title: Economic evaluation of antibiotic prophylaxis in small-cell lung cancer patients receiving chemotherapy: an EORTC double-blind placebo-controlled phase III study (08923).
abstract: BACKGROUND
  To determine whether the cost of prophylactic antibiotics during chemotherapy is offset by cost savings due to a decreased incidence of febrile leukopenia (FL).
  
  
  METHODS
  Small-cell lung cancer (SCLC) patients were randomised to standard or intensified chemotherapy with granulocyte colony-stimulating factor to assess the impact on survival (n = 244). In addition, patients were randomised to prophylactic ciprofloxacin and roxithromycin or placebo to assess the impact on FL (n = 161). The economic evaluation examined the costs and effects of patients taking antibiotics versus placebo. Medical resource utilisation was documented prospectively, including 33 patients from one centre in The Netherlands (NL) and 49 patients from one centre in Germany (GE). The evaluation takes the perspective of the health insurance systems and of the hospitals. Sensitivity analyses were performed.
  
  
  RESULTS
  In the main trial, prophylactic antibiotics reduced the incidence of FL, hospitalisation due to FL and use of therapeutic antibiotics by 50%. In GE, the incidence of FL was not reduced by prophylaxis. This resulted in an average cost difference of only 35 Euros [95% confidence interval (CI) (-)1.713-2.263] in favour of prophylaxis (not significant). In NL, prophylaxis reduced the incidence of FL by nearly 50%, comparable with the results of the main trial, resulting in a cost difference of 2706 Euros [95% CI 810-5948], demonstrating savings in favour of prophylactic antibiotics of nearly 45%. Sensitivity analyses indicate that with an efficacy of prophylaxis of 50%, and with expected costs of antibiotic prophylaxis of 500 Euros or less, cost savings will incur over a broad range of baseline risks for FL; that is, a risk >10-20% for FL per cycle.
  
  
  CONCLUSIONS
  Giving oral prophylactic antibiotics to SCLC patients undergoing chemotherapy is the dominant strategy in both GE and NL, demonstrating both cost-savings and superior efficacy. The sensitivity analyses demonstrate that, due to the efficacy of prophylactic antibiotics and their low unit cost, cost savings will incur over a broad range of baseline risks for FL. We recommend the use of prophylactic antibiotics in patients at risk for FL during chemotherapy.
authors.affiliation: University Medical Centre Nijmegen, Nijmegen, The Netherlands. v.tjan@onco.umcn.nl
authors.forename: V C G
authors.initials: VC
authors.lastname: Tjan-Heijnen
authors.forename: S
authors.initials: S
authors.lastname: Caleo
authors.forename: P E
authors.initials: PE
authors.lastname: Postmus
authors.forename: A
authors.initials: A
authors.lastname: Ardizzoni
authors.forename: J T M
authors.initials: JT
authors.lastname: Burghouts
authors.forename: E
authors.initials: E
authors.lastname: Buccholz
authors.forename: B
authors.initials: B
authors.lastname: Biesma
authors.forename: T
authors.initials: T
authors.lastname: Gorlia
authors.forename: R
authors.initials: R
authors.lastname: Crott
authors.forename: G
authors.initials: G
authors.lastname: Giaccone
authors.forename: C
authors.initials: C
authors.lastname: Debruyne
authors.forename: C
authors.initials: C
authors.lastname: Manegold
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D019072:Antibiotic Prophylaxis; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D003520:Cyclophosphamide / Q000008:administration & dosage; D004311:Double-Blind Method; D004317:Doxorubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D005334:Fever; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D017048:Health Care Costs / Q000706:statistics & numerical data; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D015994:Incidence; D007970:Leukopenia / Q000139:chemically induced* / Q000191:economics / Q000517:prevention & control*; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D012307:Risk Factors; D013534:Survival
chemical_list: D010919:Placebos; D016179:Granulocyte Colony-Stimulating Factor; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide