title: Effects of epoetin alfa on hematologic parameters and quality of life in cancer patients receiving nonplatinum chemotherapy: results of a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  This randomized, double-blind, placebo-controlled clinical trial assessed the effects of epoetin alfa on transfusion requirements, hematopoietic parameters, quality of life (QOL), and safety in anemic cancer patients receiving nonplatinum chemotherapy. The study also explored a possible relationship between increased hemoglobin and survival.
  
  
  METHODS
  Three hundred seventy-five patients with solid or nonmyeloid hematologic malignancies and hemoglobin levels < or = 10.5 g/dL, or greater than 10.5 g/dL but < or = 12.0 g/dL after a hemoglobin decrease of > or = 1.5 g/dL per cycle since starting chemotherapy, were randomized 2:1 to epoetin alfa 150 to 300 IU/kg (n = 251) or placebo (n = 124) three times per week subcutaneously for 12 to 24 weeks. The primary end point was proportion of patients transfused; secondary end points were change in hemoglobin and QOL. The protocol was amended before unblinding to prospectively collect and assess survival data 12 months after the last patient completed the study.
  
  
  RESULTS
  Epoetin alfa, compared with placebo, significantly decreased transfusion requirements (P =.0057) and increased hemoglobin (P <.001). Improvement of all primary cancer- and anemia-specific QOL domains, including energy level, ability to do daily activities, and fatigue, was significantly (P <.01) greater for epoetin alfa versus placebo patients. Although the study was not powered for survival as an end point, Kaplan-Meier estimates showed a trend in overall survival favoring epoetin alfa (P =.13, log-rank test), and Cox regression analysis showed an estimated hazards ratio of 1.309 (P =.052) favoring epoetin alfa. Adverse events were comparable between groups.
  
  
  CONCLUSIONS
  Epoetin alfa safely and effectively ameliorates anemia and significantly improves QOL in cancer patients receiving nonplatinum chemotherapy. Encouraging results regarding increased survival warrant another trial designed to confirm these findings.
authors.affiliation: John Radcliffe Hospital, Oxford, United Kingdom. tim.littlewood@orh.anglox.nhs.uk
authors.forename: T J
authors.initials: TJ
authors.lastname: Littlewood
authors.forename: E
authors.initials: E
authors.lastname: Bajetta
authors.forename: J W
authors.initials: JW
authors.lastname: Nortier
authors.forename: E
authors.initials: E
authors.lastname: Vercammen
authors.forename: B
authors.initials: B
authors.lastname: Rapoport
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced* / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001803:Blood Transfusion; D004311:Double-Blind Method; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000494:pharmacology*; D005221:Fatigue; D005260:Female; D006397:Hematinics / Q000494:pharmacology*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy; D010919:Placebos; D011788:Quality of Life; D011994:Recombinant Proteins; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D006397:Hematinics; D006454:Hemoglobins; D010919:Placebos; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa