HR+, HER2- Breast Cancer Test | Oncotype DX Test

The Oncotype DX Breast Recurrence Score test was uniquely designed to help identify which patients with HR+, HER2-, early-stage breast cancer who need chemotherapy. By revealing tumour biology beyond clinical-pathological parameters, it shifts decision-making from assumed to proven chemotherapy benefit for your patients.^1-6

Predictive markers can inform treatment decisions and avoid extrapolation from prognostic factors. Predictive markers such as ER and HER2 status identify patients responding to hormonal treatment and trastuzumab, respectively⁷. The Recurrence Score result informs whether a tumour is likely to respond to chemotherapy. The NSABP B-20 and SWOG 8814 studies established the predictive value of the Recurrence Score result and the TAILORx and RxPONDER studies further refined the estimates of chemotherapy benefit. These landmark trials showed the majority of patients do not benefit from chemotherapy. Furthermore, these two trials included analysis on age and menopausal status to allow for personalised decision making based on a patient's age and/or menopausal status as well as their Recurrence Score^® result.^1-6

In clinical practice, treatment decisions are often made based on prognostic factors such as tumour size and grade². However, such clinical-pathological parameters are prognostic and have not been demonstrated to predict chemotherapy benefit.^2,5,6,11 Furthermore, several studies have established that clinical-pathological features cannot predict Recurrence Score^® results, such as the below analysis from Germany which shows there is a range of Recurrence Score results across the clinical-pathological features.^2,12-16

whom to test with oncotype dx real world evidence clinical pathological factors treatment decisions

b Low clinical risk:
N0, T ≤3 cm and Grade 1
N0, T ≤2 cm and Grade 2
N0, T ≤1 cm and Grade 3
N1, T ≤2 cm and Grade 1
High clinical risk: all other cases

A recent study showed that relying on these clinical-pathological factors alone is associated with a high level of uncertainty amongst physicians regarding their treatment decisions. Testing with the Oncotype DX^® assay provided greater confidence to clinicians in their treatment recommendations.¹³

whom to test with oncotype dx clinical pathological factors high uncertainty amongst physicians

The TAILORx and RxPONDER studies have added to the evidence base to further refine the chemotherapy benefit by age or menopausal^2,5,6. The data also shows the Recurrence Score result is independent of clinical-pathological features². The Oncotype DX test can be considered for all HR+, HER2-, early-stage breast cancer patients to help guide their chemotherapy treatment decisions.

Abbreviations

ASCO, American Society of Clinical Oncology

IQWIG, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen

NICE: The National Institute for Health and Care Excellence

NCCN, National Comprehensive Cancer Network

HTA, Health Technology Assessment

CT, chemotherapy

ER, estrogen receptor

ET, endocrine therapy

HER2–, human epidermal growth factor receptor 2 negative

HR+, hormone receptor positive

HT, hormone therapy

N0, node-negative

NSABP, National Surgical Adjuvant Breast and Bowel Project

PR, progesterone receptor

RS, Recurrence Score^® result

SEER, Surveillance, Epidemiology and End Results program

TAILORx, Trial Assigning IndividuaLized Options for Treatment (Rx)

References

Paik et al. J Clin Oncol. 2006.
Sparano et al. N Engl J Med. 2018.
Geyer et al. npj Breast Cancer. 2018.
Albain et al. Lancet Oncol. 2010.
Kalinsky et al. NEJM. 2021.
Kalinsky et al. SABCS 2021.
Allison et al. Mod Pathol. 2021.
Rastelli and Crispino, Tumouri. 2008.
Viale et al. J Natl Cancer Inst. 2008.
Perez et al. Cancer Treat Rev. 2017.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Peto R, et al. Lancet. 2012.
Walter et al. Geburtshilfe Frauenheilkd. 2020.
Licata et al. npj breast cancer. 2023.
Barni et al. ESMO 2018. Poster 194P.
McSorley et al. J Clin Oncol 38: 2020 (suppl; abstr 540).
Curtit et al. Breast. 2019.

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Abbreviations

References