A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy
Identifieur interne : 001B69 ( Istex/Corpus ); précédent : 001B68; suivant : 001B70A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy
Auteurs : M. D. Green ; H. Koelbl ; J. Baselga ; A. Galid ; V. Guillem ; P. Gascon ; S. Siena ; R. I. Lalisang ; H. Samonigg ; M. R. Clemens ; V. Zani ; B. C. Liang ; J. Renwick ; M. J. PiccartSource :
- Annals of Oncology [ 0923-7534 ] ; 2003-01.
English descriptors
- KwdEn :
Abstract
Background: We evaluated the efficacy of a single fixed 6 mg dose of pegfilgrastim (a pegylated version of filgrastim) per cycle of chemotherapy, compared with daily administration of filgrastim, in the provision of neutrophil support. Patients and methods: Patients (n = 157) were randomized to receive either a single 6 mg subcutaneous (s.c.) injection of pegfilgrastim or daily 5 mg/kg s.c. injections of filgrastim, after doxorubicin and docetaxel chemotherapy (60 mg/m2 and 75 mg/m2, respectively). Duration of grade 4 neutropenia, depth of neutrophil nadir, incidence of febrile neutropenia, time to neutrophil recovery and safety information were recorded. Results: A single 6 mg injection of pegfilgrastim was as effective as daily injections of filgrastim for all efficacy measures for all cycles. The mean duration of grade 4 neutropenia in cycle 1 was 1.8 and 1.6 days for the pegfilgrastim and filgrastim groups, respectively. Results for all efficacy end points in cycles 2–4 were consistent with the results from cycle 1. A trend towards a lower incidence of febrile neutropenia was noted across all cycles with pegfilgrastim compared with filgrastim (13% versus 20%, respectively). A single fixed dose of pegfilgrastim was as safe and well tolerated as standard daily filgrastim. Conclusions: A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy was comparable to multiple daily injections of filgrastim in safely providing neutrophil support during myelosuppressive chemotherapy. Pegfilgrastim may have utility in other clinical settings of neutropenia.
Url:
DOI: 10.1093/annonc/mdg019
Links to Exploration step
ISTEX:D2832EDCEECA5DCA87D30B88EE6391EE180BAB5BLe document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy</title><author><name sortKey="Green, M D" sort="Green, M D" uniqKey="Green M" first="M. D." last="Green">M. D. Green</name><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Koelbl, H" sort="Koelbl, H" uniqKey="Koelbl H" first="H." last="Koelbl">H. Koelbl</name><affiliation><mods:affiliation>Martin Luther University, Halle-Wittenberg, Germany;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Baselga, J" sort="Baselga, J" uniqKey="Baselga J" first="J." last="Baselga">J. Baselga</name><affiliation><mods:affiliation>Hospital Vall d’Hebron, Barcelona, Spain;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Galid, A" sort="Galid, A" uniqKey="Galid A" first="A." last="Galid">A. Galid</name><affiliation><mods:affiliation>Universitaetsklinik fuer Frauenheilkunde, Vienna, Austria;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Guillem, V" sort="Guillem, V" uniqKey="Guillem V" first="V." last="Guillem">V. Guillem</name><affiliation><mods:affiliation>Instituto Valenciano de Oncologia, Valencia, Spain;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Gascon, P" sort="Gascon, P" uniqKey="Gascon P" first="P." last="Gascon">P. Gascon</name><affiliation><mods:affiliation>Hospital Clinic, Barcelona, Spain;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Siena, S" sort="Siena, S" uniqKey="Siena S" first="S." last="Siena">S. Siena</name><affiliation><mods:affiliation>Ospedale Niguarda Ca’ Granda, Milan, Italy;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Lalisang, R I" sort="Lalisang, R I" uniqKey="Lalisang R" first="R. I." last="Lalisang">R. I. Lalisang</name><affiliation><mods:affiliation>Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Samonigg, H" sort="Samonigg, H" uniqKey="Samonigg H" first="H." last="Samonigg">H. Samonigg</name><affiliation><mods:affiliation>Medizinische Universitaetsklinik, Graz, Austria;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Clemens, M R" sort="Clemens, M R" uniqKey="Clemens M" first="M. R." last="Clemens">M. R. Clemens</name><affiliation><mods:affiliation>Krankenanstalt Mutterhaus der Borromaerinnen, Trier, Germany;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Zani, V" sort="Zani, V" uniqKey="Zani V" first="V." last="Zani">V. Zani</name><affiliation><mods:affiliation>Amgen Inc, Thousand Oaks, CA, USA;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Liang, B C" sort="Liang, B C" uniqKey="Liang B" first="B. C." last="Liang">B. C. Liang</name><affiliation><mods:affiliation>Amgen Inc, Thousand Oaks, CA, USA;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Renwick, J" sort="Renwick, J" uniqKey="Renwick J" first="J." last="Renwick">J. Renwick</name><affiliation><mods:affiliation>Amgen Inc, Thousand Oaks, CA, USA;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Piccart, M J" sort="Piccart, M J" uniqKey="Piccart M" first="M. J." last="Piccart">M. J. Piccart</name><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B</idno><date when="2003" year="2003">2003</date><idno type="doi">10.1093/annonc/mdg019</idno><idno type="url">https://api.istex.fr/document/D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001B69</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001B69</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy</title><author><name