title: Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas.
abstract: BACKGROUND
  The role of prophylactic antibacterial agents after chemotherapy remains controversial.
  
  
  METHODS
  We conducted a randomized, double-blind, placebo-controlled trial in patients who were receiving cyclic chemotherapy for solid tumors or lymphoma and who were at risk for temporary, severe neutropenia (fewer than 500 neutrophils per cubic millimeter). Patients were randomly assigned to receive either 500 mg of levofloxacin once daily or matching placebo for seven days during the expected neutropenic period. The primary outcome was the incidence of clinically documented febrile episodes (temperature of more than 38 degrees C) attributed to infection. Secondary outcomes included the incidence of all probable infections, severe infections, and hospitalization but did not include a systematic evaluation of antibacterial resistance.
  
  
  RESULTS
  A total of 1565 patients underwent randomization (784 to placebo and 781 to levofloxacin). The tumors included breast cancer (35.4 percent), lung cancer (22.5 percent), testicular cancer (14.4 percent), and lymphoma (12.8 percent). During the first cycle of chemotherapy, 3.5 percent of patients in the levofloxacin group had at least one febrile episode, as compared with 7.9 percent in the placebo group (P<0.001). During the entire chemotherapy course, 10.8 percent of patients in the levofloxacin group had at least one febrile episode, as compared with 15.2 percent of patients in the placebo group (P=0.01); the respective rates of probable infection were 34.2 percent and 41.5 percent (P=0.004). Hospitalization was required for the treatment of infection in 15.7 percent of patients in the levofloxacin group and 21.6 percent of patients in the placebo group (P=0.004). The respective rate of severe infection was 1.0 percent and 2.0 percent (P=0.15), with four infection-related deaths in each group. An organism was isolated in 9.2 percent of probable infections.
  
  
  CONCLUSIONS
  Among patients receiving chemotherapy for solid tumors or lymphoma, the prophylactic use of levofloxacin reduces the incidence of fever, probable infection, and hospitalization.
authors.affiliation: University Hospital Birmingham Cancer Centre, Birmingham, United Kingdom. michael.cullen@uhb.nhs.uk
authors.forename: Michael
authors.initials: M
authors.lastname: Cullen
authors.forename: Neil
authors.initials: N
authors.lastname: Steven
authors.forename: Lucinda
authors.initials: L
authors.lastname: Billingham
authors.forename: Claire
authors.initials: C
authors.lastname: Gaunt
authors.forename: Mark
authors.initials: M
authors.lastname: Hastings
authors.forename: Peter
authors.initials: P
authors.lastname: Simmonds
authors.forename: Nicholas
authors.initials: N
authors.lastname: Stuart
authors.forename: Daniel
authors.initials: D
authors.lastname: Rea
authors.forename: Mark
authors.initials: M
authors.lastname: Bower
authors.forename: Indrajit
authors.initials: I
authors.lastname: Fernando
authors.forename: Robert
authors.initials: R
authors.lastname: Huddart
authors.forename: Simon
authors.initials: S
authors.lastname: Gollins
authors.forename: Andrew
authors.initials: A
authors.lastname: Stanley
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001424:Bacterial Infections / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000209:etiology / Q000517:prevention & control; D006760:Hospitalization; D006801:Humans; D007958:Leukocyte Count; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced / Q000150:complications; D015242:Ofloxacin / Q000009:adverse effects / Q000627:therapeutic use*; D012306:Risk; D018746:Systemic Inflammatory Response Syndrome / Q000209:etiology
chemical_list: D000900:Anti-Bacterial Agents; D000970:Antineoplastic Agents; D064704:Levofloxacin; D015242:Ofloxacin