Granulocyte colony-stimulating factor in the treatment of high-risk febrile neutropenia: A multicenter randomized trial

Background: Granulocyte colony-stimulating factors (G-CSFs) have been shown to help prevent febrile neutropenia in certain subgroups of cancer patient s undergoing chemotherapy, but their role in treating febrile neutropenia i s controversial. The purpose of our study was to evaluate-in a prospective multicenter randomized clinical trial-the efficacy of adding G-CSF to broad -spectrum antibiotic treatment of patients with solid tumors acid high-risk febrile neutropenia, Methods: A total of 210 patients with solid tumors tr eated with conventional-dose chemotherapy who presented with fever and grad e IV neutropenia were considered to be eligible for the trial. They met at least one of the following high-risk criteria: profound neutropenia (absolu te neutrophil count <100/mm(3)), short latency from previous chemotherapy c ycle (<10 days), sepsis or clinically documented infection at presentation, severe comorbidity, performance status of 3-4 (Eastern Cooperative Oncolog y Group scale), or prior inpatient status. Eligible patients were randomly assigned to receive the antibiotics ceftazidime and amikacin, with or witho ut C-CSF (5 mug/kg per day). The primary study end point was the duration o f hospitalization. All P values were two-sided. Results: Patients randomly assigned to receive G-CSF had a significantly shorter duration of grade IV neutropenia (median, 2 days versus 3 days; P =.0004), antibiotic therapy (m edian, 5 days versus 6 days; P =.013), and hospital stay (median, 5 days ve rsus 7 days; P =.015) than patients in the control arm. The incidence of se rious medical complications not present at the initial clinical evaluation was 10% in the G-CSF group and 17% in the control group (P =.12), including five deaths in each study arm. The median cost of hospital stay and the me dian overall cost per patient admission were reduced by 17% (P =.01) and by 11% (P =.07), respectively, in the G-CSF arm compared with the control arm . Conclusions: Adding G-CSF to antibiotic therapy shortens the duration of neutropenia, reduces the duration of antibiotic therapy and hospitalization , and decreases hospital costs in patients with high-risk febrile neutropen ia.