sortKey="Green, M D" sort="Green, M D" uniqKey="Green M" first="M. D." last="Green">M. D. Green</name><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Koelbl, H" sort="Koelbl, H" uniqKey="Koelbl H" first="H." last="Koelbl">H. Koelbl</name><affiliation><mods:affiliation>Martin Luther University, Halle-Wittenberg, Germany;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Baselga, J" sort="Baselga, J" uniqKey="Baselga J" first="J." last="Baselga">J. Baselga</name><affiliation><mods:affiliation>Hospital Vall d’Hebron, Barcelona, Spain;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Galid, A" sort="Galid, A" uniqKey="Galid A" first="A." last="Galid">A. Galid</name><affiliation><mods:affiliation>Universitaetsklinik fuer Frauenheilkunde, Vienna, Austria;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Guillem, V" sort="Guillem, V" uniqKey="Guillem V" first="V." last="Guillem">V. Guillem</name><affiliation><mods:affiliation>Instituto Valenciano de Oncologia, Valencia, Spain;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Gascon, P" sort="Gascon, P" uniqKey="Gascon P" first="P." last="Gascon">P. Gascon</name><affiliation><mods:affiliation>Hospital Clinic, Barcelona, Spain;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Siena, S" sort="Siena, S" uniqKey="Siena S" first="S." last="Siena">S. Siena</name><affiliation><mods:affiliation>Ospedale Niguarda Ca’ Granda, Milan, Italy;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Lalisang, R I" sort="Lalisang, R I" uniqKey="Lalisang R" first="R. I." last="Lalisang">R. I. Lalisang</name><affiliation><mods:affiliation>Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Samonigg, H" sort="Samonigg, H" uniqKey="Samonigg H" first="H." last="Samonigg">H. Samonigg</name><affiliation><mods:affiliation>Medizinische Universitaetsklinik, Graz, Austria;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Clemens, M R" sort="Clemens, M R" uniqKey="Clemens M" first="M. R." last="Clemens">M. R. Clemens</name><affiliation><mods:affiliation>Krankenanstalt Mutterhaus der Borromaerinnen, Trier, Germany;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Zani, V" sort="Zani, V" uniqKey="Zani V" first="V." last="Zani">V. Zani</name><affiliation><mods:affiliation>Amgen Inc, Thousand Oaks, CA, USA;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Liang, B C" sort="Liang, B C" uniqKey="Liang B" first="B. C." last="Liang">B. C. Liang</name><affiliation><mods:affiliation>Amgen Inc, Thousand Oaks, CA, USA;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Renwick, J" sort="Renwick, J" uniqKey="Renwick J" first="J." last="Renwick">J. Renwick</name><affiliation><mods:affiliation>Amgen Inc, Thousand Oaks, CA, USA;</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author><author><name sortKey="Piccart, M J" sort="Piccart, M J" uniqKey="Piccart M" first="M. J." last="Piccart">M. J. Piccart</name><affiliation><mods:affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of Oncology</title><title level="j" type="abbrev">Ann Oncol</title><idno type="ISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2003-01">2003-01</date><biblScope unit="volume">14</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="29">29</biblScope><biblScope unit="page" to="35">35</biblScope></imprint><idno type="ISSN">0923-7534</idno></series><idno type="istex">D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B</idno><idno type="DOI">10.1093/annonc/mdg019</idno><idno type="local">mdg019</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Key words: breast cancer, clinical trial, hemopoietic growth factor, multicenter study, neutropenia</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: We evaluated the efficacy of a single fixed 6 mg dose of pegfilgrastim (a pegylated version of filgrastim) per cycle of chemotherapy, compared with daily administration of filgrastim, in the provision of neutrophil support. Patients and methods: Patients (n = 157) were randomized to receive either a single 6 mg subcutaneous (s.c.) injection of pegfilgrastim or daily 5 mg/kg s.c. injections of filgrastim, after doxorubicin and docetaxel chemotherapy (60 mg/m2 and 75 mg/m2, respectively). Duration of grade 4 neutropenia, depth of neutrophil nadir, incidence of febrile neutropenia, time to neutrophil recovery and safety information were recorded. Results: A single 6 mg injection of pegfilgrastim was as effective as daily injections of filgrastim for all efficacy measures for all cycles. The mean duration of grade 4 neutropenia in cycle 1 was 1.8 and 1.6 days for the pegfilgrastim and filgrastim groups, respectively. Results for all efficacy end points in cycles 2–4 were consistent with the results from cycle 1. A trend towards a lower incidence of febrile neutropenia was noted across all cycles with pegfilgrastim compared with filgrastim (13% versus 20%, respectively). A single fixed dose of pegfilgrastim was as safe and well tolerated as standard daily filgrastim. Conclusions: A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy was comparable to multiple daily injections of filgrastim in safely providing neutrophil support during myelosuppressive chemotherapy. Pegfilgrastim may have utility in other clinical settings of neutropenia.