Abstract
BackgroundPatients 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.MethodsPatients (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.ResultsThe 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.ConclusionThese 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 registrationClinicaltrials.gov NCT00114764
Highlights
Patients with acute myeloid leukemia (AML) are often neutropenic as a result of their disease
Acute myeloid leukemia (AML) is characterized by rapid proliferation of immature clonal myeloid cells, which leads to failure of normal hematopoiesis
It was decided that the study would not be restarted, as the potential bias introduced by halting the study prematurely was felt to be outweighed by the bias that would have been associated with restarting a partially unblinded study
Summary
Patients with acute myeloid leukemia (AML) are often neutropenic as a result of their disease These patients typically experience profound neutropenia following induction and/or consolidation chemotherapy and this may result in serious, potentially lifethreatening, infection. Standard treatment for de novo AML consists of one or two cycles of intensive induction chemotherapy using cytarabine and anthracyclines with the aim of achieving complete remission. This is followed by one or more cycles of consolidation chemotherapy to maintain remission. The duration of severe neutropenia is clinically significant, as it is closely correlated with development of infectious complications and associated morbidities [6]
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