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.
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Authors | 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, WSG-PRIMe investigators in Germany, Austria, Switzerland |
Journal | Breast cancer research and treatment
(Breast Cancer Res Treat)
Vol. 175
Issue 2
Pg. 389-399
(Jun 2019)
ISSN: 1573-7217 [Electronic] Netherlands |
PMID | 30796651
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Receptors, Estrogen
- Receptors, Progesterone
- Receptor, ErbB-2
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Breast Neoplasms
(classification, drug therapy, genetics, pathology)
- Chemotherapy, Adjuvant
- Cost-Benefit Analysis
- Decision Making
- Female
- Gene Expression Regulation, Neoplastic
(drug effects)
- Humans
- In Situ Hybridization, Fluorescence
- Middle Aged
- Receptor, ErbB-2
(genetics)
- Receptors, Estrogen
(genetics)
- Receptors, Progesterone
(genetics)
- Transcriptome
(genetics)
- Treatment Outcome
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