Node-Positive and Node-Negative Evidence | Oncotype DX® Test

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Node-Negative

The clinical validity and utility of the Oncotype DX Breast Recurrence Score^® test in patients with HR+, HER2-, node-negative, early-stage, invasive breast cancer have been established through extensive clinical research in over 85,000 patients.

The Oncotype DX Breast Recurrence Score^® test was validated as prognostic of distant recurrence for node-negative, HR+ early stage breast cancer patients¹
The Oncotype DX test was uniquely validated to predict chemotherapy benefit in the 2-arm randomized clinical trial NSABP B-20^2,5,7 (interaction between Recurrence Score result and benefit from chemotherapy p=0.014⁵).
The practice-changing TAILORx prospective randomized clinical trial refined former findings, enabling a more precise threshold for CT benefit.^3,7,8

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Oncotype DX clinical evidence in node-negative patients - prediction of chemotherapy benefit makes the Oncotype DX Breast Recurrence Score test unique.

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Clinical evidence from the TAILORx and NSABP B-20 studies established that the Oncotype DX test can precisely identify two groups of patients: those who can be spared chemotherapy and those who will substantially benefit from it.^3,5

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Oncotype DX clinical evidence in node-negative patients - TAILORx and NSABP B-20 studies - who may be spared chemotherapy and who may substantially benefit from it.

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Patients with Recurrence Score results 0–25 do not benefit from the addition of chemotherapy to endocrine therapy^2,3,5

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Patients with Recurrence Score results 26–100 significantly benefit from the addition of chemotherapy to endocrine therapy^2,5

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The NSABP B-20 trial established that patients with Recurrence Score results 0-10 do not benefit from the addition of CT to ET and that patients with a Recurrence Score result 26-100 do benefit from the addition of CT⁵. The TAILORx trial was designed to determine whether ET was non-inferior to CT+ET in patients with Recurrence Score results 11-25.^3,8

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The TAILORx study met its primary and secondary endoints: patients with Recurrence Score results 11-25 treated with chemoendocrine therapy had similar rates of clinical events to patients receiving endocrine therapy alone in non-inferiority design invasive disease-free survival (primary endpoint), distant recurrence-free interval and overall survival.^3,8

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Real-world evidence is consistent with clinical studies. It confirms that the Oncotype DX test consistently identifies a minority of patients (15-20%) with Recurrence Score results 26-100 who derive substantial benefit from chemotherapy.

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Patients from the TAILORx study are comparable to those treated in clinical practice during the same period reported in the SEER registry.^3,8,11

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The Oncotype DX Breast Recurrence Score test identifies the vast majority of patients who will not benefit from the addition of chemotherapy to endocrine therapy and the important minority of patients for whom chemotherapy may be life-saving.^2-6

The Oncotype DX test has been studied in over 96,000 breast cancer patients in over 79 clinical and registry studies.
There is a consistent and large body of evidence across prospective randomised clinical trials, validation studies, and real-world registries.
The Oncotype DX test has been prospectively studied in the patient population most commonly seen in clinical practice.
The Oncotype DX is the only test validated in double-arm randomised clinical trials to identify patients responding to chemotherapy. Find out more about the difference between prognostic and predictive
The Oncotype DX test is uniquely superior to prognostic-only parameters to identify patients who will benefit from the addition of chemotherapy to endocrine therapy.
The Oncotype DX Breast Recurrence Score test is incorporated into the four major international guidelines

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The first clinical validation of the Oncotype DX Breast Recurrence Score test, the NSABP B-14 study, demonstrated that the Recurrence Score result quantifies the risk of distant recurrence in node-negative patients. It showed that the 10-year rate of distant recurrence is significantly lower for patients with low Recurrence Score results compared to patients with higher scores.

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This study determined that the Oncotype DX Breast Recurrence Score test predicts the likelihood of chemotherapy benefit for node-negative patients: a low Recurrence Score result predicted little to no benefit from the addition of chemotherapy to endocrine therapy, while a high score predicted a larger benefit from chemotherapy.

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The first prospective outcomes study providing Level 1A evidence for a multigene assay, the TAILORx Trial confirmed that, overall, patients with Recurrence Score results 11-25 do not benefit from the addition of chemotherapy to endocrine therapy and may be effectively and safely treated with hormonal therapy alone.

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Abbreviations

CI, confidence interval
CT, chemotherapy
ET, endocrine therapy
HER2–, human epidermal growth factor receptor 2 negative
HR+, hormone receptor positive
HR, hazard ratio
N0, node-negative
RS, Recurrence Score result
SEER, Surveillance, Epidemiology and End Results program
TAILORx, Trial Assigning IndividuaLized Options for Treatment (Rx)

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References

Paik et al. N Engl J Med. 2004.
Paik et al. J Clin Oncol. 2006.
Sparano et al. N Engl J Med. 2018.
Ballman et al. J Clin Oncol. 2015.
Geyer et al. NPJ Breast Cancer. 2018
Hortobagyi et al. SABCS. 2018.
Sparano and Paik. J Clin Oncol. 2008.
Sparano et al. N Engl J Med. 2015.
Stemmer et al. NPJ Breast Cancer. 2017.
Blohmer et al. ESMO. 2017.
Petkov et al. NPJ Breast Cancer. 2016.
Genomic Health. Data on File. 2019.
IQWiG. Press release. 2018.
Andre et al. J Clin Oncol. 2019.
NCCN Guidelines. 2018.
NICE. 2018.
Cardoso et al. Ann Oncol. 2019.
Burnstein et al. Ann Oncol. 2019.
Sparano et al. N Engl J Med. 2019.

