,

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.

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®) has already updated their recommendation based on the first results of RxPONDER study1.

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 with HR-positive, HER2-negative breast cancer1
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 cancer2
NICEa
Only test considered to predict chemotherapy benefit, therefore providing a cost-effective option in patients with early-stage, node-negative and micrometastatic breast cancer3
St. Gallena,b
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 decisions4
ASCO®a
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
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

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. 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 in 2021

NCCN Guidelines® for Breast Cancer support the 21-gene test (Oncotype DX) for both node-negative and node-positive (N1), hormone receptor-positive, HER2-negative early breast cancer1,*,**

NCCN
Guidelines
Node-Negative

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 elevated to “strongly consider” in the NCCN node-negative algorithm
  • NCCN Guidelines incorporate the TAILORx-based 21-gene test Recurrence Score cut-points to select patients with node-negative breast cancer for chemotherapy treatment


c Patients with T1b tumors with low-grade histology and no lymphovascular invasion should be treated with endocrine monotherapy as the TAILORx trial did not include patients with such tumors.

NCCN
Guidelines
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

  • The 21-gene test (Oncotype DX test), is the only assay recognised by NCCN Guidelines to predict adjuvant chemotherapy benefit and categorized as the “preferred” multigene assay for postmenopausal N1 (1-3 positive nodes) patients
  • NCCN recommends to “strongly consider” the 21-gene test (Oncotype DX® test) for postmenopausal N1 patients
  • The 21-gene assay (Oncotype DX test) test is also to be considered for premenopausal N1 patients

c Patients with T1b tumors with low-grade histology and no lymphovascular invasion should be treated with endocrine monotherapy as the TAILORx trial did not include patients with such tumors.
* 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

National Comprehensive Cancer Network® (NCCN®) are registered trademarks of NCCN. ASCO and ESMO are respectively 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.5.2021. © 2021 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.

German HTA body IQWiG provides clear recommendation in favour of the Oncotype DX Breast Recurrence Score® test to guide chemotherapy treatment decisions2,7

IQWiG Recommendation

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

  • Oncotype DX test able to identify women who can omit chemotherapy, or not
  • Results of IQWiG assessment cannot be transferred to other tests as they are not alike. Other tests use different gene panels and there is no evidence for an additional benefit
  • Clinical risk assessment shown to be notably unreliable in the TAILORx study; need to better understand its benefit for clinical decision-making
  • All patients to be tested for whom there is treatment uncertainty based on clinical risk assessment

About IQWiG

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.

UK health technology assessment body NICE expands recommendation for Oncotype DX Breast Recurrence Score test3

NICE Recommendation

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 testd

d For HR+, HER2- N0, N1 (1-3 nodes) early breast cancer patients.

ABBREVIATIONS
ASCO=American Society of Clinical Oncology
ER=estrogen receptor
ESMO=European Society for Medical Oncology
HER2–=human epidermal growth factor receptor 2 negative
HR=hormone receptor
HTA=Health Technology Assessment
IQWiG=German Institute for Quality and Efficiency in Healthcare
NCCN®=National Comprehensive Cancer Network® (NCCN®)
NICE=National Institute for Health and Care Excellence
N0=Node-negative
N+=Node-positive
RS=Recurrence Score result
REFERENCES
  1. NCCN Guidelines. 5.2021. 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.5.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed June 28, 2021. 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.
  2. 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
  3. NICE 2018. Available at: https://www.nice.org.uk/guidance/dg34
  4. Burstein et al. Ann Oncol. 2021.
  5. Andre et al. J Clin Oncol. 2019.
  6. Cardoso et al. Ann Oncol. 2019.
  7. IQWiG Press Release, Addendum D18-0. 2018.
  8. Paik et al. N Engl J Med. 2004.
  9. Dowsett M et al. J Clin Oncol. 2010.
  10. Paik et al. J Clin Oncol. 2006.
  11. Albain et al. Lancet Oncol. 2010.
  12. Nitz et al. Breast Cancer Res Treat. 2017.
  13. Sparano et al. N Engl J Med. 2015.
  14. Sparano et al. N Engl J Med. 2018.
  15. Miller et al. ASCO. 2017.
  16. Hortobagyi et al. SABCS. 2018.
  17. Stemmer et al. NPJ Breast Cancer. 2017.
  18. Kalinsky et al. SABCS. 2020. GS3-00.
  19. Petkov et al. Npj Breast Cancer. 2016.
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