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.

Abstract

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)

• Authors: N Schmitz, P Dreger, A R Zander, G Ehninger, H Wandt, A A Fauser, H J Kolb, A Zumsprekel, A Martin, T Hecht
• Journal: Bone marrow transplantation (Bone Marrow Transplant) Vol. 15 Issue 2 Pg. 261-6 (Feb 1995) ISSN: 0268-3369 [Print] England
• PMID: 7539668 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• Filgrastim

Topics

• Adolescent
• Adult
• Bone Marrow Transplantation
• Female
• Fever (chemically induced)
• Filgrastim
• Graft Rejection (prevention & control)
• Granulocyte Colony-Stimulating Factor (administration & dosage, adverse effects)
• Hodgkin Disease (mortality, surgery)
• Humans
• Lymphoma, Non-Hodgkin (mortality, surgery)
• Male
• Middle Aged
• Neutropenia (chemically induced)
• Recombinant Proteins (administration & dosage, adverse effects)
• Survival Analysis
• Transplantation, Autologous