It’s never been as clear to identify node-positive patients who can safely be spared chemotherapy.1–7

OncLive presents Priyanka Sharma, MD, and Lajos Pusztai, MD, PhD
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Kevin Kalinsky, MD presents Early RxPONDER Data at SABCS 2020

Node-positive patients may be overtreated

Node-positive patients are believed to have higher risk of distant recurrence and worse prognoses if not treated with chemotherapy.1 However, evidence suggests a biological spectrum exists across patients with node-positive disease similar to patients with node-negative disease.2

Nodal status does not predict tumor biology2

Only the Oncotype DX Breast Recurrence Score test can identify which node-positive (1-3 nodes) HR+, HER2- patients will and will not benefit from chemotherapy.3

The only multigene assay proven to predict chemotherapy benefit, regardless of nodal status

The 21-gene test has been incorporated into major clinical practice guidelines worldwide.8-14

NCCN Guidelines9
  • Preferred for N0 and N1 postmenopausal patients with HR+, HER2- disease, backed by level 1 evidence
  • Strongly considered for N0 and N1 postmenopausal patients with HR+, HER2- disease and tumors >0.5 cm
  • Considered for N1 premenopausal patients with HR+, HER2- disease
  • The Value of Oncotype DX Breast Recurrence Score test in node-positive patients:


  • Multiple studies have consistently clinically validated and reinforced the value of the Recurrence Score result along the node-negative to node-positive (1-3 nodes) continuum15
  • The Oncotype DX test is both prognostic and predictive of chemotherapy benefit in the node-positive population3,7
  • Prospective Level 1A evidence demonstrates that node-positive patients with low Recurrence Score results (RS≤11) have excellent outcomes with endocrine therapy alone4
  • Real-world prospective outcome studies including the SEER and Clalit registries show6,16,17:
    • Many node-positive patients had low Recurrence Score results
    • Node-positive patients with Recurrence Score results <18 have excellent outcomes on endocrine therapy alone

    Patient Vilma
    Meet Vilma
    Find out how she dealt with her node-positive cancer
    See Her Story

     
    Early Stage
     
    ER
    (+)
     
    HER2
    (-)
     
    Node
    (+)

    The Oncotype DX Breast Recurrence Score test: Predictive and Prognostic Results you can count on

    The Oncotype DX Breast Recurrence Score test identifies which node-positive patients may and or may not clinically benefit from the addition of chemotherapy to endocrine therapy.3

    Clinical Evidence

    RxPONDER Trial

    The RxPONDER trial prospectively randomized 5083 HR+, HER2-, node-positive patients with Recurrence Score results 0 to 25 to receive chemotherapy followed by endocrine therapy or endocrine therapy alone. Primary endpoints are to:18
    • Assess the chemotherapy benefit for these patients according to their Recurrence Score result
    • Determine if Recurrence Score results and chemotherapy are independently prognostic

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

    RxPONDER graphic

    First results from the study, led by the independent SWOG Cancer Research Network, and sponsored by the National Cancer Institute (NCI) indicate:19

    • The majority of HR+, HER2-, N1, post-menopausal patients can be spared chemotherapy when decisions are guided with the Oncotype DX test
    • Postmenopausal women with 1 to 3 positive nodes and Recurrence Score results 0-25 can forgo adjuvant chemotherapy regardless of clinical pathological parameters
    • Premenopausal women with 1 to 3 positive nodes and Recurrence Score results 0-25 significantly benefit from chemotherapy

    RxPONDER IDFS graphic

    SWOG 8814 Study

    In the SWOG-8814 trial , the Recurrence Score result was shown to be prognostic for disease-free survival (DFS) and overall survival (OS) in N+ patients treated with tamoxifen alone as well as predictive of cyclophosphamide/doxorubicin/fluorouracil (CAF) therapy benefit.3

    SWOG 8814 study


    * Chemotherapy benefit in addition to endocrine therapy.
    SWOG = Southwest Oncology Group; TAM = tamoxifen; CAF-T = cyclophosphamide, doxorubicin, and fluorouracil before tamoxifen; CI = confidence interval; LN = lymph node(s)

    TransATAC Study

    In a study of postmenopausal patients from the TransATAC trial , the Recurrence Score result was shown to be prognostic for distant recurrence in N+ patients treated with either tamoxifen or anastrozole.7

    TransATAC study


    LN = lymph node(s); TransATAC = translational study of anastrozole or tamoxifen alone or combined.

