Abstract
Objective. To determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) used in addition to standard inpatient antibiotic therapy shortens period of hospitalization for fever and neutropenia associated with chemotherapy. Design. Randomized, placebo-controlled phase III trial. Setting. Haematology and oncology departments of six University Hospitals (Amsterdam (Vrije Universiteit), Groningen, Leiden, Maastricht, Nijmegen, Rotterdam)) and one National Cancer Center (Dr. Daniel den Hoed Kliniek, Rotterdam), the Netherlands. Method. Patients with a haematological (n = 47) or solid tumour (n = 87) who had fever (temperature > 38°C over 12 h observation period or > 38.5°C once) and neutropenia (neutrophil count < 0.5 x 109/l) after chemotherapy were included in the study. Patients were randomly assigned to receive GM-CSF (5 μg/kg body weight per day, n = 65) or placebo (n = 69) in combination with broad-spectrum antibiotics. Patients remained on study until neutrophil count rose to ≤ 1.0 x 109/l and temperature was normal (< 37.5°C) for 2 consecutive days or at a white blood cell count of 10 x 109/l or more both followed by 24 hr observation period (hospitalization period). Results. Compared with placebo, GM-CSF accelerated the neutrophil recovery. Significantly higher neutrophil counts were observed at days 4 and 5 of treatment. No significant difference was observed with regard to median number of days < 1.0 x 109/l granulocytes (4 versus 4) or days of fever (3 versus 3). The median number of days patients were hospitalized while on study was comparable in the GM-CSF arm and placebo arm (6 (range 3-14) vs 7 (4-14) according to the intention-to-treat analysis (p > 0.05)). Conclusions. Addition of GM-CSF to the treatment of patients with fever and neutropenia following chemotherapy does not shorten the hospitalization period.
Translated title of the contribution | Faster recovery of leukocytes due to haemopoietic growth factor in patients with chemotherapy-related granulocytopenia and fever, but no shortened hospital stay |
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Original language | Dutch |
Pages (from-to) | 1650-1655 |
Number of pages | 6 |
Journal | Nederlands Tijdschrift voor Geneeskunde |
Volume | 140 |
Issue number | 32 |
Publication status | Published - 10-Aug-1996 |