title: Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy.
abstract: Estimating distant recurrence (DR) risk among women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative early breast cancer helps decisions on using adjuvant chemotherapy. The 21-gene Oncotype DX recurrence score (RS) is widely used for this. EndoPredict (EPclin) is an alternative test combining prognostic information from an eight-gene signature (EP score) with tumor size and nodal status. We compared the prognostic information provided by RS and EPclin for 10-year DR risk.
  
  
  
  We used likelihood ratio χ² and Kaplan-Meier survival analyses to compare prognostic information provided by EP, EPclin, RS, and the clinical treatment score (CTS) of clinicopathologic parameters in 928 patients with ER+ disease treated with five years' anastrozole or tamoxifen. Comparisons were made for early (0-5 years) and late (5-10 years) DR according to nodal status. All statistical tests were two-sided.
  
  
  
  In the overall population, EP and EPclin provided substantially more prognostic information than RS (LRχ(2): EP = 49.3; LRχ(2): EPclin = 139.3; LRχ(2): RS = 29.1), with greater differences in late DR and in node-positive patients. EP and EPclin remained statistically significantly prognostic when adjusted for RS (ΔLRχ(2): EP+RS vs RS = 20.2; ΔLRχ(2): EPclin+RS vs RS = 113.8). Using predefined cut-offs, EPclin and RS identified 58.8% and 61.7% patients as low risk, with hazard ratios for non-low vs low risk of 5.99 (95% confidence interval [CI] = 3.94 to 9.11) and 2.73 (95% CI = 1.91 to 3.89), respectively.
  
  
  
  EP and EPclin were highly prognostic for DR in endocrine-treated patients with ER+, HER2-negative disease. EPclin provided more prognostic information than RS. This was partly but not entirely because of EPclin integrating molecular data with nodal status and tumor size.
authors.affiliation: Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
authors.forename: Richard
authors.initials: R
authors.lastname: Buus
authors.affiliation: Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
authors.forename: Ivana
authors.initials: I
authors.lastname: Sestak
authors.affiliation: Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
authors.forename: Ralf
authors.initials: R
authors.lastname: Kronenwett
authors.affiliation: Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
authors.forename: Carsten
authors.initials: C
authors.lastname: Denkert
authors.affiliation: Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
authors.forename: Peter
authors.initials: P
authors.lastname: Dubsky
authors.affiliation: Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
authors.forename: Kristin
authors.initials: K
authors.lastname: Krappmann
authors.affiliation: Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
authors.forename: Marsel
authors.initials: M
authors.lastname: Scheer
authors.affiliation: Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
authors.forename: Christoph
authors.initials: C
authors.lastname: Petry
authors.affiliation: Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
authors.forename: Jack
authors.initials: J
authors.lastname: Cuzick
authors.affiliation: Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
authors.forename: Mitch
authors.initials: M
authors.lastname: Dowsett
mesh_terms: D000077384:Anastrozole; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy / Q000235:genetics* / Q000473:pathology*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D016013:Likelihood Functions; D008198:Lymph Nodes / Q000473:pathology*; D008207:Lymphatic Metastasis; D009570:Nitriles / Q000627:therapeutic use; D011237:Predictive Value of Tests; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D011960:Receptors, Estrogen / Q000032:analysis; D018570:Risk Assessment / Q000379:methods; D013629:Tamoxifen / Q000627:therapeutic use; D014230:Triazoles / Q000627:therapeutic use; D047368:Tumor Burden
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