OncLive presents Priyanka Sharma, MD, and Lajos Pusztai, MD, PhD
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
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
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
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
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
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
* 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)
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
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
Gluzet al. ESMO 2017
* 29% of (N0 to N1, RS 0-11 with ET alone) patients were ≤50 years old. Data on file.
- >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.
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.
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:
* Includes patients with micrometastases (N1mi).
STANDARD OF CARE
with prospective outcomes in over 96,000 patients4-6,19-21 - including over 12,000 node-positive patients4-6*
to be predictive of chemotherapy benefit in both node-positive and node-negative patients3,22
in multiple studies with consistent results (Level 1 evidence for risk of distant recurrence and prediction of chemotherapy benefit)3,22