Clinical Impact and Economic Studies

Multiple decision impact studies in ER-positive node-positive patients demonstrate that use of the Oncotype DX® Breast Recurrence Score changes treatment recommendations in approximately 30% of patients.1-9 The majority of these changes are from utilizing hormonal therapy plus chemotherapy to hormonal therapy alone in patients identified as low risk by the Oncotype DX Breast Recurrence Score. Economic studies conducted worldwide in patients in node-positive cohorts of early stage breast cancer patients consistently report the assay to be cost-effective/cost-saving regardless of country and local cost data.1,7,10-17



1. 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 UK. Br J Cancer. 2013;108(11): 2250-8.
2. 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.
3. Gligorov J, Pivot XB, Jacot W, et al. Prospective clinical utility study of the use of the 21-gene assay in adjuvant clinical decision making in women with estrogen receptor-positive early invasive breast cancer: Results from the SWITCH study. The Oncologist 2015;20:1-7.
4. J, Pivot XB, Naman HL, et al. Prospective study of the impact of using the 21-gene recurrence score assay on clinical decision making in women with estrogen receptor-positive, HER2-negative, early stage breast cancer in France. Poster presented: American Society for Clinical Oncology Annual Meeting; June 2012; Chicago, IL.
5. 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 Aus. 2013;199: 205-8.
6. 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.
7. Yamauchi H, Nakagawa C, Yamshige S, et al. Decision impact and economic evaluation of the 21-gene Recurrence Score assay for physicians and patients in Japan. Poster presented: European Society for Medical Oncology Congress; September 2011; Stockholm, Sweden.
8. Bargallo JER, Lara F, Shaw Dulin RJ, et al. A study of the impact of the 21-gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital. Poster presented at: European Society for Medical Oncology Congress; September 2012; Vienna, Austria.
9. Kuchel A, Robinson T, Comins C. et al. A prospective multi-centre study of the impact of Oncotype DX on adjuvant treatment decisions in patients in the UK with oestrogen receptor positive early breast cancer. Presented: European Cancer Congress; September 2013; Amsterdam, Netherlands.
10. Chung PS, Tong AC, Leunh RC, et al. Initial experience with the Oncotype DX assay in decision-making for adjuvant therapy of early oestrogen receptor–positive breast cancer in Hong Kong. Hong Kong Med J 2014;20:Epub 20 June 2014.
11. O'Leary B, Yoshizawa C, Foteff C, Chao C. Cost-effectiveness of the Oncotype DX assay in Australia: an exploratory analysis. Presented at International Society for Pharmoeconomics and Outcomes Research; May 2010; Atlanta, GA.
12. Hall PS, McCabe C, Stein RC, et al. Economic evaluation of genomic test-directed chemotherapy for early-stage lymph node-positive breast cancer. J Natl Cancer Inst. 2012; 104(1): 56-66.
13. Vanderlaan BF, Broder MS, Chang EY, et al. Cost-effectiveness of 21-gene assay in node-positive, early-stage breast cancer. Am J Manag Care 2011; 17 (7): 455-64.
14. Lamond NW, Skedgel C, Rayson D, Lethbridge L, Youniset T. Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer. Breast Cancer Res Treat. 2012;133(3): 1115-23.
15. Kondo M, Hoshi SL, Yamanaka T, et al. 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 Cancer Res Treat. 2011; 127(3): 739-49.
16. Blohmer JU, Rezai M, Kümmel S, et al. Using the 21-gene assay to guide adjuvant chemotherapy decision-making in early-stage breast cancer: a cost-effectiveness evaluation in the German setting. J Med Econ. 2012.
17. Hannouf MB, Xie B, Brackstone M, Zaric GS. Cost-effectiveness of a 21-gene recurrence score assay versus Canadian clinical practice in women with early-stage estrogen- or progesterone-receptor-positive, axillary lymph-node negative breast cancer. BMC Cancer. 2012;12: 447.


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