Journal
LEUKEMIA
Volume 21, Issue 1, Pages 66-71Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/sj.leu.2404434
Keywords
gemtuzumab ozogamicin; Mylotarg; acute myeloblastic leukemia; treatment of relapsed AML; multidrug resistance proteins
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Pivotal phase II studies in acute myeloblastic leukemia (AML) patients in first relapse have used gemtuzumab ozogamicin (GO) (Mylotarg) at a dose of 9mg/m(2) on days 1 and 14. These studies showed a 26% response rate (13% complete remission (CR) and 13% CRp (complete remission with incomplete platelet recovery)) but with high degree of hematological and liver toxicities. Based on in vitro studies showing a re-expression of CD33 antigenic sites on the cell surface of blasts cells after exposure to GO, we hypothesized that fractionated doses of GO may be efficient and better tolerated. Fifty-seven patients with AML in first relapse received GO at a dose of 3mg/m(2) on days 1, 4 and 7 for one course. Fifteen patients ( 26%) achieved CR and four (7%) CRp. Remission rate correlated strongly with P-glycoprotein and MRP1 activities. The median relapse-free survival was II months, similar for CR or CRp patients. Median duration of neutropenia < 500/mu l and thrombocytopenia < 50 000/mu l were, respectively, 23 and 21 days. No grade 3 or 4 liver toxicity was observed. No veno-occlusive disease occurred after GO or after hematopoietic stem cell transplantation given after GO in seven patients. Mylotarg administered in fractionated doses demonstrated an excellent efficacy/safety profile.
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