Understanding the Oncotype DX Test | Oncotype DX® Test

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The Oncotype DX Breast Recurrence Score^® test has been developed for patients with early-stage HR+, HER2- breast cancer to:

Identify those patients who will derive benefit from chemotherapy
Determine the magnitude of chemotherapy benefit
Make chemotherapy a personalised treatment

Chemotherapy causes both short- and long-term side effects affecting current and future health, quality of life, family life and work life.^1-3 The vast majority of patients with HR+, HER2- early-stage breast cancer do not benefit from adjuvant chemotherapy.⁴

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The Oncotype DX test was developed to assess disease prognosis and predicts benefit from chemotherapy (CT) in patients with early-stage, HR+, HER2- breast cancer⁹. 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 patients^5,13 and SWOG-8814 for node-positive patients⁸. The landmark TAILORx study⁶ showed that ET was non-inferior to CT + ET in patients with node-negative disease and Recurrence Score results 11 to 25. In addition, RxPONDER study¹¹ initial results demonstrated that postmenopausal patients with Recurrence Score results 0-25 can be spared chemotherapy independent of clinical pathologic parameters. This supports earlier research indicating that the majority of patients do not benefit from the addition of chemotherapy.⁴

The Oncotype DX test was developed to predict chemotherapy benefit based on a unique understanding of tumour biology^5,9. The Oncotype DX test quantifies expression of 21 genes in fixed, paraffin-embedded tumour tissue using high-throughput, real-time, reverse transcription-polymerase chain reaction. Three independent breast cancer studies were used to select the panel of 16 cancer-related and five reference genes that are tested in the Oncotype DX assay. Based on the expression levels of the 21 genes, a Recurrence Score result is calculated for each tumour sample.

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The Oncotype DX test identifies patients who will 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.

Learn more about the Oncotype DX test for:

Node-negative patients

Node-positive patients

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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.

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Abbreviations

CT, chemotherapy

ET, endocrine therapy

HER2–, human epidermal growth factor receptor 2 negative

HR+, hormone receptor positive

N0, node-negative

References

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. J Clin Oncol. 2006.
Sparano JA et al. N Engl J Med. 2018.
Ballman et al. J Clin Oncol. 2015.
Albain et al. Lancet Oncol. 2010.
Paik et al. N Engl J Med. 2004.
Dowsett M et al. J Clin Oncol. 2010.
Kalinsky. N Engl J Med. 2021.
Kalinsky et al. SABCS. 2021 GS2-07.
Nitz et al. Breast Cancer Res Treat. 2017.
Geyer et al. NPJ Breast Cancer. 2018.
Hortobagyi et al. SABCS 2018.
Stemmer et al. St. Gallen Conference. 2019.
Stemmer et al. NPJ Breast Cancer. 2017.
Mamounas et al. NPJ Breast Cancer. 2018.
Petkov et al. Npj Breast Cancer. 2016.
Blohmer et al. ESMO 2017.
Bello et al. Ann Surg Onc. 2018.
Sparano and Paik. J Clin Oncol. 2008.
Sparano et al. N Engl J Med. 2019.

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Have questions about Oncotype DX^®?

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About the test

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What is the Oncotype DX^® test, and what makes it unique?

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Prediction of chemotherapy benefit based on prospective clinical trials makes the Oncotype DX test unique.

Development of the Oncotype DX Test

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The Oncotype DX test reveals individual tumour biology based on measuring the expression of 21 genes⁹

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What information does the Oncotype DX test provide?

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Guiding treatment with the Oncotype DX test

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Abbreviations

References

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Development of the Oncotype DX Test

The Oncotype DX test reveals individual tumour biology based on measuring the expression of 21 genes⁹

What information does the Oncotype DX test provide?

Guiding treatment with the Oncotype DX test

References

About the test

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What is the Oncotype DX® test, and what makes it unique?

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Prediction of chemotherapy benefit based on prospective clinical trials makes the Oncotype DX test unique.

Development of the Oncotype DX Test

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The Oncotype DX test reveals individual tumour biology based on measuring the expression of 21 genes9

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What information does the Oncotype DX test provide?

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Guiding treatment with the Oncotype DX test

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Abbreviations

References

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Development of the Oncotype DX Test

The Oncotype DX test reveals individual tumour biology based on measuring the expression of 21 genes9

What information does the Oncotype DX test provide?

Guiding treatment with the Oncotype DX test

References

What is the Oncotype DX^® test, and what makes it unique?

The Oncotype DX test reveals individual tumour biology based on measuring the expression of 21 genes⁹

The Oncotype DX test reveals individual tumour biology based on measuring the expression of 21 genes⁹