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document
A randomized trial of prophylactic palifermin on gastrointestinal toxicity after intensive induction therapy for acute myeloid leukaemia . Gastrointestinal toxicity , including oral mucositis , is a frequent complication of intensive combination chemotherapy for acute myeloid leukaemia ( AML ) and contributes substantially to treatment-related mortality . We conducted a placebo-controlled randomized trial to evaluate the efficacy of palifermin ( keratinocyte growth factor ) , given at 60 μg/kg per daily IV for 3 d before and after chemotherapy , for mucosal protection in adult patients with previously untreated AML receiving induction therapy with idarubicin , high-dose cytarabine and etoposide . Among 155 randomized patients , there was no statistically significant difference in the rate of grade 3 and 4 oral mucositis ( primary study endpoint ) between the two treatment arms ( three in palifermin arm ( 4 % ) , 8 in placebo arm ( 10 % ; P = 0·21 ) ; however , when considering the severity of oral mucositis ( World Health Organization grade 0-4 ) , there was evidence of reduced rates of higher grades of oral mucositis in the palifermin arm ( P = 0·0007 , test for trend ) . There was a statistically significantly lower rate of grades 3 and 4 gastrointestinal adverse events in the palifermin arm ( 21 % vs. 44 % in placebo arm ; P = 0·003 ) , mainly due to a reduction in severe diarrhoea ( 8 % palifermin , 26 % placebo ; P = 0·01 ) . Palifermin has activity as a mucosal protectant in AML patients receiving intensive chemotherapy . This trial is registered at ACTRN012605000095662 .
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Intervention_Pharmacological
prophylactic palifermin
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Intervention_Pharmacological
palifermin
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Participant_Condition
acute myeloid leukaemia
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Participant_Age
adult patients
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Participant_Condition
with previously untreated AML receiving induction therapy with idarubicin
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Participant_Condition
high-dose cytarabine and etoposide
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Participant_Sample-size
Among 155 randomized patients