</div></front></TEI><istex><corpusName>oup</corpusName><author><json:item><name>M. D. Green</name><affiliations><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>H. Koelbl</name><affiliations><json:string>Martin Luther University, Halle-Wittenberg, Germany;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>J. Baselga</name><affiliations><json:string>Hospital Vall d’Hebron, Barcelona, Spain;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>A. Galid</name><affiliations><json:string>Universitaetsklinik fuer Frauenheilkunde, Vienna, Austria;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>V. Guillem</name><affiliations><json:string>Instituto Valenciano de Oncologia, Valencia, Spain;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>P. Gascon</name><affiliations><json:string>Hospital Clinic, Barcelona, Spain;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>S. Siena</name><affiliations><json:string>Ospedale Niguarda Ca’ Granda, Milan, Italy;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>R. I. Lalisang</name><affiliations><json:string>Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>H. Samonigg</name><affiliations><json:string>Medizinische Universitaetsklinik, Graz, Austria;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>M. R. Clemens</name><affiliations><json:string>Krankenanstalt Mutterhaus der Borromaerinnen, Trier, Germany;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>V. Zani</name><affiliations><json:string>Amgen Inc, Thousand Oaks, CA, USA;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>B. C. Liang</name><affiliations><json:string>Amgen Inc, Thousand Oaks, CA, USA;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>J. Renwick</name><affiliations><json:string>Amgen Inc, Thousand Oaks, CA, USA;</json:string><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item><json:item><name>M. J. Piccart</name><affiliations><json:string>Royal Melbourne and Western Hospitals, Melbourne, Australia;</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Key words: breast cancer, clinical trial, hemopoietic growth factor, multicenter study, neutropenia</value></json:item></subject><language><json:string>eng</json:string></language><originalGenre><json:string>other</json:string></originalGenre><abstract>Background: We evaluated the efficacy of a single fixed 6 mg dose of pegfilgrastim (a pegylated version of filgrastim) per cycle of chemotherapy, compared with daily administration of filgrastim, in the provision of neutrophil support. Patients and methods: Patients (n = 157) were randomized to receive either a single 6 mg subcutaneous (s.c.) injection of pegfilgrastim or daily 5 mg/kg s.c. injections of filgrastim, after doxorubicin and docetaxel chemotherapy (60 mg/m2 and 75 mg/m2, respectively). Duration of grade 4 neutropenia, depth of neutrophil nadir, incidence of febrile neutropenia, time to neutrophil recovery and safety information were recorded. Results: A single 6 mg injection of pegfilgrastim was as effective as daily injections of filgrastim for all efficacy measures for all cycles. The mean duration of grade 4 neutropenia in cycle 1 was 1.8 and 1.6 days for the pegfilgrastim and filgrastim groups, respectively. Results for all efficacy end points in cycles 2–4 were consistent with the results from cycle 1. A trend towards a lower incidence of febrile neutropenia was noted across all cycles with pegfilgrastim compared with filgrastim (13% versus 20%, respectively). A single fixed dose of pegfilgrastim was as safe and well tolerated as standard daily filgrastim. Conclusions: A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy was comparable to multiple daily injections of filgrastim in safely providing neutrophil support during myelosuppressive chemotherapy. Pegfilgrastim may have utility in other clinical settings of neutropenia.</abstract><qualityIndicators><score>8.972</score><pdfVersion>1.2</pdfVersion><pdfPageSize>612 x 792 pts (letter)</pdfPageSize><refBibsNative>false</refBibsNative><keywordCount>1</keywordCount><abstractCharCount>1597</abstractCharCount><pdfWordCount>4128</pdfWordCount><pdfCharCount>26241</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>237</abstractWordCount></qualityIndicators><title>A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy</title><refBibs><json:item><author><json:item><name>S Bashir</name></json:item><json:item><name>L,R Hill</name></json:item><json:item><name>J,M A Inc</name></json:item><json:item><name>Thousand Oaks</name></json:item><json:item><name>Ca </name></json:item><json:item><name>Usa,G Cocconi</name></json:item><json:item><name>Azienda Ospedaliera Di Parma</name></json:item><json:item><name> Parma</name></json:item><json:item><name>;,V Italy</name></json:item><json:item><name>Universitair Cocquyt</name></json:item><json:item><name> Ziekenhuis</name></json:item><json:item><name> Gent</name></json:item><json:item><name>;,R E Belgium</name></json:item><json:item><name>M,J Coleman</name></json:item><json:item><name>G,E Lind</name></json:item><json:item><name> Richardson</name></json:item></author><host><author></author><title>Additional members of the Pegfilgrastim 749 Study Group: S. P. Ackland, Newcastle Mater Misericordiae Hospital</title></host><title>Breddy assisted with the statistical analysis; and Foote with the writing of this manuscript. Financial support: this study was sponsored by Waratah, Australia; R. Andreesen, Universitaetsklinik Regensburg, Regensburg, Germany; J. Bashford, Wesley Medical Centre, Auchenflower, Australia; S. Cascinu, Azienda Ospedaliera di Parma</title></json:item><json:item><author><json:item><name>Gp Bodey</name></json:item><json:item><name>M Buckley</name></json:item><json:item><name>Ys Sathe</name></json:item></author><host><volume>64</volume><pages><last>340</last><first>328</first></pages><author></author><title>Ann Intern Med</title><publicationDate>1966</publicationDate></host><title>Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia</title><publicationDate>1966</publicationDate></json:item><json:item><author><json:item><name>Jl Gabrilove</name></json:item><json:item><name>A Jakubowski</name></json:item><json:item><name>H Scher</name></json:item></author><host><volume>318</volume><pages><last>1422</last><first>1414</first></pages><author></author><title>N Engl J Med</title><publicationDate>1988</publicationDate></host><title>The effect of granulocyte colony-stimulating factor on neutropenia and associated morbidity due to chemotherapy for transitional-cell carcinoma of the urothelium</title><publicationDate>1988</publicationDate></json:item><json:item><author><json:item><name>G Morstyn</name></json:item><json:item><name>L Campbell</name></json:item><json:item><name>Lm Souza</name></json:item></author><host><volume>1</volume><pages><last>672</last><first>667</first></pages><author></author><title>Lancet</title><publicationDate>1988</publicationDate></host><title>Effects of granulocyte colony stimulating factor on neutropenia induced by cytotoxic chemotherapy</title><publicationDate>1988</publicationDate></json:item><json:item><author><json:item><name>J Crawford</name></json:item><json:item><name>H Ozer</name></json:item><json:item><name>R Stoller</name></json:item></author><host><volume>325</volume><pages><last>170</last><first>164</first></pages><author></author><title>N Engl J Med</title><publicationDate>1991</publicationDate></host><title>Reduction by granulocyte colonystimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer</title><publicationDate>1991</publicationDate></json:item><json:item><author><json:item><name>V Trillet-Lenoir</name></json:item><json:item><name>J Green</name></json:item><json:item><name>C Manegold</name></json:item></author><host><volume>29</volume><pages><last>324</last><first>319</first></pages><author></author><title>Eur J Cancer</title><publicationDate>1993</publicationDate></host><title>Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy</title><publicationDate>1993</publicationDate></json:item><json:item><host><pages><last>116</last><first>103</first></pages><author><json:item><name>S Blackwell</name></json:item><json:item><name>J Crawford</name></json:item></author><title>Filgrastim (r-metHuG-CSF) in the chemotherapy setting Filgrastim (r-metHuG-CSF) in Clinical Practice</title><publicationDate>1993</publicationDate></host></json:item><json:item><author><json:item><name>K Welte</name></json:item><json:item><name>J Gabrilove</name></json:item><json:item><name>Mh Bronchud</name></json:item></author><host><volume>88</volume><pages><last>1929</last><first>1907</first></pages><author></author><title>Blood</title><publicationDate>1996</publicationDate></host><title>Filgrastim (r-metHuG-CSF): the first 10 years</title><publicationDate>1996</publicationDate></json:item><json:item><author><json:item><name>G Molineux</name></json:item><json:item><name>O Kinstler</name></json:item><json:item><name>B Briddell</name></json:item></author><host><volume>27</volume><pages><last>1734</last><first>1724</first></pages><author></author><title>Exp Hematol</title><publicationDate>1999</publicationDate></host><title>A new form of filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans</title><publicationDate>1999</publicationDate></json:item><json:item><author><json:item><name>Je Layton</name></json:item><json:item><name>H Hockman</name></json:item><json:item><name>Wp Sheridan</name></json:item><json:item><name>G Morstyn</name></json:item></author><host><volume>74</volume><pages><last>1307</last><first>1303</first></pages><author></author><title>Blood</title><publicationDate>1989</publicationDate></host><title>Evidence for a novel in vivo control mechanism of granulopoiesis: mature cell-related control of a regulatory growth factor</title><publicationDate>1989</publicationDate></json:item><json:item><host><pages><last>71</last><first>51</first></pages><author><json:item><name>Lk Roskos</name></json:item><json:item><name>En Cheung</name></json:item><json:item><name>M Vincent</name></json:item></author><title>Pharmacology of filgrastim (r-metHuG-CSF) Filgrastim (r-metHuG-CSF) in Clinical Practice</title><publicationDate>1998</publicationDate></host></json:item><json:item><author><json:item><name>C Delgado</name></json:item><json:item><name>Ge Francis</name></json:item><json:item><name>D Fisher</name></json:item></author><host><volume>9</volume><pages><last>304</last><first>249</first></pages><author></author><title>Crit Rev Ther Drug Carrier Syst</title><publicationDate>1992</publicationDate></host><title>The uses and properties of PEG-linked proteins</title><publicationDate>1992</publicationDate></json:item><json:item><author><json:item><name>E Johnston</name></json:item><json:item><name>J Crawford</name></json:item><json:item><name>S Blackwell</name></json:item></author><host><volume>18</volume><pages><last>2528</last><first>2522</first></pages><author></author><title>J Clin Oncol</title><publicationDate>2000</publicationDate></host><title>Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy</title><publicationDate>2000</publicationDate></json:item><json:item><author><json:item><name>Fa Holmes</name></json:item><json:item><name>Se Jones</name></json:item><json:item><name>O Shaughnessy</name></json:item><json:item><name>J </name></json:item></author><host><volume>13</volume><pages><last>909</last><first>903</first></pages><author></author><title>Ann Oncol</title><publicationDate>2002</publicationDate></host><title>Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dosefinding study in women with breast cancer</title><publicationDate>2002</publicationDate></json:item><json:item><author><json:item><name>G Heil</name></json:item><json:item><name>D Hoelzer</name></json:item><json:item><name>Ma Sanz</name></json:item></author><host><volume>90</volume><pages><last>4718</last><first>4710</first></pages><author></author><title>Blood</title><publicationDate>1997</publicationDate></host><title>A randomized, double-blind, placebocontrolled , phase III study of filgrastim in remission induction and consolidation therapy for adults with de novo acute myeloid leukemia</title><publicationDate>1997</publicationDate></json:item><json:item><author><json:item><name>Fa Holmes</name></json:item><json:item><name>O Shaughnessy</name></json:item><json:item><name>Ja Vukelja</name></json:item><json:item><name>S </name></json:item></author><host><volume>20</volume><pages><last>731</last><first>727</first></pages><author></author><title>J Clin Oncol</title><publicationDate>2002</publicationDate></host><title>Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer</title><publicationDate>2002</publicationDate></json:item><json:item><author><json:item><name>Bb Yang</name></json:item><json:item><name>P Lum</name></json:item><json:item><name>J Renwick</name></json:item></author><host><volume>96</volume><pages><last>4384</last><first>157</first></pages><author></author><title>Blood</title><publicationDate>2000</publicationDate></host><title>Pharmacokinetic rationale for a fixed-dose regimen of a sustained-duration form of filgrastim in cancer patients</title><publicationDate>2000</publicationDate></json:item></refBibs><genre><json:string>other</json:string></genre><host><volume>14</volume><publisherId><json:string>annonc</json:string></publisherId><pages><last>35</last><first>29</first></pages><issn><json:string>0923-7534</json:string></issn><issue>1</issue><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1569-8041</json:string></eissn><title>Annals of Oncology</title></host><categories><wos><json:string>science</json:string><json:string>oncology</json:string></wos><scienceMetrix><json:string>health sciences</json:string><json:string>clinical medicine</json:string><json:string>oncology & carcinogenesis</json:string></scienceMetrix></categories><publicationDate>2003</publicationDate><copyrightDate>2003</copyrightDate><doi><json:string>10.1093/annonc/mdg019</json:string></doi><id>D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B</id><score>0.13598235</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy</title><respStmt><resp>Références bibliographiques récupérées via GROBID</resp><name resp="ISTEX-API">ISTEX-API (INIST-CNRS)</name></respStmt></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Oxford University Press</publisher><availability><p>OUP</p></availability><date>2003</date></publicationStmt><notesStmt><note>Received 20 March 2002; revised 3 June 2002; accepted 17 July 2002</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy</title><author xml:id="author-1"><persName><forename type="first">M. D.</forename><surname>Green</surname></persName><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-2"><persName><forename type="first">H.</forename><surname>Koelbl</surname></persName><affiliation>Martin Luther University, Halle-Wittenberg, Germany;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-3"><persName><forename type="first">J.</forename><surname>Baselga</surname></persName><affiliation>Hospital Vall d’Hebron, Barcelona, Spain;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-4"><persName><forename type="first">A.</forename><surname>Galid</surname></persName><affiliation>Universitaetsklinik fuer Frauenheilkunde, Vienna, Austria;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-5"><persName><forename type="first">V.</forename><surname>Guillem</surname></persName><affiliation>Instituto Valenciano de Oncologia, Valencia, Spain;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-6"><persName><forename type="first">P.</forename><surname>Gascon</surname></persName><affiliation>Hospital Clinic, Barcelona, Spain;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-7"><persName><forename type="first">S.</forename><surname>Siena</surname></persName><affiliation>Ospedale Niguarda Ca’ Granda, Milan, Italy;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-8"><persName><forename type="first">R. I.</forename><surname>Lalisang</surname></persName><affiliation>Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-9"><persName><forename type="first">H.</forename><surname>Samonigg</surname></persName><affiliation>Medizinische Universitaetsklinik, Graz, Austria;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-10"><persName><forename type="first">M. R.</forename><surname>Clemens</surname></persName><affiliation>Krankenanstalt Mutterhaus der Borromaerinnen, Trier, Germany;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-11"><persName><forename type="first">V.</forename><surname>Zani</surname></persName><affiliation>Amgen Inc, Thousand Oaks, CA, USA;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-12"><persName><forename type="first">B. C.</forename><surname>Liang</surname></persName><affiliation>Amgen Inc, Thousand Oaks, CA, USA;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-13"><persName><forename type="first">J.</forename><surname>Renwick</surname></persName><affiliation>Amgen Inc, Thousand Oaks, CA, USA;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author><author xml:id="author-14"><persName><forename type="first">M. J.</forename><surname>Piccart</surname></persName><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation></author></analytic><monogr><title level="j">Annals of Oncology</title><title level="j" type="abbrev">Ann Oncol</title><idno type="pISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2003-01"></date><biblScope unit="volume">14</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="29">29</biblScope><biblScope unit="page" to="35">35</biblScope></imprint></monogr><idno type="istex">D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B</idno><idno type="DOI">10.1093/annonc/mdg019</idno><idno type="local">mdg019</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2003</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Background: We evaluated the efficacy of a single fixed 6 mg dose of pegfilgrastim (a pegylated version of filgrastim) per cycle of chemotherapy, compared with daily administration of filgrastim, in the provision of neutrophil support. Patients and methods: Patients (n = 157) were randomized to receive either a single 6 mg subcutaneous (s.c.) injection of pegfilgrastim or daily 5 mg/kg s.c. injections of filgrastim, after doxorubicin and docetaxel chemotherapy (60 mg/m2 and 75 mg/m2, respectively). Duration of grade 4 neutropenia, depth of neutrophil nadir, incidence of febrile neutropenia, time to neutrophil recovery and safety information were recorded. Results: A single 6 mg injection of pegfilgrastim was as effective as daily injections of filgrastim for all efficacy measures for all cycles. The mean duration of grade 4 neutropenia in cycle 1 was 1.8 and 1.6 days for the pegfilgrastim and filgrastim groups, respectively. Results for all efficacy end points in cycles 2–4 were consistent with the results from cycle 1. A trend towards a lower incidence of febrile neutropenia was noted across all cycles with pegfilgrastim compared with filgrastim (13% versus 20%, respectively). A single fixed dose of pegfilgrastim was as safe and well tolerated as standard daily filgrastim. Conclusions: A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy was comparable to multiple daily injections of filgrastim in safely providing neutrophil support during myelosuppressive chemotherapy. Pegfilgrastim may have utility in other clinical settings of neutropenia.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>KWD</head><item><term>Key words: breast cancer, clinical trial, hemopoietic growth factor, multicenter study, neutropenia</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2003-01">Published</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2016-12-22">References added</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus oup" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="US-ASCII"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article xml:lang="en" article-type="other"><front><journal-meta><journal-id journal-id-type="hwp">annonc</journal-id><journal-id journal-id-type="nlm-ta">Ann Oncol</journal-id><journal-id journal-id-type="publisher-id">annonc</journal-id><journal-title>Annals of Oncology</journal-title><abbrev-journal-title abbrev-type="publisher">Ann Oncol</abbrev-journal-title><issn pub-type="ppub">0923-7534</issn><issn pub-type="epub">1569-8041</issn><publisher><publisher-name>Oxford University Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="other">mdg019</article-id><article-id pub-id-type="doi">10.1093/annonc/mdg019</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original article</subject><subj-group><subject>Quality of life and supportive care</subject></subj-group></subj-group></article-categories><title-group><article-title>A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Green</surname><given-names>M. D.</given-names></name><xref rid="CHDBJEDC">1</xref><xref rid="FN1">+</xref></contrib><contrib contrib-type="author"><name><surname>Koelbl</surname><given-names>H.</given-names></name><xref rid="CHDGBHHG">2</xref></contrib><contrib contrib-type="author"><name><surname>Baselga</surname><given-names>J.</given-names></name><xref rid="CHDIEIBF">3</xref></contrib><contrib contrib-type="author"><name><surname>Galid</surname><given-names>A.</given-names></name><xref rid="CHDIEBFJ">4</xref></contrib><contrib contrib-type="author"><name><surname>Guillem</surname><given-names>V.</given-names></name><xref rid="CHDBIAFG">5</xref></contrib><contrib contrib-type="author"><name><surname>Gascon</surname><given-names>P.</given-names></name><xref rid="CHDHGHGE">6</xref></contrib><contrib contrib-type="author"><name><surname>Siena</surname><given-names>S.</given-names></name><xref rid="CHDEDIDD">7</xref></contrib><contrib contrib-type="author"><name><surname>Lalisang</surname><given-names>R. I.</given-names></name><xref rid="CHDGHCAA">8</xref></contrib><contrib contrib-type="author"><name><surname>Samonigg</surname><given-names>H.</given-names></name><xref rid="CHDDJBGD">9</xref></contrib><contrib contrib-type="author"><name><surname>Clemens</surname><given-names>M. R.</given-names></name><xref rid="CHDJDEJH">10</xref></contrib><contrib contrib-type="author"><name><surname>Zani</surname><given-names>V.</given-names></name><xref rid="CHDJIDHA">11</xref></contrib><contrib contrib-type="author"><name><surname>Liang</surname><given-names>B. C.</given-names></name><xref rid="CHDJIDHA">11</xref></contrib><contrib contrib-type="author"><name><surname>Renwick</surname><given-names>J.</given-names></name><xref rid="CHDJIDHA">11</xref></contrib><contrib contrib-type="author"><name><surname>Piccart</surname><given-names>M. J.</given-names></name></contrib><contrib contrib-type="group-author"><on-behalf-of> On behalf of the International Pegfilgrastim 749 Study Group</on-behalf-of><xref rid="CHDDFABF">12</xref><xref rid="FN2">§</xref></contrib><aff><target target-type="aff" id="CHDBJEDC"></target><label>1</label>Royal Melbourne and Western Hospitals, Melbourne, Australia; <target target-type="aff" id="CHDGBHHG"></target><label>2</label>Martin Luther University, Halle-Wittenberg, Germany; <target target-type="aff" id="CHDIEIBF"></target><label>3</label>Hospital Vall d’Hebron, Barcelona, Spain; <target target-type="aff" id="CHDIEBFJ"></target><label>4</label>Universitaetsklinik fuer Frauenheilkunde, Vienna, Austria; <target target-type="aff" id="CHDBIAFG"></target><label>5</label>Instituto Valenciano de Oncologia, Valencia, Spain; <target target-type="aff" id="CHDHGHGE"></target><label>6</label>Hospital Clinic, Barcelona, Spain; <target target-type="aff" id="CHDEDIDD"></target><label>7</label>Ospedale Niguarda Ca’ Granda, Milan, Italy; <target target-type="aff" id="CHDGHCAA"></target><label>8</label>Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands; <target target-type="aff" id="CHDDJBGD"></target><label>9</label>Medizinische Universitaetsklinik, Graz, Austria; <target target-type="aff" id="CHDJDEJH"></target><label>10</label>Krankenanstalt Mutterhaus der Borromaerinnen, Trier, Germany; <target target-type="aff" id="CHDJIDHA"></target><label>11</label>Amgen Inc, Thousand Oaks, CA, USA; <target target-type="aff" id="CHDDFABF"></target><label>12</label>Institut Jules Bordet, Brussels, Belgium</aff></contrib-group><pub-date pub-type="ppub"><month>01</month><year>2003</year></pub-date><volume>14</volume><issue>1</issue><fpage>29</fpage><lpage>35</lpage><permissions><copyright-year>2003</copyright-year></permissions><abstract xml:lang="en"><p><bold>Background:</bold></p><p>We evaluated the efficacy of a single fixed 6 mg dose of pegfilgrastim (a pegylated version of filgrastim) per cycle of chemotherapy, compared with daily administration of filgrastim, in the provision of neutrophil support.</p><p><bold>Patients and methods:</bold></p><p>Patients (<italic>n</italic> = 157) were randomized to receive either a single 6 mg subcutaneous (s.c.) injection of pegfilgrastim or daily 5 mg/kg s.c. injections of filgrastim, after doxorubicin and docetaxel chemotherapy (60 mg/m<sup>2</sup> and 75 mg/m<sup>2</sup>, respectively). Duration of grade 4 neutropenia, depth of neutrophil nadir, incidence of febrile neutropenia, time to neutrophil recovery and safety information were recorded.</p><p><bold>Results:</bold></p><p>A single 6 mg injection of pegfilgrastim was as effective as daily injections of filgrastim for all efficacy measures for all cycles. The mean duration of grade 4 neutropenia in cycle 1 was 1.8 and 1.6 days for the pegfilgrastim and filgrastim groups, respectively. Results for all efficacy end points in cycles 2–4 were consistent with the results from cycle 1. A trend towards a lower incidence of febrile neutropenia was noted across all cycles with pegfilgrastim compared with filgrastim (13% versus 20%, respectively). A single fixed dose of pegfilgrastim was as safe and well tolerated as standard daily filgrastim.</p><p><bold>Conclusions:</bold></p><p>A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy was comparable to multiple daily injections of filgrastim in safely providing neutrophil support during myelosuppressive chemotherapy. Pegfilgrastim may have utility in other clinical settings of neutropenia.</p></abstract><kwd-group kwd-group-type="KWD" xml:lang="en"><kwd><bold>Key words:</bold> breast cancer, clinical trial, hemopoietic growth factor, multicenter study, neutropenia</kwd></kwd-group><custom-meta-wrap><custom-meta><meta-name>hwp-legacy-fpage</meta-name><meta-value>29</meta-value></custom-meta><custom-meta><meta-name>hwp-legacy-dochead</meta-name><meta-value>Original Paper</meta-value></custom-meta></custom-meta-wrap></article-meta><notes><p content-type="arthw-misc">Received 20 March 2002; revised 3 June 2002; accepted 17 July 2002</p></notes></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy</title></titleInfo><name type="personal"><namePart type="given">M. D.</namePart><namePart type="family">Green</namePart><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Koelbl</namePart><affiliation>Martin Luther University, Halle-Wittenberg, Germany;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Baselga</namePart><affiliation>Hospital Vall d’Hebron, Barcelona, Spain;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Galid</namePart><affiliation>Universitaetsklinik fuer Frauenheilkunde, Vienna, Austria;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Guillem</namePart><affiliation>Instituto Valenciano de Oncologia, Valencia, Spain;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="family">Gascon</namePart><affiliation>Hospital Clinic, Barcelona, Spain;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Siena</namePart><affiliation>Ospedale Niguarda Ca’ Granda, Milan, Italy;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R. I.</namePart><namePart type="family">Lalisang</namePart><affiliation>Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Samonigg</namePart><affiliation>Medizinische Universitaetsklinik, Graz, Austria;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M. R.</namePart><namePart type="family">Clemens</namePart><affiliation>Krankenanstalt Mutterhaus der Borromaerinnen, Trier, Germany;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Zani</namePart><affiliation>Amgen Inc, Thousand Oaks, CA, USA;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B. C.</namePart><namePart type="family">Liang</namePart><affiliation>Amgen Inc, Thousand Oaks, CA, USA;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Renwick</namePart><affiliation>Amgen Inc, Thousand Oaks, CA, USA;</affiliation><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M. J.</namePart><namePart type="family">Piccart</namePart><affiliation>Royal Melbourne and Western Hospitals, Melbourne, Australia;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="other" displayLabel="other"></genre><originInfo><publisher>Oxford University Press</publisher><dateIssued encoding="w3cdtf">2003-01</dateIssued><copyrightDate encoding="w3cdtf">2003</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">Background: We evaluated the efficacy of a single fixed 6 mg dose of pegfilgrastim (a pegylated version of filgrastim) per cycle of chemotherapy, compared with daily administration of filgrastim, in the provision of neutrophil support. Patients and methods: Patients (n = 157) were randomized to receive either a single 6 mg subcutaneous (s.c.) injection of pegfilgrastim or daily 5 mg/kg s.c. injections of filgrastim, after doxorubicin and docetaxel chemotherapy (60 mg/m2 and 75 mg/m2, respectively). Duration of grade 4 neutropenia, depth of neutrophil nadir, incidence of febrile neutropenia, time to neutrophil recovery and safety information were recorded. Results: A single 6 mg injection of pegfilgrastim was as effective as daily injections of filgrastim for all efficacy measures for all cycles. The mean duration of grade 4 neutropenia in cycle 1 was 1.8 and 1.6 days for the pegfilgrastim and filgrastim groups, respectively. Results for all efficacy end points in cycles 2–4 were consistent with the results from cycle 1. A trend towards a lower incidence of febrile neutropenia was noted across all cycles with pegfilgrastim compared with filgrastim (13% versus 20%, respectively). A single fixed dose of pegfilgrastim was as safe and well tolerated as standard daily filgrastim. Conclusions: A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy was comparable to multiple daily injections of filgrastim in safely providing neutrophil support during myelosuppressive chemotherapy. Pegfilgrastim may have utility in other clinical settings of neutropenia.</abstract><note>Received 20 March 2002; revised 3 June 2002; accepted 17 July 2002</note><subject lang="en"><genre>KWD</genre><topic>Key words: breast cancer, clinical trial, hemopoietic growth factor, multicenter study, neutropenia</topic></subject><relatedItem type="host"><titleInfo><title>Annals of Oncology</title></titleInfo><titleInfo type="abbreviated"><title>Ann Oncol</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0923-7534</identifier><identifier type="eISSN">1569-8041</identifier><identifier type="PublisherID">annonc</identifier><identifier type="PublisherID-hwp">annonc</identifier><identifier type="PublisherID-nlm-ta">Ann Oncol</identifier><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>14</number></detail><detail type="issue"><caption>no.</caption><number>1</number></detail><extent unit="pages"><start>29</start><end>35</end></extent></part></relatedItem><identifier type="istex">D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B</identifier><identifier type="DOI">10.1093/annonc/mdg019</identifier><identifier type="local">mdg019</identifier><recordInfo><recordContentSource>OUP</recordContentSource></recordInfo></mods></metadata><annexes><json:item><extension>jpeg</extension><original>true</original><mimetype>image/jpeg</mimetype><uri>https://api.istex.fr/document/D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B/annexes/jpeg</uri></json:item></annexes><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Rhénanie/explor/UnivTrevesV1/Data/Istex/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001B69 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Istex/Corpus/biblio.hfd -nk 001B69 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Rhénanie
|area= UnivTrevesV1
|flux= Istex
|étape= Corpus
|type= RBID
|clé= ISTEX:D2832EDCEECA5DCA87D30B88EE6391EE180BAB5B
|texte= A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy
}}
| This area was generated with Dilib version V0.6.31. |  |