passages: 1097
passages: document
passages: Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer . PURPOSE To compare maintenance epoetin alfa administered once every 3 weeks with continued weekly epoetin alfa for patients with cancer-associated anemia . PATIENTS AND METHODS Eligible patients were randomly assigned at enrollment to receive three weekly doses of epoetin alfa 40,000 U subcutaneously ( SC ) , followed by either standard weekly epoetin alfa ( 40K arm ) or 120,000 U of epoetin alfa ( 120K arm ) SC every 3 weeks for 18 additional weeks . RESULTS Three hundred sixty-five patients were enrolled . One hundred eighty-three patients were assigned to the 40K arm , and 182 were assigned to the 120K arm . There was no difference in the proportion of patients requiring transfusions during the study ( 23 % in 40K arm and 18 % in 120K arm , P = .22 ) or specifically during the maintenance phase ( 13 % in 40K arm v 15 % in 120K arm , P = .58 ) . Patients randomly assigned to the 40K arm were more likely to have a > or = 2 or > or = 3 g/dL hemoglobin ( Hb ) increment , were more likely to have a drug dose held because of high Hb , and had higher mean end-of-study Hb levels . Toxicities , including thromboembolism , and overall survival were similar . Patients in the 40K arm had a higher global quality of life ( QOL ) at baseline for unclear reasons , whereas patients in the 120K arm had a greater global QOL improvement during the study , so end-of-study QOL was equivalent . CONCLUSION After three weekly doses of epoetin alfa 40,000 U , a dose of 120,000 U can be administered safely once every 3 weeks without increasing transfusion needs or sacrificing QOL . The Hb increment is somewhat greater with continued weekly epoetin alfa . Lack of blinding as a result of different treatment schedules may have confounded results .
entities: 1098
entities: Intervention_Pharmacological
entities: erythropoietin
entities: 1099
entities: Intervention_Pharmacological
entities: epoetin alfa
entities: 1100
entities: Intervention_Pharmacological
entities: epoetin alfa
entities: 1101
entities: Intervention_Pharmacological
entities: epoetin alfa
entities: 1102
entities: Intervention_Pharmacological
entities: epoetin alfa
entities: 1103
entities: Intervention_Pharmacological
entities: epoetin alfa
entities: 1104
entities: Intervention_Pharmacological
entities: epoetin alfa
entities: 1105
entities: Intervention_Pharmacological
entities: epoetin alfa .
entities: 1106
entities: Outcome_Physical
entities: requiring transfusions
entities: 1107
entities: Outcome_Physical
entities: hemoglobin ( Hb ) increment
entities: 1108
entities: Outcome_Physical
entities: drug dose
entities: 1109
entities: Outcome_Physical
entities: Hb
entities: 1110
entities: Outcome_Physical
entities: Hb
entities: 1111
entities: Outcome_Adverse-effects
entities: Toxicities
entities: 1112
entities: Outcome_Adverse-effects
entities: thromboembolism
entities: 1113
entities: Outcome_Mortality
entities: overall survival
entities: 1114
entities: Outcome_Other
entities: global quality of life ( QOL )
entities: 1115
entities: Outcome_Other
entities: global QOL
entities: 1116
entities: Outcome_Other
entities: QOL
entities: 1117
entities: Outcome_Physical
entities: transfusion needs
entities: 1118
entities: Outcome_Other
entities: QOL
entities: 1119
entities: Outcome_Physical
entities: .
entities: 1120
entities: Outcome_Physical
entities: Hb increment
entities: 1121
entities: Participant_Condition
entities: anemic patients with cancer .
entities: 1122
entities: Participant_Condition
entities: patients with cancer-associated anemia .
entities: 1123
entities: Participant_Sample-size
entities: Three hundred sixty-five patients