
The Oncotype DX Breast Recurrence Score® test offers prognosis and prediction
Data shows that the majority of HR+, HER2-, early-stage breast cancer patients do not benefit from chemotherapy.1 Despite this fact, a significant number of patients were receiving chemotherapy, often based on prognostic clinical-pathological features.2,3 The developers of the Oncotype DX® test felt there could be a better way to select which patients need chemotherapy. With this question in mind, the Oncotype DX test was uniquely designed to help identify patients who need chemotherapy.4
Prognosis – how likely is it that the cancer will return4
Prediction – can chemotherapy help reduce the risk of the cancer returning5
The Oncotype DX test offers two important pieces of information:
What is a prognostic test?
Prognosis relates to the natural disease progression. A prognostic biomarker informs about a likely cancer outcome (e.g., disease recurrence, disease progression or death) independent of treatment received.1
What is a predictive test?
A biomarker is predictive if the treatment effect (experimental compared with control) is different for biomarker-positive patients compared with biomarker-negative patients.6

Only the Oncotype DX test has been proven to be predictive
In order to be classed as a predictive test, a multigene assay must be trialed in a two-arm study designed to show an interaction between the biomarker and the treatment groups, and the interaction must be statistically significant to show a positive outcome.6
Other multigene assays in early-stage breast cancer were designed to answer different questions and have not been proven to predict chemotherapy benefit. Clinical-pathological factors, whilst playing an important role in a patient’s diagnosis, are only proven to be prognostic.7
Only the Oncotype DX Breast Recurrence Score test was designed to be both prognostic and predictive, meaning it can help identify which patients need chemotherapy. Therefore, when ordering a genomic test to guide chemotherapy decisions for your patients with HR+, HER2-, early-stage breast cancer, only the Oncotype DX test provides a reliable, actionable answer. The test is backed by over 120,000 patients’ worth of data4,5,8-15 and recommended by all major guidelines16-23.Abbreviations
CT, chemotherapy
ER, estrogen receptor
ET, endocrine therapy
HER2–, human epidermal growth factor receptor 2 negative
HR+, hormone receptor positive
N+, node positive
RCT, randomised clinical trial
RS, Recurrence Score result
ER, estrogen receptor
ET, endocrine therapy
HER2–, human epidermal growth factor receptor 2 negative
HR+, hormone receptor positive
N+, node positive
RCT, randomised clinical trial
RS, Recurrence Score result
References
- EBCTCG. Lancet. 2012
- Griggs. J Clin Oncol. 2012
- Zhang et al. Breast Can Res Treat. 2020
- Paik et al. N Engl J Med. 2004.
- Paik et al. J Clin Oncol. 2006.
- Ballman et al. J Clin Oncol. 2015
- European Society for Medical Oncology (ESMO) textbook: Breast Cancer: Essentials for Clinicians
- Dowsett et al. J Clin Oncol. 2010.
- Albain et al. Lancet Oncol. 2010.
- Nitz et al. Breast Cancer Res Treat. 2017.
- Sparano et al. N Engl J Med. 2015.
- Sparano et al. N Engl J Med. 2018.
- Kalinsky et al. New Engl J Med. 2021.
- Zhang et al. Breast Can Res Treat. 2020.
- Stemmer et al. npj Breast Cancer. 2017.
- NCCN Guidelines Insights: Breast Cancer, version 4.2022.
https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf - Andre et al. J Clin Oncol 2022.
- Burstein et al. Ann Oncol. 2021
- Curigliano et al. Ann Oncol. 2023
- Cardoso et al. Ann Oncol 2019.
- Loibl et al. Annals of Oncology 2024
- NICE Diagnostics Guidance DG58 December 2018.
https://www.nice.org.uk/guidance/dg58 accessed October 2024. - IQWIG Press Release, September 2018
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