title: Efficacy and safety analysis of epoetin alfa in patients with small-cell lung cancer: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  This randomized, double-blind, placebo-controlled trial (N93-004) evaluated the effects of epoetin alfa on tumor response to chemotherapy and survival in patients with small-cell lung cancer (SCLC).
  
  
  METHODS
  Adult patients with hemoglobin < or = 14.5 g/dL starting chemotherapy received epoetin alfa 150 U/kg or placebo subcutaneously 3 times weekly until 3 weeks after completion of chemotherapy. Survival was assessed for 3 years. The primary end point was the proportion of patients with complete or partial response after three chemotherapy cycles.
  
  
  RESULTS
  The trial was terminated prematurely after 224 of a projected 400 patients were accrued. Baseline characteristics were similar between groups. Epoetin alfa and placebo patients (n = 109 and n = 115, respectively) had mean baseline hemoglobin of 12.8 g/dL and 13.0 g/dL, respectively. Overall tumor response was similar between the epoetin alfa and placebo groups after three chemotherapy cycles (72% and 67%, respectively; 95% CI of difference, -6% to 18%) and after completion of chemotherapy (60% and 56%, respectively; 95% CI of difference, -9% to 17%). Epoetin alfa and placebo groups had similar median overall survival (10.5 and 10.4 months, respectively) and overall mortality (91.7% and 87.8%, respectively; hazard ratio, 1.172; 95% CI, 0.887 to 1.549; P = .264). Hemoglobin was maintained in the prechemotherapy range in epoetin alfa patients, but decreased substantially in placebo patients. Fewer epoetin alfa patients than placebo patients required transfusion.
  
  
  CONCLUSIONS
  These results suggest that in newly diagnosed patients with SCLC epoetin alfa does not affect tumor response to chemotherapy or survival. However, the early trial closure makes these conclusions preliminary.
authors.affiliation: Forsyth Regional Cancer Center, Winston-Salem, NC 27103, USA. tgrote@phoa.org
authors.forename: Thomas
authors.initials: T
authors.lastname: Grote
authors.forename: Allen L
authors.initials: AL
authors.lastname: Yeilding
authors.forename: Rene
authors.initials: R
authors.lastname: Castillo
authors.forename: Dean
authors.initials: D
authors.lastname: Butler
authors.forename: Ellioth
authors.initials: E
authors.lastname: Fishkin
authors.forename: David H
authors.initials: DH
authors.lastname: Henry
authors.forename: Michael
authors.initials: M
authors.lastname: DeLeo
authors.forename: Kenneth
authors.initials: K
authors.lastname: Fink
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Sullivan
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000188:drug therapy / Q000209:etiology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D018288:Carcinoma, Small Cell / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications / Q000188:drug therapy*; D008875:Middle Aged; D010919:Placebos; D011994:Recombinant Proteins; D016019:Survival Analysis
chemical_list: D006397:Hematinics; D010919:Placebos; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa