Comparative study of cefepime versus ceftazidime in the empiric treatment of pediatric cancer patients with fever and neutropenia

Background. In view of the recent trend toward monotherapy in the treatment of bacterial infection, we evaluate the clinical efficacy and safety of ce fepime us. ceftazidime for the empiric treatment of febrile episodes in neu tropenic pediatric cancer patients. Methods. In a single site, open label study, 104 neutropenic pediatric canc er patients [96% with absolute neutrophil count (ANC) of <500 neutrophils/m m(3)] with a median age of 6 years were randomized (1:1) to receive either intravenous cefepime or ceftazidime (50 mg/kg/dose every 8 h; <less than or equal to>6 g/day) for empiric treatment of fever (temperature >38.0 degree sC occurring at least twice in 24 h, or single >38.5 degreesC), Febrile epi sodes were classified as either microbiologically or clinically documented infection or fever of unknown origin. Therapy continued until the ANC was g reater than or equal to 1000 neutrophils/mm(3) or there was an increasing A NC in low risk patients (maximum duration of treatment, 8 weeks). The prima ry efficacy endpoints assessed were clinical and microbiologic response to assigned drug therapy, Secondary outcome measures were rate of early discon tinuation of study drug and use of concomitant antibiotic therapy to modify initial study drug regimen, Results. Of 68 patients who could be evaluated for efficacy, 74% (26 of 35) of cefepime-treated patients and 70% (23 of 33) of ceftazidime-treated pat ients responded to treatment. The small number of study patients precluded statistical analysis of results. In a modified intent-to-treat analysis, 59 % of the patients treated with cefepime and 47% of ceftazidime-treated pati ents responded to therapy. Cefepime patients developed fewer new infections than ceftazidime patients (9% vs. 21%, respectively) and early discontinua tion of study drug therapy occurred slightly more often in the ceftazidime group. Further, the use of concomitant systemic antimicrobial therapy (most ly vancomycin) occurred less often in the cefepime-treated patients, as com pared with the ceftazidime group [35% [17 of 49] us. 44% (24 of 55), respec tively]. No deaths or serious adverse events were considered to be related to study therapy. The most frequent adverse event was rash that was moderat e in severity, and it occurred equally in both groups. Conclusion. Cefepime appears to be safe and effective compared with ceftazi dime for initial empiric therapy of febrile episodes in neutropenic pediatr ic cancer patients.