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document
Granulocyte-macrophage colony-stimulating factor ( GM-CSF ) as adjunct therapy in relapsed Hodgkin disease . OBJECTIVE To determine the clinical and economic effects of granulocyte macrophage colony-stimulating factor ( GM-CSF ) as adjunct therapy in relapsed or refractory Hodgkin disease . DESIGN A randomized , double-blind , phase III clinical trial . SETTING A tertiary referral center . PATIENTS Twenty-four patients ( twelve of whom were controls ) treated with high-dose chemotherapy and autologous bone marrow transplantation . MAIN RESULTS The 12 patients treated with GM-CSF , when compared with placebo recipients , had shorter periods of neutropenia ( median duration of an absolute neutrophil count of less than 1000 cells/mm3 , 16 days compared with 27 days ; P = 0.02 ) , shorter periods of platelet-transfusion dependency ( median duration , 13.5 days compared with 21 days ; P = 0.03 ) , and shorter hospitalizations ( median hospital stay , 32 days compared with 40.5 days ; P = 0.004 ) . Other clinical outcomes , such as frequency and severity of toxicities , development of pneumonia or infection , in-hospital death , and response rate were similar in the two groups . Actuarial long-term disease-free survival was 64 % for patients treated with GM-CSF and 58 % for patients who received placebo after 32 months of follow-up ( P = 0.15 ) . The group treated with GM-CSF had lower total charges after infusion of autologous marrow than the placebo group ( median in-hospital charges , $ 39,800 compared with $ 62,500 ; P = 0.005 ) because of lower post-infusion charges for room and board , antibiotic therapy , transfusions , laboratory tests , and physical therapy visits . CONCLUSIONS Administration of GM-CSF was associated with acceleration of myeloid and platelet recovery and was cost effective in the treatment of patients with relapsed Hodgkin disease who received intensive chemotherapy .
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Intervention_Pharmacological
Granulocyte-macrophage colony-stimulating factor ( GM-CSF )
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Intervention_Pharmacological
granulocyte macrophage colony-stimulating factor ( GM-CSF )
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Intervention_Psychological
high-dose chemotherapy
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Intervention_Surgical
autologous bone marrow transplantation .
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Intervention_Pharmacological
GM-CSF
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Intervention_Control
placebo
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Intervention_Pharmacological
GM-CSF
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Intervention_Control
placebo
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Intervention_Pharmacological
GM-CSF
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Intervention_Control
placebo
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Intervention_Pharmacological
GM-CSF
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Outcome_Physical
periods of neutropenia
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Outcome_Physical
shorter periods of platelet-transfusion dependency
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Outcome_Other
shorter hospitalizations
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Outcome_Physical
frequency and severity of toxicities
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Outcome_Physical
development of pneumonia or infection
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Outcome_Mortality
in-hospital death
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Outcome_Mental
response rate
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Outcome_Mortality
long-term disease-free survival
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Outcome_Physical
lower total charges after infusion of autologous marrow
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Outcome_Physical
lower post-infusion charges
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Outcome_Physical
acceleration of myeloid and platelet recovery
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Outcome_Other
cost effective
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Participant_Condition
relapsed Hodgkin disease .
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Participant_Condition
relapsed or refractory Hodgkin disease .