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document
Evaluation of AMSA in children with acute leukemia . A Pediatric Oncology Group study . One hundred four children with advanced leukemia in relapse ( 74 with acute lymphocytic leukemia [ ALL ] and 30 with acute nonlymphocytic leukemia [ ANLL ] ) received AMSA ( 4'- ( 9-Acridinylamino ) methanesulfon -m-anisidide ) at a dose of 120 mg/m2/day for 5 days ( Regimen I ) or 60 mg/m2/day for 10 days ( Regimen II ) . Children with ALL were randomized between Regimens I and II ( 31 and 36 evaluable patients , respectively ) . All 29 evaluable patients with ANLL were treated on Regimen I. Eighty-eight percent of evaluable patients experienced severe or life-threatening toxicity , with no statistical differences between Regimens I and II . Bacterial or fungal infections ( considered life-threatening or fatal ) occurred in 17 children with ALL and in 7 with ANLL . Fatal cardiac toxicity occurred in one patient . Complete or partial response occurred in 25.0 % ( SE = 8.8 % ) , 28.1 % ( SE = 8.0 % ) , and 25.9 % ( SE = 8.4 % ) of evaluable patients on ALL Regimen I , ALL Regimen II , and ANLL , respectively . However , responses were of short duration ( 16-91 days ) . There was no significant difference in the duration of survival from treatment start for the two ALL regimens ( P = 0.46 ) . The median duration of survival for ANLL patients was significantly longer ( P = 0.004 ) than that of ALL patients treated on Regimens I and II combined . Eighty-two percent of the complete or partial responses ( 18 of 22 ) occurred after the first course of AMSA . At the dose schedules investigated , and in a heavily pretreated patient population , AMSA had activity in childhood leukemia . However , the high incidence of severe , life-threatening , or fatal infections meant that the quality and quantity of responses and survival was not commensurate with the toxicity , and that it would be difficult to incorporate this drug into combination chemotherapy with other myelosuppressive agents .
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Intervention_Pharmacological
AMSA
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Intervention_Pharmacological
AMSA ( 4'- ( 9-Acridinylamino ) methanesulfon -m-anisidide )
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Intervention_Pharmacological
AMSA .
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Outcome_Adverse-effects
severe or life-threatening toxicity
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Outcome_Adverse-effects
Bacterial or fungal infections
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Outcome_Adverse-effects
Fatal cardiac toxicity
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Outcome_Physical
Complete or partial response
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Outcome_Physical
responses
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Outcome_Mortality
duration of survival
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Outcome_Mortality
median duration of survival
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Outcome_Physical
activity in childhood leukemia
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Outcome_Physical
incidence of severe , life-threatening , or fatal infections
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Outcome_Mortality
quality and quantity of responses and survival
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Outcome_Physical
toxicity
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Participant_Age
children
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Participant_Condition
acute leukemia
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Participant_Sample-size
One hundred four
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Participant_Age
children
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Participant_Condition
advanced leukemia
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Participant_Sample-size
74
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Participant_Condition
acute lymphocytic leukemia [ ALL ]
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Participant_Sample-size
30
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Participant_Condition
acute nonlymphocytic leukemia [ ANLL ] )
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Participant_Age
Children
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Participant_Condition
ALL
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Participant_Condition
ANLL
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Participant_Condition
Fatal cardiac toxicity