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Wuerstlein, R.; Kates, R.; Gluz, O.; Grischke, E. M.; Schem, C.; Thill, M.; Hasmüller, S.; Köhler, A.; Otremba, B.; Griesinger, F.; Schindlbeck, C.; Trojan, A.; Otto, F.; Knauer, M.; Pusch, R. und Harbeck, N. (2019): Strong impact of MammaPrint and BluePrint on treatment decisions in luminal early breast cancer: results of the WSG-PRIMe study. In: Breast Cancer Research and Treatment, Bd. 175, Nr. 2: S. 389-399

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Abstract

PurposeThe WSG-PRIMe Study prospectively evaluated the impact of the 70-gene signature MammaPrint (R) (MP) and the 80-gene molecular subtyping assay BluePrint (R) on clinical therapy decisions in luminal early breast cancer.Methods452 hormone receptor (HR)-positive and HER2-negative patients were recruited (N0, N1). Physicians provided initial therapy recommendations based on clinicopathological factors. After prospective risk classification by MammaPrint/BluePrint was revealed, post-test treatment recommendations and actual treatment were recorded. Decisional Conflict and anxiety were measured by questionnaires.ResultsPost-test switch (in chemotherapy (CT) recommendation) occurred in 29.1% of cases. Overall, physician adherence to MP risk assessment was 92.3% for low-risk and 94.3% for high-risk MP scores. Adherence was remarkably high in discordant groups: 74.7% of physicians initially recommending CT switched to CT omission following low-risk MP scores;conversely, 88.9% of physicians initially recommending CT omission switched to CT recommendations following high-risk MP scores. Most patients (99.2%) recommended to forgo CT post-test and 21.3% of patients with post-test CT recommendations did not undergo CT;among MP low-risk patients with pre-test and post-test CT recommendations, 40% did not actually undergo CT. Luminal subtype assessment by BluePrint was discordant with IHC assessment in 34% of patients. Patients' State Anxiety scores improved significantly overall, particularly in MP low-risk patients. Trait Anxiety scores increased slightly in MP high risk and decreased slightly in MP low-risk patients.ConclusionsMammaPrint and BluePrint test results strongly impacted physicians' therapy decisions in luminal EBC with up to three involved lymph nodes. The high adherence to genetically determined risk assessment represents a key prerequisite for achieving a personalized cost-effective approach to disease management of early breast cancer.

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