The German Institute for High quality and Effectivity in Well being Care (IQWiG) has examined the professionals and cons of biomarker-based assessments to tell selections about adjuvant chemotherapy for sufferers with a sure sort of breast most cancers, i.e., first-time, hormone receptor-positive and HER2/neu-negative breast most cancers.
In keeping with the findings, girls with breast most cancers aged as much as 50 or premenopausal shouldn’t resolve in opposition to adjuvant chemotherapy on the premise of the “MammaPrint” or “Oncotype DX” biomarker-based assessments. It’s because no matter whether or not their lymph nodes are already affected by most cancers or not, they could then forgo remedy that would forestall a recurrence.
Biomarker-based assessments decide whether or not the danger of a tumor recurring after surgical elimination is low or excessive. These assessments are primarily used when the person threat of recurrence can’t be reliably decided by the use of scientific components equivalent to sure tumor traits. If the danger of recurrence is low, chemotherapy could be an pointless burden.
For main breast most cancers, the German statutory medical insurance funds presently reimburse 4 biomarker-based assessments: MammaPrint, Oncotype DX, EndoPredict and Prosigna. Docs can presently use these assessments in outpatient care if the affected person’s lymph nodes haven’t but been affected by the most cancers.
Outcomes rely upon menopausal standing
Significant knowledge from randomized managed trials (RCTs) is barely obtainable for MammaPrint (MINDACT examine) and Oncotype DX (RxPONDER and TAILORx research).
IQWiG attracts the next primary conclusions from these three research:
- In premenopausal sufferers (as much as 50 years of age), RCT proof doesn’t help the usage of a biomarker-based take a look at to information breast most cancers remedy.
- In postmenopausal sufferers (over 50 years of age), RCT proof helps the usage of a biomarker-based take a look at (Oncotype DX) to information breast most cancers remedy.
It isn’t potential to confirm whether or not this analysis additionally applies to different biomarker-based assessments, equivalent to EndoPredict or Prosigna, as no appropriate knowledge is accessible.
Summarizing the outcomes of the IQWiG report, Daniel Fleer, Deputy Head of IQWiG’s Non-Drug Interventions Division, says, “The danger of mistakenly forgoing chemotherapy on the premise of a biomarker-based take a look at is due to this fact considerably increased in premenopausal than in postmenopausal breast most cancers sufferers.”
Process of report manufacturing
In Could 2023, the Federal Joint Committee (G-BA) commissioned IQWiG to evaluate the usage of biomarker-based assessments to tell selections about adjuvant systemic chemotherapy for main breast most cancers involving one to a few lymph nodes.
In September 2023, the G-BA additionally commissioned the Institute to evaluate the identical query for premenopausal sufferers with main breast most cancers with out lymph node involvement. IQWiG printed the preliminary outcomes, the preliminary report, in June 2024 and invited feedback.
Following the commenting process, the report was revised and despatched as a ultimate report back to G-BA, the contracting company, in October 2024. The written feedback submitted on the preliminary report have been printed in a separate doc similtaneously the ultimate report in November 2024. An English translation was printed in July 2025.
Extra data:
Biomarker-based assessments for deciding for or in opposition to adjuvant systemic chemotherapy in main breast most cancers with involvement of 1 to three lymph nodes and in premenopausal sufferers with out lymph node involvement (2025). DOI: 10.60584/d23-01b_en
Quotation:
Breast most cancers: Remedy selections on foundation of biomarker-based take a look at may be dangerous (2025, July 7)
retrieved 7 July 2025
from https://medicalxpress.com/information/2025-07-breast-cancer-treatment-decisions-basis.html
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