The Oncotype DX® test as standard of care to guide chemotherapy treatment decisions
Recommended in all major international guidelines
Based on 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.
Below is a high-level overview of each of the major guidelines and HTA bodies worldwide.
NCCNa
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
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 quality5
St. Gallena,c
Test strongly endorsed for 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 decisions4
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 chemotherapy6
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 cancer3
AJCC 8th Edition Staging Manuald
The Oncotype DX Breast Recurrence Score® test is included in the AJCC breast cancer staging criteria and may be used to assign prognostic stage group. Stage IB and stage IIA early stage node-negative breast cancer patients can downstage to stage IA with Recurrence Score® results <11.
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, 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 All NICE guidance is subject to regular review and may be updated or withdrawn.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
d AJCC is a trademark of the American College of Surgeons. AJCC does not endorse any product or therapy.
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 | ✓ | |||
| AJCC 8th edition Staging Table | ✓ | ✓ | ✓ | ✓ |
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References