title: EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer.
abstract: BACKGROUND
  In early estrogen receptor (ER)-positive/HER2-negative breast cancer, the decision to administer chemotherapy is largely based on prognostic criteria. The combined molecular/clinical EndoPredict test (EPclin) has been validated to accurately assess prognosis in this population. In this study, the clinical relevance of EPclin in relation to well-established clinical guidelines is assessed.
  
  
  METHODS
  We assigned risk groups to 1702 ER-positive/HER2-negative postmenopausal women from two large phase III trials treated only with endocrine therapy. Prognosis was assigned according to National Comprehensive Cancer Center Network-, German S3-, St Gallen guidelines and the EPclin. Prognostic groups were compared using the Kaplan-Meier survival analysis.
  
  
  RESULTS
  After 10 years, absolute risk reductions (ARR) between the high- and low-risk groups ranged from 6.9% to 11.2% if assigned according to guidelines. It was at 18.7% for EPclin. EPclin reassigned 58%-61% of women classified as high-/intermediate-risk (according to clinical guidelines) to low risk. Women reclassified to low risk showed a 5% rate of distant metastasis at 10 years.
  
  
  CONCLUSIONS
  The EPclin score is able to predict favorable prognosis in a majority of patients that clinical guidelines would assign to intermediate or high risk. EPclin may reduce the indications for chemotherapy in ER-positive postmenopausal women with a limited number of clinical risk factors.
authors.affiliation: Departments of Surgery, Medical University Vienna, A-1090 Vienna, Austria. peter.dubsky@meduniwien.ac.at
authors.forename: P
authors.initials: P
authors.lastname: Dubsky
authors.forename: M
authors.initials: M
authors.lastname: Filipits
authors.forename: R
authors.initials: R
authors.lastname: Jakesz
authors.forename: M
authors.initials: M
authors.lastname: Rudas
authors.forename: C F
authors.initials: CF
authors.lastname: Singer
authors.forename: R
authors.initials: R
authors.lastname: Greil
authors.forename: O
authors.initials: O
authors.lastname: Dietze
authors.forename: I
authors.initials: I
authors.lastname: Luisser
authors.forename: E
authors.initials: E
authors.lastname: Klug
authors.forename: R
authors.initials: R
authors.lastname: Sedivy
authors.forename: M
authors.initials: M
authors.lastname: Bachner
authors.forename: D
authors.initials: D
authors.lastname: Mayr
authors.forename: M
authors.initials: M
authors.lastname: Schmidt
authors.forename: M C
authors.initials: MC
authors.lastname: Gehrmann
authors.forename: C
authors.initials: C
authors.lastname: Petry
authors.forename: K E
authors.initials: KE
authors.lastname: Weber
authors.forename: R
authors.initials: R
authors.lastname: Kronenwett
authors.forename: J C
authors.initials: JC
authors.lastname: Brase
authors.forename: M
authors.initials: M
authors.lastname: Gnant
mesh_terms: D000077384:Anastrozole; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000145:classification / Q000175:diagnosis* / Q000188:drug therapy / Q000401:mortality; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage; D017410:Practice Guidelines as Topic; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D011960:Receptors, Estrogen / Q000378:metabolism*; D012189:Retrospective Studies; D018570:Risk Assessment; D013629:Tamoxifen / Q000008:administration & dosage; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage
chemical_list: D000077384:Anastrozole; D018931:Antineoplastic Agents, Hormonal; D009570:Nitriles; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D013629:Tamoxifen; D014230:Triazoles; C508053:ERBB2 protein, human