Abstract
Objective:
To assess whether the addition of a brief course of intravenous corticosteroids reduces the incidence of infusion-related adverse events associated with gemtuzumab ozogamicin (GO) administration.
Methods:
One hundred forty-three sequential patients received GO-based therapy for refractory myeloid leukemias: 110 patients received the standard regimen of acetaminophen 650 mg orally with diphenhydramine 50 mg intravenously and 33 patients received the same premedications with methylprednisolone sodium succinate 50 mg intravenous piggyback (IVPB) prior to infusion and repeated 1 hour into the infusion.
Results:
Of 110 patients who received GO with standard premedications alone, 32 (29%) had grade 2 or above infusion-related adverse events. In 33 patients who received these premedications with methylprednisolone 50 mg IVPB prior to infusion and repeated 1 hour into the infusion, only 1 (3%) experienced any infusion-related adverse events (p = 0.0009, 95% CI 0.16 to 0.36). There was no significant difference between the patient cohorts in terms of hepatotoxicity, rate of development of hepatic venoocclusive disease, response rates, or infectious complications.
Conclusions:
A brief course of intravenous corticosteroids significantly reduces the incidence of GO infusion-related adverse events.
Publication types
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Clinical Trial
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Comparative Study
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Controlled Clinical Trial
MeSH terms
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Acetaminophen / adverse effects
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Acetaminophen / therapeutic use
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Adult
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Aminoglycosides*
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Analgesics, Non-Narcotic / adverse effects
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Analgesics, Non-Narcotic / therapeutic use
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Anti-Bacterial Agents / administration & dosage
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Anti-Bacterial Agents / adverse effects*
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Anti-Inflammatory Agents / administration & dosage
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Anti-Inflammatory Agents / therapeutic use*
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Antibodies, Monoclonal / administration & dosage
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Antibodies, Monoclonal / adverse effects*
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Antibodies, Monoclonal, Humanized
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Atrial Fibrillation / chemically induced
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Atrial Fibrillation / prevention & control
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Chills / chemically induced
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Chills / prevention & control
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Dyspnea / chemically induced
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Dyspnea / prevention & control
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Erythema / chemically induced
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Erythema / prevention & control
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Fever / chemically induced
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Fever / prevention & control
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Gemtuzumab
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Hepatic Veno-Occlusive Disease / chemically induced
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Hepatic Veno-Occlusive Disease / prevention & control
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Humans
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Hypertension / chemically induced
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Hypertension / prevention & control
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Hypotension / chemically induced
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Hypotension / prevention & control
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Immunotoxins / administration & dosage
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Immunotoxins / adverse effects*
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Infusions, Intravenous
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Leukemia, Myeloid, Acute / drug therapy*
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Methylprednisolone Hemisuccinate / administration & dosage
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Methylprednisolone Hemisuccinate / therapeutic use*
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Pain / chemically induced
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Pain / prevention & control
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Rhabdomyolysis / chemically induced
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Rhabdomyolysis / prevention & control
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Vomiting / chemically induced
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Vomiting / prevention & control
Substances
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Aminoglycosides
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Analgesics, Non-Narcotic
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Anti-Bacterial Agents
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Anti-Inflammatory Agents
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Antibodies, Monoclonal
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Antibodies, Monoclonal, Humanized
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Immunotoxins
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Acetaminophen
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Methylprednisolone Hemisuccinate
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Gemtuzumab