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Clinical Trial
. 2008 Jul 10:8:195.
doi: 10.1186/1471-2407-8-195.

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

Jorge Sierra  1 , Jeffrey Szer, Jeannine Kassis, Richard Herrmann, Mario Lazzarino, Xavier Thomas, Stephen J Noga, Nigel Baker, Roger Dansey, Alberto Bosi
Affiliations
Clinical Trial

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

Jorge Sierra et al. BMC Cancer. .

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 mug/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.

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Figures

Figure 1
Figure 1
Kaplan-Meier estimates of time to recovery from severe neutropenia in Induction 1.
Figure 2
Figure 2
Median absolute neutrophil count for pegfilgrastim and filgrastim recipients in Induction 1.
Figure 3
Figure 3
Relationship between days to pegfilgrastim concentration falling below 2 ng/mL and days to absolute neutrophil count > 0.5 × 109/L
Figure 4
Figure 4
Proportion of patients in complete remission overall and by subgroup.
See this image and copyright information in PMC

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