Clinical Utility and Health Economic Studies

Multiple decision impact studies utilizing consistent methodology involving >2,500 patients from around the world have been conducted.1-17 Meta-analysis reveals that the Oncotype DX® Breast Recurrence Score results in an approximate 30% change in treatment recommendations pre- vs post-assay.18 Of treatment changes 22-24% are reductions in the utilization from adjuvant chemotherapy and hormonal therapy to hormonal therapy alone in patients with low Breast Recurrence Score values.18 Health economic studies consistently report the assay to be cost-saving to various healthcare systems. These savings were primarily as a result reduced utilization of chemotherapy.19-24



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. 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.
5. 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.
6. 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.
7. Albanell J, Gonzalez A, Ruiz-Borrego M, et al. Prospective transGEICAM 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.
8. Chung PS, Tong AC, Leung 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.
9. Liang H, Brufsky AM, Lembersky BB. A retrospective anaylsis of the impact of Oncotype DX low Recurrence Score results on treatment decisions in a single academic breast cancer center. Presented at: San Antonio Breast Cancer Symposium; December 2007; San Antonio, TX.
10. 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.
11. Schneider JG, Khalil DN. Why does Oncotype DX recurrence score reduce adjuvant chemotherapy use? Breast Cancer Res Treat. 2012; 134(3):1125-32.
12. 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.
13. 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.
14. 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.
15. Geffen DB, Abu-Ghanem S, Sion-Vardy N, et al. The impact of the 21-gene recurrence score assay on decision making about adjuvant chemotherapy in early-stage estrogen-receptor-positive breast cancer in an oncology practice with a unified treatment policy. Ann Oncol. 2011; 22(11): 2381-6.
16. Davidson JA, Cromwell I, Ellard S, 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; S0959-8049(13):00211-6.
17. Bargallo JE, Lara F, Shaw-Dulin R, 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. J Surg Oncol. 2014 Oct 6. doi: 10.1002/jso.23794. [Epub ahead of print]
18. Hornberger J and Chien R. Meta-analysis of the decision impact of the 21-gene breast cancer Recurrence Score in clinical practice. Presented at: St. Gallen Breast Cancer Conference; March 2011; St. Gallen, Switzerland.
19. Lacey L, Chien R, Hornberger J. Cost-utility of the 21-gene breast cancer assay (Oncotype DX) in the Irish healthcare setting. Presented at San Antonio Breast Cancer Symposium; December 2011; San Antonio, TX.
20. Falahee M, Ercoli K, Plun-Favreau. Retrospective budget impact analysis on the use of the Oncotype DX test in Ireland. Presented at the St. Gallen Breast Cancer Conference; March 2013; St. Gallen, Switzerland.
21. Hassan S, Mittman N. A cost benefit analysis of the 21-gene breast cancer assay within a Canadian health care system. Presented at the American Society for Clinical Oncology Annual Meeting; June 2011; Chicago, IL.
22. Wilson E, McDonnell D, Gullo G, et al. Economic impact of Oncotype DX assay in axillary node negative breast cancer, (ANX-BC) with positive hormone receptor (REC1) and normal HER-2 (HER2-). Presented at the European Society for Medical Oncology; October 2010; Milan, Italy.
23. Ragaz J, Wilson KS, Wong H, et al. Molecular Classification with 21 Gene Assay (Oncotype DX) Shows in 196,967 ER Positive Patients High Frequency of Low Recurrence Score [LRS] in Both Node Positive (N+) and Negative (N-) Breast Cancer (BrCa) Cohorts. Definition of Chemoresistance Based on LRS with Cost and Guideline Implications. Presented at the San Antonio Breast Cancer Symposium; December 2011; San Antonio, TX.
24. Bacchi CE, Prisco F, Carvalho FM, et al. Potential economic impact of the 21-gene expression assay on the treatment of breast cancer in Brazil. Rev Assoc Med Bras. 2010;56(2):186-91.


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