Backed by Major Guidelines | Oncotype DX Test

Only the Oncotype DX Breast Recurrence Score test is incorporated in the four major international guidelines and recommended by two major European health technology assessment (HTA) bodies.

Due to the comprehensive dataset of the Oncotype DX Breast Recurrence Score test, guidelines and HTA body recommendations position the Oncotype DX test as the preferred multigene assay.^1-8

The majority of recommendations have been updated after the publication of the two major clinical trials TAILORx and RxPONDER.

The most recent update is of the St Gallen guidelines. The 2023 update states it is commonplace to use genomic assays to determine whether HR+, HER2- early-stage breast cancer patients require adjuvant chemotherapy in addition to adjuvant endocrine therapy. It acknowledges that the practice-changing trials TAILORx and RxPONDER have shown that adding chemotherapy to endocrine therapy does not improve outcomes in postmenopausal patients whose tumours have low Recurrence Score^®results. The update also highlights the need to test premenopausal patients as not all require chemotherapy.⁴

Below is a high-level overview of each of the major guidelines and HTA bodies worldwide.

Only assay recognized by NCCN Guidelines^® to predict adjuvant chemotherapy benefit and the only assay classified as the “preferred” test in both N0 and postmenopausal N1 patients. In addition, guidelines recommend to “consider” the Oncotype DX test for premenopausal N1 patients¹

Only test strongly recommended for all N0 and postmenopausal N1 patients with ER+, HER2- early breast cancer. Recommendation is irrespective of clinical risk, with high evidence quality²

Test strongly endorsed for the vast majority of N0 and N1, HR+, HER2- early-stage breast cancer patients, irrespective of grade or menopausal status. TAILORx and RxPONDER cutoffs to guide treatment decisions.³ The 2023 update highlights the need to test premenopausal patients as not all require chemotherapy⁴

May be used to gain additional prognostic and/or predictive information with 1A evidence to complement pathology assessment and to predict the benefit of adjuvant chemotherapy⁵

Only test considered to predict chemotherapy benefit, therefore providing a cost-effective option in patients with early-stage, node-negative and micrometastatic breast cancer⁶

With the results of TAILORx, only Oncotype DX has sufficient evidence to guide adjuvant chemotherapy decisions in patients with early-stage, node-negative, invasive breast cancer^7,8

National Comprehensive Cancer Network^® (NCCN^®) are registered trademarks of NCCN. ASCO and ESMO are trademarks of the American Society of Clinical Oncology and European Society for Medical Oncology, respectively. NCCN, National Institute for Health and Care Excellence (NICE), St Gallen International Consensus Panel, ASCO and ESMO do not endorse any product or therapy.
National Institute for Health and Care Excellence (NICE) Diagnostics Guidance DG34, December 2018. www.nice.org.uk/guidance/dg34 (6 Feb 2020). All rights reserved. Subject to Notice of rights NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
As voted by a clear majority of the St Gallen International Expert Consensus panel

Oncotype DX inclusion in Major Guidelines and Health Technology Assessment bodies.

In summary, the guideline recommendations and the clinical validation make the Oncotype DX^® test the preferred choice for your HR+, HER2-, early-stage breast cancer patients. Learn more about the evidence behind the Oncotype DX test in node-negative and node-positive patients:

Node-negative clinical evidence

The clinical validity and utility of the Oncotype DX Breast Recurrence Score^®test in patients with HR+, HER2-, node-negative, early-stage, invasive breast cancer have been established through extensive clinical research in over 85,000 patients.

Node-positive clinical evidence

The Recurrence Score^®result has been proven to be predictive of chemotherapy benefit for HR+, HER2-, node-positive postmenopausal patients in the retrospective SWOG-8814 study.

References

NCCN Guidelines. Version 4.2023. Available at: https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed May 24, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Andre et al. J Clin Oncol. 2022.
Burstein et al. Ann Oncol. 2021.
Curigliano et al. Ann Oncol. 2023.
Cardoso et al. Ann Oncol. 2019.
NICE 2018. Available at: https://www.nice.org.uk/guidance/DG34/chapter/1-recommendations Accessed: May 24, 2022
IQWiG Press Release, September 2018. Available at: https://www.iqwig.de/en/press/press-releases/biomarker-tests-in-breast-cancer-new-study-data-indicate-advantage-for-certain-patients.10059.html Accessed: May 24, 2022
IQWiG Press Release, Addendum D18-0. 2018. Available at: https://www.iqwig.de/en/projects/d18-01.html Accessed: May 24, 2022

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Inclusion in guidelines

Only the Oncotype DX Breast Recurrence Score test is incorporated in the four major international guidelines and recommended by two major European health technology assessment (HTA) bodies.

References