title: Economic evaluation in a randomized phase III clinical trial comparing gemcitabine/cisplatin and etoposide/cisplatin in non-small cell lung cancer.
abstract: BACKGROUND
  Information on the relative cost-effectiveness of treatments for cancer is being increasingly sought as pressure on health care resources increases. The objective of this study was to assess the cost-effectiveness of gemcitabine/cisplatin (GC) versus cisplatin/etoposide (CE) in patients with advanced non-small cell lung cancer (NSCLC), using resource utilization data collected in conjunction with the first randomized clinical trial comparing both combinations.
  
  
  METHODS
  Efficacy and medical care resource utilization data were collected prospectively in an open-label, multicenter, randomized, comparative, phase III trial conducted in Spain which compared gemcitabine/cisplatin and cisplatin/etoposide in 135 chemonaive patients with Stage IIIB or IV NSCLC. There were no differences between both regimens when survival was used as primary end-point, so a cost-minimization analysis was used to compare them. In addition, cost-effectiveness analyses were conducted when percentage of responses and time to progression were used as secondary end-points.
  
  
  RESULTS
  There were no differences between both regimens when survival was selected as the efficacy end-point. Despite the higher chemotherapy cost of GC when compared to CE, there were no differences in total direct costs (584523 pts for GC and 589630 pts for CE; P=NS) between both regimens. Potential savings with GC were mainly associated with a decrease in hospitalization rate. There were differences in favor of GC when response rate (40.6% for GC and 21.9% for CE; P<0.05) and time to disease progression (8.7 months for GC and 7.2 months for CE; P<0. 05) were used as clinical end-points. GC presented a favorable cost-effectiveness profile when compared to CE.
  
  
  CONCLUSIONS
  This prospective economic evaluation conducted alongside a clinical trial offers valuable preliminary information on the potential efficiency of the combination gemcitabine-cisplatin in NSCLC. Future assessments based on larger clinical trials focused on survival and naturalistic economic studies conducted in real clinical practice settings are necessary to confirm these findings.
authors.affiliation: From Hospital Germans Trias i Pujol, Badalona (Barcelona) Hospital Duran i Reynals, Barcelona Hospital Miguel Servet, Zaragoza, Spain. sacristan_jose@lilly.com
authors.forename: J A
authors.initials: JA
authors.lastname: Sacristán
authors.forename: T
authors.initials: T
authors.lastname: Kennedy-Martin
authors.forename: R
authors.initials: R
authors.lastname: Rosell
authors.forename: F
authors.initials: F
authors.lastname: Cardenal
authors.forename: A
authors.initials: A
authors.lastname: Antón
authors.forename: M
authors.initials: M
authors.lastname: Lomas
authors.forename: V
authors.initials: V
authors.lastname: Alberola
authors.forename: B
authors.initials: B
authors.lastname: Massuti
authors.forename: A
authors.initials: A
authors.lastname: Carrato
authors.forename: M
authors.initials: M
authors.lastname: Minshall
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000191:economics; D002945:Cisplatin / Q000008:administration & dosage; D017326:Clinical Trials, Phase III as Topic / Q000191:economics*; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000191:economics; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000191:economics*; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D005047:Etoposide; D002945:Cisplatin; D000093542:Gemcitabine