RANDOMIZED COMPARISON BETWEEN ANTIBIOTICS ALONE AND ANTIBIOTICS PLUS GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (ESCHERICHIA COLI-DERIVED) IN CANCER-PATIENTS WITH FEVER AND NEUTROPENIA

PURPOSE: A prospective, randomized study was conducted to determine if recombinant human granulocyte-macrophage colony-stimulating factor (r h-GMCSF) (Escherichia coli-derived) could improve response rates to an tibiotic therapy and shorten the duration of neutropenia in cancer pat ients. PATIENTS AND METHODS: A total Of 107 febrile neutropenic cancer patients were randomly assigned to empiric therapy with ticarcillin-c lavulanate (4 g ticarcillin + 0.1 g clavulanate IV every 4 hours) plus netilmicin (2 mg/kg IV every 8 hours) with or without rh-GMCSF (3 mu g/kg per day IV). Clinical improvement, duration of neutropenia, and t oxicity were monitored. RESULTS: Addition of rh-GMCSF to the antibioti cs significantly improved the response rate (96% versus 82%, P = 0.03) , but not the survival rate (93% versus 93%), in the evaluable patient s. This difference in response rate was not significant when consideri ng all patients in an intent-to-treat analysis. The number of patients who recovered from severe neutropenia (<100 cells/mu L) during the pe riod of observation in the study was significantly greater among patie nts receiving the colony-stimulating factor, although the median durat ion of neutropenia was not affected. Superinfections and subsequent in fections were not significantly different among the two treatment regi mens. Side effects were more common among patients treated with the co lony-stimulating factor. CONCLUSIONS: Our data do not support the rout ine administration of rh-GMCSF with antibiotics for patients with feve r and neutropenia. Further studies should be conducted to identify tho se patients most likely to benefit from rh-GMCSF therapy, such as pati ents with persistent profound neutropenia and refractory infections.