dc.contributor.author |
Sierra Gil, Jorge |
dc.contributor.author |
Szer, Jeffrey |
dc.contributor.author |
Kassis, Jeannine |
dc.contributor.author |
Herrmann, Richard |
dc.contributor.author |
Lazzarino, Mario |
dc.contributor.author |
Thomas, Xavier |
dc.contributor.author |
Noga, Stephen J. |
dc.contributor.author |
Baker, Nigel |
dc.contributor.author |
Dansey, Roger |
dc.contributor.author |
Bosi, Alberto |
dc.contributor.author |
Universitat Autònoma de Barcelona |
dc.date |
2008 |
dc.identifier |
https://ddd.uab.cat/record/112411 |
dc.identifier |
urn:10.1186/1471-2407-8-195 |
dc.identifier |
urn:oai:ddd.uab.cat:112411 |
dc.identifier |
urn:pmid:18616811 |
dc.identifier |
urn:recercauab:ARE-70423 |
dc.identifier |
urn:scopus_id:48449100628 |
dc.identifier |
urn:wos_id:000258101100001 |
dc.identifier |
urn:altmetric_id:7645806 |
dc.identifier |
urn:oai:egreta.uab.cat:publications/871f0467-fb43-4606-8e08-ae85ab26cde5 |
dc.identifier |
urn:pmc-uid:2483721 |
dc.identifier |
urn:pmcid:PMC2483721 |
dc.identifier |
urn:oai:pubmedcentral.nih.gov:2483721 |
dc.identifier |
urn:wos_id:000438796500010 |
dc.format |
application/pdf |
dc.language |
eng |
dc.publisher |
|
dc.relation |
BMC Cancer ; Vol. 8, N. 195 (July 2008), p. 1-10 |
dc.rights |
open access |
dc.rights |
Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. |
dc.rights |
https://creativecommons.org/licenses/by/2.0/ |
dc.title |
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 |
dc.type |
Article |
dc.description.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 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. |