What is the Oncotype DX^® test?

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

The Oncotype DX test is the only multigene assay that is both predictive of chemotherapy treatment effect and prognostic of disease outcome^5-13

The Oncotype DX test is the only test clinically validated to identify patients likely to benefit from chemotherapy, or not.^5-13

Learn more about the difference between prognostic and predictive tests

See the difference

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

*TAILORx showed that endocrine therapy was non-inferior to chemoendocrine therapy in node-negative patients with Recurrence Score^® results 11-25. RxPONDER showed that node-positive postmenopausal patients with Recurrence Score^® results 0-25 do not benefit from chemotherapy while premenopausal patients with 1 to 3 positive nodes and RS^® results 0-25 have a modest benefit from chemotherapy.

Development of the Oncotype DX Test

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.

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

16 Cancer Genes and 5 Reference Genes

What information does the Oncotype DX test provide?

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 INTERPRETING THE RESULTS OF THE ONCOTYPE DX TEST FOR
NODE-NEGATIVE AND NODE-POSITIVE PATIENTS

The Oncotype DX test for node-negative patients

In node-negative, early-stage, HR+, HER2- breast cancer patients, studies including > 95,000 patients have established that the Oncotype DX test consistently identifies the vast majority of patients (80%) who can be spared chemotherapy and the important minority (20%) who may substantially benefit from it.^5,6,9,13-15 This includes the largest prospective, randomised adjuvant clinical trial in breast cancer: the landmark TAILORx study, which enrolled more than 10,000 patients.⁶

Patient selection using the Oncotype DX test in node-negative patients

a The Oncotype DX test consistently identifies the ∼80% of ER+/HER2-/EBC patients who can avoid chemotherapy, and 20% of patients for whom it may be life-saving ^{6,13-16,18-19}

In the HR+, HER2-, early breast cancer population, about 20% of node-negative patients have Recurrence Score results 26-100. These patients have been shown to derive substantial benefit from chemotherapy^5,8. Pacientes de >50 anos de idade com resultados Recurrence Score de 0 a 25 demonstraram não se beneficiar da quimioterapia e podem abrir mão do ônus e das toxicidades desse tratamento.^5-6,8,11 Patients >50 years of age with Recurrence Score results 0-25 have been shown not to benefit from chemotherapy and may forgo the burden and toxicities of this treatment.^5-6,8,11For patients 50 or younger, some benefit from chemotherapy may be relevant below the Recurrence Score result of 25 and should be discussed between the treating physician and the patient.^5-6,8,11

Learn more about reducing the risk of over- and undertreatment in
node-negative patients

The Oncotype DX test for node-positive patients

The test’s predictive ability in the node-positive setting was validated in the two-arm prospective retrospective clinical trial SWOG-8814 for postmenopausal patients (comparing CT+ Endocrine Therapy (ET) versus ET alone)⁸. Initial results from the RxPONDER study further refined the chemotherapy benefit estimates for patients with Recurrence Score results 0-25 and 1 to 3 positive nodes. Results from these trials are summarized in the graphic below. Postmenopausal patients with one to three positive lymph nodes and Recurrence Score results 0-25 did not benefit from chemotherapy in addition to endocrine therapy^8,11. Premenopausal patients with Recurrence Score results 0-25 and 1 to 3 positive nodes derived a 2.9% chemotherapy benefit in terms of distant recurrence as first site at 5 years.¹¹

Patient selection using the Oncotype DX test in node-positive patients⁸

*CT benefit expressed in percentage points based on probability of distant recurrence with/without CT at 5 years. No CT benefit is considered for an absolute benefit <1%. Benefit of chemotherapy for premenopausal N1 patients with RS^® results 26-100 has not been formally assessed in a randomised study. The benefit derived from chemotherapy was significant for RS^® results 0-13 and 14-25 in the RxPONDER study and it is inferred to be substantial for patients with RS^® 26-100.

Learn more about reducing the risk of over- and undertreatment in
node-positive patients

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.

CT benefit expressed in percentage points based on probability of distant recurrence (N0) or distant recurrence-free interval (N1) with/without CT;
No CT benefit is considered for an absolute benefit <1%;
Node-negative (N0) patients: TAILORx analyses were performed by age and demonstrated patients ≤ 50 years derived some clinically meaningful benefit from CT at 9 years starting with an RS^® result of 16;
Node-positive (N1) patients: RxPONDER data were analysed according to menopausal status and demonstrated that premenopausal patients with RS^® results 0-25 overall derived benefit from chemotherapy at 5 years.
* Benefit of chemotherapy for premenopausal N1 patients with RS^® results 26-100 has not been formally assessed in a randomised study. The benefit derived from chemotherapy was modest for RS results 0-13 and 14-25 in the RxPONDER study and it is inferred to be substantial for patients with RS result 26-100.

ABBREVIATION

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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What is the Oncotype DX® test?

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The Oncotype DX test is the only multigene assay that is both predictive of chemotherapy treatment effect and prognostic of disease outcome5-13

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 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

Landmark RxPONDER Trial results presented at the 2020 SABCS

Prospective Outcomes: TAILORx

Real-world Evidence: SEER

Online ordering for the Oncotype DX® test

Contact Us

What is the Oncotype DX^® test?

The Oncotype DX test is the only multigene assay that is both predictive of chemotherapy treatment effect and prognostic of disease outcome^5-13

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

Prospective Outcomes:
TAILORx

Real-world Evidence:
SEER

Online ordering for the Oncotype DX^® test