In a groundbreaking development for early-stage breast cancer patients, the gene profiling test Oncotype DX has emerged as a powerful tool to guide treatment decisions. This test, designed to estimate the risk of recurrence and predict the effectiveness of chemotherapy, is particularly valuable for patients characterized as estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-).
The objective of a recent single technology assessment (STA) was to comprehensively evaluate Oncotype DX’s capabilities and impact on breast cancer treatment strategies. The assessment, based on documentation submitted by Oecona on behalf of Exact Sciences, aimed to answer critical questions regarding the test’s effectiveness, cost-effectiveness, and potential to reduce chemotherapy use.
Clinical Effectiveness: Four rigorously conducted randomized controlled trials (RCTs) were reviewed to assess Oncotype DX’s ability to predict chemotherapy benefit in ER+ HER2- early-stage breast cancer patients. The results provided compelling evidence that:
Patients with low or intermediate Recurrence Scores (RS) (0-25) showed no significant chemotherapy benefit.
Patients with a high RS (>25) benefitted from chemotherapy by reducing the risk of recurrence.
Node-negative women below 50 years with RS 16-25 showed a small chemotherapy benefit.
Additionally, Oncotype DX was found to provide valuable prognostic information, suggesting that approximately 75-90% of breast cancer patients with node-negative and node-positive disease can potentially omit chemotherapy based on their RS. Decision-impact studies revealed that the test reduced chemotherapy assignments significantly, although treatment decisions were not solely based on RS.
The cost-effectiveness analysis demonstrated that Oncotype DX outperformed traditional clinical parameter assessment for both node-negative and postmenopausal node-positive patients, offering greater quality-adjusted life years (QALYs) at a lower cost. Sensitivity analyses indicated the test’s cost-effectiveness across various scenarios, with a high probability of being cost-effective.
Budget impact analyses revealed net costs for implementing Oncotype DX for node-negative patients and net savings for postmenopausal node-positive patients over the first five years following implementation. However, it’s important to note that this analysis compared Oncotype DX to no gene profiling test rather than comparing it to Prosigna.
Oncotype DX has proven to be a game-changer in breast cancer treatment decision-making. It accurately predicts chemotherapy benefits, offers valuable prognostic information, and has the potential to substantially reduce chemotherapy use in the targeted patient populations. The test appears to be both more effective and cost-effective compared to traditional clinical assessments.
While the comparison with Prosigna remains unexplored in this assessment, Oncotype DX fills a critical gap in breast cancer care, particularly for postmenopausal patients with node-positive disease. As healthcare continues to evolve, the implementation of this gene profiling test holds the promise of improved outcomes and reduced treatment-related side effects for breast cancer patients.
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