The 21-gene recurrence score assay impacts adjuvant therapy recommendations for er-positive, nodenegative and node-positive early breast cancer resulting in a risk-adapted change in chemotherapy use

Annals of Oncology

Volumn 24, Issue 3, 2013, Pages 618-624

  Eiermann, W ^a   Rezai, M ^b   Kummel S ^c   Kuhn T ^d   Warm, M ^e   Friedrichs, K ^f   Schneeweiss, A ^g   Markmann, S ^h   Eggemann, H ⁱ   Hilfrich, J ^j   Jackisch, C ^k   Witzel, I ^l   Eidtmann, H ^m   Bachinger, A ⁿ   Hell, S ^o   Blohmer, J ^p  

^a Interdisciplinary Oncology Center   (Germany)

^b Breast Center   (Germany)

^c Hospital Essen Mitte   (Germany)

^d Hospital Esslingen   (Germany)

^e City Hospital of Cologne   (Germany)

^f University Breast Center   (Germany)

^g GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^h ROSTOCK UNIVERSITY MEDICAL CENTER   (Germany)

ⁱ UNIVERSITY HOSPITAL MAGDEBURG   (Germany)

^j Eilenriedeklinik   (Germany)

^k Offenbach Hospital   (Germany)

^l UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^m UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

ⁿ CLINASSESS GMBH   (Germany)

^o Medical Affairs Consulting   (Germany)

^p Sankt Gertrauden Hospital   (Germany)

more..

Author keywords

Adjuvant; Breast cancer; Chemotherapy; Node negative; Node positive; Recurrence score

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2;

21 GENE RECURRENCE SCORE ASSAY; ADULT; ARTICLE; ASSAY; CANCER ADJUVANT THERAPY; CANCER CHEMOTHERAPY; CLINICAL PRACTICE; COST CONTROL; EARLY CANCER; ESTROGEN RECEPTOR POSITIVE BREAST CANCER; FEMALE; HUMAN; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; MEDICAL DECISION MAKING; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; PATIENT DECISION MAKING; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RECURRENCE SCORE; SCORING SYSTEM;

EID: 84874579353     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mds512     Document Type: Article

References (35)

