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Prospectively randomized toxicity study of high-dose versus low-dose treatment strategies for lymphoblastoid interferon . It is unclear from preliminary laboratory studies whether a high- or a low-dose interferon treatment strategy is optimal . As part of an ongoing study of mechanisms of interferon action , we have evaluated toxicity in a two-arm protocol in which patients were randomly assigned to receive lymphoblastoid interferon by either a low-dose treatment strategy ( 2 X 10 ( 6 ) units/m2 daily X 28 days then daily X 5 days every other week by im injection ) or a high-dose treatment strategy ( 5 X 10 ( 6 ) units/m2 by continuous iv infusion over 24 hours , escalating by 5 X 10 ( 6 ) units/m2/day as tolerated over 10 days , repeated every 28 days ) . The main toxic effects in both arms were fever , fatigue , and anorexia . Marked interpatient differences within each dose arm were greater than differences between arms . Additional significant toxic effects included nausea and vomiting , hypotension , leukopenia , thrombocytopenia , and evidence of hepatic toxicity . Minor changes in serum electrolytes were noted . Coagulation studies were normal . The dose-limiting toxic effect for the high-dose arm was myelosuppression . Median maximum tolerated dose among high-dose strategy patients was 18 X 10 ( 6 ) units/m2 , but there was marked interpatient variation . We conclude that both dose schedules were relatively well-tolerated . Because of individual variation in tolerance , high-dose treatment should include a dose escalation strategy .
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Intervention_Pharmacological
lymphoblastoid interferon .
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Intervention_Pharmacological
high- or a low-dose interferon
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Intervention_Pharmacological
interferon
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Intervention_Pharmacological
lymphoblastoid interferon
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Outcome_Adverse-effects
toxicity
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Outcome_Adverse-effects
toxicity
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Outcome_Adverse-effects
main toxic effects
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Outcome_Adverse-effects
fever , fatigue , and anorexia .
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Outcome_Adverse-effects
significant toxic effects included nausea and vomiting , hypotension , leukopenia , thrombocytopenia , and evidence of hepatic toxicity
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Outcome_Adverse-effects
changes in serum electrolytes
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Outcome_Physical
Coagulation studies
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Outcome_Adverse-effects
toxic effect
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Outcome_Adverse-effects
myelosuppression
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Outcome_Other
maximum tolerated dose
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Outcome_Other
relatively well-tolerated .
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Outcome_Other
tolerance
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Participant_Condition
lymphoblastoid interferon