Based on the results of TAILORx study, guidelines and HTA body recommendations clearly position the Oncotype DX Breast Recurrence Score test as the preferred assay2-6. The National Comprehensive Cancer Network® (NCCN®), St. Gallen, and ASCO have already updated their recommendations based on the RxPONDER study results1,4,5,18,19.
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 with HR-positive, HER2-negative breast cancer1. In addition, guidelines recommend to “consider” the Oncotype DX test for premenopausal N1 patients1
Oncotype DX is the only test to predict adjuvant chemotherapy benefit and to be recognised as “preferred” for node-negative patients
NCCN guideline node 1-3 positive
Oncotype DX is the only test that predicts adjuvant chemotherapy benefit and is recognised as “preferred” for postmenopausal N1 (1-3 positive nodes) patients
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NCCN, National Institute for Health and Care Excellence (NICE), St Gallen International Consensus Panel, ASCO and ESMO do not endorse any product or therapy.
* In premenopausal patients with RS® results 0-25, the addition of chemotherapy to endocrine therapy was associated with a lower rate of distant recurrence compared with endocrine monotherapy, but it is unclear if the benefit was due to the ovarian suppression effects promoted by chemotherapy1
** Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.3.2022. © 2022 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.
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.
A secondary analysis of a prospective trial suggests that Oncotype DX® test is predictive of chemotherapy benefit for women with 1–3 involved axillary nodes. Other multigene assays have not proven to be predictive of chemotherapy benefit.
Oncotype DX assay is the only test with evidence for benefit in guiding decisions for or against adjuvant chemotherapy in early HR+, HER2-, node-negative breast cancer
IQWiG is one of the most respected HTA bodies in the world. It puts strong emphasis on high quality studies – only considering 1A studies with the highest level of evidence – and focuses its primary assessment on additional benefit based on clinical outcomes. Recommendations by IQWiG guide final decisions by G-BA (Joint Federal Committee) on public reimbursement in Germany.
NICE recommendation
Oncotype DX assay now recommended for both node-negative and micrometastatic early breast cancer
Read more about clinical evidence
