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document
Granulocyte-macrophage colony-stimulating factor ( GM-CSF ) allows acceleration and dose intensity increase of CEF chemotherapy : a randomised study in patients with advanced breast cancer . A randomised study was conducted in 62 patients with advanced breast cancer to assess whether granulocyte-macrophage colony-stimulating factor ( GM-CSF ) would yield an increase in the dose intensity of a standard-dose CEF regimen through an acceleration of chemotherapy administration . Patients received CEF ( cyclophosphamide 600 mg m-2 , epidoxorubicin 60 mg m-2 and fluorouracil 600 mg m-2 ) i.v . on day 1 or the same chemotherapy , plus GM-CSF 10 micrograms kg-1 s.c. starting from day 4 , repeated as soon as haematopoietic recovery from nadir occurred . Patients in the CEF + GM-CSF group received chemotherapy at a median interval of 16 days compared with 20 days in the control group . This led to a significant increase ( P = 0.02 ) in the dose intensity actually administered in the third , fourth and sixth cycles : +28 % , +25 % , +20 % respectively . Non-haematological toxicity was mild . GM-CSF had to be reduced or suspended in 50 % of patients because of toxicity . Haematological toxicity , mainly cumulative anaemia and thrombocytopenia , was manageable . An increase in response rate for patients with measurable disease , of borderline statistical significance ( P = 0.088 , P for trend = 0.018 ) , from 42 % in the CEF group to 69 % in the CEF + GM-CSF group , was observed . This randomised trial indicates that GM-CSF is useful for chemotherapy acceleration . Accelerated CEF + GM-CSF is a moderately dose-intensive regimen that can be administered in an outpatient clinic and is associated with a high objective response .
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Intervention_Physical
Granulocyte-macrophage colony-stimulating factor ( GM-CSF )
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Intervention_Physical
CEF chemotherapy
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Intervention_Physical
GM-CSF
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Intervention_Physical
standard-dose CEF regimen
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Intervention_Physical
chemotherapy
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Intervention_Pharmacological
CEF
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Intervention_Pharmacological
cyclophosphamide 600 mg m-2
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Intervention_Pharmacological
epidoxorubicin 60 mg m-2
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Intervention_Pharmacological
fluorouracil 600 mg m-2
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Intervention_Physical
chemotherapy
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Intervention_Physical
GM-CSF
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Intervention_Physical
CEF + GM-CSF
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Intervention_Physical
GM-CSF
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Intervention_Pharmacological
CEF
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Intervention_Pharmacological
CEF + GM-CSF
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Intervention_Pharmacological
GM-CSF
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Intervention_Pharmacological
CEF + GM-CSF
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Outcome_Adverse-effects
Non-haematological toxicity
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Outcome_Adverse-effects
toxicity
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Outcome_Adverse-effects
Haematological toxicity
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Outcome_Adverse-effects
cumulative anaemia and thrombocytopenia
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Outcome_Other
response rate
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Participant_Condition
patients with advanced breast cancer .
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Participant_Sample-size
62
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Participant_Condition
patients with advanced breast cancer