What is the Oncotype DX® test, and what makes it unique?
The Oncotype DX Breast Recurrence Score® test has been developed for patients with early-stage HR+, HER2- breast cancer to:
- Identify those patients who may benefit from chemotherapy1,2
- Determine the magnitude of chemotherapy benefit1-5
- Support treatment decisions1-5
Chemotherapy can cause both short- and long-term side effects affecting current and future health, quality of life, family life and work life.6-8 The vast majority of patients with HR+, HER2- early-stage breast cancer do not benefit from adjuvant chemotherapy.9
Oncotype DX: predicts chemotherapy effects and disease outcome
The Oncotype DX test is the only test clinically validated to identify patients likely to benefit from chemotherapy, or not.1-5,10-14
Prediction of chemotherapy benefit based on prospective clinical trials makes the Oncotype DX test unique.
Development of the Oncotype DX Test
The Oncotype DX test was developed to assess disease prognosis and predict benefit from chemotherapy (CT) in patients with early-stage, HR+, HER2- breast cancer.10 Genes were selected accordingly, and the test’s predictive abilities were validated in two-arm retrospective prospective clinical trials (comparing CT+ Endocrine Therapy (ET) versus ET alone): the NSABP B-20 for node-negative patients1,13 and SWOG-8814 for node-positive patients.2 The test was then further validated in two prospective studies. The landmark TAILORx study showed that ET was non-inferior to CT + ET in patients with node-negative disease and Recurrence Score results 11 to 25.2,16 In addition, RxPONDER study initial results demonstrated that postmenopausal patients with Recurrence Score results 0-25 do not benefit from chemotherapy, independent of clinical pathologic parameters.4,5 The results of the practice-changing TAILORx and RxPONDER studies supports earlier research indicating that the majority of patients do not benefit from the addition of chemotherapy.3,4,5,9
The Oncotype DX test was developed to predict chemotherapy benefit based on a unique understanding of tumour biology.1,10 The Oncotype DX test quantifies expression of 21 genes, 16 cancer-related and five reference genes.10 Based on the expression levels of the 21 genes, a Recurrence Score result is calculated for each tumour sample.10The Oncotype DX test reveals individual tumour biology based on measuring the expression of 21 genes1,10
What information does the Oncotype DX test provide?
The Oncotype DX test identifies patients who may benefit from adjuvant chemotherapy, or not, by providing three pieces of information: the Recurrence Score result, the risk of distant recurrence, and the estimated chemotherapy benefit.1-5,10-11,13
Learn more about the Oncotype DX test for:
Guiding treatment with the Oncotype DX test
In summary, thanks to the comprehensive clinical evidence for both node-negative and node-positive patients, the Oncotype DX test can help guide confident chemotherapy treatment decisions.
Abbreviations
CT, chemotherapy
ET, endocrine therapy
HER2–, human epidermal growth factor receptor 2 negative
HR+, hormone receptor positive
N+, node-positive
N0, node-negative
References
- Paik et al. J Clin Oncol. 2006.
- Albain et al. Lancet Oncol. 2010.
- Sparano JA et al. N Engl J Med. 2018.
- Kalinsky. N Engl J Med. 2021.
- Kalinsky et al. SABCS. 2021 GS2-07.
- Partridge et al. J Natl Cancer Inst Monogr. 2001.
- Friese et al. Cancer. 2017.
- Groenvold. Dan Med Bull. 2010.
- EBCTCG. Lancet. 2012.
- Paik et al. N Engl J Med. 2004.
- Dowsett M et al. J Clin Oncol. 2010.
- Nitz et al. Breast Cancer Res Treat. 2017.
- Geyer et al. NPJ Breast Cancer. 2018.
- Ballman et al. J Clin Oncol. 2015.
- Sparano et al. N Engl J Med. 2019.
- Sparano et al. Abstract GS1-05, SABCS 2022.
- Sparano and Paik. J Clin Oncol. 2008.
