title: Short term quality of life with epirubicin-fluorouracil-cyclophosphamid (FEC) and sequential epirubicin/cyclophosphamid-docetaxel (EC-DOC) chemotherapy in patients with primary breast cancer - Results from the prospective multi-center randomized ADEBAR trial.
abstract: BACKGROUND
  The recommendation for adjuvant dose-dense chemotherapy in high risk primary breast cancer is heterogeneous among guidelines. Understanding the impact on QoL is thereby a crucial factor, especially if the benefit is potentially low. This study aims to assess QoL as a secondary outcome in the prospective randomized multi-center ADEBAR trial.
  
  
  METHODS
  QoL was assessed at baseline (t1), before cycle 4 FEC and cycle 5 EC-DOC (t2), 4 weeks after chemotherapy (t3) and 6 weeks after radiation (t4) using the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Breast Cancer-Specific Module (QLQ-BR23).
  
  
  RESULTS
  1306 patients were enrolled into the ADEBAR trial. 675 were assigned to the FEC and 688 to the EC-DOC arm. After the beginning of treatment, global QoL dropped in both arm by 3-4 points. In the EC-DOC arm, QoL dropped further at t3 by 7 points and stayed stable in the FEC arm. 6 weeks after radiation, QoL exceeded baseline in both arms by 6-8 points. The differences between treatment arms were strongest at t3 (53.0 vs. 49.5) but did not reach clinical relevance at any point in time. Physical functioning, nausea and vomiting, fatigue and systemic therapy side effects followed with some minor exceptions similar patterns but showed higher amplitudes.
  
  
  CONCLUSIONS
  In conclusion, we could not detect a clinically relevant difference between the two treatment arms in global QoL, although the results consistently show that patients on EC-DOC report worse scores during the treatment.
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany. Electronic address: lukas.schwentner@yahoo.de.
authors.forename: Lukas
authors.initials: L
authors.lastname: Schwentner
authors.affiliation: Breast Cancer Center, University of Munich, Munich, Germany.
authors.forename: Nadia
authors.initials: N
authors.lastname: Harbeck
authors.affiliation: Insitute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Centre Mainz, Mainz, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Singer
authors.affiliation: Insitute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Centre Mainz, Mainz, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Eichler
authors.affiliation: Department of Gynecology and Obstetrics, Ludwig-Maximilians-University of Munich, Munich, Germany.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Rack
authors.affiliation: Clinics Troisdorf, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Forstbauer
authors.affiliation: Breast Center, Clinics Augsburg, Augsburg, Germany.
authors.forename: Arthur
authors.initials: A
authors.lastname: Wischnik
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Scholz
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Huober
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
authors.forename: Thomas W P
authors.initials: TW
authors.lastname: Friedl
authors.affiliation: Department of Gynecology and Obstetrics, Ludwig-Maximilians-University of Munich, Munich, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Weissenbacher
authors.affiliation: Fresenius Hochschule, Munich, Germany.
authors.forename: Kristin
authors.initials: K
authors.lastname: Härtl
authors.affiliation: Department of Obstetrics and Gynecology, Technical University Clinics Rechts der Isar Munich, Munich, Germany.
authors.forename: Marion
authors.initials: M
authors.lastname: Kiechle
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Janni
authors.affiliation: Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
authors.forename: Visnja
authors.initials: V
authors.lastname: Fink
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000523:psychology*; D017024:Chemotherapy, Adjuvant / Q000379:methods / Q000523:psychology; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil
keywords: Adjuvant chemotherapy; Breast cancer; Quality of life