title: Weekly administration of epoetin beta for chemotherapy-induced anemia in cancer patients: results of a multicenter, Phase III, randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  The efficacy and safety of weekly administration of epoetin beta (EPO) for chemotherapy-induced anemia (CIA) patients was evaluated.
  
  
  METHODS
  One hundred and twenty-two patients with lung cancer or malignant lymphoma undergoing chemotherapy were randomized to the EPO 36 000 IU group or the placebo group. Hematological response and red blood cell (RBC) transfusion requirement were assessed. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire.
  
  
  RESULTS
  Mean change in hemoglobin level with EPO increased significantly over placebo (1.4 +/- 1.9 g/dl versus -0.8 +/- 1.5 g/dl; P < 0.001). The proportion of patients with change in hemoglobin level > or =2.0 g/dl was higher for EPO than those for placebo (P < 0.001). After 4 weeks of administration, the proportion of RBC transfusion or hemoglobin level <8.0 g/dl was significantly lower for EPO than those for placebo (P = 0.046). The changes in the FACT-An total Fatigue Subscale Score (FSS) were less deteriorated with EPO than those with placebo. Progressive disease (PD) did not influence the change in hemoglobin level but there was less decrease in FSS in non-PD patients. No significant differences in adverse events were observed. Thrombovascular events and pure red cell aplasia related to EPO were not observed. Retrospective analysis of survival showing the hazard ratio of EPO to placebo was 0.94.
  
  
  CONCLUSIONS
  Weekly administration of EPO 36 000 IU significantly increased hemoglobin level and ameliorated the decline of QOL in CIA patients over the 8-week administration period.
authors.affiliation: Department of Thoracic Surgery and Oncology, Tokyo Medical University and Hospital, 6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, Japan. mtsuboi@za2.so-net.ne.jp
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuboi
authors.forename: Kohji
authors.initials: K
authors.lastname: Ezaki
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000097:blood / Q000139:chemically induced* / Q000188:drug therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D015415:Biomarkers / Q000097:blood; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin