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
Identifieur interne : 008632 ( Main/Exploration ); précédent : 008631; suivant : 008633A 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
Auteurs : Jorge Sierra [Espagne] ; Jeffrey Szer [Australie] ; Jeannine Kassis [Canada] ; Richard Herrmann [Australie] ; Mario Lazzarino [Italie] ; Xavier Thomas [France] ; Stephen J. Noga [États-Unis] ; Nigel Baker [Royaume-Uni] ; Roger Dansey [États-Unis] ; Alberto Bosi [Italie]Source :
- BMC Cancer [ 1471-2407 ] ; 2008.
Abstract
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
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.
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.
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
Clinicaltrials.gov NCT00114764
Url:
DOI: 10.1186/1471-2407-8-195
PubMed: 18616811
PubMed Central: 2483721
Affiliations:
- Australie, Canada, Espagne, France, Italie, Royaume-Uni, États-Unis
- Auvergne-Rhône-Alpes, Californie, Catalogne, Maryland, Québec, Rhône-Alpes, Victoria (État)
- Baltimore, Barcelone, Lyon, Melbourne, Montréal
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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><author><name sortKey="Sierra, Jorge" sort="Sierra, Jorge" uniqKey="Sierra J" first="Jorge" last="Sierra">Jorge Sierra</name><affiliation wicri:level="3"><nlm:aff id="I1">Division of Clinical Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Division of Clinical Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Szer, Jeffrey" sort="Szer, Jeffrey" uniqKey="Szer J" first="Jeffrey" last="Szer">Jeffrey Szer</name><affiliation wicri:level="3"><nlm:aff id="I2">Department of Clinical Hematology, Royal Melbourne Hospital, Melbourne, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Clinical Hematology, Royal Melbourne Hospital, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Kassis, Jeannine" sort="Kassis, Jeannine" uniqKey="Kassis J" first="Jeannine" last="Kassis">Jeannine Kassis</name><affiliation wicri:level="3"><nlm:aff id="I3">Department of Hematology, Hospital Maisonneuve-Rosemont, Montreal, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Hematology, Hospital Maisonneuve-Rosemont, Montreal</wicri:regionArea><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Herrmann, Richard" sort="Herrmann, Richard" uniqKey="Herrmann R" first="Richard" last="Herrmann">Richard Herrmann</name><affiliation wicri:level="1"><nlm:aff id="I4">Department of Hematology, Royal Perth Hospital, Perth, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Hematology, Royal Perth Hospital, Perth</wicri:regionArea><wicri:noRegion>Perth</wicri:noRegion></affiliation></author><author><name sortKey="Lazzarino, Mario" sort="Lazzarino, Mario" uniqKey="Lazzarino M" first="Mario" last="Lazzarino">Mario Lazzarino</name><affiliation wicri:level="1"><nlm:aff id="I5">Division of Hematology, IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Division of Hematology, IRCCS Policlinico San Matteo and University of Pavia, Pavia</wicri:regionArea><wicri:noRegion>Pavia</wicri:noRegion></affiliation></author><author><name sortKey="Thomas, Xavier" sort="Thomas, Xavier" uniqKey="Thomas X" first="Xavier" last="Thomas">Xavier Thomas</name><affiliation wicri:level="3"><nlm:aff id="I6">Hematology Service, Edouard Herriot Hospital, Lyon, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hematology Service, Edouard Herriot Hospital, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Noga, Stephen J" sort="Noga, Stephen J" uniqKey="Noga S" first="Stephen J" last="Noga">Stephen J. Noga</name><affiliation wicri:level="3"><nlm:aff id="I7">Department of Medical Oncology/Hematology, Alvin and Lois Lapidus Cancer Institute, Baltimore, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medical Oncology/Hematology, Alvin and Lois Lapidus Cancer Institute, Baltimore</wicri:regionArea><placeName><settlement type="city">Baltimore</settlement><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Baker, Nigel" sort="Baker, Nigel" uniqKey="Baker N" first="Nigel" last="Baker">Nigel Baker</name><affiliation wicri:level="1"><nlm:aff id="I8">Biostatistics, Amgen Ltd, Cambridge, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Biostatistics, Amgen Ltd, Cambridge</wicri:regionArea><wicri:noRegion>Cambridge</wicri:noRegion></affiliation></author><author><name sortKey="Dansey, Roger" sort="Dansey, Roger" uniqKey="Dansey R" first="Roger" last="Dansey">Roger Dansey</name><affiliation wicri:level="2"><nlm:aff id="I9">Clinical Development, Amgen Inc., Thousand Oaks, CA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Clinical Development, Amgen Inc., Thousand Oaks, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Bosi, Alberto" sort="Bosi, Alberto" uniqKey="Bosi A" first="Alberto" last="Bosi">Alberto Bosi</name><affiliation wicri:level="1"><nlm:aff id="I10">Hematology Unit, Department of Critical Care, University of Florence, Florence, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Hematology Unit, Department of Critical Care, University of Florence, Florence</wicri:regionArea><wicri:noRegion>Florence</wicri:noRegion></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><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 <italic>de novo </italic>AML in patients with low-to-intermediate risk cytogenetics.</p></sec><sec sec-type="methods"><title>Methods</title><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></sec><sec><title>Results</title><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></sec><sec><title>Conclusion</title><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 <italic>de novo </italic>AML patients with low-to-intermediate risk cytogenetics.</p></sec><sec><title>Trial registration</title><p>Clinicaltrials.gov NCT00114764</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>Espagne</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Californie</li><li>Catalogne</li><li>Maryland</li><li>Québec</li><li>Rhône-Alpes</li><li>Victoria (État)</li></region><settlement><li>Baltimore</li><li>Barcelone</li><li>Lyon</li><li>Melbourne</li><li>Montréal</li></settlement></list><tree><country name="Espagne"><region name="Catalogne"><name sortKey="Sierra, Jorge" sort="Sierra, Jorge" uniqKey="Sierra J" first="Jorge" last="Sierra">Jorge Sierra</name></region></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Szer, Jeffrey" sort="Szer, Jeffrey" uniqKey="Szer J" first="Jeffrey" last="Szer">Jeffrey Szer</name></region><name sortKey="Herrmann, Richard" sort="Herrmann, Richard" uniqKey="Herrmann R" first="Richard" last="Herrmann">Richard Herrmann</name></country><country name="Canada"><region name="Québec"><name sortKey="Kassis, Jeannine" sort="Kassis, Jeannine" uniqKey="Kassis J" first="Jeannine" last="Kassis">Jeannine Kassis</name></region></country><country name="Italie"><noRegion><name sortKey="Lazzarino, Mario" sort="Lazzarino, Mario" uniqKey="Lazzarino M" first="Mario" last="Lazzarino">Mario Lazzarino</name></noRegion><name sortKey="Bosi, Alberto" sort="Bosi, Alberto" uniqKey="Bosi A" first="Alberto" last="Bosi">Alberto Bosi</name></country><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Thomas, Xavier" sort="Thomas, Xavier" uniqKey="Thomas X" first="Xavier" last="Thomas">Xavier Thomas</name></region></country><country name="États-Unis"><region name="Maryland"><name sortKey="Noga, Stephen J" sort="Noga, Stephen J" uniqKey="Noga S" first="Stephen J" last="Noga">Stephen J. Noga</name></region><name sortKey="Dansey, Roger" sort="Dansey, Roger" uniqKey="Dansey R" first="Roger" last="Dansey">Roger Dansey</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Baker, Nigel" sort="Baker, Nigel" uniqKey="Baker N" first="Nigel" last="Baker">Nigel Baker</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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