title: Toxicity Analysis in the ADEBAR Trial: Sequential Anthracycline-Taxane Therapy Compared with FEC120 for the Adjuvant Treatment of High-Risk Breast Cancer.
abstract: BACKGROUND
  Data from meta-analyses have shown taxane-containing therapies to be superior to anthracycline-based treatments for high-risk breast cancer.
  
  
  METHODS
  The ADEBAR trial was a multicenter phase III trial in which patients with lymph node-positive breast cancer were prospectively randomized for either sequential anthracycline-taxane or FEC120 therapy. Patients received 4× epirubicin (90 mg/m(2)) and cyclophosphamide (600 mg/m(2)) every 3 weeks (q3w), followed by 4× docetaxel (100 mg/m(2)) q3w (EC-Doc arm), or 6× epirubicin (60 mg/m(2)) and 5-fluorouracil (500 mg/m(2)) on days 1 and 8 and cyclophosphamide (75 mg/m(2)) on days 1-14, q4w (FEC arm). We compared both arms with respect to toxicity and feasibility.
  
  
  RESULTS
  Hematological toxicity was found significantly more often in the FEC arm. Febrile neutropenia was seen in 11.3% of patients in the FEC arm and in 8.4% of patients in the EC-Doc arm (p = 0.027). Non-hematological side effects of grade 3/4 were rarely seen in either arm. Therapy was terminated due to toxicity in 3.7% of the patients in the EC-Doc arm and in 8.0% of the patients in the FEC arm (p = 0.0009).
  
  
  CONCLUSIONS
  The sequential anthracycline-taxane regimen is a well-tolerated and feasible alternative to FEC120 therapy.
authors.affiliation: Frauenklinik des Universitätsklinikums Düsseldorf, Stuttgart, Germany.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Schönherr
authors.forename: Viktoria
authors.initials: V
authors.lastname: Aivazova-Fuchs
authors.forename: Katja
authors.initials: K
authors.lastname: Annecke
authors.forename: Julia
authors.initials: J
authors.lastname: Jückstock
authors.forename: Philip
authors.initials: P
authors.lastname: Hepp
authors.forename: Ulrich
authors.initials: U
authors.lastname: Andergassen
authors.forename: Doris
authors.initials: D
authors.lastname: Augustin
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Simon
authors.forename: Arthur
authors.initials: A
authors.lastname: Wischnik
authors.forename: Svjetlana
authors.initials: S
authors.lastname: Mohrmann
authors.forename: Jessica
authors.initials: J
authors.lastname: Salmen
authors.forename: Thomas
authors.initials: T
authors.lastname: Zwingers
authors.forename: Marion
authors.initials: M
authors.lastname: Kiechle
authors.forename: Nadja
authors.initials: N
authors.lastname: Harbeck
authors.forename: Klaus
authors.initials: K
authors.lastname: Friese
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Janni
authors.forename: Brigitte
authors.initials: B
authors.lastname: Rack
keywords: ADEBAR trial; Anthracycline; Breast cancer; Taxane; Toxicity
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