Scientists at University of Versailles Saint-Quentin-en-Yvelines target acute myeloblastic leukemia therapy

03-02-2007

A new study, "High efficacy and safety profile of fractionated doses of Mylotarg as induction therapy in patients with relapsed acute myeloblastic leukemia: a prospective study of the alfa group," is now available. "Pivotal phase II studies in acute myeloblastic leukemia (AML) patients in first relapse have used gemtuzumab ozogamicin (GO) (Mylotarg) at a dose of 9 mg/m2 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," scientists writing in the journal Leukemia report.

"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 3 mg/m2 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 11 months, similar for CR or CRp patients. Median duration of neutropenia <500/microl and thrombocytopenia <50,000/microl 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," wrote A.L. Taksin and colleagues, University of Versailles Saint-Quentin-en-Yvelines.

The researchers concluded: "Mylotarg administered in fractionated doses demonstrated an excellent efficacy/safety profile."

Taksin and colleagues published their study in Leukemia (High efficacy and safety profile of fractionated doses of Mylotarg as induction therapy in patients with relapsed acute myeloblastic leukemia: a prospective study of the alfa group. Leukemia, 2007;21(1):66-71).

Additional information can be obtained by contacting A.L. Taksin, Universite de Versailles-Saint Quentin en Yvelines, Departement d'Hematologie et Oncologie, Hopital Mignot, Versailles, France.

The publisher of the journal Leukemia can be contacted at: Nature Publishing Group, Macmillan Building, 4 Crinan St., London N1 9XW, England.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.