Review of the clinical studies using the 21-gene assay

Oncologist

Volumn 15, Issue 5, 2010, Pages 447-456

  Kelly, Catherine M ^a   Warner, Ellen ^a   Tsoi, Daphne T ^a   Verma, Sunil ^a   Pritchard, Kathleen I ^a  

^a UNIVERSITY OF TORONTO   (Canada)

Author keywords

Adjuvant chemotherapy; Breast cancer; Prognostic test; Recurrence score

Indexed keywords

ANASTROZOLE; ANTINEOPLASTIC AGENT; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ESTROGEN RECEPTOR; FLUOROURACIL; FORMALDEHYDE; HORMONE RECEPTOR; KI 67 ANTIGEN; METHOTREXATE; PARAFFIN; PLACEBO; PROGESTERONE RECEPTOR; TAMOXIFEN;

21 GENE ASSAY; ACCURACY; ADJUVANT THERAPY; AGE; ANXIETY; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER GRADING; CANCER HORMONE THERAPY; CANCER MORTALITY; CANCER RECURRENCE; CLINICAL TRIAL; COMPUTER PROGRAM; COST EFFECTIVENESS ANALYSIS; COST UTILITY ANALYSIS; DISEASE FREE SURVIVAL; DRUG COST; DRUG RESPONSE; GENE EXPRESSION PROFILING; HIGH RISK POPULATION; HUMAN; IMMUNOHISTOCHEMISTRY; LIFE EXPECTANCY; LYMPH NODE; MEDICAL DECISION MAKING; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; PATIENT SATISFACTION; POSTMENOPAUSE; PREDICTION; PRIORITY JOURNAL; PROBABILITY; PROGNOSIS; QUALITY ADJUSTED LIFE YEAR; RECURRENCE RISK; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; REVIEW; RISK ASSESSMENT; SCORING SYSTEM; SENSITIVITY AND SPECIFICITY; SURVIVAL RATE; SURVIVAL TIME; TISSUE FIXATION; TUMOR VOLUME;

BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; COST-BENEFIT ANALYSIS; FEMALE; GENE EXPRESSION; GENES, NEOPLASM; HUMANS; LYMPHATIC METASTASIS; NEOPLASM RECURRENCE, LOCAL; PATIENT SELECTION; PROGNOSIS; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; TREATMENT OUTCOME;

EID: 77952593779     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2009-0277     Document Type: Review

References (44)

