Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Dubsky, P; Van't, Veer, L; Gnant, M; Rudas, M; Bago-Horvath, Z; Greil, R; Lujinovic, E; Buresch, J; Rinnerthaler, G; Hulla, W; Moinfar, F; Egle, D; Herz, W; Dreezen, C; Frantal, S; Filipits, M.
A clinical validation study of MammaPrint in hormone receptor-positive breast cancer from the Austrian Breast and Colorectal Cancer Study Group 8 (ABCSG-8) biomarker cohort.
ESMO Open. 2021; 6(1):100006
Doi: 10.1016/j.esmoop.2020.100006
[OPEN ACCESS]
Web of Science
PubMed
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- Co-authors Med Uni Graz
- Rinnerthaler Gabriel
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- Abstract:
- BACKGROUND: MammaPrint is a prognostic assay based on gene expression in tumors from patients with early breast cancer. MammaPrint has been extensively validated and Food and Drug Administration cleared in fresh and formalin-fixed and paraffin-embedded (FFPE) tissue. We aimed to assess its prognostic performance in the biomarker cohort of the Austrian Breast and Colorectal Cancer Study Group 8 (ABCSG-8) patient population, and to obtain a higher level of evidence with regard to its clinical validity after RNA extraction from FFPE biobank tissue. PATIENTS AND METHODS: A prespecified retrospective analysis to test the prognostic performance of the MammaPrint test to predict distant recurrence-free survival at 5 and 10 years as primary end point was carried out. MammaPrint risk, clinicopathological factors (after central pathological review), and clinical risk (using a modified version of Adjuvant! Online) were evaluated by Cox regression analyses. RESULTS: From 1347 available samples, 607 (45%) failed quality control after RNA extraction. In total, 658 (49%) patients were included in survival analyses: MammaPrint low risk versus high risk is a significant prognostic factor for distant recurrence-free survival at 5 years (94.0% versus 91.6%) with a significant risk reduction of 6.5% at 10 years (log-rank P value = 0.017, low risk 91.3% versus high risk 84.8%). The multivariable models suggest that hazard ratio (HR) is primarily driven by tumor stage (5-year HR 3.89; confidence interval 1.97-7.71) and nodal status (5-year HR 1.73; confidence interval 0.91-3.21). After adjustment for clinical risk groups, MammaPrint HRs remain stable with values just below 2.0 after the first 3 years. CONCLUSIONS: The MammaPrint test showed significant prognostic performance at 5 and 10 years of follow-up. In the particular cohort of ABCSG-8, the statistical independence from clinically assessed covariates remains unclear, and no conclusions concerning the clinical validity of the test can be drawn.
- Find related publications in this database (using NLM MeSH Indexing)
- Austria - administration & dosage
- Biomarkers - administration & dosage
- Breast Neoplasms - diagnosis, genetics
- Colorectal Neoplasms - diagnosis, genetics
- Female - administration & dosage
- Hormones - administration & dosage
- Humans - administration & dosage
- Retrospective Studies - administration & dosage
- United States - administration & dosage
- Find related publications in this database (Keywords)
- ER-positive/HER2-negative
- early breast cancer
- ABCSG-8
- prognostic biomarkers
- MammaPrint
- clinical validation