes) estrogen receptor-positive breast cancer patients. Breast Cancer Res Treat 2013; 140(1):83-92
37. Asad J, Jacobson AF, Estabrook A, 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
38. Mukherjee A, Rakha EA. Integrating breast cancer genetics into clinical practice. Womens Health (Lond Engl) 2012;8(1): 99-112
39. Marchant GE, Lindor RA, Campos-Outcalt DE. Physician liability: the next big thing for personalized medicine?. Pers Med 2011;8(4):457-67
40. Albain KS, Barlow WE, Shak S, 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
41. Sparano JA. TAILORx: trial assigning individualized options for treatment (Rx). Clin Breast Cancer 2006;7(4):347-50
42. Viale G, Slaets L, Bogaerts J, et al. High concordance of protein (by IHC), gene (by FISH; HER2 only), and microarray readout (by TargetPrint) of ER, PgR, and HER2: results from the EORTC 10041/BIG 03-04 MINDACT trial. Ann Oncol 2014; 25(4):816-23
43. Mook S, Knauer M, Bueno-de-Mesquita JM, et al. Metastatic potential of T1 breast cancer can be predicted by the 70-gene MammaPrint signature. Ann Surg Oncol 2010;17(5): 1406-13
44. Knauer M, Mook S, Rutgers EJ, et al. The predictive value of the 70-gene signature for adjuvant chemotherapy in early breast cancer. Breast Cancer Res Treat 2010; 120(3):655-61
45. Buyse M, Loi S, van'Veer L, et al. Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. J Natl Cancer Inst 2006;98(17):1183-92
46. Van de Vijver MJ, He YD, van'Veer LJ, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med 2002;347(25):1999-2009
47. Bueno-de-Mesquita JM, Linn SC, Keijzer R, et al. Validation of 70-gene prognosis signature in node-negative breast cancer. Breast Cancer Res Treat 2009;117(3):483-95
48. Mook S, Schmidt MK, Viale G, et al. The 70-gene prognosis-signature predicts disease outcome in breast cancer patients with 1-3 positive lymph nodes in an independent validation study. Breast Cancer Res Treat 2009;116(2):295-302
49. Saghatchian M, Mook S, Pruneri G, et al. Additional prognostic value of the 70-gene signature (MammaPrint(-)) among breast cancer patients with 4-9 positive lymph nodes. Breast 2013;22(5):682-90
50. Knauer M, Cardoso F, Wesseling J, et al. Identification of a low-risk subgroup of HER-2-positive breast cancer by the 70-gene prognosis signature. Br J Cancer 2010;103(12):1788-93
51. Glas AM, Floore A, Delahaye LJ, et al. Converting a breast cancer microarray signature into a high-Throughput diagnostic test. BMC Genomics 2006;7:278
52. Mook S, Schmidt MK, Weigelt B, et al. The 70-gene prognosis signature predicts early metastasis in breast cancer patients between 55 and 70 years of age. Ann Oncol 2010;21(4):717-22
53. Ross DT, Kim CY, Tang G, et al. Chemosensitivity and stratification by a five monoclonal antibody immunohistochemistry test in the NSABP B14 and B20 trials. Clin Cancer Res 2008;14(20):6602-9
54. Zhang Y, Sieuwerts AM, McGreevy M, et al. The 76-gene signature defines high-risk patients that benefit from adjuvant tamoxifen therapy. Breast Cancer Res Treat 2009;116(2):303-9
55. Gray RG, Quirke P, Handley K, et al. Validation study of a quantitative multigene reverse transcriptase-polymerase chain reaction assay for assessment of recurrence risk in patients with stage II colon cancer. J Clin Oncol 2011;29(35):4611-19
56. Dowsett M, Cuzick J, Wale C, 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
57. 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 2006;24(23):3726-34
58. Wang Y, Klijn JG, Zhang Y, et al. Gene-expression profiles to predict distant metastasis of lymph-node-negative primary breast cancer. Lancet 2005;365(9460):671-9
59. Desmedt C, Piette F, Loi S, et al. Strong time dependence of the 76-gene prognostic signature for node-negative breast cancer patients in the TRANSBIG multicenter independent validation series. Clin Cancer Res 2007;13:3207-14
60. Foekens JA, Atkins D, Zhang Y, et al. Multicenter validation of a gene expression-based prognostic signature in lymph node-negative primary breast cancer. J Clin Oncol 2006;24(11):1665-71
61. Prat A, Parker JS, Fan C, et al. Concordance among gene expression-based predictors for ER-positive breast cancer treated with adjuvant tamoxifen. Ann Oncol 2012;23(11):2866-73
62. Oratz R, Paul D, Cohn AL, et al. Impact of a commercial reference laboratory test recurrence score on decision making in early-stage breast cancer. J Oncol Pract 2007;3(4):182-6
63. Erb C, Fox KR, Patel M, et al. Evaluation of practice patterns in the treatment of node-negative, hormone-receptor positive breast cancer patients with the use of the oncotype DX assay at the University of Pennsylvania. Presented at 30th Annual San Antonio Breast Cancer Symposium;13-16 December 2007; St. Antonio, Texas. 2007
64. Henry LR, Stojadinovic A, Swain SM, et al. The influence of a gene expression profile on breast cancer decisions. J Surg Oncol 2009;99(6):319-23
65. Geffen DB, Amir N, Sion-Vardy N, 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
66. Klang SH, Hammerman A, Liebermann N, et al. Economic implications of 21-gene breast cancer risk assay from the perspective of an Israeli-managed health-care organization. Value Health 2010;13(4): 381-7
67. 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 2011;126(3):797-802
68. Oratz R, Kim B, Chao C, et al. 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 2011;7(2):94-9
69. Joh JE, Esposito NN, Kiluk JV, et al. The effect of Oncotype DX recurrence score on treatment recommendations for patients with estrogen receptor-positive early stage breast cancer and correlation with estimation of recurrence risk by breast cancer specialists. Oncologist 2011;16(11): 1520-6
70. Malo TL, Lipkus I, Wilson T, et al. Treatment choices based on Oncotype DX in the breast oncology care setting. J Cancer Epidemiol 2012;2012(2012):941495
71. Holt S, Bertelli G, Humphreys I, et al. A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the U.K. Br J Cancer 2013; 108(11):2250-8
72. Davidson JA, Cromwell I, Ellard SL, et al. A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score- assay in oestrogen receptor positive node negative breast cancer. Eur J Cancer 2013;49(11): 2469-75
73. Yamauchi H, Nakagawa C, Takei H, et al. Prospective study of the effect of the 21-gene assay on adjuvant clinical decision-making in Japanese women with estrogen receptor-positive, node-negative, and node-positive breast cancer. Clin Breast Cancer 2014;14(3):191-7
74. Fried G, Moskovitz M. Treatment decisions in estrogen receptor-positive early breast cancer patients with intermediate Oncotype DX recurrence score results. Springerplus 2014;3:71