A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy

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. Piccart, B. B. Yang, S. Bashir, L. R. Hill, J. Breddy, M. A. Foote, S. P. AcklandR. Andreesen, J. Bashford, S. Cascinu, G. Cocconi, V. Cocquyt, R. E. Coleman, D. Dunlop, Axel F Grothey, F. A. Holmes, B. Koczwara, M. J. Lind, A. Lluch, F. Marques, D. Miles, G. E. Richardson, A. Santoro, M. R. Schaafsma

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)29-35
Number of pages7
JournalAnnals of Oncology
Volume14
Issue number1
DOIs
StatePublished - Jan 1 2003
Externally publishedYes

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Drug Therapy
Neutrophils
Neutropenia
Febrile Neutropenia
docetaxel
Subcutaneous Injections
Filgrastim
Injections
Incidence
Doxorubicin
Safety

Keywords

  • Breast cancer
  • Clinical trial
  • Hemopoietic growth factor
  • Multicenter study
  • Neutropenia

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. / 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, Axel F; Holmes, F. A.; Koczwara, B.; Lind, M. J.; Lluch, A.; Marques, F.; Miles, D.; Richardson, G. E.; Santoro, A.; Schaafsma, M. R.

In: Annals of Oncology, Vol. 14, No. 1, 01.01.2003, p. 29-35.

Research output: Contribution to journalArticle

Green, MD, Koelbl, H, Baselga, J, Galid, A, Guillem, V, Gascon, P, Siena, S, Lalisang, RI, Samonigg, H, Clemens, MR, Zani, V, Liang, BC, Renwick, J, Piccart, MJ, Yang, BB, Bashir, S, Hill, LR, Breddy, J, Foote, MA, Ackland, SP, Andreesen, R, Bashford, J, Cascinu, S, Cocconi, G, Cocquyt, V, Coleman, RE, Dunlop, D, Grothey, AF, Holmes, FA, Koczwara, B, Lind, MJ, Lluch, A, Marques, F, Miles, D, Richardson, GE, Santoro, A & Schaafsma, MR 2003, 'A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy', Annals of Oncology, vol. 14, no. 1, pp. 29-35. https://doi.org/10.1093/annonc/mdg019
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, Axel F ; Holmes, F. A. ; Koczwara, B. ; Lind, M. J. ; Lluch, A. ; Marques, F. ; Miles, D. ; Richardson, G. E. ; Santoro, A. ; Schaafsma, M. R. / A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. In: Annals of Oncology. 2003 ; Vol. 14, No. 1. pp. 29-35.
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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.",
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author = "Green, {M. D.} and H. Koelbl and J. Baselga and A. Galid and V. Guillem and P. Gascon and S. Siena and Lalisang, {R. I.} and H. Samonigg and Clemens, {M. R.} and V. Zani and Liang, {B. C.} and J. Renwick and Piccart, {M. J.} and Yang, {B. B.} and S. Bashir and Hill, {L. R.} and J. Breddy and Foote, {M. A.} and Ackland, {S. P.} and R. Andreesen and J. Bashford and S. Cascinu and G. Cocconi and V. Cocquyt and Coleman, {R. E.} and D. Dunlop and Grothey, {Axel F} and Holmes, {F. A.} and B. Koczwara and Lind, {M. J.} and A. Lluch and F. Marques and D. Miles and Richardson, {G. E.} and A. Santoro and Schaafsma, {M. R.}",
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T1 - A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy

AU - Green, M. D.

AU - Koelbl, H.

AU - Baselga, J.

AU - Galid, A.

AU - Guillem, V.

AU - Gascon, P.

AU - Siena, S.

AU - Lalisang, R. I.

AU - Samonigg, H.

AU - Clemens, M. R.

AU - Zani, V.

AU - Liang, B. C.

AU - Renwick, J.

AU - Piccart, M. J.

AU - Yang, B. B.

AU - Bashir, S.

AU - Hill, L. R.

AU - Breddy, J.

AU - Foote, M. A.

AU - Ackland, S. P.

AU - Andreesen, R.

AU - Bashford, J.

AU - Cascinu, S.

AU - Cocconi, G.

AU - Cocquyt, V.

AU - Coleman, R. E.

AU - Dunlop, D.

AU - Grothey, Axel F

AU - Holmes, F. A.

AU - Koczwara, B.

AU - Lind, M. J.

AU - Lluch, A.

AU - Marques, F.

AU - Miles, D.

AU - Richardson, G. E.

AU - Santoro, A.

AU - Schaafsma, M. R.

PY - 2003/1/1

Y1 - 2003/1/1

N2 - 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.

AB - 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.

KW - Breast cancer

KW - Clinical trial

KW - Hemopoietic growth factor

KW - Multicenter study

KW - Neutropenia

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U2 - 10.1093/annonc/mdg019

DO - 10.1093/annonc/mdg019

M3 - Article

C2 - 12488289

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JO - Annals of Oncology

JF - Annals of Oncology

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