title: Randomized phase III trial of docetaxel plus carboplatin with or without levofloxacin prophylaxis in elderly patients with advanced non-small cell lung cancer: the APRONTA trial.
abstract: OBJECTIVE
  To examine the effect of levofloxacin prophylaxis on infection rates during chemotherapy with docetaxel plus carboplatin in elderly patients with advanced non-small cell lung cancer.
  
  
  METHODS
  In a randomized, double-blind, phase III study, patients (≥65 years) with untreated, histologically/cytologically proven stage IIIB/IV non-small cell lung cancer received docetaxel (75 mg/m) plus carboplatin (area under the curve 6) on day 1 every 3 weeks, plus once-daily levofloxacin (500 mg orally) or placebo on days 5 to 11. The primary end point was the rate of grade 3/4 infections or grade 1/2 infections treated with additional antibiotics. Secondary end points included overall infection rate, toxicity, overall survival, and progression-free survival.
  
  
  RESULTS
  In total, 187 patients were randomized to levofloxacin (n = 95) or placebo (n = 92). The rate of grade 3/4 infections or grade 1/2 infections treated with additional antibiotics (intent-to-treat population) was 27.5% (95% confidence interval, 19.3-39.0%) for levofloxacin versus 36.7% (95% confidence interval, 27.1-48.0%) for placebo. Median time to first infection was 67 days for levofloxacin versus 46 days for placebo. Grade 3/4 infections occurred in 8.8% of patients in the levofloxacin group versus 26.7% for placebo. There was one grade 5 infection in each group. Grade ≥3 toxicities (levofloxacin versus placebo) included leukopenia (63.2 versus 52.2%), neutropenia (62.1 versus 51.1%), dyspnea (12.6 versus 8.7%), and pain (10.5 versus 9.8%). There was no significant difference in overall survival or progression-free survival between groups.
  
  
  CONCLUSIONS
  Levofloxacin prophylaxis reduces the rate of infection compared with placebo and is well tolerated in elderly patients receiving docetaxel plus carboplatin.
authors: Klinik fuer Innere Medizin II, Krankenhaus Martha-Maria Halle-Dölau, Halle, Germany.
authors: Wolfgang
authors: W
authors: Schuette
authors: Sylke
authors: S
authors: Nagel
authors: Ludwig Fischer
authors: LF
authors: von Weikersthal
authors: Stefan
authors: S
authors: Pabst
authors: Christian
authors: C
authors: Schumann
authors: Burkhard
authors: B
authors: Deuss
authors: Thorsten
authors: T
authors: Salm
authors: Katrin
authors: K
authors: Roscher
authors: Nicolas
authors: N
authors: Dickgreber
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000150:complications / Q000517:prevention & control*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004311:Double-Blind Method; D004417:Dyspnea / Q000139:chemically induced; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D007970:Leukopenia / Q000139:chemically induced; D064704:Levofloxacin; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000150:complications; D015242:Ofloxacin / Q000627:therapeutic use*; D010146:Pain / Q000139:chemically induced; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000890:Anti-Infective Agents; D043823:Taxoids; D000077143:Docetaxel; D064704:Levofloxacin; D015242:Ofloxacin; D016190:Carboplatin