    WSG PlanB Trial

    The WSG PlanB trial is a study of node-positive (N+) and high-risk node-negative (N0) patients who used the Oncotype DX test prospectively to guide treatment decision making.4

    WSG PlanB trial
    Gluzet al. ESMO 2017

    • >97% Distant Disease Free Survival at 5 years in patients with 1 to 3 positive nodes and Recurrence Score results 0-11 treated with hormonal therapy alone4
    • These results are very similar to the TAILORx Arm A data17 despite the PlanB cohort representing higher-risk node-negative and node-positive patients.
    • The consistency across the two populations supports the idea that biology surpasses traditional clinical and pathological risk markers.
    * 29% of (N0 to N1, RS 0-11 with ET alone) patients were ≤50 years old. Data on file.
     

    Hear from one of the Study Investigators

    Dr. Oleg Gluz, from the West German Study Group, Mönchengladbach, Germany, talks about the rationale and design of PlanB, a prospective phase 3 trial evaluating the Oncotype DX Breast Recurrence Score test for defining a low-risk subgroup of breast cancer patients with node-positive disease who could be treated with adjuvant endocrine therapy alone.

     

    Hear a Medical Oncologist’s perspective

    Neelima Denduluri, MD, medical oncologist, Virginia Cancer Specialists, discusses the use of the Oncotype DX assay in early-stage hormone receptor—positive, HER2-negative breast cancer in node negative and node positive patients.

    Only the Oncotype DX Breast Recurrence Score test is:


    STANDARD OF CARE

    icon fast
    with prospective outcomes in over 96,000 patients4-6,19-21 - including over 12,000 node-positive patients4-6*

    PROVEN

    icon comprehensive
    to be predictive of chemotherapy benefit in both node-positive and node-negative patients3,22

    CLINICALLY VALIDATED

    icon actionable
    in multiple studies with consistent results (Level 1 evidence for risk of distant recurrence and prediction of chemotherapy benefit)3,22

    * Includes patients with micrometastases (N1mi).



    REFERENCES

    1. Mamounas et al. npj Breast Cancer. 2018.
    2. Bello et al. Ann Surg Oncol. 2018.
    3. Albain et al. Lancet Oncol. 2010.
    4. Nitz et al. Breast Cancer Res Treat. 2017.
    5. Roberts et al. Breast Cancer Res Treat. 2017.
    6. Stemmer et al. npj Breast Cancer. 2017; 3:32.
    7. Dowsett et al. J Clin Oncol. 2010.
    8. Telli et al. J Natl Compr Cancer Ntwk. 2019.
    9. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Breast Cancer. V3.2021.
    10. Senkus et al. Ann Oncol. 2015.
    11. Harris et al. J Clin Oncol. 2016.
    12. Coates et al. N Engl J Med. 2015.
    13. NICE Diagnostics Guidance. December 2018.
    14. Andre et al. J Clin Oncol. 2019.
    15. Goldstein et al. J Clin Oncol. 2008.
    16. Petkov et al. npj Breast Cancer. 2016.
    17. Roberts et al. Breast Cancer Res Treat. 2017.
    18. RxPONDER, NCT01272037.
    19. Kalinsky, K. et al. Oral Presentation: [GS3-00]. San Antonio Breast Cancer Symposium; December 2020.
    20. Stemmer et al. npj Breast Cancer Res Treat. 2017; 3:33.
    21. Sparano et al. N Engl J Med. 2018.
    22. Sparano et al. N Engl J Med. 2015.
    23. Paik et al. J Clin Oncol. 2006.

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