A PROSPECTIVE EVALUATION OF THE ACTIVITY OF HUMAN GRANULOCYTE-COLONY-STIMULATING FACTOR ON THE PREVENTION OF CHEMOTHERAPY-RELATED NEUTROPENIA IN PATIENTS WITH ADVANCED-CARCINOMA

After informed consent, 86 patients with advanced cancer undergoing po tentially myelosuppressive cytotoxic chemotherapy were randomized to r eceive placebo or subcutaneous granulocyte - colony stimulating factor (G-CSF) 5 mug/Kg/day in order to prevent severe neutropenia and its r elated morbidity. The incidence of neutropenia (absolute neutrophil co unt <1,000/mm3) was significantly reduced in patients receiving G-CSF than in controls (18% versus 42%; P <0.05). The duration of neutropeni a was also shortened by the administration of G-CSF (4.8 versus 8.2 da ys; P <0.05). Therapy with G-CSF has also a positive impact on the dos e-intensity of employed regimens. Patients treated with G-CSF showed o ral fungal disease in 9% of cases, while control patients had a 21% in cidence (NS). Patients treated with G-CSF received 91% of the programm ed dose-intensity as compared to 71% of control patients (P <0.05). Th ese data strengthen the clinical usefulness of G-CSF in the prevention of chemotherapy-related neutropenia, infections, and reduction in dos e-intensity. Further studies are required to establish if the increase in dose-intensity allowed by G-CSF treatment may positively influence the outcome of cancer patients.