1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology™. Breast Cancer. V.I. 2010. Available at http://www. nccn.org/professionals/physician_gls/PDF/breast.pdf, accessed January 19,2010.
2. Goldhirsch A, Ingle JN, Gelber RD et al. Thresholds for therapies: Highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2009. Ann Oncol 2009;20:1319-1329.
3. National Institutes of Health. Adjuvant Therapy for Breast Cancer. NIH Consens Statement 2000;17:1-35.
4. Ravdin PM, Siminoff LA, Davis GJ et al. Computer program to assist in making decisions about adjuvant therapy for women with early breast cancer. J Clin Oncol 2001;19:980-991.
5. Olivotto IA, Bajdik CD, Ravdin PM et al. Population-based validation of the prognostic model ADJUVANT! for early breast cancer. J Clin Oncol 2005;23:2716-2725.
6. Marchionni L, Wilson RF, Wolff AC et al. Systematic review: Gene expression profiling assays in early-stage breast cancer. Ann Intern Med 2008;148:358-369.
7. Sotiriou C, Pusztai L. Gene-expression signatures in breast cancer. N Engl J Med 2009;360:790-800.
8. Desmedt C, Ruiz-Garci´a E, Andre´ F. Gene expression predictors in breast cancer: Current status, limitations and perspectives. Eur J Cancer 2008;44: 2714-2720.
9. Ross JS, Hatzis C, Symmans WF et al. Commercialized multigene predictors of clinical outcome for breast cancer. The Oncologist 2008;13:477-493.
10. Dowsett M, Dunbier AK. Emerging biomarkers and new understanding of traditional markers in personalized therapy for breast cancer. Clin Cancer Res 2008;14:8019-8026.
11. Paik S. Development and clinical utility of a 21-gene recurrence score prognostic assay in patients with early breast cancer treated with tamoxifen. The Oncologist 2007;12:631-635.
12. Sparano JA, Paik S. Development of the 21-gene assay and its application in clinical practice and clinical trials. J Clin Oncol 2008;26:721-728.
13. Jaeschke R, Guyatt GH, Sackett DL. Users' guides to the medical literature. III. How to use an article about a diagnostic test. B. What are the results and will they help me in caring for my patients? The Evidence-Based Medicine Working Group. JAMA 1994;271:703-707.
14. Fisher B, Costantino J, Redmond C et al. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med 1989;320: 479-484.
15. 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 2004;351: 2817-2826.
16. Fisher B, Redmond C. Systemic therapy in node-negative patients: Updated findings from NSABP clinical trials. National Surgical Adjuvant Breast and Bowel Project. J Natl Cancer Inst Monogr 1992;(11):105-116.
17. 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;24:3726-3734.
18. 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 2006;8:R25.
19. Mamounas E, Tang G, Fisher B 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 Jan 11 [Epub ahead of print]. doi: 10.1200/JCO.2009.23.7610.
20. 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 2005;11: 3315-3319.
21. Paik S, Shak S, Tang G et al. Expression of the 21-genes of the recurrence score assay and tamoxifen clinical benefit in the NSABP study B-14 of node negative, estrogen receptor positive breast cancer. J Clin Oncol 2005; 23(16 suppl):510.
22. Albain KS, Barlow WE, Shak S et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with nodepositive, oestrogen-receptor-positive breast cancer on chemotherapy: A retrospective analysis of a randomised trial. Lancet Oncol 2010;11:55-65.
23. Dowsett M, Cuzick J, Wales C et al. Risk of recurrence using OncotypeDX in postmenopausal primary breast cancer patients treated with anastrozole or tamoxifen: A TransATAC study. Presented at the 31st San Antonio Breast Cancer Symposium, San Antonio, TX, December 10-14, 2008.
24. Goldstein L, O'Neill A, Sparano J et al. E2197: Phase III AT (doxorubicin/ docetaxel) vs. AC (doxorubicin/cyclophosphamide) in the adjuvant treatment of node-positive and high risk node-negative breast cancer. J Clin Oncol 2005;23(16 suppl):512.
25. Goldstein L, Gray R, Childs BH et al. Prognostic utility of the 21-gene assay in hormone receptor positive operable breast cancer and 0-3 positive axillary nodes treated with adjuvant chemohormonal therapy: An analysis of Intergroup Trial E2197. J Clin Oncol 2007;25(18 suppl):526.
26. Gianni L, Zambetti M, Clark K et al. Gene expression profiles in paraffinembedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer. J Clin Oncol 2005;23: 7265-7277.
27. Adjuvant! Online Available at http://www.adjuvantonline.com, accessed December 1, 2009.
28. Bryant J. Toward a more rational selection of tailored adjuvant therapy. Data from the National Surgical Adjuvant Breast and Bowel Project. Presented at the Primary Therapy of Early Breast Cancer 9th International Conference, St. Gallen, Switzerland, January 26-28, 2005.
29. Goldstein LJ, Gray R, Badve 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;26:4063-4071.
30. Cuzick J, Dowsett M, Wale C et al. Prognostic value of a combined ER, PgR, Ki67, HER2 immunohistochemical (IHC4) score and comparison with the GHI recurrence score-results from TransATAC. Presented at the 32nd CTRC-AACR Annual San Antonio Breast Cancer Symposium, San Antonio, Texas, December 9-13, 2009.
31. Bartlett J, Brookes C, Robson T. The TEAM trial pathology study identifies potential prognostic and predictive biomarker models for postmenopausal patients treated with endocrine therapy. Presented at the 32nd CTRCAACR Annual San Antonio Breast Cancer Symposium, San Antonio, Texas, December 9-13, 2009.
32. Viale G, Regan MM, Dell'Orto P et al. Central review of ER, PgR and HER2 in BIG 1-98 evaluating letrozole vs. letrozole followed by tamoxifen vs. tamoxifen followed by letrozole as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. Presented at the 32nd CTRC-AACR Annual San Antonio Breast Cancer Symposium, San Antonio, Texas, December 9-13, 2009.
33. Mumby P, Lo S, Norton J et al. Prospective multicenter study of the impact of the 21-gene recurrence score assay on patient satisfaction, anxiety and decisional conflict for adjuvant breast cancer treatment selection. Breast Cancer Res Treat 2007;106(1 suppl):10.
34. Lo SS, Norton, P, Mumby PB 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 2007;25(18 suppl):577.
35. Liang H, Brufsky AM, Lembersky BB et al. A retrospective analysis of the impact of OncotypeDX low recurrence score results on treatment decisions in a single academic breast cancer center. Breast Cancer Res Treat 2007; 106(1 suppl):2061.
36. Ben-Baruch N, Hammerman A, Klang S et al. A prospective study of the impact of the 21-gene assay recurrence score on treatment decisions in N,ER earlybreastcancerpatients.JClinOncol2007;25(18suppl): 11008.
37. 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 OncotypeDX assay at the University of Pennsylvania. Breast Cancer Res Treat 2007;106(1 suppl):3082.
38. Oratz R, Paul D, Cohn AL et al. Impact of OncotypeDX on decision making in breast cancer clinical practice. J Oncol Pract 2007;3:182-186.
39. Lillie SE, Brewer NT, O'Neill SC et al. Retention and use of breast cancer recurrence risk information from genomic tests: The role of health literacy. Cancer Epidemiol Biomarkers Prev 2007;16:249-255.
40. 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; 11:313-324.
41. Lyman GH, Cosler LE, Kuderer NM et al. 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;109:1011-1018.
42. Kondo M, Hoshi SL, Ishiguro H et al. 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 Cancer Res Treat 2008;112:175-187.
43. 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 2007;25:5287-5312.
44. Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Recommendations from the EGAPP Working Group: Can tumor gene expression profiling improve outcomes in patients with breast cancer? Genet Med 2009;11:66-73.