Clinical Summary
Validated Clinical Benefits
Numerous studies have shown that the Oncotype DX assay delivers consistent, reproducible and accurate results. Based on the nearly 4,000 patients studied to date, the Oncotype DX assay delivers clinically valuable information that can be used to help make decisions about adjuvant therapy. The assay informs your treatment options and can give patients more confidence in their decisions.
NSABP B-14—Prospective Analysis of Archival Tissue: Likelihood of Distant Breast Cancer Recurrence4
- 668 stage I or II, node-negative, estrogen-receptor-positive, tamoxifen-treated patients
- Validation conducted using prospectively defined endpoints
- The Oncotype DX assay validated as quantifying the likelihood of distant breast cancer recurrence for individual patients
- Recurrence Score result performance is superior to that of patient age and tumor size in prognostic power and superior to tumor grade in reproducibility
In a statistical analysis in which distant recurrence was evaluated in relation to the Recurrence Score (RS) result, age and tumor size, the RS result provided predictive power that was independent of those traditional prognostic variables. When it was combined with age and tumor size data, only the Recurrence Score result remained statistically significant.
NSABP B-20—Prospective Analysis of Archival Tissue: Magnitude of Benefit from Chemotherapy5
- The Oncotype DX assay predicts the magnitude of benefit from chemotherapy: Proportion without distance recurrence at 10 years with vs. without treatment
- 651 patient samples that were node-negative, estrogen-receptor-positive from the NSABP B-20 Study were studied
- -227 patients were treated with tamoxifen alone
- -424 patients were treated with chemotherapy (CMF) and tamoxifen
- Patients with tumors that have Recurrence Score results of:
- -Greater than or equal to 31 have a substantial absolute benefit from chemotherapy
- -18 to 30 did not appear to receive a substantial benefit from chemotherapy, but a clinically important benefit cannot be excluded
- -Less than 18 derive minimal, if any, benefit from chemotherapy
Insight Beyond Traditional Markers
The Recurrence Score result provides additional insight into the likelihood of breast cancer recurrence that goes beyond traditional measures such as patient age, tumor size, ER status and tumor grade.
Impact on Treatment Decisions
The question of whether the Oncotype DX assay report impacts treatment decisions has been explored in more than eight studies. One of these studies, a multi-center study with 17 medical oncologists, was designed to prospectively examine how the Recurrence Score result impacts adjuvant treatment decision making in breast cancer.
- In 31.5% of cases, medical oncologists changed their recommendation after receiving the Recurrence Score result, and the great majority of these changes were from "chemo-hormonal therapy" to "hormonal therapy" alone
- In 76% of cases, the physician agreed or strongly agreed with the statement, "I am more confident in my treatment recommendation after ordering the Oncotype DX assay"
- Patients reported significantly lower conflict about the decision for adjuvant treatment, greater satisfaction with decision making and decreased situational anxiety
Multiple studies in both the academic and community settings were pooled to examine the treatment selection based on Recurrence Score results. A low Recurrence Score result provided actionable information for physicians that led to a recommendation for no chemotherapy (91%) and resulted in no chemotherapy given (95%) in virtually all low Recurrence Score result patients.
Expansion of Clinical Utility
Genomic Health is committed to expanding the clinical utility of the Oncotype DX assay—expanding the clinical experience information to additional populations of patients with breast cancer and bringing more valuable information to physicians.
- A recent study demonstrates that the Oncotype DX assay Recurrence Score result is informative for post-menopausal patients with node-positive, hormone-receptor-positive (HR+) breast cancer11
- The Oncotype DX assay is a predictive assay for chemotherapy (CAF) benefit (change in disease-free survival)
- The Oncotype DX assay is a prognostic for disease-free survival at 5 years
