TY - JOUR A1 - Würstlein, Rachel A1 - Kates, Ronald E. A1 - Gluz, Oleg A1 - Grischke, Eva-Maria A1 - Schem, Christian A1 - Thill, Marc A1 - Hasmüller, Stephan A1 - Köhler, Andreas A1 - Otremba, Burkhard A1 - Griesinger, Frank A1 - Schindlbeck, Christian A1 - Trojan, Andreas A1 - Otto, Florian A1 - Knauer, Michael A1 - Pusch, Renate A1 - Harbeck, Nadia T1 - Strong impact of MammaPrint and BluePrint on treatment decisions in luminal early breast cancer: results of the WSG-PRIMe study T2 - Breast cancer research and treatment N2 - 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. KW - Breast cancer KW - Diagnostic test KW - MammaPrint KW - BluePrint KW - Molecular profiling KW - Decision impact Y1 - 2019 UR - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/53414 UR - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-534146 SN - 1573-7217 SN - 0167-6806 N1 - Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. VL - 175 SP - 389 EP - 399 PB - Springer Science + Business Media B.V. CY - Dordrecht [u. a.] ER -