Journal
LEUKEMIA
Volume 16, Issue 9, Pages 1627-1636Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/sj.leu.2402677
Keywords
antibody-targeted chemotherapy; calicheamicin; CD33-positive acute myeloid leukemia; gemtuzumab ozogamicin; humanized anti-CD33 antibody; therapeutic trials
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We analyzed the safety and efficacy of Mylotarg (gemtuzumab ozogamicin, an anti body-targeted chemotherapy consisting of a humanized anti-CD33 antibody linked to calicheamicin, a potent antitumor antibiotic) in the treatment of 101 patients greater than or equal to60 years of age with acute myeloid leukemia (AML) in untreated first relapse in three open-label trials. Mylotarg is administered as a 2-h intravenous infusion at 9 mg/m(2) for two doses with 14 days between doses. The overall remission rate was 28%, with complete remission (CR) in 13% of patients and complete remission with incomplete platelet recovery (CRp) in 15%. Median survival was 5.4 months for all patients and 14.5 months and 11.8 months for patients achieving CR and CRp respectively. CD33 antigen is present on normal hematopoietic progenitor cells; thus, an expected high incidence of grade 3 or 4 neutropenia (99%) and thrombocytopenia (99%) was observed. The incidences of grade 3 or 4 elevations of bilirubin and hepatic transaminases were 24% and 15%, respectively. There was a low incidence of grade 3 or 4 mucositis (4%) and infections (27%) and no treatment-related cardlotoxicity, cerebellar toxicity, or alopecia. Mylotarg is an effective treatment for older patients with CD33-positive AML in first relapse and has acceptable toxicity.
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