title: Molecular and protein markers for clinical decision making in breast cancer: today and tomorrow.
abstract: In early breast cancer (eBC), established clinicopathological factors are not sufficient for clinical decision making particularly regarding adjuvant chemotherapy since substantial over- or undertreatment may occur. Thus, novel protein- and molecular markers have been put forward as decision aids. Since these potential prognosis and/or predictive tests differ substantially regarding their methodology, analytical and clinical validation, this review attempts to summarize the essential facts for clinicians. This review focuses on those markers which are the most advanced so far in their development towards routine clinical application, i.e. two protein markers (i.e. uPA/PAI-1 and IHC4) and six molecular multigene tests (i.e. Mammaprint®, Oncotype DX®, PAM50, Endopredict®, the 97-gene genomic grade, and 76 gene Rotterdam signatures). Next to methodological aspects, we summarized the clinical evidences, in particular the main prospective clinical trials which have already been fully recruited (i.e. MINDACT, TAILORx, WSG PLAN B) or are still ongoing (i.e. RxPONDER/SWOG S1007, WSG-ADAPT). Last but not least, this review points out the key elements for clinicians to select one test among the wide panel of proposed assays, for a specific population of patients in term of level of evidence, analytical and clinical validity as well as cost effectiveness.
authors.affiliation: Brustzentrum, Universitätsfrauenklinik, Klinikum Großhadern, Marchioninistr. 15, München, Germany. Electronic address: Nadia.Harbeck@med.uni-muenchen.de.
authors.forename: Nadia
authors.initials: N
authors.lastname: Harbeck
authors.affiliation: Pathologisches Institut, Ludwig-Maximilians-Universität München, Thalkirchner Strasse. 36, München, Germany. Electronic address: Karl.Sotlar@med.uni-muenchen.de.
authors.forename: Karl
authors.initials: K
authors.lastname: Sotlar
authors.affiliation: Brustzentrum, Klinikum der Universität München, Maistraße 11, 80337 Munich, Germany. Electronic address: Rachel.Wuerstlein@med.uni-muenchen.de.
authors.forename: Rachel
authors.initials: R
authors.lastname: Wuerstlein
authors.affiliation: Brustzentrum, Klinikum der Universität München, Maistraße 11, 80337 Munich, Germany; Université Paul Sabatier Toulouse III, Faculté des Sciences Pharmaceutiques, 31062 Toulouse Cedex 09, France. Electronic address: Sophie.DoisneauSixou@med.uni-muenchen.de.
authors.forename: Sophie
authors.initials: S
authors.lastname: Doisneau-Sixou
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood*; D001943:Breast Neoplasms / Q000097:blood / Q000175:diagnosis / Q000628:therapy; D003131:Combined Modality Therapy / Q000379:methods; D003657:Decision Making; D042241:Early Diagnosis; D005260:Female; D006801:Humans
chemical_list: D014408:Biomarkers, Tumor
keywords: Breast cancer; Endopredict®; Mammaprint®; Multigene tests; Oncotype DX®; PAM50; uPA/PAI-1