1. Strong impact of MammaPrint and BluePrint on treatment decisions in luminal early breast cancer: results of the WSG-PRIMe study
- Author
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R, Wuerstlein, R, Kates, O, Gluz, E M, Grischke, C, Schem, M, Thill, S, Hasmueller, A, Köhler, B, Otremba, F, Griesinger, C, Schindlbeck, A, Trojan, F, Otto, M, Knauer, R, Pusch, N, Harbeck, and WSG-PRIMe investigators in Germany, Austria, Switzerland more...
- Subjects
0301 basic medicine ,Cancer Research ,Receptor, ErbB-2 ,Cost-Benefit Analysis ,medicine.medical_treatment ,Molecular profiling ,Breast cancer ,0302 clinical medicine ,MammaPrint ,In Situ Hybridization, Fluorescence ,Early breast cancer ,Aged, 80 and over ,medicine.diagnostic_test ,Middle Aged ,Diagnostic test ,BluePrint ,Clinical Trial ,3. Good health ,Gene Expression Regulation, Neoplastic ,Clinical therapy ,Treatment Outcome ,Receptors, Estrogen ,Oncology ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Anxiety ,Female ,medicine.symptom ,Receptors, Progesterone ,Risk assessment ,Adult ,medicine.medical_specialty ,Decision Making ,Breast Neoplasms ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,ddc:610 ,Aged ,Chemotherapy ,business.industry ,medicine.disease ,Decision impact ,030104 developmental biology ,Treatment decision making ,Transcriptome ,business - Abstract
Purpose: The WSG-PRIMe Study prospectively evaluated the impact of the 70-gene signature MammaPrint® (MP) and the 80-gene molecular subtyping assay BluePrint® on clinical therapy decisions in luminal early breast cancer. Methods: 452 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. Results: Post-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. Conclusions: MammaPrint 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. more...
- Published
- 2019