Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support

Research output: Contribution to journalArticle

Abstract

Background: American Society of Clinical Oncology guidelines recommend the use of growth factor after high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) support. This randomized trial aims to demonstrate the noninferiority of pegfilgrastim (PEG) compared with filgrastim (FIL) after HDC. Patients and methods: Eighty patients were assigned to FIL at a daily dose of 5 μg/kg or a single fixed dose of PEG (6 mg) 1 day after PBSC. The primary end point was the duration of neutropenia both in terms of absolute neutrophil count (ANC) 0.5 × 10 9/l. Results: The mean duration of neutropenia was 6 and 6.2 days and the mean time to reach an ANC >0.5 × 109/l was 11.5 and 10.8 in the FIL and PEG group, respectively. No differences were observed in the mean time to reach an ANC >1.0 × 10 9/l (12.2 versus 12.0 days) in the incidence of fever (62% versus 56%) and of documented infections (31% versus 25%). The mean duration of antibiotic therapy was 5.7 and 4.0 days in FIL and PEG group, respectively. Conclusion: PEG is not inferior to FIL in hematological reconstitution and represents an effective alternative after HDC and PBSC.

Original languageEnglish
Pages (from-to)1482-1485
Number of pages4
JournalAnnals of Oncology
Volume21
Issue number7
DOIs
Publication statusPublished - Dec 11 2009

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Drug Therapy
Neutrophils
Neutropenia
Intercellular Signaling Peptides and Proteins
Fever
Peripheral Blood Stem Cells
Filgrastim
pegfilgrastim
Guidelines
Anti-Bacterial Agents
Incidence
Infection
Therapeutics

Keywords

  • Autologous stem cell transplantation
  • Filgrastim
  • Pegfilgrastim

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

@article{506fe5c113664a44945c51a639850efa,
title = "Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support",
abstract = "Background: American Society of Clinical Oncology guidelines recommend the use of growth factor after high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) support. This randomized trial aims to demonstrate the noninferiority of pegfilgrastim (PEG) compared with filgrastim (FIL) after HDC. Patients and methods: Eighty patients were assigned to FIL at a daily dose of 5 μg/kg or a single fixed dose of PEG (6 mg) 1 day after PBSC. The primary end point was the duration of neutropenia both in terms of absolute neutrophil count (ANC) 0.5 × 10 9/l. Results: The mean duration of neutropenia was 6 and 6.2 days and the mean time to reach an ANC >0.5 × 109/l was 11.5 and 10.8 in the FIL and PEG group, respectively. No differences were observed in the mean time to reach an ANC >1.0 × 10 9/l (12.2 versus 12.0 days) in the incidence of fever (62{\%} versus 56{\%}) and of documented infections (31{\%} versus 25{\%}). The mean duration of antibiotic therapy was 5.7 and 4.0 days in FIL and PEG group, respectively. Conclusion: PEG is not inferior to FIL in hematological reconstitution and represents an effective alternative after HDC and PBSC.",
keywords = "Autologous stem cell transplantation, Filgrastim, Pegfilgrastim",
author = "L. Castagna and S. Bramanti and A. Levis and Michieli, {M. G.} and A. Anastasia and R. Mazza and L. Giordano and B. Sarina and E. Todisco and Gregorini, {A. I.} and A. Santoro",
year = "2009",
month = "12",
day = "11",
doi = "10.1093/annonc/mdp576",
language = "English",
volume = "21",
pages = "1482--1485",
journal = "Annals of Oncology",
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}

TY - JOUR

T1 - Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support

AU - Castagna, L.

AU - Bramanti, S.

AU - Levis, A.

AU - Michieli, M. G.

AU - Anastasia, A.

AU - Mazza, R.

AU - Giordano, L.

AU - Sarina, B.

AU - Todisco, E.

AU - Gregorini, A. I.

AU - Santoro, A.

PY - 2009/12/11

Y1 - 2009/12/11

N2 - Background: American Society of Clinical Oncology guidelines recommend the use of growth factor after high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) support. This randomized trial aims to demonstrate the noninferiority of pegfilgrastim (PEG) compared with filgrastim (FIL) after HDC. Patients and methods: Eighty patients were assigned to FIL at a daily dose of 5 μg/kg or a single fixed dose of PEG (6 mg) 1 day after PBSC. The primary end point was the duration of neutropenia both in terms of absolute neutrophil count (ANC) 0.5 × 10 9/l. Results: The mean duration of neutropenia was 6 and 6.2 days and the mean time to reach an ANC >0.5 × 109/l was 11.5 and 10.8 in the FIL and PEG group, respectively. No differences were observed in the mean time to reach an ANC >1.0 × 10 9/l (12.2 versus 12.0 days) in the incidence of fever (62% versus 56%) and of documented infections (31% versus 25%). The mean duration of antibiotic therapy was 5.7 and 4.0 days in FIL and PEG group, respectively. Conclusion: PEG is not inferior to FIL in hematological reconstitution and represents an effective alternative after HDC and PBSC.

AB - Background: American Society of Clinical Oncology guidelines recommend the use of growth factor after high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) support. This randomized trial aims to demonstrate the noninferiority of pegfilgrastim (PEG) compared with filgrastim (FIL) after HDC. Patients and methods: Eighty patients were assigned to FIL at a daily dose of 5 μg/kg or a single fixed dose of PEG (6 mg) 1 day after PBSC. The primary end point was the duration of neutropenia both in terms of absolute neutrophil count (ANC) 0.5 × 10 9/l. Results: The mean duration of neutropenia was 6 and 6.2 days and the mean time to reach an ANC >0.5 × 109/l was 11.5 and 10.8 in the FIL and PEG group, respectively. No differences were observed in the mean time to reach an ANC >1.0 × 10 9/l (12.2 versus 12.0 days) in the incidence of fever (62% versus 56%) and of documented infections (31% versus 25%). The mean duration of antibiotic therapy was 5.7 and 4.0 days in FIL and PEG group, respectively. Conclusion: PEG is not inferior to FIL in hematological reconstitution and represents an effective alternative after HDC and PBSC.

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KW - Filgrastim

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