HMN 2025: How Treatment selections on foundation of biomarker-based check might be dangerous

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined the professionals and cons of biomarker-based checks to tell selections about adjuvant chemotherapy for sufferers with a sure kind of breast cancer, i.e., first-time, hormone receptor-positive and HER2/neu-negative breast cancer.

According to the findings, ladies with breast cancer aged as much as 50 or premenopausal mustn’t determine towards adjuvant chemotherapy on the idea of the “MammaPrint” or “Oncotype DX” biomarker-based checks. This is as a result of no matter whether or not their lymph nodes are already affected by cancer or not, they might then forgo remedy that might stop a recurrence.

Biomarker-based checks decide whether or not the chance of a tumor recurring after surgical removing is low or excessive. These checks are primarily used when the person danger of recurrence can’t be reliably decided by way of medical elements akin to sure tumor traits. If the chance of recurrence is low, chemotherapy could be an pointless burden.

For major breast cancer, the German statutory medical health insurance funds at the moment reimburse 4 biomarker-based checks: MammaPrint, Oncotype DX, EndoPredict and Prosigna. Doctors can at the moment use these checks in outpatient care if the affected person’s lymph nodes haven’t but been affected by the cancer.

Results rely upon menopausal standing

Meaningful information from randomized managed trials (RCTs) is just accessible for MammaPrint (MINDACT study) and Oncotype DX (RxPONDER and TAILORx research).

IQWiG attracts the next predominant conclusions from these three research:

• In premenopausal sufferers (as much as 50 years of age), RCT proof doesn’t assist the usage of a biomarker-based check to information breast cancer remedy.
• In postmenopausal sufferers (over 50 years of age), RCT proof helps the usage of a biomarker-based check (Oncotype DX) to information breast cancer remedy.

It just isn’t doable to confirm whether or not this analysis additionally applies to different biomarker-based checks, akin to EndoPredict or Prosigna, as no appropriate information is out there.

Summarizing the outcomes of the IQWiG report, Daniel Fleer, Deputy Head of IQWiG’s Non-Drug Interventions Department, says, “The danger of mistakenly forgoing chemotherapy on the idea of a biomarker-based check is due to this fact considerably larger in premenopausal than in postmenopausal breast cancer sufferers.”

Procedure of report manufacturing

In May 2023, the Federal Joint Committee (G-BA) commissioned IQWiG to evaluate the usage of biomarker-based checks to tell selections about adjuvant systemic chemotherapy for major breast cancer involving one to 3 lymph nodes.

In September 2023, the G-BA additionally commissioned the Institute to evaluate the identical query for premenopausal sufferers with major breast cancer with out lymph node involvement. IQWiG revealed the preliminary outcomes, the preliminary report, in June 2024 and invited feedback.

Following the commenting process, the report was revised and despatched as a remaining report back to G-BA, the contracting company, in October 2024. The written feedback submitted on the preliminary report had been revealed in a separate doc similtaneously the remaining report in November 2024. An English translation was revealed in July 2025.