The Annals of pharmacotherapy · 2003
Intravenous corticosteroids to reduce gemtuzumab ozogamicin infusion reactions.
Клиническое исследованиеСравнительное исследованиеКонтролируемое клиническое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Giles Francis J, Cortes Jorge E, Halliburton Terri A, Mallard Susie J, Estey Elihu H, Waddelow Tracey A, Lim JoAnn T
Аннотация
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.
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.
Предметные рубрики MeSH
AcetaminophenAdultAminoglycosidesAnalgesics, Non-NarcoticAnti-Bacterial AgentsAnti-Inflammatory AgentsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAtrial FibrillationChillsDyspneaErythemaFeverGemtuzumabHepatic Veno-Occlusive DiseaseHumansHypertensionHypotensionImmunotoxinsInfusions, IntravenousLeukemia, Myeloid, AcuteMethylprednisolone HemisuccinatePainRhabdomyolysisVomiting