Oral ciprofloxacin in the management of children with cancer with lower risk febrile neutropenia - A randomized controlled trial

BACKGROUND. Recent reports and a previous randomized trial conducted at the authors' institution suggested that a lower risk subset of children with f ebrile neutropenia under chemotherapy might benefit of an oral antibiotic o utpatient approach. METHODS. The objective of this study was to test the efficacy of oral cipro floxacin in the treatment of lower risk febrile neutropenia (LRFN) in child ren treated for malignant diseases. From November 1998 to December 1999, 93 episodes of LRFN in 87 children (median age, 5.5 pears; range, 0.9-15.8 ye ars) were included in a prospective randomized controlled single institutio n trial. Inclusion criteria included fever (> 38 degreesC), severe neutrope nia (absolute neutrophil count, < 500/mm(3)), and lower risk features (e.g. , absence of severe comorbidity factors, good clinical condition, negative blood cultures, control of local infection, prediction of a period of neutr openia less than 10 days after admission, and compliant parents). After 24 hours of a single intravenous ceftriaxone (100 mg/kg) plus amikacin (15 mg/ kg) and completed risk assessment workup, patients were discharged and rand omly allocated to two groups. Group A (48 episodes) received ciprofloxacin 20 mg/kg/day orally (p.o.) every 12 hours for 6 days. Group B (45 episodes) received intravenous ceftriaxone plus amikacin for 2 days more followed by cefixime (8 mg/kg/day p.o.) every 24 hours for 4 additional days. Failure was defined as the need of a second hospitalization during the same episode . RESULTS. Most of the patients (59% in Group A and 52% in Group B) were trea ted for malignant solid tumors. Fifteen (31%) children in Group A and 15 (3 3%) in Group B presented with fever of unknown origin (P value was not sign ificant). No significant differences were found in sites of initial infecti on between both groups. Overall results in this study were excellent. Only one patient with respiratory failure was detected in Group B, who did well with secondary treatment. CONCLUSIONS. In febrile neutropenic children after anticancer therapy and l ower risk features, oral ciprofloxacin for 6 days after 24 hours of intrave nous ceftraxione plus amikacin appears to be as efficacious as intravenous ceftriaxone plus amikacin for 2 days more followed by cefixime for 4 additi onal days. These results contribute to strengthen the concept of LRFN. Canc er 2001;91:1563-7. (C) 2001 American Cancer Society.