Testing Core Biopsy Specimens
The COVID-19 pandemic has had a life-altering effect on the lives of the general population, but most notably health care providers and those with a diagnosis of cancer. We are all aware that in order to optimize provider, hospital, and clinic delivery of care, decisions are being made that are resulting in the postponement of both screening and diagnostic oncology services as well as elective surgery.
Our Oncotype DX® tests remain readily available and our laboratory continues to operate.
Core biopsies are the initial diagnostic procedure of choice for breast masses identified by physical exam or by imaging techniques.
The Oncotype DX test process was optimized to require only small amounts of tumor tissue and can be performed on a core biopsy of the breast cancer in lieu of the final resection specimen.
Guidance from the COVID-19 Pandemic Breast Cancer Consortium* references that a low-risk Recurrence Score® result from a core biopsy may be used to treat patients with Stage 1 or 2 disease, including N+ (1-3), with endocrine therapy alone when delaying surgery.a
View the new data on the molecular characterization of breast cancer needle core biopsy specimens by the 21‐gene Breast Recurrence Score test.
Read a case study about "A 62-Year-Old Woman with Early Breast Cancer during the Covid-19 Pandemic" from the New England Journal of Medicine.
Managing Breast Cancer During the COVID-19 Pandemic with the Oncotype DX Breast Recurrence Score Test
Featuring speakers Christy Russell, MD (Sr. Medical Director, US Oncology) and Rick Baehner, MD (Chief Medical Officer, Precision Oncology)
a. The COVID-19 Pandemic Breast Cancer Consortium. “COVID-19 Recommendations for Prioritization, Treatment and Triage of Breast Cancer Patients During the COVID-19 Pandemic.” The American Society of Breast Surgeons. Posted online April 7, 2020; Accessed April 9, 2020: https://www.breastsurgeons.org.
* Includes representatives from ASBrS, NAPBC, NCCN, CoC, ACR
Node-negative cancer
Whether patients have node-negative or node-positive breast cancer, the Breast Recurrence Score test is both prognostic and predictive – providing both important prognostic information about the estimated risk of distant recurrence and the likelihood of adjuvant chemotherapy benefit.
1-6
Learn more about the study results:
Prognostic Clinical Trial Results:
Predictive Clinical Trial Results:
Predictive Clinical Trial Results:
Not all patients benefit from chemotherapy1
The Oncotype DX Breast Recurrence Score test reveals individual tumor biology based on measuring the expression of 16 cancer genes and 5 reference genes.
2,3
The only multigene assay with both prognostic and predictive validation studies2-5
Prognostic: The ability to use biomarkers to inform about a likely clinical outcome.
Predictive: The ability to predict the response to a specific treatment (ie, chemotherapy benefit).
Node-Negative Predictive Clinical Trial Results
Node-Negative Predictive Clinical Trial Results
Only the Oncotype DX Breast Recurrence Score test predicts the likelihood of chemotherapy benefit for node-negative patients.2
NSABP B-20 Study: Low Recurrence Score
NSABP B-20 Study: Low Recurrence Score result predicted little to no benefit from chemotherapy
NSABP B-20 Study: High Recurrence Score
NSABP B-20 Study: High Recurrence Score result predicted large benefit from chemotherapy
Prospective analysis of archived tissue from 651 patients with ER-positive, node-negative, invasive breast cancer treated with tamoxifen or tamoxifen plus CMF/MF. Approximately 45% of the patients were < 50 years of age, two-thirds of tumors were ≤ 2.0 cm in size, and 16% of tumors were progesterone receptor-negative.
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Node-Negative Prognostic Clinical Trial Results
The Recurrence Score result is directly associated with the rate of distant recurrence.1, 4
NSABP B-14 Study
NSABP B-14 Study
10-year rate of distant recurrence was significantly lower for patients with low Recurrence Score results compared to high results
Prospective analysis of archived tissue from 668 stage I or II patients with estrogen receptor (ER)-positive, node-negative, invasive breast cancer treated with tamoxifen. Twenty-nine percent of patients were < 50 years of age, and 62% had tumors that were ≤ 2.0 cm in size. The majority of patients (51%) in this study had low Recurrence Score results.
1
Only the Oncotype DX Breast Recurrence Score test is:
STANDARD OF CARE
with prospective outcomes in over 96,000 patients4-6,19-21 - including over 12,000 node-positive patients4-6*
PROVEN
to be predictive of chemotherapy benefit in both node-positive and node-negative patients3,22
CLINICALLY VALIDATED
in multiple studies with consistent results (Level 1 evidence for risk of distant recurrence and prediction of chemotherapy benefit)3,22