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A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-tointermediate risk acute myeloid leukemia : results from a randomized, double-blind, phase 2 tria
Sierra Gil, Jorge (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Szer, Jeffrey (Royal Melbourne Hospital (Melbourne, Austràlia))
Kassis, Jeannine (Hospital Maisonneuve-Rosemont (Montreal, Canadà))
Herrmann, Richard (Royal Perth Hospital (Perth, Austràlia))
Lazzarino, Mario (University of Pavia (Itàlia))
Thomas, Xavier (Edouard Herriot Hospital (Lyon, França))
Noga, Stephen J. (Alvin and Lois Lapidus Cancer Institute (Baltimore, Estats Units d'Amèrica))
Baker, Nigel (Biostatistics, Amgen Ltd. (Cambridge, Regne Unit))
Dansey, Roger (Clinical Development, Amgen Inc. (Thousand Oaks, Estats Units d'Amèrica))
Bosi, Alberto (University of Florence (Itàlia). Department of Critical Care)

Data: 2008
Resum: 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 μg/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.
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Llengua: Anglès.
Document: article ; publishedVersion
Publicat a: BMC Cancer, Vol. 8, N. 195 (July 2008) , p. 1-10, ISSN 1471-2407

DOI: 10.1186/1471-2407-8-195

10 p, 306.7 KB

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