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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.

Sierra J, Szer J, Kassis J, Herrmann R, Lazzarino M, Thomas X, Noga SJ, Baker N, Dansey R, Bosi A - BMC Cancer (2008)

Bottom Line: Patients with acute myeloid leukemia (AML) are often neutropenic as a result of their disease.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).Pegfilgrastim was well tolerated, with an adverse event profile similar to that of filgrastim.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Clinical Hematology, Hospital de Santa Creu i Sant Pau, Barcelona, Spain. jsierra@santpau.es

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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Kaplan-Meier estimates of time to recovery from severe neutropenia in Induction 1.
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Figure 1: Kaplan-Meier estimates of time to recovery from severe neutropenia in Induction 1.

Mentions: All patients had severe neutropenia in Induction 1, and ANC recovered in most patients (Table 2). For both treatment groups, the estimated median time to ANC recovery was 22.0 days (difference between groups 0.0; 95% CI: -1.9 to 1.9 days) (Figure 1). Results were also similar when analyzed by age (<55 or ≥ 55 years) and cytogenetic type (intermediate or favorable), with median time to ANC recovery ranging from 22.0 to 24.0 days across subgroups and treatments (data not shown).


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.

Sierra J, Szer J, Kassis J, Herrmann R, Lazzarino M, Thomas X, Noga SJ, Baker N, Dansey R, Bosi A - BMC Cancer (2008)

Kaplan-Meier estimates of time to recovery from severe neutropenia in Induction 1.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2483721&req=5

Figure 1: Kaplan-Meier estimates of time to recovery from severe neutropenia in Induction 1.
Mentions: All patients had severe neutropenia in Induction 1, and ANC recovered in most patients (Table 2). For both treatment groups, the estimated median time to ANC recovery was 22.0 days (difference between groups 0.0; 95% CI: -1.9 to 1.9 days) (Figure 1). Results were also similar when analyzed by age (<55 or ≥ 55 years) and cytogenetic type (intermediate or favorable), with median time to ANC recovery ranging from 22.0 to 24.0 days across subgroups and treatments (data not shown).

Bottom Line: Patients with acute myeloid leukemia (AML) are often neutropenic as a result of their disease.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).Pegfilgrastim was well tolerated, with an adverse event profile similar to that of filgrastim.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Clinical Hematology, Hospital de Santa Creu i Sant Pau, Barcelona, Spain. jsierra@santpau.es

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.

Show MeSH
Related in: MedlinePlus