Oral administration of cefixime to lower risk febrile neutropenic childrenwith cancer

BACKGROUND. Febrile neutropenia is a heterogeneous condition. Recently, sev eral risk factors have been defined, permitting the definition of a lower r isk group of patients who may benefit form less aggressive therapy. The use of an oral antibiotic approach was tested in the current trial. METHODS. From May 1997 to March 1998, 154 episodes of lower risk febrile ne utropenia in 128 children with a mean age of 62 (range, 8-200) months were enrolled in this randomized, single-institution trial. Inclusion criteria w ere fever (> 38 degrees C), neutropenia (absolute neutrophil count < 500/mm (3)), lower risk features (i.e., absence of severe comorbidity factors, goo d clinical condition, negative blood cultures, control of local infection, no fever during the last 24 hours), and compliance of parents. After 3 days of ceftriaxone (100 mg/kg/day administered intravenously [i.v.]) every 12 hours plus amikacin (15 mg/kg/day i.v.) every 24 hours for 3 days, all pati ents were discharged and randomized to be allocated to 2 treatment arms. Gr oup A (n = 74) received ceftriaxone cefixime (8 mg/kg/day administered oral ly) every 24 hours for 4 days, whereas Group B (n = 80) was treated with ce ftriaxone plus amikacin for 7 days. Failure was defined as the need for sec ond hospitalization during the same episode of neutropenia, or fever during the 7 days after discharge. RESULTS. Most of the patients (49% in Group A and 55% in Group B) had acute leukemia. Fifty-four (72%) children in Group A and 46 (56%) in Group B had fever of unknown origin (P = not significant [NS]). No significant differe nces were found in the sites of initial infection between the two groups. O verall results were outstanding, with a favorable outcome in 73 of 78 cases (98.6%) in Group A and 78 of 80 cases (97.5%) in Group B (P = NS). Three p atients needed a second hospitalization due to failure of the initial thera py: one in Group A and two in Group B. All three did well with secondary tr eatment. CONCLUSIONS. In lower risk febrile neutropenic children receiving anticance r therapy, the efficacy of oral cefixime, given for 4 days after 72 hours o f intravenous ceftriaxone plus amikacin, was similar to that of 7 days of p arenteral ceftriaxone plus amikacin. The oral outpatient therapy approach t o the treatment of lower risk febrile neutropenia after chemotherapy is saf e and may be cost-saving. This strategy might be adopted as standard therap y in the future. (C) 2000 American Cancer Society.