11581
document
Dexamethasone versus prednisone and daily oral versus weekly intravenous mercaptopurine for patients with standard-risk acute lymphoblastic leukemia : a report from the Children 's Cancer Group . Conventional therapy for childhood acute lymphoblastic leukemia ( ALL ) includes prednisone and oral 6-mercaptopurine . Prior observations suggested potential advantages for dexamethasone over prednisone and for intravenous ( IV ) over oral 6-mercaptopurine , which remain to be validated . We report the results of a randomized trial of more than 1000 subjects that examined the efficacy of dexamethasone and IV 6-mercaptopurine . Children with National Cancer Institute standard-risk ALL were randomly assigned in a 2 x 2 factorial design to receive dexamethasone ( 6 mg/m ( 2 ) /d ) for 28 days in induction , plus taper , compared with prednisone ( 40 mg/m ( 2 ) /d ) . The second randomized assignment was for daily oral or weekly IV 6-mercaptopurine during consolidation . During maintenance , 5 days of the randomized steroid was given monthly , at the same dose , and all patients received daily oral 6-mercaptopurine . During delayed intensification , all patients received a dexamethasone dosage of 10 mg/m ( 2 ) /d for 21 days , with taper . Intrathecal ( IT ) methotrexate was the sole central nervous system-directed therapy . Patients randomly assigned to receive dexamethasone had a 6-year isolated central nervous system-relapse rate of 3.7 % +/- 0.8 % , compared with 7.1 % +/- 1.1 % for prednisone ( P =.01 ) . There was also a trend toward fewer isolated bone marrow relapses with dexamethasone . The 6-year event-free survival ( EFS ) was 85 % +/- 2 % for dexamethasone and 77 % +/- 2 % for prednisone ( P =.002 ) . EFS was similar with oral or IV 6-mercaptopurine ; however , patients assigned to IV 6-mercaptopurine had decreased survival after relapse .
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Intervention_Pharmacological
Dexamethasone
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Intervention_Pharmacological
prednisone
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Intervention_Pharmacological
intravenous mercaptopurine
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Intervention_Pharmacological
Conventional therapy
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Intervention_Pharmacological
prednisone
11587
Intervention_Pharmacological
6-mercaptopurine
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Intervention_Pharmacological
dexamethasone
11589
Intervention_Pharmacological
prednisone
11590
Intervention_Pharmacological
intravenous ( IV )
11591
Intervention_Pharmacological
oral 6-mercaptopurine
11592
Intervention_Pharmacological
dexamethasone
11593
Intervention_Pharmacological
IV 6-mercaptopurine
11594
Intervention_Pharmacological
prednisone
11595
Intervention_Pharmacological
IV 6-mercaptopurine
11596
Intervention_Pharmacological
oral 6-mercaptopurine
11597
Intervention_Pharmacological
dexamethasone
11598
Intervention_Pharmacological
Intrathecal ( IT ) methotrexate
11599
Intervention_Pharmacological
dexamethasone
11600
Intervention_Pharmacological
prednisone
11601
Intervention_Pharmacological
dexamethasone
11602
Intervention_Pharmacological
dexamethasone
11603
Intervention_Pharmacological
prednisone
11604
Intervention_Pharmacological
oral or IV 6-mercaptopurine
11605
Intervention_Pharmacological
IV 6-mercaptopurine
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Outcome_Other
efficacy
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Outcome_Physical
6-year isolated central nervous system-relapse rate
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Outcome_Physical
isolated bone marrow relapses
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Outcome_Mortality
6-year event-free survival ( EFS )
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Outcome_Mortality
survival after relapse .
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Participant_Condition
patients with standard-risk acute lymphoblastic leukemia :
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Participant_Condition
childhood acute lymphoblastic leukemia ( ALL )