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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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Proportion of patients in complete remission overall and by subgroup.
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Figure 4: Proportion of patients in complete remission overall and by subgroup.

Mentions: At the end of Induction 1, 33 pegfilgrastim (79%) versus 26 filgrastim recipients (63%) achieved complete remission. Two additional filgrastim recipients achieved complete remission after Induction 2, resulting in overall complete remission rates of 79% (33/42) in the pegfilgrastim group versus 68% (28/41) in the filgrastim group. No difference in complete remission was observed between treatment groups, overall (95% CI for difference in proportions: -9% to 29%), or when analyzed by cytogenetic type or age group (Figure 4). When rates for patients with FAB subtype M4 (the subgroup with the largest difference between treatment groups) were compared with those having other FAB subtypes, the complete remission rate was higher within the M4 subtype for pegfilgrastim patients, however due to the width of the CIs, no clear differences emerged ("M4:" pegfilgrastim 14/15 (93%) vs filgrastim 5/7 (71%); "Not M4:" pegfilgrastim 18/27 (67%) vs filgrastim 23/34 (68%)).


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)

Proportion of patients in complete remission overall and by subgroup.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 4: Proportion of patients in complete remission overall and by subgroup.
Mentions: At the end of Induction 1, 33 pegfilgrastim (79%) versus 26 filgrastim recipients (63%) achieved complete remission. Two additional filgrastim recipients achieved complete remission after Induction 2, resulting in overall complete remission rates of 79% (33/42) in the pegfilgrastim group versus 68% (28/41) in the filgrastim group. No difference in complete remission was observed between treatment groups, overall (95% CI for difference in proportions: -9% to 29%), or when analyzed by cytogenetic type or age group (Figure 4). When rates for patients with FAB subtype M4 (the subgroup with the largest difference between treatment groups) were compared with those having other FAB subtypes, the complete remission rate was higher within the M4 subtype for pegfilgrastim patients, however due to the width of the CIs, no clear differences emerged ("M4:" pegfilgrastim 14/15 (93%) vs filgrastim 5/7 (71%); "Not M4:" pegfilgrastim 18/27 (67%) vs filgrastim 23/34 (68%)).

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