Oncotype DX Breast Recurrence Score®

Clinical evidence for the Oncotype DX® test in node-positive patients

The Recurrence Score® result has been proven to be predictive of chemotherapy benefit for HR+, HER2-, node-positive patients1. A comprehensive set of studies, including more than 12,000 patients suggests that a significant proportion of patients with up to 3 positive lymph nodes could be spared chemotherapy. Indeed, HR+, HER2-, node-positive patients with a Recurrence Score result 0-17 consistently show excellent clinical outcomes when treated with endocrine therapy alone while node-positive patients with Recurrence Score results 31 to 100 derived a significant benefit from chemotherapy.

Excellent clinical outcomes for node-positive patients with a Recurrence Score result 0-17 treated without chemotherapy

CT = chemotherapy; ET = endocrine therapy; RS = Recurrence Score result
* The SEER registry prospectively captured breast cancer-specific survival; the Clalit registry prospectively captured distant recurrence and breast cancer death outcomes; the Plan B prospective study assessed disease-free survival, overall survival and distant recurrence.

Clinical Evidence

SWOG-8814 study

The analysis of the SWOG-8814 trial, in which HR+, node-positive patients were prospectively randomized 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.12

The Recurrence Score result was a strong predictive factor of chemotherapy benefit for disease-free survival (P interaction = 0.029), overall survival and breast cancer-specific survival in the first five years.

WSG PlanB trial

This prospective trial showed that patients with Recurrence Score results 0–11 treated with endocrine therapy alone had excellent 5-year disease-free survival outcomes. In this study, outcomes were similar for patients with Recurrence Score result 0 to 11 whether node-negative with a risk factor (pT >2 cm, G2–3, high uPA / PAI-1, HR-negative or age <35 years) or node-positive (up to 3 positive nodes)4,6

WSG Plan B study design: node-positive and high-risk node-negative patients with Recurrence Score results 0 – 11 were assigned to endocrine therapy alone

a Node-positive (N+) had T1–4, grade 1–3 and HR (hormone receptor)+ or HR− disease
b High-risk node-negative (N0) had T >2 cm, grade 2–3 or HR− disease, had elevated uPA / PAI-1 levels or were ≤35 years of age
c Endocrine therapy and radiotherapy according to national guidelines

Patients with Recurrence Score results 0–11 have excellent outcomes on endocrine therapy alone4

a As treated population; High-risk patients (pT >2 cm, G2–3, uPA / PAI-1, HR-negative, age ≤35 years)
b Patients with RS 0–11 received endocrine therapy alone;
c Patients with RS 12–25 or 26–100 received chemotherapy according to protocol

RxPONDER trial

The trial prospectively randomised HR+, HER2-, node-positive patients with Recurrence Score results 0 to 25 to receive chemoendocrine therapy or endocrine therapy alone. The primary endpoint is to assess the chemotherapy benefit for these patients according to their Recurrence Score result. The study is fully recruited and upon completion is intended to further refine adjuvant treatment decisions in HR+, HER2–, node-positive breast cancer patients.5

RxPONDER study design: node-positive (1-3 nodes) patients with Recurrence Score results 0 – 25 were randomised to endocrine therapy alone or chemoendocrine therapy

Real-World Evidence

Real-world evidence of the value of the Recurrence Score results to identify node-positive (N1mi, N1) patients who can spare chemotherapy.

Clalit Registry

Clalit Health Services, the largest health maintenance organisation in Israel, has collected data on all patients tested with the Oncotype DX test since 2006.

Excellent 5-year clinical outcomes observed in N1mi/N1 patients with Recurrence Score results 0–17 on endocrine therapy alone2 reinforce the evidence that these patients can be spared chemotherapy

SEER Registry

The Surveillance, Epidemiology, and End Results (SEER) registry from the USA National Cancer Institute program collects real-world cancer data3,21

Nine-year prospective outcomes were reported by Recurrence Score groups and nodal status in patients treated without chemotherapy and showed a breast cancer-specific survival > 97% for patients with Recurrence Score result 0-17 regardless of nodal status.3 This corroborated other results on the clinical utility of the Oncotype DX testing to identify patients who can benefit or spare chemotherapy.

