title: Once daily, oral, outpatient quinolone monotherapy for low-risk cancer patients with fever and neutropenia: a pilot study of 40 patients based on validated risk-prediction rules.
abstract: BACKGROUND
  The objective of this study was to assess the feasibility of empiric, oral, outpatient quinolone monotherapy in 40 adult patients with fever and neutropenia who were at low risk for serious medical complications.
  
  
  METHODS
  Patients with breast cancer or sarcoma who presented with fever and neutropenia and were identified as low risk received empiric, oral, quinolone monotherapy (gatifloxacin at a dose of 400 mg once daily). Patients who had a significant source/focus of infection on presentation were excluded. After an initial observation period of 4 to 8 hours in the emergency center, the remainder of their management was ambulatory. Patients were evaluated for response to therapy, development of complications and/or the need for hospital admission, and drug-related adverse events.
  
  
  RESULTS
  Three of 43 patients studied were ineligible medically because of the presence of Common Toxicity Criteria (version 3.0) Grade>2 mucositis. Of the 40 eligible patients, 38 patients (95%) responded to gatifloxacin monotherapy, although 1 patient requested hospital admission (92% response for ambulatory management). The mean duration of therapy was 7 days, and the median number of days from enrollment to defervescence was 4 days. There were no serious medical complications, no drug-related adverse events, and no deaths on study or during 30 days of follow-up.
  
  
  CONCLUSIONS
  The results from this study indicated that outpatient quinolone monotherapy in low-risk febrile neutropenic patients is safe, effective, and well received. These conclusions need to be validated in a randomized trial.
authors.affiliation: Division of Internal Medicine, The University of Texas, M. D. Anderson Cancer Center, Houston, Texas 77030, USA. krolston@mdanderson.org
authors.forename: Kenneth V I
authors.initials: KV
authors.lastname: Rolston
authors.forename: Ellen F
authors.initials: EF
authors.lastname: Manzullo
authors.forename: Linda S
authors.initials: LS
authors.lastname: Elting
authors.forename: Susan E
authors.initials: SE
authors.lastname: Frisbee-Hume
authors.forename: Leslie
authors.initials: L
authors.lastname: McMahon
authors.forename: Richard L
authors.initials: RL
authors.lastname: Theriault
authors.forename: Shreyaskumar
authors.initials: S
authors.lastname: Patel
authors.forename: Robert S
authors.initials: RS
authors.lastname: Benjamin
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy; D005240:Feasibility Studies; D005260:Female; D005334:Fever / Q000188:drug therapy*; D024841:Fluoroquinolones / Q000008:administration & dosage*; D000077734:Gatifloxacin; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000188:drug therapy*; D010045:Outpatients; D010865:Pilot Projects; D012307:Risk Factors; D012509:Sarcoma / Q000150:complications* / Q000188:drug therapy
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D000077734:Gatifloxacin