Randomized comparison of cefepime versus ceftazidime monotherapy for feverand neutropenia in children with solid tumors

Background. With the availability of new broad-spectrum antibiotics, initia l therapy with a single agent has become an alternative to classic combinat ions, especially beta -lactam antibiotics plus aminoglycosides, in the mana gement of febrile neutropenic cancer patients. Procedure. Since January 1994, monotherapy has been used for empiric initia l treatment at our center. The aim of this prospective randomized study is to compare the efficacy of cefepime (CFP), a new fourth-generation cephalos porin, and ceftazidime (CFZ) as empirical monotherapy of febrile neutropeni c patients with solid tumors. From January 1998 to November 1998, 63 episod es of fever and neutropenia occurring in 33 children with solid tumors incl uding lymphomas, were randomized to receive treatment with either CFP or CF Z. The patients were analyzed for leukocyte count and absolute neutrophil c ount (ANC) at entry, days in fever, neutropenia and hospitalization, and si de effects of drugs. Success with or without modifications of the initial a ntibiotic was defined as survival through neutropenia; failure was death du e to infection. Results. In our study group, with a median age of 7 [(1/12)-14] years, CFP was administered in 32, and CFZ in 31 episodes. An infection was documented microbiologically in eight episodes (25%) in the CFP arm and in nine episo des (29%) in the CFZ arm. The success rate with initial empiric monotherapy was 62.5% in the CFP arm and 61.3% in the CFZ arm respectively (P > 0.05). The total success rate (success with or without modification) was 100% in both arms. No major adverse effects were observed in either groups. Conclusion. CFP is as effective and safe as CFZ for the empirical treatment of febrile episodes in neutropenic patients with solid tumors. Med. Pediat r. Oncol. 36:434-441, 2001. (C) 2001 Wiley-Liss, Inc.