Results of a randomised, controlled, multicentre study of recombinant human granulocyte colony-stimulating factor (filgrastim) in patients with Hodgkin's disease and non-Hodgkin's lymphoma undergoing autologous bone marrow transplantation.
In 54 patients with malignant lymphoma, haematopoietic recovery after high-dose chemotherapy and autologous bone marrow transplantation (BMT) was compared between patients randomised to receive 10 or 30 micrograms/kg/day of r-metHuG-CSF (filgrastim) or no growth factor. After standard high-dose chemotherapy with cyclophosphamide, etoposide and BCNU (CVB regimen for patients with Hodgkin's disease) or BCNU, etoposide, cytosine arabinoside and melphalan (BEAM regimen for patients suffering from non-Hodgkin's lymphoma) followed by autologous BMT, r-metHuG-CSF was administered by continuous intravenous infusion from the first day after autologous BMT until neutrophil recovery. When the r-metHuG-CSF groups were compared with the control group the major findings were: the median time to reach an absolute neutrophil count (ANC) > or = 0.5 x 10(9)/L was 20 days in the control group and 12 and 14 days, respectively, in the r-metHuG-CSF groups (P = 0.0004). The duration of neutropenia (ANC < 0.5 x 10(9)/L) was reduced from 27 days in the control group to 11 and 13 days in the r-metHuG-CSF groups (P = 0.0001). In addition, fewer days of febrile neutropenia were observed in the r-metHuG-CSF groups (5 and 6 days) than in the control group (10 days; P = 0.036). No significant effects of r-metHuG-CSF administration on the number of days with fever, the use of intravenous antibiotics and hospitalisation were detected. R-metHuG-CSF was well tolerated without any serious side-effects.(ABSTRACT TRUNCATED AT 250 WORDS)
Schmitz
N
N
Department of Internal Medicine II, University of Kiel, Germany.
Dreger
P
P
Zander
A R
AR
Ehninger
G
G
Wandt
H
H
Fauser
A A
AA
Kolb
H J
HJ
Zumsprekel
A
A
Martin
A
A
Hecht
T
T
D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation; D005260:Female; D005334:Fever / Q000139:chemically induced; D000069585:Filgrastim; D006084:Graft Rejection / Q000517:prevention & control*; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006689:Hodgkin Disease / Q000401:mortality / Q000601:surgery*; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000401:mortality / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D014182:Transplantation, Autologous
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim