| Autor: |
Ernst, Peter, Bacigalupo, Andrea, Ringdén, Olle, Ruutu, Tapani, Kolb, Hans J., Lawrinson, Susan, Skacel, Tomas |
| Zdroj: |
Archives of Drug Information; 2008, Vol. 1 Issue 3, p89-96, 8p |
| Abstrakt: |
ABSTRACT Introduction. Recombinant granulocyte colony-stimulating factor (G-CSF) may aid engraftment post high-dose chemo-/radiotherapy in patients with haematological malignancies undergoing allogeneic bone marrow transplantation (BMT); however, the effects of G-CSF on graft-versus-host disease (GvHD), relapse, and survival are not well defined. Methods. In this double-blind, randomized, placebo-controlled, multicentre, phase 3 study, the effects of the G-CSF Filgrastim on neutrophil and platelet recovery, and on clinical outcomes were evaluated. Patients (12-55 years) receiving an allogeneic BMT for a haematological malignancy were randomized to receive Filgrastim 5 µg/kg or placebo. Study treatment was continued until patients achieved an absolute neutrophil count (ANC) ≥0.5 × 109/L, or until day 42. Results. Fifty-one patients (Filgrastim, N = 25; placebo, N = 26) were evaluable. Patients treated with Filgrastim had significantly faster engraftment with ANC ≥0.5 × 109/L being achieved after a median (range) of 15.0 (1.0-22.0) days vs. 19.0 (15.0-28.0) days for placebo ( P < 0.0001). The incidence of GvHD was comparable for both groups. During the limited follow-up (2 years), Filgrastim had no adverse effect on mortality and possibly reduced the rate of relapse. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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