title: Final results from the prospective phase III WSG-ARA trial: impact of adjuvant darbepoetin alfa on event-free survival in early breast cancer.
abstract: BACKGROUND
  WSG-ARA plus trial evaluated the effect of adjuvant darbepoetin alfa (DA) on outcome in node positive primary breast cancer (BC).
  
  
  METHODS
  One thousand two hundred thirty-four patients were randomized to chemotherapy either with DA (DA+; n = 615) or without DA (DA-; n = 619). DA (500 µg q3w) was started at hemoglobin (Hb) levels <13.0 g/dl (<12 g/dl after DA label amendment) and stopped at Hb levels ≥14.0 g/dl (12 g/dl after label amendment). Primary efficacy end point was event-free survival (EFS); secondary end points were toxicity, quality of life (QoL) and overall survival (OS).
  
  
  RESULTS
  Venous thrombosis (DA+: 3.0%, DA-: 1.0%; P = 0.013) was significantly higher for DA+, but not pulmonary embolism (0.3% in both arms). Median Hb levels were stable in DA+ (12.6 g/dl) and decreased in DA- (11.7 g/dl). Hb levels >15 g/dl were reported in 0.8% of cycles. QoL parameters did not significantly differ between arms. At 39 months, DA had no significant impact on EFS (DA+: 89.3%, DA-: 87.5%; Plog-rank = 0.55) or OS (DA+: 95.5%, DA-: 95.4%; Plog-rank = 0.77).
  
  
  CONCLUSIONS
  DA treatment did not impact EFS or OS in routine adjuvant BC treatment.
authors.affiliation: Breast Center Niederrhein, Evangelic Hospital Bethesda, Moenchengladbach.
authors.forename: U
authors.initials: U
authors.lastname: Nitz
authors.forename: O
authors.initials: O
authors.lastname: Gluz
authors.forename: I
authors.initials: I
authors.lastname: Zuna
authors.forename: C
authors.initials: C
authors.lastname: Oberhoff
authors.forename: T
authors.initials: T
authors.lastname: Reimer
authors.forename: C
authors.initials: C
authors.lastname: Schumacher
authors.forename: J
authors.initials: J
authors.lastname: Hackmann
authors.forename: M
authors.initials: M
authors.lastname: Warm
authors.forename: C
authors.initials: C
authors.lastname: Uleer
authors.forename: V
authors.initials: V
authors.lastname: Runde
authors.forename: J
authors.initials: J
authors.lastname: Dünnebacke
authors.forename: N
authors.initials: N
authors.lastname: Belzl
authors.forename: D
authors.initials: D
authors.lastname: Augustin
authors.forename: R E
authors.initials: RE
authors.lastname: Kates
authors.forename: N
authors.initials: N
authors.lastname: Harbeck
mesh_terms: D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D000068256:Darbepoetin alfa; D018572:Disease-Free Survival; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D016016:Proportional Hazards Models; D016896:Treatment Outcome
chemical_list: D006397:Hematinics; D004921:Erythropoietin; D000068256:Darbepoetin alfa
keywords: adjuvant chemotherapy; anemia; breast cancer; epoetin; safety