The German Institute for Quality and Efficiency in Health Care (IQWiG) reinvestigated the benefit of biomarker tests to support the decision for or against adjuvant systemic chemotherapy in certain breast cancer patients, that is, women with primary hormone receptor-positive, HER2/neu-negative breast cancer and 0 to 3 affected lymph nodes.
When the Institute presented its final report on this question at the end of 2016, the evidence was inadequate to assess the benefit of such tests. The only usable data at that time were from the MINDACT study, which investigated the effects of omitting chemotherapy based on favourable MammaPrint test results in the first five years. Since important results of the large TAILORx study were published in spring 2018, the Federal Joint Committee (G-BA) commissioned IQWiG to assess these results in an addendum to the final report.
IQWiG concluded that the Oncotype DX test can identify women who can omit chemotherapy. However, only women without affected lymph nodes participated in the study. It is unclear whether women with affected lymph nodes also benefit from this test. It is also uncertain whether the clinical risk assessment, which was surprisingly unreliable in the TAILORx study, was in line with everyday health care
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