CEFEPIME VERSUS IMIPENEM-CILASTATIN AS EMPIRICAL MONOTHERAPY IN 400 FEBRILE PATIENTS WITH SHORT-DURATION NEUTROPENIA

This open, comparative, randomized, multicentre equivalence study comp ared cefepime 2 g bd and imipenem-cilastatin 1 g tds (50 mg/kg/day) as empirical monotherapy for febrile episodes in a homogeneous cohort of cancer patients with short duration neutropenia following chemotherap y for solid tumour, lymphoma or myeloma. The study was conducted in 17 French anti-cancer centres in 1995 and 1996. Response to monotherapy was assessed 7 days after treatment and was based on resolution of fev er and signs and symptoms, eradication of pathogens, absence of new in fection, relapse, and death of infectious origin, without addition of other antibiotics. Patients were treated for a minimum of 4 days. Of t he 400 episodes randomized, 344 (86%) were evaluable for efficacy. Pat ient characteristics were comparable between treatment groups. Success of monotherapy was observed in 79% of episodes with cefepime and 72% with imipenem-cilastatin (equivalence, P <0.0001). The response rate f or microbiologically documented infections was 66% with cefepime and 6 1% with imipenem-cilastatin (bacteraemic episodes: 63% for cefepime; 4 4% for imipenem-cilastatin). A second antibiotic (usually a glycopepti de) was added in 20% and 21% of the cases, respectively. Overall, the response to therapy, with or without an additional antibiotic, was 95% (cefepime) and 90% (imipenem-cilastatin). Survival was similar in bot h groups (95% and 98%, respectively). Cefepime treatment was better to lerated, with 9% of the patients experiencing related intercurrent eve nts compared with 19% in the imipenem-cilastatin group (P = 0.003). Na usea/vomiting was significantly more frequent in the imipenem-cilastat in group (15%) than in the cefepime group (5%; P = 0.001). Cefepime mo notherapy was as effective as, and better tolerated than, imipenem-cil astatin in the empirical treatment of fever during short duration neut ropenia.