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Open Access 01-12-2008 | Research article

A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: results from a randomized, double-blind, phase 2 trial

Authors: Jorge Sierra, Jeffrey Szer, Jeannine Kassis, Richard Herrmann, Mario Lazzarino, Xavier Thomas, Stephen J Noga, Nigel Baker, Roger Dansey, Alberto Bosi

Published in: BMC Cancer | Issue 1/2008

Abstract

Background

Patients with acute myeloid leukemia (AML) are often neutropenic as a result of their disease. Furthermore, these patients typically experience profound neutropenia following induction and/or consolidation chemotherapy and this may result in serious, potentially life-threatening, infection. This randomized, double-blind, phase 2 clinical trial compared the efficacy and tolerability of pegfilgrastim with filgrastim for assisting neutrophil recovery following induction and consolidation chemotherapy for de novo AML in patients with low-to-intermediate risk cytogenetics.

Methods

Patients (n = 84) received one or two courses of standard induction chemotherapy (idarubicin + cytarabine), followed by one course of consolidation therapy (high-dose cytarabine) if complete remission was achieved. They were randomized to receive either single-dose pegfilgrastim 6 mg or daily filgrastim 5 μg/kg, beginning 24 hours after induction and consolidation chemotherapy.

Results

The median time to recovery from severe neutropenia was 22.0 days for both pegfilgrastim (n = 42) and filgrastim (n = 41) groups during Induction 1 (difference 0.0 days; 95% CI: -1.9 to 1.9). During Consolidation, recovery occurred after a median of 17.0 days for pegfilgrastim versus 16.5 days for filgrastim (difference 0.5 days; 95% CI: -1.1 to 2.1). Therapeutic pegfilgrastim serum concentrations were maintained throughout neutropenia. Pegfilgrastim was well tolerated, with an adverse event profile similar to that of filgrastim.

Conclusion

These data suggest no clinically meaningful difference between a single dose of pegfilgrastim and multiple daily doses of filgrastim for shortening the duration of severe neutropenia following chemotherapy in de novo AML patients with low-to-intermediate risk cytogenetics.

Trial registration

Clinicaltrials.gov NCT00114764

Available only for authorised users

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2407/8/195/prepub

Title: A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: results from a randomized, double-blind, phase 2 trial
Authors: Jorge Sierra
Jeffrey Szer
Jeannine Kassis
Richard Herrmann
Mario Lazzarino
Xavier Thomas
Stephen J Noga
Nigel Baker
Roger Dansey
Alberto Bosi
Publication date: 01-12-2008
Publisher: BioMed Central
Published in: BMC Cancer / Issue 1/2008
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/1471-2407-8-195

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