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ONCOLOGY

Intravenous Corticosteroids to Reduce Gemtuzumab Ozogamicin Infusion Reactions

Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX

Jorge E Cortes, MD

Associate Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center

Terri A Halliburton, BS

Pharmacy Practitioner, Department of Pharmacy, University of Texas MD Anderson Cancer Center

Susie J Mallard, BS

Pharmacy Practitioner, Department of Pharmacy, University of Texas MD Anderson Cancer Center

Elihu H Estey, MD

Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center

Tracey A Waddelow, BS PhD

Program Director, Department of Leukemia, University of Texas MD Anderson Cancer Center

JoAnn T Lim, PhD

Pharmacy Clinical Specialist, Department of Pharmacy, University of Texas MD Anderson Cancer Center

Reprints: Francis J Giles MD, Department of Leukemia, Box 428, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030-4009, FAX 713/794-4297, frankgiles{at}aol.com

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 infusionñrelated adverse events.

Key Words: gemtuzumab ozogamicin, hepatic venoocclusive disease, infusion-related adverse events, methylprednisolone

Published Online, July 17, 2003. www.theannals.com, DOI 10.1345/aph.1C511

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