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Use of pegylated recombinant filgrastim (Pegfilgrastim) in patients with acute myeloid leukemia: pharmacokinetics and impact on leukocyte recovery

Leukemia volume 22, pages 1284–1285 (2008)Cite this article

Several clinical trials have proven the safety and feasibility of recombinant granulocyte colony-stimulating factor in the induction treatment of primary acute myeloid leukemia.1, 2, 3 An impact on overall survival has so far only been shown in relapsed disease where a significant reduction of neutropenia by granulocyte colony-stimulating factor support translated into improved survival due to reduction of the early-death rate.4 Pegfilgrastim is a pegylated formulation of filgrastim with a sustained effect due to a negligible renal elimination5 and a context-sensitive half-life due to a neutrophil-count-dependent clearance. To date, no data on pegfilgrastim in acute myeloid leukemia have been published.

We report on our experience with this novel compound focusing on its pharmacokinetics and pharmacodynamics after induction polychemotherapy. These analyses were performed in the context of a phase II study and were approved by the local ethics committee. Prior to initiation of study medication, all patients gave their written informed consent. Seven days after the end of induction chemotherapy comprising high-dose cytarabine and mitoxantron, 6 mg of pegfilgrastim (Neulasta) was administered subcutaneously in patients showing complete blast clearance in routine bone marrow aspiration. A second injection was scheduled for those patients remaining leukopenic (that is, leukocytes <1 G l–1) 10 days after the first injection. Blood samples were obtained before the first application and then daily until leukocyte recovery. Pegfilgrastim plasma levels were measured by commercial granulocyte colony-stimulating factor ELISA (R&D Systems, GmbH, Wiesbaden-Nordenstadt, Germany).

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  1. Department of Internal Medicine III, University Hospital Munich, Campus Grosshadern, Marchioninistr, Munich, Germany

    M Fiegl, W Hiddemann & J Braess

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  1. M Fiegl
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  2. W Hiddemann
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  3. J Braess
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for the AML Cooperative-Group

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Correspondence to J Braess.

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Fiegl, M., Hiddemann, W., Braess, J. et al. Use of pegylated recombinant filgrastim (Pegfilgrastim) in patients with acute myeloid leukemia: pharmacokinetics and impact on leukocyte recovery. Leukemia 22, 1284–1285 (2008). https://doi.org/10.1038/sj.leu.2405038

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