title: Randomized study of cefepime versus ceftazidime plus amikacin in patients with solid tumors treated with high dose chemotherapy (HDC) and peripheral blood stem cell support (PBSCS) with febrile neutropenia.
abstract: OBJECTIVE
  This randomized clinical trial evaluated the efficacy and safety of monotherapy with cefepime for patients with solid tumors treated with high dose chemotherapy (HDC) and peripheral blood stem cell support (PBSCS) with febrile neutropenia.
  
  
  METHODS
  Patients with solid tumors treated with HDC and PBSCS, that developed fever and neutropenia (absolute neutrophil count < 500 cells/microL) were eligible, and randomly assigned to receive ceftazidime plus amikacin or cefepime.
  
  
  RESULTS
  Fifty-one episodes were randomized, and all were evaluable (27 received ceftazidime plus amikacin arm, and 24 cefepime). Major efficacy endpoints did not show significant differences, with success rates of 44.4% and 54.2% (p = 0.481) for the combination arm and the monotherapy arm, respectively. The proportion of patients that became afebrile in the first 24 hours was significantly higher in the cefepime group (41.7% vs 11.1%, respectively; p = 0.012). However, due to its premature closure and small sample size, this study lacks the adequate power to definitely address this question.
  
  
  CONCLUSIONS
  Cefepime monotherapy appeared to have an equivalent efficacy and safety as empiric treatment in febrile neutropenia episodes in a highrisk population compared with ceftazidime and amikacin. Nevertheless, this study is not adequately powered to answer this question. Given the small number of patients randomized and the single-center nature of this study, these results must be cautiously interpreted.
authors.affiliation: Department of Medical Oncology, University Hospital 12 de Octubre, Madrid, Spain. ajimeno1@jhmi.edu
authors.forename: A
authors.initials: A
authors.lastname: Jimeno
authors.forename: A
authors.initials: A
authors.lastname: Arcediano
authors.forename: S
authors.initials: S
authors.lastname: Bazares
authors.forename: M L
authors.initials: ML
authors.lastname: Amador
authors.forename: L
authors.initials: L
authors.lastname: González-Cortijo
authors.forename: E
authors.initials: E
authors.lastname: Ciruelos
authors.forename: L
authors.initials: L
authors.lastname: Robles
authors.forename: D
authors.initials: D
authors.lastname: Castellano
authors.forename: L
authors.initials: L
authors.lastname: Paz-Ares
authors.forename: C
authors.initials: C
authors.lastname: Lumbreras
authors.forename: J
authors.initials: J
authors.lastname: Hornedo
authors.forename: H
authors.initials: H
authors.lastname: Cortés-Funes
mesh_terms: D000328:Adult; D000583:Amikacin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D000077723:Cefepime; D002442:Ceftazidime / Q000008:administration & dosage*; D002511:Cephalosporins / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced / Q000188:drug therapy*; D033581:Stem Cell Transplantation; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D000077723:Cefepime; D000583:Amikacin; D002442:Ceftazidime