USE OF GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR IN THE TREATMENT OF INFECTION AND SEVERE GRANULOCYTOPENIA

To compare the efficacy and toxicity of granulocyte-macrophage colony- stimulating factor (GM-CSF) in the treatment of infection in 116 sever e granulocytopenic patients with hematological malignancies after chem otherapy we began an prospective clinical trial. Patients were randoml y assigned to receive either antibiotics alone (ceftazidime, 2g, iv, e very 8 hours + amikicine, 7.5 mg/kg, every 12 hours) or the same antim icrobial regimen plus GM-CSF (5 ug/kg/day, subcutaneously). Measuremen ts were clinical improvement, eradication of the infecting agent and t oxicity. Patients who received antibiotics plus GM-CSF had more clinic al response (83% vs 60%), less superinfections (7% vs 18%), mortality (6 vs 15 patients), less hospitalized days (median 10.4 vs 21.1) and a ntibiotic usage compared to patients whose received only antibiotics. Hematological recovery (granulocytes > 1.8 x 10(9)/L) was also more sh orter in this patients: 11.6 days vs 18.4 days. We conclude that the a ddition of GM-CSF to broad spectrum antibiotics is useful in patients with infection and severe granulocytopenia and allow the use of more i ntensive chemotherapy.