OBJECTIVES: Gemcitabine (Gemzar) belongs to new third-generation chemotherapeutic agents that are now commonly used in combination with cisplatin or carboplatin in advanced non-small cell lung cancer (NSCLC). We compared the direct health care costs of a gemcitabine/cisplatin regimen (Gem/Cis) with paclitaxel/carboplatin (Pac/Car) and vinorelbine/cisplatin (Vin/Cis) regimens in the treatment of NSCLC in France. METHODS: The economic analysis was performed based on chemotherapy and medical resource utilisation by 612 patients in the randomised, controlled trial published by Scagliotti et al.(2002), which found no difference in efficacy between the three regimens. Trial data were combined with unit cost data from French official DRG charges for chemotherapy medication (reimbursed over the DRGs), chemotherapy administration, hospitalisations due to adverse events, and other medical resources (blood transfusions, onerous concomitant medications) for each regimen to provide total cost per patient. RESULTS: In France, the total treatment costs per patient by 21 months were 10,957€ for Gem/Cis, 12,512€ for Vin/Cis and 13,268€ for Pac/Car. The average number of chemotherapy cycles in the clinical trial was 4.02, 4.23, and 3.25 for Gem/Cis, Pac/Carbo and Vin/Cis, respectively, giving a lower total treatment cost per chemotherapy cycle for Gem/Cis (2721€) than for Pac/Car (3136€) or Vin/Cis (3,850€). The total cost difference between Gem/Cis and Pac/Car (2330€) was mainly due to the highest chemotherapy acquisition costs for Pac/Car, which were not offset by lower costs elsewhere. The difference in total costs between Gem/Cis and Vin/Cis (1575€) were due primarily to the higher rate of hospitalisation in the Vin/Cis group. CONCLUSIONS: Gem/Cis administered as a 3-week cycle incurs lower costs per patient than a 3-week cycle of Pac/Carbo and a 4-week cycle of Vin/Cis when other direct costs are considered in addition to chemotherapy acquisition costs. Notably, hospitalisation costs due to adverse events are a major cost driver for some chemotherapy regimens.