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
<p>Abstract</p> <p>Background</p> <p>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 r...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2008-07-01
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| Series: | BMC Cancer |
| Online Access: | http://www.biomedcentral.com/1471-2407/8/195 |
| _version_ | 1811266243582230528 |
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| author | Noga Stephen J Thomas Xavier Lazzarino Mario Herrmann Richard Kassis Jeannine Szer Jeffrey Sierra Jorge Baker Nigel Dansey Roger Bosi Alberto |
| author_facet | Noga Stephen J Thomas Xavier Lazzarino Mario Herrmann Richard Kassis Jeannine Szer Jeffrey Sierra Jorge Baker Nigel Dansey Roger Bosi Alberto |
| author_sort | Noga Stephen J |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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 <it>de novo </it>AML in patients with low-to-intermediate risk cytogenetics.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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 <it>de novo </it>AML patients with low-to-intermediate risk cytogenetics.</p> <p>Trial registration</p> <p>Clinicaltrials.gov NCT00114764</p> |
| first_indexed | 2024-04-12T20:38:35Z |
| format | Article |
| id | doaj.art-b1b2acaecda740348d6a8576be1b91be |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-12T20:38:35Z |
| publishDate | 2008-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-b1b2acaecda740348d6a8576be1b91be2022-12-22T03:17:30ZengBMCBMC Cancer1471-24072008-07-018119510.1186/1471-2407-8-195A 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 trialNoga Stephen JThomas XavierLazzarino MarioHerrmann RichardKassis JeannineSzer JeffreySierra JorgeBaker NigelDansey RogerBosi Alberto<p>Abstract</p> <p>Background</p> <p>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 <it>de novo </it>AML in patients with low-to-intermediate risk cytogenetics.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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 <it>de novo </it>AML patients with low-to-intermediate risk cytogenetics.</p> <p>Trial registration</p> <p>Clinicaltrials.gov NCT00114764</p>http://www.biomedcentral.com/1471-2407/8/195 |
| spellingShingle | Noga Stephen J Thomas Xavier Lazzarino Mario Herrmann Richard Kassis Jeannine Szer Jeffrey Sierra Jorge Baker Nigel Dansey Roger Bosi Alberto 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 BMC Cancer |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://www.biomedcentral.com/1471-2407/8/195 |
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