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


METHODS
Eighty patients were assigned to FIL at a daily dose of 5 mug/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 x 10(9)/l and of days to reach an ANC >0.5 x 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 x 10(9)/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 x 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.


CONCLUSIONS
PEG is not inferior to FIL in hematological reconstitution and represents an effective alternative after HDC and PBSC.
Castagna
L
L
Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
Bramanti
S
S
Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan. Electronic address: stefania.bramanti@humanitas.it.
Levis
A
A
Division of Hematology, Ospedale SS Antonio e Biagio, Alessandria.
Michieli
M G
MG
Department of Medical Oncology, Centro di Riferimento Oncologico, Aviano.
Anastasia
A
A
Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
Mazza
R
R
Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
Giordano
L
L
Statistic Unit, Istituto Clinico Humanitas, Rozzano, Milan, Italy.
Sarina
B
B
Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
Todisco
E
E
Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
Gregorini
A I
AI
Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
Santoro
A
A
Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000473:pathology / Q000628:therapy*; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012074:Remission Induction; D015996:Survival Rate; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim