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Title: | A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. | Authors: | Santoro A.;Holmes F.A.;Koczwara B.;Lind M.J.;Lluch A.;Marques F.;Miles D.;Richardson G.E.;Schaafsma M.R.;Green M.D.;Koelbl H.;Baselga J.;Galid A.;Guillem V.;Gascon P.;Siena S.;Lalisang R.I.;Samonigg H.;Clemens M.R.;Zani V.;Liang B.C.;Renwick J.;Piccart M.J.;Yang B.-B.;Bashir S.;Hill L.R.;Breddy J.;Foote M.A.;Ackland S.P.;Andreesen R.;Bashford J.;Cascinu S.;Cocconi G.;Cocquyt V.;Coleman R.E.;Dunlop D.;Grothey A. | Institution: | (Green) Royal Melbourne/Western Hospitals, Melbourne, Vic., Australia (Koelbl) Martin Luther University, Halle-Wittenberg, Germany (Baselga) Hospital Vall d'Hebron, Barcelona, Spain (Galid) Universitaetsklinik Frauenheilkunde, Vienna, Austria (Guillem) Instituto Valenciano de Oncologia, Valencia, Spain (Gascon) Hospital Clinic, Barcelona, Spain (Siena) Ospedale Niguarda Ca' Granda, Milan, Italy (Lalisang) Academisch Ziekenhuis Maastricht, Maastricht, Netherlands (Samonigg) Medizinische Universitaetsklinik, Graz, Austria (Clemens) Krankenanstalt Mutterhaus de Borrow., Trier, Germany (Zani, Liang, Renwick, Yang, Bashir, Hill, Breddy, Foote) Amgen Incorporated, Thousand Oaks, CA, United States (Piccart) Institut Jules Bordet, Brussels, Belgium (Andreesen) Universitaetsklinik Regensburg, Regensburg, Germany (Bashford) Azienda Ospedaliera di Parma, Parma, Italy (Cocquyt) Universitair Ziekenhuis, Gent, Belgium (Coleman) Weston Park Hospital, Sheffield, United Kingdom (Dunlop) Glasgow Royal Infirmary, Glasgow, United Kingdom (Grothey) Martin-Luther Univ. Halle-Wittenberg, Halle an der Saale, Germany (Holmes) Texas Oncology, Houston, TX, United States (Koczwara) Flinders Medical Centre, Bedford Park, SA, Australia (Lind) Princess Royal Hospital, Hull, United Kingdom (Lluch) Hospital Clinico de Valencia, Valencia, Spain (Marques) Hospital Geral de Santo Antonio, Porto, Portugal (Miles) Guy's Hospital, London, United Kingdom (Richardson) Monash Medical Centre, Clayton, Vic, Australia (Santoro) Instituto Clinico Humanitas, Rozzano, Italy (Schaafsma) Medisch Spectrum Twente, Enschede, Netherlands | Issue Date: | 19-Oct-2012 | Copyright year: | 2003 | Publisher: | Oxford University Press (Great Clarendon Street, Oxford OX2 6DP, United Kingdom) | Place of publication: | United Kingdom | Publication information: | Annals of Oncology. 14 (1) (pp 29-35), 2003. Date of Publication: 01 Jan 2003. | 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. Result(s): 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. Conclusion(s): 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. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1093/annonc/mdg019 | PubMed URL: | 12488289 [http://www.ncbi.nlm.nih.gov/pubmed/?term=12488289] | ISSN: | 0923-7534 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/32704 | Type: | Article | Subjects: | doxorubicin/ae [Adverse Drug Reaction] doxorubicin/do [Drug Dose] doxorubicin/dt [Drug Therapy] *recombinant granulocyte colony stimulating factor/ae [Adverse Drug Reaction] *recombinant granulocyte colony stimulating factor/ct [Clinical Trial] *recombinant granulocyte colony stimulating factor/do [Drug Dose] *recombinant granulocyte colony stimulating factor/dt [Drug Therapy] *recombinant granulocyte colony stimulating factor/pd [Pharmacology] *recombinant granulocyte colony stimulating factor/sc [Subcutaneous Drug Administration] doxorubicin/iv [Intravenous Drug Administration] adult respiratory distress syndrome/si [Side Effect] aged anemia/si [Side Effect] article bone marrow suppression/dt [Drug Therapy] bone marrow suppression/si [Side Effect] bone pain/si [Side Effect] bronchopneumonia/si [Side Effect] cancer radiotherapy clinical trial controlled clinical trial adult controlled study disease duration disease severity dose response double blind procedure drug efficacy drug information drug safety drug tolerability febrile neutropenia/si [Side Effect] female human hypoxia/si [Side Effect] incidence intermethod comparison leukocyte count major clinical study male malignant neoplastic disease/dt [Drug Therapy] malignant neoplastic disease/rt [Radiotherapy] medical documentation multicenter study *neutropenia/dt [Drug Therapy] *neutropenia/si [Side Effect] phase 3 clinical trial pneumonia/si [Side Effect] priority journal randomized controlled trial sepsis/si [Side Effect] thorax pain/si [Side Effect] thrombocytopenia/si [Side Effect] time treatment outcome docetaxel/ae [Adverse Drug Reaction] docetaxel/do [Drug Dose] docetaxel/dt [Drug Therapy] docetaxel/iv [Intravenous Drug Administration] clinical trial controlled clinical trial controlled study disease duration disease severity dose response double blind procedure drug efficacy drug information drug safety drug tolerability febrile neutropenia / side effect female human hypoxia / side effect incidence intermethod comparison leukocyte count major clinical study male malignant neoplastic disease / drug therapy / radiotherapy medical documentation multicenter study *neutropenia / *drug therapy / *side effect phase 3 clinical trial pneumonia / side effect priority journal randomized controlled trial sepsis / side effect thorax pain / side effect thrombocytopenia / side effect treatment outcome adult time adult respiratory distress syndrome / side effect aged anemia / side effect article bone marrow suppression / drug therapy / side effect bone pain / side effect bronchopneumonia / side effect cancer radiotherapy |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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