Individually determined dosing of filgrastim after autologous peripheral stem cell transplantation in patients with malignant lymphoma--results of a prospective multicentre controlled trial.
OBJECTIVE
To explore the safety and effectiveness of the individually determined application granulocyte-colony stimulating factor (G-CSF) after autologous peripheral blood stem cell transplantation (ASCT).


METHODS
The administration of G-CSF from day +5 (arm A) was compared in a randomised, controlled trial with delayed, individually determined administration (G-CSF started when WBC >or= 0.5 x 10(9)/L and ANC >or= 0.1 x 10(9)/L or at day +10; arm B), and with placebo (arm C).


RESULTS
One hundred and six patients, median age 45 (range 21-64), all with malignant lymphoma treated with BEAM chemotherapy were analysed. A significant difference in the time to neutrophil engraftment and in the duration of neutropenia <0.5 x 10(9)/L and <1.0 x 10(9)/L was observed between the arms (P = 0.04-<0.0001) with a 1-d prolongation of the median durations in arm B in comparison with arm A but a 2-4-d prolongation in the placebo arm C in comparison with arm B. The median number and range of days to neutrophil engraftment >0.5 x 10(9)/L after graft re-infusion was 10 (9-14) in arm A; 11 (9-19) in arm B; and 14 (10-30) in arm C (P < 0.0001). Engraftment of platelets to >20 x 10(9)/L and >50 x 10(9)/L was significantly delayed in the arms using G-CSF in comparison with placebo (P = 0.04-0.002) without any increase in bleeding or in transfusion requirement. There was no difference in the incidence and duration of transplant-related complications and their treatment between the arms.


CONCLUSIONS
Our study has confirmed the safety of individually determined administration of G-CSF. The optimal timing of G-CSF application after ASCT in patients with good-quality grafts is shortly before expected spontaneous engraftment.
Faber
Edgar
E
Department of Hemato-Oncology, University Hospital, Olomouc, Czech Republic. edgar.faber@fnol.cz
Pytlík
Robert
R
Slabý
Jirí
J
Zapletalová
Jana
J
Kozák
Tomás
T
Raida
Ludek
L
Papajík
Tomás
T
Zikesová
Eva
E
Maresová
Ivana
I
Hamouzová
Marie
M
Indrák
Karel
K
Trnený
Marek
M
D000328:Adult; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000627:therapeutic use*; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009504:Neutrophils / Q000187:drug effects / Q000378:metabolism; D036102:Peripheral Blood Stem Cell Transplantation / Q000379:methods*; D010919:Placebos; D011446:Prospective Studies; D011994:Recombinant Proteins; D013997:Time Factors; D014182:Transplantation, Autologous / Q000379:methods*
D010919:Placebos; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim