Abstract
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▴ Gemtuzumab ozogamicin is a humanised monoclonal IgG4 antibody, linked to a cytotoxic calicheamicin derivative. It effects cell necrosis by specifically targeting the CD33 antigen which is expressed on the surface of leukaemic cell blasts in more than 90% of patients with acute myeloid leukaemia (AML), but is not present on normal stem cells.
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▴ Therapy with gemtuzumab ozogamicin (2 doses of 9 mg/m2) in 3 noncomparative studies produced complete remission in 16% of adult patients with AML in first relapse, and complete remission with incomplete platelet recovery in an additional 13% of patients. Rates of remission did not differ between those aged less than 60 years and older than 60 years.
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▴ Many patients were able to receive both doses of gemtuzumab ozogamicin therapy as outpatients. Survival duration was similar between those treated as outpatients and those requiring hospitalisation.
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▴ About one-third of 11 children and adolescents treated with 2 doses of 9 mg/m2 gemtuzumab ozogamicin in a phase I study showed >5% bone marrow blasts after completion of therapy.
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▴ The most commonly encountered adverse events in clinical trials with gemtuzumab ozogamicin were myelosuppression, increased levels of hepatic enzymes, infection, fever, bleeding, chills, nausea and vomiting and dyspnoea. No treatment-related renal failure or alopecia was reported.
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McGavin, J.K., Spencer, C.M. Gemtuzumab ozogamicin. Drugs 61, 1317–1322 (2001). https://doi.org/10.2165/00003495-200161090-00007
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DOI: https://doi.org/10.2165/00003495-200161090-00007