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

L. Castagna; S. Bramanti; A. Levis; M. G. Michieli; A. Anastasia; R. Mazza; L. Giordano; B. Sarina; E. Todisco; A. I. Gregorini; A. Santoro

doi:10.1093/annonc/mdp576

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

L. Castagna, S. Bramanti, A. Levis, M. G. Michieli, A. Anastasia, R. Mazza, L. Giordano, B. Sarina, E. Todisco, A. I. Gregorini, A. Santoro

Research output: Contribution to journal › Article › peer-review

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 language	English
Pages (from-to)	1482-1485
Number of pages	4
Journal	Annals of Oncology
Volume	21
Issue number	7
DOIs	https://doi.org/10.1093/annonc/mdp576
Publication status	Published - Dec 11 2009

Keywords

Autologous stem cell transplantation
Filgrastim
Pegfilgrastim

ASJC Scopus subject areas

Oncology
Hematology

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10.1093/annonc/mdp576

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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",

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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

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

Abstract

Keywords

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