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Individually determined dosing of filgrastim after autologous peripheral stem cell transplantation in patients with malignant lymphoma – results of a prospective multicentre controlled trial
Author(s) -
Faber Edgar,
Pytlík Robert,
Slabý Jiří,
Zapletalová Jana,
Kozák Tomáš,
Raida Luděk,
Papajík Tomáš,
Žikešová Eva,
Marešová Ivana,
Hamouzová Marie,
Indrák Karel,
Trněný Marek
Publication year - 2006
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/j.1600-0609.2006.00741.x
Subject(s) - medicine , filgrastim , granulocyte colony stimulating factor , placebo , neutropenia , transplantation , surgery , gastroenterology , chemotherapy , absolute neutrophil count , autologous stem cell transplantation , dosing , pathology , alternative medicine
Objectives : 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 ≥ 0.5 × 10 9 /L and ANC ≥ 0.1 × 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 × 10 9 /L and <1.0 × 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 × 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 × 10 9 /L and >50 × 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.