title: Randomized comparison between antibiotics alone and antibiotics plus granulocyte-macrophage colony-stimulating factor (Escherichia coli-derived in cancer patients with fever and neutropenia.
abstract: OBJECTIVE
  A prospective, randomized study was conducted to determine if recombinant human granulocyte-macrophage colony-stimulating factor (rh-GMCSF) (Escherichia coli-derived) could improve response rates to antibiotic therapy and shorten the duration of neutropenia in cancer patients.
  
  
  METHODS
  A total of 107 febrile neutropenic cancer patients were randomly assigned to empiric therapy with ticarcillin-clavulanate (4 g ticarcillin + 0.1 g clavulanate i.v. every 4 hours) plus netilmicin (2 mg/kg i.v. every 8 hours) with or without rh-GMCSF (3 micrograms/kg per day i.v.). Clinical improvement, duration of neutropenia, and toxicity were monitored.
  
  
  RESULTS
  Addition of rh-GMCSF to the antibiotics significantly improved the response rate (96% versus 82%, P = 0.03), but not the survival rate (93% versus 93%), in the evaluable patients. This difference in response rate was not significant when considering all patients in an intent-to-treat analysis. The number of patients who recovered from severe neutropenia ( < 100 cells/microliter) during the period of observation in the study was significantly greater among patients receiving the colony-stimulating factor, although the median duration of neutropenia was not affected. Superinfections and subsequent infections were not significantly different among the two treatment regimens. Side effects were more common among patients treated with the colony-stimulating factor.
  
  
  CONCLUSIONS
  Our data do not support the routine administration of rh-GMCSF with antibiotics for patients with fever and neutropenia. Further studies should be conducted to identify those patients most likely to benefit from rh-GMCSF therapy, such as patients with persistent profound neutropenia and refractory infections.
authors.affiliation: Department of Medical Specialties, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
authors.forename: E J
authors.initials: EJ
authors.lastname: Anaissie
authors.forename: S
authors.initials: S
authors.lastname: Vartivarian
authors.forename: G P
authors.initials: GP
authors.lastname: Bodey
authors.forename: C
authors.initials: C
authors.lastname: Legrand
authors.forename: H
authors.initials: H
authors.lastname: Kantarjian
authors.forename: D
authors.initials: D
authors.lastname: Abi-Said
authors.forename: C
authors.initials: C
authors.lastname: Karl
authors.forename: S
authors.initials: S
authors.lastname: Vadhan-Raj
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019818:Clavulanic Acid; D002969:Clavulanic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004926:Escherichia coli; D005334:Fever / Q000188:drug therapy*; D005839:Gentamicins / Q000008:administration & dosage / Q000627:therapeutic use*; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D009428:Netilmicin / Q000008:administration & dosage / Q000627:therapeutic use*; D009503:Neutropenia / Q000188:drug therapy*; D010406:Penicillins / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D012074:Remission Induction; D015163:Superinfection / Q000209:etiology; D015996:Survival Rate; D013982:Ticarcillin / Q000008:administration & dosage / Q000627:therapeutic use*; D065093:beta-Lactamase Inhibitors
chemical_list: D000900:Anti-Bacterial Agents; D002969:Clavulanic Acids; D004338:Drug Combinations; D005839:Gentamicins; D010406:Penicillins; D065093:beta-Lactamase Inhibitors; D019818:Clavulanic Acid; D009428:Netilmicin; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D013982:Ticarcillin