86154
document
Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy . BACKGROUND Patients with advanced cancer frequently experience clinically significant anemia , which is often exacerbated by myelosuppressive chemotherapy . Consistent with the anemia of chronic disease , studies have documented serum erythropoietin levels that are inappropriately low for the degree of anemia in cancer patients . Myelosuppressive chemotherapy impairs erythropoiesis , which may not fully recover between treatment cycles . Recombinant human erythropoietin ( rHuEPO ) has been used safely and effectively to treat anemia in AIDS patients receiving zidovudine ( AZT ) and in patients with chronic renal failure . PURPOSE This study was designed to evaluate the clinical role of rHuEPO in reducing symptomatic anemia in patients with advanced cancer who were receiving myelosuppressive chemotherapy ( excluding cisplatin ) . METHODS We studied 153 anemic cancer patients receiving cyclic combination chemotherapy in a prospective multicenter , double-blind , placebo-controlled trial . The patients were randomly assigned to receive either rHuEPO ( 150 U/kg ) or placebo subcutaneously three times a week for a maximum of 12 weeks or until the hematocrit level increased to 38 % -40 % . If the hematocrit reached this target level before 12 weeks , the rHuEPO dose could be reduced to maintain the hematocrit at that level for the duration of the study . Response to rHuEPO therapy was assessed by measuring changes in hematocrit level , transfusion requirements , and quality of life . Quality-of-life assessment was based on patients ' responses to questionnaires before and after the courses of therapy . RESULTS The increase in hematocrit in the rHuEPO-treated group compared with hematocrit in the placebo-treated group was statistically significant ( P = .0001 ) as measured by percentage point of change from baseline to final evaluation , by an increase in hematocrit level of six percentage points or more unrelated to transfusion , and by a rise in hematocrit level to 38 % or more unrelated to transfusion . There was a trend toward the reduction in mean units of blood transfused per patient during months 2 and 3 of therapy combined in rHuEPO-treated patients compared with placebo-treated patients ( 0.91 U versus 1.65 U ; P = .056 ) . In addition , rHuEPO-treated patients experienced a statistically significant improvement in energy level and ability to perform daily activities ( P < or = .05 ) . The two treatment groups showed no statistically significant differences in toxic effects except for increased incidence of diaphoresis ( P < .05 ) and diarrhea ( P = .05 ) in the rHuEPO-treated group . CONCLUSIONS We conclude that rHuEPO is safe and effective for reversing anemia related to advanced cancer or to chemotherapy for cancer .
86155
Intervention_Pharmacological
Recombinant human erythropoietin therapy
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Intervention_Pharmacological
Recombinant human erythropoietin ( rHuEPO )
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Intervention_Pharmacological
rHuEPO
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Intervention_Control
placebo
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Intervention_Pharmacological
rHuEPO
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Intervention_Pharmacological
rHuEPO
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Intervention_Pharmacological
rHuEPO-treated
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Intervention_Control
placebo-treated
86163
Intervention_Pharmacological
rHuEPO-treated
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Intervention_Pharmacological
rHuEPO-treated
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Intervention_Pharmacological
rHuEPO
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Outcome_Adverse-effects
clinically significant
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Outcome_Physical
anemia
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Outcome_Physical
symptomatic anemia
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Outcome_Physical
hematocrit level
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Outcome_Physical
hematocrit
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Outcome_Physical
changes in hematocrit level
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Outcome_Other
, transfusion requirements , and quality of life
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Outcome_Other
Quality-of-life
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Outcome_Physical
increase in hematocrit
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Outcome_Physical
hematocrit
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Outcome_Physical
hematocrit
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Outcome_Physical
hematocrit level
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Outcome_Other
mean units of blood transfused per patient
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Outcome_Other
energy level and ability to perform daily activities
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Outcome_Adverse-effects
toxic effects
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Outcome_Adverse-effects
diaphoresis
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Outcome_Adverse-effects
diarrhea
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Outcome_Physical
anemia
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Participant_Condition
anemic cancer patients on combination chemotherapy
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Participant_Condition
Patients with advanced cancer frequently experience clinically significant anemia
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Participant_Condition
cancer patients
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Participant_Condition
patients with advanced cancer who were receiving myelosuppressive chemotherapy ( excluding cisplatin )
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Participant_Sample-size
153
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Participant_Condition
receiving cyclic combination chemotherapy
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Participant_Condition
rHuEPO-treated group
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Participant_Condition
placebo-treated
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Participant_Condition
rHuEPO-treated patients
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Participant_Condition
rHuEPO-treated group