1. The value ofTOP2Agene copy number variation as a biomarker in breast cancer: Update of DBCG trial 89D
- Author
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Helle Charlotte Knudsen, Bent Ejlertsen, Henning T. Mouridsen, Susanne Møller, Jan Trøst Jørgensen, Ann Knoop, and Kirsten Vang Nielsen
- Subjects
Oncology ,Receptor, erbB-2 ,medicine.medical_specialty ,Cyclophosphamide ,Receptor, ErbB-2 ,Gene Dosage ,Breast Neoplasms ,Disease-Free Survival ,law.invention ,Breast cancer ,Randomized controlled trial ,Antigens, Neoplasm ,law ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Biomarkers, Tumor ,medicine ,Clinical endpoint ,Humans ,Radiology, Nuclear Medicine and imaging ,Poly-ADP-Ribose Binding Proteins ,skin and connective tissue diseases ,In Situ Hybridization, Fluorescence ,Epirubicin ,Retrospective Studies ,Gynecology ,business.industry ,Hematology ,General Medicine ,medicine.disease ,DNA-Binding Proteins ,Clinical trial ,DNA Topoisomerases, Type II ,Methotrexate ,Tumor Markers, Biological ,Fluorouracil ,DNA Topoisomerases, Type II, Eukaryotic ,Multivariate Analysis ,Biomarker (medicine) ,Female ,business ,medicine.drug - Abstract
Udgivelsesdato: 2008 BACKGROUND: Previous analyses of TOP2A and HER2 in the Danish Breast Cancer Coopererative Group (DBCG) trial 89D suggested that TOP2A amplifications and possible also deletions are predictive markers for the effect of adjuvant epirubicin in patients with primary breast cancer. We present an updated and extended statistical analysis, requested for IVD-labeling of TOP2A testing. MATERIAL AND METHODS: In the DBCG trial 89D 980 Danish patients were randomly assigned to nine cycles of intravenous CMF (cyclophosphamide, methotrexate, and fluorouracil) or CEF (cyclophosphamide, epirubicin, and fluorouracil). Archival tumor tissue was collected retrospectively from 806 of these patients in a prospectively designed, biological sub-study, and was successfully analyzed for TOP2A aberrations and HER2 status in 773 samples (96%). Recurrence-free survival (RFS) was the primary endpoint. RESULTS: TOP2A aberrations (amplifications and deletions) were significantly associated with shorter RFS (p
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- 2008