OncotypeDX Breast Recurrence Score®


Oncotype DX Breast Recurrence Score measures the expression of 21 specific genes from a patient's tumor sample and based on the results of this measurement provides following information:
• prognostic - individual recurrence risk in 10 years
• predictive - predicts the likelihood that the patient will benefit from added chemotherapy


The Oncotype DX test is designed for patients of all ages with newly diagnosed early-stage breast cancer, estrogen receptor positive (ER +), human epidermal growth factor receptor (HER2-) negative, with no lymph nodes involvement or with 1-3 positive lymph nodes.


OncotypeDX is a standard of care in many countries and is part of the all international treatment guidelines (St. Gallen, ESMO, ASCO, NCCN, NICE) [7-11,18]. In Czech Republic the test is also included in local guidelines Modra Kniha (ČOS ČLS JEP) [16]. It has been used in medical practice in the Czech Republic for more than 3 years with proven results (according to data from the Czech OncotypeDX registry maintained by IBA MU, the reduction of chemotherapy is 62.4%) [12]. The latest data from the groundbreaking study TAILORx has shown that up to 70% with most common breast cancer do not benefit from chemotherapy. [1]. The results were published at the annual American Society for Clinical Oncology Conference (ASCO) in Chicago on June 3, 2018 and clearly demonstrate the benefits of using the OncotypeDX test. The TAILORx study has also led to the revision of the NCCN's medical recommendations [17], and new recommendations have also been published by the German Institute for quality IQWiG [18], which consistently recommends the use of the OncotypeDX test for adjuvant treatment.

Test Oncotype DX has the highest level of clinical evidence 1A [1,2], supported by many clinical studies (prospective data with long-term outcomes) with more then 63 000 patients. [2-6]

Oncotype DX test for invasive breast cancer is reimbursed by VZP and some other insurance companies for a certain type of tumors. A patient who does not meet the criteria for reimbursement from an insurance company can pay for the test at her/his own expense. For more information about the price, please contact us by phone or email.
Short reportage about TAILORx study: https://ct24.ceskatelevize.cz/veda/2499823-u-nekterych-pacientek-s-rakovinou-prsu-je-chemoterapie-zbytecna-tvrdi-autori-velke


References:
1. Sparano J.A. et al. NEJM (2018)
2. Nitz et al. Breast Cancer Res Treat (2017)
3. Stemmer et al. npj Breast Cancer 2017;3:32 and 2017;3:33
4. Sparano et al. N Engl J Med 2015
5. Roberts et al. Breast Cancer Res Treat 2017
6. Shak et al. ESMO 2016. Oral presentation 1460
7. Curigliano et al. Ann Oncol 2017
8. Krop et al. J Clin Oncol 2017
9. Senkus et al. Ann Oncol 2015
10. NICE Diagnostics Guidance DG10 September 2013. www.nice.org.uk/Guidance/DG10 accessed January 2017
11. NCCN Guidelines Insights: Breast Cancer, version 1.2017. www.nccn.org/professionals/physician_gls/pdf/ accessed April 2017
12. Registr ONCOTYPE, Decision impact study, IBA MU 2016
13. Gluz et al. SABCS 2011. Abstract S4-3
14. Paik et al. J Clin Oncol 2006
15. Stemmer et al. ESMO 2016
16. Modrá kniha www.linkos.cz 2018
17. The National Comprehensive Cancer Network® (NCCN®), 2018
18. IQWiG, press release 2018, https://www.iqwig.de/en/press/
IQWiG=German Institute for Quality and Efficiency in Health Care