41495
document
Randomized trial of daily versus weekly administration of 2-chlorodeoxyadenosine in patients with hairy cell leukemia : a multicenter phase III trial ( SAKK 32/98 ) . Daily administration of 2-chlorodeoxyadenosine ( Cladribine , CDA ) is a standard treatment for hairy cell leukemia , but may cause severe neutropenia and neutropenic fever . This trial compared toxicity and efficacy of weekly versus daily CDA administration . One hundred patients were randomized to receive standard ( CDA 0.14 mg/kg/day day 1-5 [ Arm A ] ) or experimental treatment ( CDA 0.14 mg/kg/day once weekly for 5 weeks [ Arm B ] ) . The primary endpoint was average leukocyte count within 6 weeks from randomization . Secondary endpoints included response rates , other acute hematotoxicity , acute infection rate , hospital admission , remission duration , event-free , and overall survival . There was no significant difference in average leukocyte count . Response rate ( complete + partial remission ) at week 10 was 78 % ( 95 % confidence interval ( CI ) 64-88 % ) in Arm A and 68 % ( 95 % CI 54-80 % ) in Arm B ( p = 0.13 ) . Best response rates during follow-up were identical ( 86 % ) in both arms . No significant difference was found in the rate of grade 3+4 leukocytopenia ( 94 % vs . 84 % ) , grade 3+4 neutropenia ( 90 % vs . 80 % ) , acute infection ( 44 % vs . 40 % ) , hospitalization ( 38 % vs . 34 % ) , and erythrocyte support ( 22 % vs . 30 % ) within 10 weeks . Overall , these findings indicate that there are no apparent advantages in toxicity and efficacy by giving CDA weekly rather than daily .
41496
Intervention_Pharmacological
2-chlorodeoxyadenosine
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Intervention_Pharmacological
2-chlorodeoxyadenosine
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Intervention_Pharmacological
Cladribine , CDA
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Intervention_Pharmacological
CDA
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Intervention_Pharmacological
CDA
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Intervention_Pharmacological
CDA
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Intervention_Pharmacological
CDA
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Outcome_Physical
neutropenia and neutropenic fever
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Outcome_Physical
average leukocyte count
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Outcome_Physical
response rates
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Outcome_Adverse-effects
other acute hematotoxicity
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Outcome_Adverse-effects
acute infection rate
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Outcome_Other
hospital admission
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Outcome_Other
remission duration
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Outcome_Mortality
event-free , and overall survival
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Outcome_Physical
leukocyte count
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Outcome_Physical
Response rate
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Outcome_Physical
response rates
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Outcome_Physical
grade 3+4 leukocytopenia
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Outcome_Physical
grade 3+4 neutropenia
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Outcome_Physical
acute infection
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Outcome_Other
hospitalization
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Outcome_Physical
erythrocyte support
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Outcome_Other
toxicity and efficacy