Excellent clinical outcome for node-positive patients (N1mic, N1) with a Recurrence Score result 0-17 treated without chemotherapy

KEY STUDY DETAILS

  • TransATAC Study:20 Consistent with NSABP B-14 results for node-negative patients, this study confirmed that the Oncotype DX Breast Recurrence Score test provides prognostic information for node-positive patients as well. The rate of distant recurrence increased as the Recurrence Score result increased.
  • SWOG-8814:1 This study determined that the Oncotype DX Breast Recurrence Score test is associated with the likelihood of chemotherapy benefit in node-positive patients, with a significant interaction demonstrated between Recurrence Score results and chemotherapy response (P interaction = 0.029 in the first 5 years). Patients with Recurrence Score results 0-17 do not benefit from the addition of chemotherapy, while patients with Recurrence Score results 31-100 benefit significantly from chemotherapy.
  • WSG PlanB phase III prospective trial:4,6 The WSG PlanB Trial confirmed the clinical utility of the Recurrence Score result in node-positive and clinically high-risk node-negative patients with Level 1A prospective evidence. It showed that patients with Recurrence Score results 0-11 can be safely spared chemotherapy.
  • SEER registry:3,21 SEER is a prospectively designed registry evaluating treatment and clinical outcomes in breast cancer patients who have had the Oncotype DX Breast Recurrence Score test. It confirms the clinical utility of the Oncotype DX Breast Recurrence Score test, with 9-year outcomes that are consistent with the results in the TAILORx Trial for node-negative patients. SEER 9-year real world evidence also supports the option of hormone therapy alone for patients with 1-3 positive nodes and Recurrence Score results 0-17.
  • Clalit registry:2 The Clalit registry is a real-world, observational cohort of over 2,000 patients, for whom the Recurrence Score result was used to guide their treatment decisions. The Clalit registry evidence was consistent with all studies confirming the utility of the Oncotype DX test to identify patients who do not benefit from chemotherapy.
  • RxPONDER trial:5 RxPONDER is an ongoing randomised clinical trial that has enrolled 5,000 HR+, HER2-, node-positive patients to prospectively assess the value of Recurrence Score results for predicting chemotherapy response.
ABBREVIATIONS

BCSS=Breast Cancer Specific Survival
CI=confidence interval
CT=chemotherapy
DDFS=distant-disease free survival
HER2–=human epidermal growth factor receptor 2 negative
HR+=hormone receptor positive
N+=node-positive
N0=node-negative
N1mi=node-lymph node micrometastases
N1=1–3 positive nodes
RS=Recurrence Score result
SEER=Surveillance, Epidemiology and End Results program
TAILORx=Trial Assigning IndividuaLized Options for Treatment (Rx)
WSG=West German Study Group

REFERENCES
  1. Albain et al. Lancet Oncol. 2010.
  2. Stemmer et al. NPJ Breast Cancer. 2017.
  3. Hortobagyi et al. SABCS. 2018.
  4. Nitz et al. Breast Cancer Res Treat. 2017.
  5. RxPONDER, NCT01272037.
  6. Gluz et al. J Clin Oncol. 2016.
  7. Gluz et al. ESMO. 2017.
  8. Nitz et al. J Clin Oncol. 2019.
  9. Genomic Health. Data on File. 2019.
  10. Paik et al. N Engl J Med. 2004.
  11. Paik et al. J Clin Oncol. 2006.
  12. Geyer et al. NPJ Breast Cancer. 2018.
  13. Sparano et al. N Engl J Med. 2018.
  14. IQWiG. Press release. 2018.
  15. Andre et al. J Clin Oncol. 2019.
  16. NCCN Guidelines. 2018.
  17. NICE. 2018.
  18. Burstein et al. Ann Oncol. 2019.
  19. Cardoso et al. Annals of Oncology. 2019.
  20. Dowsett et al. J Clin Oncol. 2010.
  21. Petkov et al. NPJ Breast Cancer. 2016.
  22. Bello et al, Ann Surg Onc. 2018.

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