Prognostic & Predictive Testing | Oncotype DX Test

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 may benefit from chemotherapy. With this question in mind, the Oncotype DX test was uniquely designed to help identify patients who need chemotherapy.4

The Oncotype DX test offers two important pieces of information:

Prognosis – how likely is it that the cancer will return4
Prediction – can chemotherapy help reduce the risk of the cancer returning5

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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.6

A biomarker is predictive if the treatment effect (experimental compared with control) is different for biomarker-positive patients compared with biomarker-negative patients.⁶

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In order to be classified 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 guidelines16-21.

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Abbreviations

CT, chemotherapy

ER, estrogen receptor

ET, endocrine therapy

HER2–, human epidermal growth factor receptor 2 negative

HR+, hormone receptor positive

N+, node positive

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 1.2026. 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. 2025.
Loibl et al. Ann Oncol. 2024.
NICE 2024. Available at https://www.nice.org.uk/guidance/dg58/chapter/1-Recommendation.
IQWIG 2024. Available at https://www.iqwig.de/en/projects/d23-01.html.

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Have questions about Oncotype DX^®?

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Prognosis vs Prediction - why it matters

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Abbreviations

References

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References