1. 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(8): 1319-1329.
2. 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(27): 2817-2826.
3. 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.
4. 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(3): R25.
5. 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): 1829-1834.
6. Albain K, Barlow WE, Shak S et al. Prognostic and predictive value of the 21gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncology 2010; 11(1): 55-65.
7. 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(33): 5287-5312.
8. National Comprehensive Cancer Network Practice Guidelines in Oncology. Breast Cancer (version v2.2011). http://www.NCCN.org.
9. Aebi S, Davidson T, Gruber G et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010; 21 (Suppl 5): v9-v14.
10. Goldhirsch A, Wood C, Coates AS. Strategies for subtypes-dealing with the diversity of breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol 2011; 22: 1736-1747.
11. Lo S, Mumby P, 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: 1671-1676.
12. Albanell J, Gonzales A, Ruiz-Borrego M et al. Prospective transGEICAM Study of Oncotype DX® in clinical decision making in women with estrogen receptorpositive, node-negative breast cancer. Ann Oncol 2012; 23: 625-631.
13. Holt SDH, Durrani S, Pudney D et al. Results from a prospective clinical study on the impact of Oncotype DX® on adjuvant treatment decision in a cohort of 142 UK patients. SABCS 2011; Abstract #P5-14-26.
14. Yamauchi H, Nakagawa C, Yamashige S et al. Decision Impact and Economic Evaluation of the 21-Gene Recurrence Score® Assay for Physicians and Patients in Japan, Stockholm, Sweden: Poster presented at the annual European Society for Medical Oncology Congress 2011.
15. De Boer RH, Baker C, Speakman D et al. Australian Decision Impact Study: the impact of Oncotype DX Recurrence Score (RS) on adjuvant treatment decisions in hormone receptor positive (HR+), node negative and node positive (N+9 early breast cancer (ESBC) in the multidisciplinary clinic. SABCS 2011; Abstract #P4-09-18.
16. Hornberger J, Chien R. Meta-analysis of the decision impact of the 21-gene breast cancer Recurrence Score in clinical practice. In Poster Presented at the St Gallen International Breast Cancer Conference, St Gallen, Switzerland, March 2011. Abstract P201.
17. Klang SH, Hammerman A, Liebermann N et al. Economic implications of 21gene breast cancer risk assay from the perspective of an Israeli-managed healthcare organization. Value Health 2010; 13: 381-387.
18. Tsoi DT, Inoue M, Kelly CM et al. Cost-effectiveness analysis of recurrence scoreguided treatment using a 21-gene assay in early breast cancer. Oncologist 2010; 15: 457-465.
19. Kondo M, Hoshi S, Yamanaka T et al. Economic evaluation of the 21-gene signature (Oncotype DX) in lymph node negative/positive hormone receptorpositive early-stage breast cancer based on Japanese validation study (JBCRGTR03). Breast Cancer Res Treat 2011; 127: 739-749.
20. Lyman GH, Cosler LE, NM 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.
21. Pronzato P, Plun-Favreau J. Is the 21-gene breast cancer test (Oncotype DX) cost-effective. SABCS 2012, P1-10-05.
22. 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): 94-99.
23. Blohmer J, Kühn T, Rezai M et al. German multicentre decision impact study of Oncotype DX recurrence score (RS) on adjuvant treatment in estrogen receptor positive (ER+) node negative (N0) and node positive (N+) early breast cancer. In Presented as a Poster at the 12th International St. Gallen Breast Cancer Conference, 2011, P206.
24. O'Connor A. Validation of a decisional conflict scale. Med Decis Making 1995; 15: 25-30.
25. Höldtke B. Evidence based medicine für Laien. Modellhafte Entwicklung eines Konzeptes zur Vermittlung von wissenschaftlichen Informationen zum Thema, Früherkennung von Brustkrebs mit Mammographie, Hamburg 2002.
26. Blohmer JU, Rezai M, Kümmel S et al. Using Oncotype DX® to guide adjuvant chemotherapy decision making in early-stage breast cancer: a cost-effectiveness evaluation in the German setting. J Med Econ 2012, in press.
27. Hassett M, Niland JC, Hughes ME et al. Gene expression profile testing for breast cancer: Patterns and predictors of use and impact on chemotherapy. J Clin Oncol 2010; 28: 15s, (Suppl; abstr 566).
28. Tang G, Cuzick J, Costantino JP et al. Risk of recurrence and chemotherapy benefit for patients with node-negative, estrogen receptor-positive breast cancer: recurrence score alone and integrated with pathologic and clinical factors. J Clin Oncol 2011; 29(33): 4365-4372.
29. Varga Z, Diebold J, Dommann-Scherrer C et al. How reliable is Ki-67 immunohistochemistry in Grade 2 breast carcinomas? A QA study of the Swiss working group of breastand gynecopathologists. PLoS ONE 2012; 7(5): e37379.
30. Gluz O, Kreipe HH, Christgen M. Prospective comparison of recurrence score and independent central pathology assessment of prognostic tools in early breast cancer (BC): Focus on HER2, ER, PR, Ki-67 results from the phase III WSG-Plan B trial. J Clin Oncol 2012; 30 (Suppl; abstr 552).
31. Gluz O, Kreipe HH, Degenhardt T et al. Prospective comparison of risk assessment in early breast cancer: correlation analysís from the Phase III WSGPlan B Trial. Ann Oncol 2012; 23(suppl 2): ii17-ii24.
32. Viale G, Regan MM, Mastropasqua MG et al. Predictive value of tumor Ki-67 expression in two randomized trials of adjuvant chemoendocrine therapy for node-negative breast cancer. J Natl Cancer Inst 2008; 100: 207-212.
33. Cuzick J, Dowsett M, Pineda S et al. Prognostic value of a combined estrogen receptor, porgesterone 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 2011; 29: 4273-4278.
34. Hammond ME, Hayes DF, Dowsett M et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Clin Oncol 2010; 28: 2784-2795.
35. Wolff AC, Hammond ME, Schwartz JN et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol 2007; 25: 118-145.