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Node-Positive

The Recurrence Score^® result has been proven to be predictive of chemotherapy benefit for HR+, HER2-, node-positive postmenopausal patients in the retrospective SWOG-8814 study.¹ he prospective randomised trial RxPONDER including more than 5,000 patients was designed to refine chemotherapy benefit estimates for HR+, HER2- patients with Recurrence Score results 0-25 and 1 to 3 positive nodes.³ Initial results of the RxPONDER study have been described as practice-changing.^3-5

The majority of N1 postmenopausal patients may be spared chemotherapy based on Recurrence Score^® results 0-25, independent of clinical pathological parameters^3-5
N1 premenopausal patients with Recurrence Score results 0-25 have a modest 2.4% benefit from chemotherapy in terms of distant recurrence-free interval at 5 years⁴

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The retrospective analysis of the SWOG-8814 trial, in which HR+, node-positive, postmenopausal patients were randomised to chemoendocrine therapy vs endocrine therapy alone, established that the Recurrence Score result is predictive of chemotherapy benefit in node-positive patients¹, consistent with the findings in the node-negative setting in the NSABP B-20 clinical trial.^6-7

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RxPONDER (SWOG S1007) is an ongoing prospective, randomised trial to determine the effect of chemotherapy in patients with hormone receptor-positive (HR+), HER2-negative breast cancer with 1-3 positive axillary lymph nodes, including micrometastases.^2,4 For this purpose, eligible patients with Recurrence Score^® (RS^®) results 0-25 were randomised to adjuvant chemotherapy followed by endocrine therapy or to endocrine therapy alone.^2,4

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Professor Catherine Kelly from the Trinity St James Cancer Institute in Dublin presents in the RxPONDER results.

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The Oncotype DX Breast Recurrence Score test identifies the vast majority of women who may not receive a benefit from chemotherapy and can ultimately be spared chemotherapy.¹

Oncotype DX is the only test that has been clinically validated to predict chemotherapy benefit and that can thus be used to distinguish patients who will benefit from chemotherapy from those who may be spared chemotherapy.^1,6-7 Find out more about the difference between prognostic and predictive tests
The Oncotype DX test has been studied in over 96,000 breast cancer patients in over 79 clinical and registry studies.^1-14
There is a consistent and large body of evidence across randomised, prospective and retrospective studies and real-world evidence.^1-14
The Oncotype DX Breast Recurrence Score test is incorporated in the four major international guidelines and recommended as the “preferred” test by NCCN^®. In addition, it is recommended by two major European health technology assessment bodies.^15-20

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Abbreviations

CET=chemo-endocrine therapy
CI=confidence interval
CT=chemotherapy
DDFS=distant-disease free survival
ER= Endocrine therapy
HER2–=human epidermal growth factor receptor 2 negative
HR+=hormone receptor positive
N+=node-positive
N0=node-negative
N1mi=lymph node micrometastases
N1=1–3 positive nodes
RS=Recurrence Score result
RxPONDER=Rx for Positive Node, Endocrine Responsive Breast Cancer
TAILORx=Trial Assigning IndividuaLized Options for Treatment (Rx)

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References

Albain et al. Lancet Oncol. 2010.
SWOG. Press release. 2020.
Kalinsky et al. SABCS. 2020 GS3-00.
Kalinsky et al. SABCS. 2021 GS2-07.
Kalinsky. N Eng J Med. 2021.
Paik et al. J Clin Oncol. 2006.
Geyer et al. NPJ Breast Cancer. 2018.
Stemmer et al. NPJ Breast Cancer. 2017.
Hortobagyi et al. SABCS. 2018.
Nitz et al. Breast Cancer Res Treat. 2017.
Paik et al. N Engl J Med. 2004.
Sparano et al. N Engl J Med. 2018.
Dowsett et al. J Clin Oncol. 2010.
Petkov et al. NPJ Breast Cancer. 2016.
IQWiG. Press release. 2018.
Andre et al. J Clin Oncol. 2019.
NCCN Guidelines. 2021.
NICE. 2018.
Burstein et al. Ann Oncol. 2019.
Cardoso et al. Annals of Oncology. 2019.

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Clinical evidence

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TAILORx proved that patients with Recurrence Score results 11-25 do not benefit from chemotherapy

References

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Abbreviations

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References

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SWOG-8814 study

References

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RxPONDER trial

References

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Abbreviations

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References

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Get in touch

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TAILORx proved that patients with Recurrence Score results 11-25 do not benefit from chemotherapy

References

Abbreviations

References

SWOG-8814 study

References

RxPONDER trial

References

Abbreviations

References

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