The Oncotype DX® test as standard of care to guide chemotherapy treatment decisions
The Oncotype DX Breast Recurrence Score test has been incorporated into major clinical practice guidelines worldwide.
Based on the practice-changing results of the TAILORx study, updated guidelines and health technology assessment body recommendations clearly position the Oncotype DX Breast Recurrence Score test as the preferred assay.
Only assay recognized by NCCN Guidelines to predict adjuvant chemotherapy benefit and the only assay classified as the “preferred” multigene test in node-negative patients with HR-positive, HER2-negative breast cancer1
May be used to guide decisions on adjuvant systemic chemotherapy based on TAILORx cutoffs in node-negative patients with ER-positive, HER2-negative breast cancer5
Test strongly endorsed for guiding adjuvant CT treatment decisions in both node-negative and node-positive early breast cancer. TAILORx cutoffs to guide decisions in node-negative patients4
Only test considered to predict chemotherapy benefit, therefore providing a cost-effective option in patients with early-stage, node-negative and micrometastatic breast cancer3
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 cancer2
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
a National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. ASCO and ESMO are trademarks of the American Society of Clinical Oncology and European Society for Medical Oncology. 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 As voted by a clear majority of the St Gallen International Expert Consensus panel
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer support the 21-gene test (Oncotype DX) for both node-negative and node-positive, hormone receptor-positive, HER2-negative early breast cancer1*
Oncotype DX is the only test to predict adjuvant chemotherapy benefit and to be recognised as “preferred” for node-negative patients
- The Oncotype DX (21-gene) test is the only assay recognised by NCCN Guidelines® to predict adjuvant chemotherapy benefit and categorised as the “preferred” multigene assay for node-negative patients with HR-positive, HER2-negative breast cancer
- The Oncotype DX (21-gene) test is now elevated to “strongly consider” in the NCCN® node-negative algorithm
- NCCN Guidelines® incorporate the new TAILORx-based 21-gene test Recurrence Score cut-points to select patients with node-negative breast cancer for chemotherapy treatment
The Oncotype DX test should be considered as an “option” for consideration in patients with micrometastasis / node 1–3 positive
National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. ASCO and ESMO are trademarks of the American Society of Clinical Oncology and European Society for Medical Oncology.
NCCN, National Institute for Health and Care Excellence (NICE), St Gallen International Consensus Panel, ASCO and ESMO do not endorse any product or therapy.
*Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.2.2019. © 2019 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. NCCN does not endorse any product or therapy. 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.
a Consider the use of adjuvant chemotherapy in women =50 with a Recurrence Score® result 16–25 based on an exploratory analysis from the TAILORx study demonstrating lower distant recurrence in women =50 randomised to chemotherapy.
b A secondary analysis of a prospective trial suggests that Oncotype DX® test is predictive for women with 1–3 involved axillary nodes. Other multigene assays have not proven to be predictive of chemotherapy benefit.
Inclusion of the Oncotype DX Breast Recurrence Score test into AJCC 8th Edition Staging Manual
Oncotype DX assay is the only multigene test supported by prospective Level 1 evidence for Recurrence Score results 0-10 and included in the AJCC breast cancer staging criteria to assign Prognostic Stage Group7-8
When the Recurrence Score®result is less than 11...*
|When TNM is...
||And G is...
||And HER2 Status is...
||And ER Status is...
||And PR Status...
||The Prognostic Stage Group is...
|T1 N0 M0
T2 N0 M0
AJCC 8th Edition Stage IB and IIA patients can downstage to Stage IA with a Recurrence Score® result <11
In T2 patients with ER+, HER2-, lymph-node negative disease, an Oncotype DX Breast Recurrence Score® result <11 will downstage patients to Pathological Prognostic Stage Group 1A8
Only the Oncotype DX® test can determine if your patient can be reclassified to Stage IA,8 and if she will benefit from chemotherapy9
UK health technology assessment body NICE expands recommendation for Oncotype DX Breast Recurrence Score test3
Oncotype DX assay now recommended for both node-negative and micrometastatic early breast cancer
- Only test considered to predict chemotherapy benefit, therefore providing a cost-effective option
- The only recommended test shown to de-escalate chemotherapy compared to the other assays reviewed
- Recommendation expanded to include patients with micrometastatic disease
TAILORx adds to the extensive body of evidence for the Oncotype DX Breast Recurrence Score testa
a Includes all patients N0, N1 (1–3 nodes) and N2 (=4)
b RxPONDER: ClinicalTrials.gov Identifier: NCT01272037, ongoing, estimated enrolment=5,000 patients