title: Randomised phase III trial of FEC120 vs EC-docetaxel in patients with high-risk node-positive primary breast cancer: final survival analysis of the ADEBAR study.
abstract: BACKGROUND
  Taxane-containing adjuvant chemotherapy has been established as standard treatment in node-positive breast cancer. This study compared efficacy and tolerability of epirubicin (E)/cyclophosphamide (C) followed by docetaxel (Doc) with a dose-dense 5-fluorouracil (F)+E+ C regimen.
  
  
  METHODS
  The ADEBAR study was a randomised phase III trial for women with primary invasive breast cancer and ⩾4 metastatic axillary lymph nodes (n=1364). Treatment consisted of four 21-day cycles of E plus C, followed by four 21-day cycles of Doc (EC-Doc), or six 28-day cycles of E plus F plus C (FEC120).
  
  
  RESULTS
  Disease-free survival (DFS) was similar in the two treatment arms as shown by multivariate Cox regression adjusted for other prognostic factors (EC-Doc vs FEC120, hazard ratio (HR): 1.087; 95% confidence interval (CI): 0.878-1.346, P=0.444). In addition, there was no significant difference in overall survival (OS) between the two groups (HR: 0.974; 95% CI: 0.750-1.264, P=0.841). Haematologic toxicity was more common in FEC120 recipients; non-haematologic toxicities occurred more frequently in the EC-Doc arm. The serious adverse event rate was significantly higher in the FEC120 group (29.7% vs 22.5%).
  
  
  CONCLUSIONS
  EC-Doc provides a feasible and effective alternative therapy option to FEC120 with a different safety profile in this high-risk breast cancer cohort.
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital Ulm, Prittwitzstrasse 43, 89075 Ulm, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Janni
authors.affiliation: Department of Gynecology and Obstetrics, Breast Center, Ludwig-Maximilian-University Munich, Marchioninistraße 15, 81377 München, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Harbeck
authors.affiliation: Department of Gynecology and Obstetrics, Ludwig-Maximilians-University Munich, Maistraße 11, 80337 München, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Rack
authors.affiliation: Breast Center, Department of Gynecology and Obstetrics, Hospital Deggendorf, Perlasberger Strasse 41, 94469 Deggendorf, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Augustin
authors.affiliation: Department of Gynecology and Obstetrics, Ludwig-Maximilians-University Munich, Maistraße 11, 80337 München, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Jueckstock
authors.affiliation: Breast Center, Department of Gynecology, Klinikum Augsburg, Stenglinstrasse 2, 86156 Augsburg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Wischnik
authors.affiliation: Department of Obstetrics and Gynecology, Technical University Clinics Rechts der Isar, Ismaninger Strasse 22, 81675 München, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Annecke
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital Ulm, Prittwitzstrasse 43, 89075 Ulm, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Scholz
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital Ulm, Prittwitzstrasse 43, 89075 Ulm, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Huober
authors.affiliation: Estimate GmbH, Konrad-Adenauer-Allee 1, 86150 Augsburg, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Zwingers
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital Ulm, Prittwitzstrasse 43, 89075 Ulm, Germany.
authors.forename: T W P
authors.initials: TW
authors.lastname: Friedl
authors.affiliation: Department of Obstetrics and Gynecology, Technical University Clinics Rechts der Isar, Ismaninger Strasse 22, 81675 München, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Kiechle
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001365:Axilla / Q000473:pathology; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis / Q000473:pathology; D008875:Middle Aged; D016019:Survival Analysis; D043823:Taxoids / Q000627:therapeutic use*
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil