Impact of Biomarker-Based Tests on Breast Cancer Treatment Decisions

Studies reveal that biomarker-based tests like MammaPrint and Oncotype DX may lead to inappropriate treatment decisions in breast cancer, especially for premenopausal women, highlighting the need for careful clinical judgment.
Recent evaluations by the German Institute for Quality and Efficiency in Health Care (IQWiG) have highlighted the potential risks associated with relying solely on biomarker-based tests such as MammaPrint and Oncotype DX to guide adjuvant chemotherapy decisions in breast cancer patients. These tests assess the likelihood of cancer recurrence by analyzing tumor characteristics, especially useful when clinical indicators are insufficient. However, the evidence suggests that treatment decisions, particularly for women under 50 or premenopausal women, based on these tests may lead to inappropriate withholding of chemotherapy. This is critical because chemotherapy can significantly reduce the risk of recurrence and improve long-term outcomes.
The studies supporting the use of these tests include the MINDACT trial for MammaPrint and the RxPONDER and TAILORx trials for Oncotype DX. Findings indicate that in premenopausal women, the evidence does not support making treatment decisions based solely on biomarker results, regardless of lymph node involvement. Conversely, in postmenopausal women over 50, there is support for using these tests to inform therapy options.
The key concern is the higher risk of mistakenly omitting beneficial chemotherapy in premenopausal women, which could lead to higher recurrence rates. Therefore, clinicians should exercise caution and consider menopausal status when utilizing biomarker tests for treatment planning. The comprehensive assessment and clinical judgment remain crucial in managing breast cancer effectively.
This review was part of a broader effort by IQWiG, initiated by the G-BA, to ensure that biomarker-guided decision-making in breast cancer aligns with validated evidence. The findings underscore the importance of personalized treatment approaches and warn against sole reliance on biomarker tests for crucial treatment decisions.
Source: https://medicalxpress.com/news/2025-07-breast-cancer-treatment-decisions-basis.html
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