77148
document
Immunotherapy using BCG during remission induction and as the sole form of maintenance in acute myeloid leukaemia . Thirty-two adults with acute myeloid leukaemia ( AML ) were randomized to receive , from the time of diagnosis , either chemotherapy alone ( C group ) or chemotherapy plus Bacille Calmette-Guérin vaccine ( BCG ) ( C+I group ) . After remission induction and consolidation , chemotherapy was stopped in both groups but BCG was continued in the C+I group . The overall survival of the C+I group was significantly increased ( P less than 0.05 ) . There was no significant increase in the duration of first remission in the C+I group ( 0.05 less than P less than 0.1 ) nor in the time from first relapse to death ( 0.05 less than P less than 0.1 ) . There was no significant difference in the incidence of first or second remissions , and the time taken to enter remission did not differ significantly between the two groups . Comparison with the results of other trials suggests that the use of maintenance chemotherapy in addition to immunotherapy produces longer remissions . Five patients in the C group developed leukaemic central-nervous-system ( CSN ) involvement , in comparison with none in the C+I group . CNS relapse did not produce a significant decrease in remission length ( P greater than 0.1 ) but reduction in survival after CNS relapse was highly significant ( P = 0.001 ) . These results suggest that administration of BCG from an early stage in the treatment of AML may protect the CNS against leukaemic infiltration and therefore serve as a simple , innocuous form of CNS prophylaxis .
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Intervention_Pharmacological
Immunotherapy
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Intervention_Pharmacological
BCG
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Intervention_Control
chemotherapy alone
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Outcome_Mortality
survival
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Outcome_Physical
duration of first remission
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Outcome_Mortality
first relapse to death
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Outcome_Physical
incidence of first or second remissions
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Outcome_Physical
time taken to enter remission
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Outcome_Physical
remissions
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Outcome_Adverse-effects
leukaemic central-nervous-system ( CSN ) involvement
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Outcome_Physical
remission length
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Outcome_Mortality
survival
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Outcome_Physical
leukaemic infiltration
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Outcome_Physical
prophylaxis
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Participant_Condition
acute myeloid leukaemia .
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Participant_Sample-size
Thirty-two
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Participant_Age
adults