A phase III randomized double-blind placebo-controlled study of epoetin beta for the treatment of chemotherapy-induced anemia in cancer patients

INTERVENTION: Intervention name : Recombinant human erythropoietin Dosage And administration of the intervention : Subcutaneous injection CONDITION: Chemotherapy‐induced anemia PRIMARY OUTCOME: Primary endpoint; The proportion of the subjects who receive RBC transfusion and/or Hb concentration < 8.0 g/dL ; Secondary endpoints; ‐ Change in Hb; ‐ Change in FACT‐An total Fatigue subscale score (FSS); ‐ Requirement for RBC transfusion INCLUSION CRITERIA: ‐ Lung cancer or gynecologic cancer ‐ Underwent platinum‐based chemotherapy repeated for >= 2 cycles after EPO or placebo administration ‐ 8.0 g/dL >= hemoglobin concentration (Hb) =< 10.0 g/dL ‐ 20 ‐ 79 years old ‐ Performance status : 0 ‐ 2 ‐ No iron deficiency anemia ‐ No red blood cell transfusion within 4 weeks before treatment ‐ No erythropoetin therapy within 8 weeks before treatment