The Oncotype DX® test as standard of care to guide chemotherapy treatment decisions
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 Recurence Score test, guidelines and HTA body recommendations position the Oncotype DX test as the preferred multigene assay1-8.
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 chemotherapy4.
Below is a high-level overview of each of the major guidelines and HTA bodies worldwide.
NCCNa
Only assay recognized by the NCCN Guidelines® to predict adjuvant chemotherapy benefit and the only assay classified as the “preferred” test in both N0 and post-menopausal N1 patients. In addition, guidelines recommend to “consider” the Oncotype DX test for premenopausal N1 patients1
ASCO®a
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
St. Gallena,c
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 decisions3. The 2023 update highlights the need to test premenopausal patients as not all require chemotherapy4
ESMO®a
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
NICEa,b
Only test considered to predict chemotherapy benefit, therefore providing a cost-effective option in patients with early-stage, node-negative and micrometastatic breast cancer6
IQWiG
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 cancer7,8
a 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.
b 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.
c As voted by a clear majority of the St Gallen International Expert Consensus panel
Inclusion in Major Guidelines and Health Technology Assessment bodies
| Oncotype DX® | MammaPrint® | EndoPredict® | Prosigna® | |
|---|---|---|---|---|
| NCCN Category: Preferred 1 |
✓ | |||
| ASCO 2 | ✓ Strongly recommended for all NO and postmenopausal N1 patients |
✓ Strongly recommended for high-clinical risk, and postmenopausal N0 and N1 patients |
✓ Moderately recommended for postmenopausal N0 and N1 patients |
✓ Moderately recommended for postmenopausal N0 patients |
| St. Gallen 3,4 | ✓ | ✓ | ||
| ESMO 5 | ✓ | ✓ | ✓ | ✓ |
| NICE Diagnostics Guidance (UK) 6 | ✓ | ✓ | ✓ | |
| IQWiG (Germany) 7 | ✓ |
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:
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References