title: Randomized, open-label comparison of epoetin alfa extended dosing (80 000 U Q2W) vs weekly dosing (40 000 U QW) in patients with chemotherapy-induced anemia.
abstract: OBJECTIVE
  This randomized, open-label, multicenter study compared the efficacy and safety of epoetin alfa (EPO) 80 000 U every 2 weeks (Q2W) to the FDA-approved regimen of 40 000 U weekly (QW) in patients with chemotherapy-induced anemia.
  
  
  METHODS
  A total of 310 patients with nonmyeloid malignancy and baseline hemoglobin (Hb) <or= 11 g/dL who were scheduled to receive chemotherapy for a minimum of 12 weeks were randomized to EPO Q2W or QW for up to 12 weeks, with dose modification to maintain Hb at approximately 12 g/dL. Efficacy analyses used the per-protocol population (patients who completed the study with a value for Hb change) for the primary endpoint only and the modified intent-to-treat (mITT) population (patients who received study drug and had at least one postbaseline Hb value) for the primary and secondary endpoints.
  
  
  RESULTS
  Analysis of the primary endpoint revealed that the mean change in Hb from baseline to study end was comparable between the Q2W and QW groups in the per-protocol population (1.6 g/dL vs 1.8 g/dL, respectively; treatment difference, -0.2 g/dL; one-sided 95% confidence interval [-0.56, -]); similar results were observed in the mITT population. Among patients on study at Day 29, 9.6% (13/135) and 11.1% (14/126) of patients in the Q2W and QW groups, respectively, received a transfusion between Day 29 and the end of the study (p = 0.709). Dose withholds (21% vs 42%, p < 0.001) and dose reductions (41% vs 59%, p = 0.003) were less common for Q2W than QW. Safety profiles were similar between groups; clinically relevant thrombotic vascular events occurred in 8% of patients in each group. The open-label dosing and the patient attrition rate did not appear to influence overall study results.
  
  
  CONCLUSIONS
  Extended dosing (80 000 U Q2W) and once-weekly dosing (40 000 U QW) of EPO provided comparable safety and efficacy for chemotherapy-induced anemia.
authors.affiliation: Joan Karnell Cancer Center, Pennsylvania Hospital, Philadelphia, PA, USA.
authors.forename: David H
authors.initials: DH
authors.lastname: Henry
authors.forename: Lucio N
authors.initials: LN
authors.lastname: Gordan
authors.forename: Veena
authors.initials: V
authors.lastname: Charu
authors.forename: Francois E
authors.initials: FE
authors.lastname: Wilhelm
authors.forename: Denise
authors.initials: D
authors.lastname: Williams
authors.forename: John
authors.initials: J
authors.lastname: Xie
authors.forename: Richard C
authors.initials: RC
authors.lastname: Woodman
mesh_terms: D000740:Anemia / Q000139:chemically induced* / Q000188:drug therapy*; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D011446:Prospective Studies; D011994:Recombinant Proteins
chemical_list: D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa