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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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Related in: MedlinePlus

Relationship between days to pegfilgrastim concentration falling below 2 ng/mL and days to absolute neutrophil count > 0.5 × 109/L
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Figure 3: Relationship between days to pegfilgrastim concentration falling below 2 ng/mL and days to absolute neutrophil count > 0.5 × 109/L

Mentions: After a single dose in Induction 1, median pegfilgrastim serum concentrations reached a maximum (181 ng/mL) 72 hours postdose and remained above the clinically relevant threshold (2 ng/mL, derived from modeling) [21] throughout the prolonged duration of neutropenia (approximately 21 days). Pegfilgrastim concentrations declined on ANC recovery, consistent with a neutrophil-mediated clearance mechanism. A positive correlation (Spearman rank correlation = 0.485, P = 0.004) was observed between time to ANC recovery and time to pegfilgrastim concentration falling below 2 ng/mL (Figure 3).


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)

Relationship between days to pegfilgrastim concentration falling below 2 ng/mL and days to absolute neutrophil count > 0.5 × 109/L
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 3: Relationship between days to pegfilgrastim concentration falling below 2 ng/mL and days to absolute neutrophil count > 0.5 × 109/L
Mentions: After a single dose in Induction 1, median pegfilgrastim serum concentrations reached a maximum (181 ng/mL) 72 hours postdose and remained above the clinically relevant threshold (2 ng/mL, derived from modeling) [21] throughout the prolonged duration of neutropenia (approximately 21 days). Pegfilgrastim concentrations declined on ANC recovery, consistent with a neutrophil-mediated clearance mechanism. A positive correlation (Spearman rank correlation = 0.485, P = 0.004) was observed between time to ANC recovery and time to pegfilgrastim concentration falling below 2 ng/mL (Figure 3).

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