Abstract
To increase the efficacy of bone marrow transplantation (BMT), we have tried to add etoposide (VP-16) to busulfan/cyclophosphamide (BU/CY). Twelve patients received 16 mg/kg of BU and 120 mg/kg of CY with 15-30 mg/kg of VP-16. Another two patients received 5 micrograms/kg of G-CSF with 30 mg/kg of VP-16. Patients tolerated escalating doses of VP-16 without any significant hepatotoxicity. Their maximal level of bilirubin was 37.6 micromol/L (2.2 mg/dl), and there was no significant skin toxicity or mucositis. By contrast, two patients who received G-CSF with 30 mg/kg of VP-16 developed hyperbilirubinemia and veno-occlusive disease, which terminated this phase I study. VP-16 can be safely combined with BU/CY < or = 30 mg/kg in three divided doses, and its effect on survival should be evaluated. G-CSF added to this regimen, however, should be used with great caution.
Publication types
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Clinical Trial
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Clinical Trial, Phase I
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Comparative Study
MeSH terms
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Adolescent
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Adult
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Bone Marrow / drug effects
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Bone Marrow Transplantation*
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Busulfan* / administration & dosage
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Busulfan* / adverse effects
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Busulfan* / pharmacology
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Cyclophosphamide* / administration & dosage
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Cyclophosphamide* / adverse effects
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Cyclophosphamide* / pharmacology
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Drug Administration Schedule
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Drug Synergism
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Etoposide* / administration & dosage
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Etoposide* / adverse effects
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Etoposide* / pharmacology
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Female
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Granulocyte Colony-Stimulating Factor / administration & dosage
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Granulocyte Colony-Stimulating Factor / pharmacology
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Granulocyte Colony-Stimulating Factor / therapeutic use*
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Hematopoiesis / drug effects
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Hepatic Veno-Occlusive Disease / chemically induced
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Humans
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Hyperbilirubinemia / chemically induced
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Immunologic Factors / administration & dosage
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Immunologic Factors / pharmacology
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Immunologic Factors / therapeutic use*
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Leukemia, Myeloid / pathology
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Leukemia, Myeloid / therapy
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Leukopenia / chemically induced
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Male
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Middle Aged
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Premedication*
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Salvage Therapy
Substances
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Immunologic Factors
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Granulocyte Colony-Stimulating Factor
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Etoposide
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Cyclophosphamide
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Busulfan