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document
Comparison of maintenance treatment regimens for first central nervous system relapse in children with acute lymphocytic leukemia . A Pediatric Oncology Group study . Eighty-seven children with central nervous system ( CNS ) leukemia were randomized to receive either induction intrathecal chemotherapy ( ITC ) and cranial irradiation ( CRT ) plus maintenance ITC , or induction ITC and craniospinal irradiation ( CSpRT ) with no maintenance ITC . ITC consisted of six weekly injections of methotrexate , hydrocortisone , and arabinosylcytosine . Also , intensification of systemic induction and maintenance chemotherapy was given . CRT + ITC was given as CRT , 2400 rad in 12 fractions followed by ITC maintenance bimonthly for 2 years . Craniospinal irradiation consisted of CRT + 1400 rad in ten fractions to the spine . Randomization was stratified according to whether CNS leukemia occurred at initial diagnosis of acute lymphocytic leukemia ( ALL ) ( Stratum I , 15 patients ) , during first bone marrow ( BM ) remission ( Stratum II , 49 patients ) , simultaneous with first BM relapse ( Stratum III , 12 patients ) , or during second BM remission ( Stratum IV , 11 patients ) . The median follow-up for patients who remain at risk is 15 + months . Eight children ( seven on CRT + ITC , one on CSpRT ) developed presumed therapy related encephalopathy . In Stratum II , 16 of 29 ( 55 % ) patients receiving CRT + ITC experienced adverse events : 3 deaths during continuous complete remission ( CCR ) and 13 relapses ( 2 CNS , 1 CNS + BM , 1 BM + testes , and 2 testes ) as compared with only 5 relapses in 20 ( 25 % ) patients on CSpRT ( 1 CNS , 1 CNS + BM , 1 BM , and 2 testes ) . The children on both regimens were comparable for sex , race , age at initial ALL diagnosis , time from ALL diagnosis to first episode of CNS leukemia , systemic therapy both before and after CNS relapse , and number of blasts in the spinal fluid at diagnosis of CNS leukemia . The conclusion is that children with isolated CNS leukemia can achieve prolonged survival with aggressive therapy , and that CSpRT is possibly less toxic and more likely than is CRT + ITC to prevent subsequent BM and testicular relapse ( P less than 0.02 ) , but not subsequent CNS relapse ( P = 0.7 ) . A possible systemic therapy effect of spinal irradiation is postulated to explain the superiority of CSpRT .
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Intervention_Physical
induction intrathecal chemotherapy
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Intervention_Pharmacological
( ITC )
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Intervention_Physical
cranial irradiation ( CRT )
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Intervention_Pharmacological
plus
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Intervention_Physical
maintenance ITC
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Intervention_Physical
induction ITC
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Intervention_Pharmacological
and craniospinal irradiation ( CSpRT ) with no maintenance ITC
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Intervention_Pharmacological
methotrexate
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Intervention_Pharmacological
hydrocortisone
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Intervention_Pharmacological
arabinosylcytosine
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Intervention_Physical
intensification of systemic induction
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Intervention_Physical
maintenance chemotherapy
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Intervention_Physical
CRT
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Intervention_Pharmacological
+
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Intervention_Physical
ITC
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Intervention_Physical
CRT
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Intervention_Physical
ITC
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Intervention_Physical
Craniospinal irradiation consisted of CRT
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Intervention_Physical
CSpRT
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Outcome_Physical
presumed therapy related encephalopathy .
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Outcome_Physical
adverse events :
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Outcome_Physical
deaths during continuous complete remission ( CCR )
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Outcome_Physical
relapses
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Outcome_Physical
relapses
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Outcome_Physical
time from ALL diagnosis to first episode of CNS leukemia , systemic therapy both before and after CNS relapse , and number of blasts in the spinal fluid at diagnosis of CNS leukemia .
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Outcome_Mental
prolonged survival with aggressive therapy
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Outcome_Physical
CSpRT is possibly less toxic
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Outcome_Physical
subsequent BM and testicular relapse
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Outcome_Physical
CNS relapse
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Outcome_Physical
spinal irradiation
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Outcome_Physical
superiority of CSpRT .
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Participant_Condition
central nervous system relapse
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Participant_Age
children
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Participant_Condition
acute lymphocytic leukemia
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Participant_Sample-size
Eighty-seven
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Participant_Condition
central nervous system ( CNS ) leukemia