High efficacy and safety profile of fractionated doses of Mylotarg as induction therapy in patients with relapsed acute myeloblastic leukemia: ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2006-10-19

AUTHORS

A-L Taksin, O Legrand, E Raffoux, T de Revel, X Thomas, N Contentin, R Bouabdallah, C Pautas, P Turlure, O Reman, C Gardin, B Varet, S de Botton, F Pousset, H Farhat, S Chevret, H Dombret, S Castaigne

ABSTRACT

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. 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/μl and thrombocytopenia <50 000/μl 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. More... »

PAGES

66-71

Journal

TITLE

Leukemia

ISSUE

1

VOLUME

21

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/sj.leu.2404434

DOI

http://dx.doi.org/10.1038/sj.leu.2404434

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1008085123

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/17051246


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