Economic evaluation in a randomized phase III clinical trial comparing gemcitabine/cisplatin and etoposide/cisplatin in non-small cell lung cancer

Introduction: Information on the relative cost-effectiveness of treatments for cancer is being increasingly sought as pressure on health care resource s increases. The objective of this study was to assess the cost-effectivene ss of gemcitabine/cisplatin (GC) versus cisplatin/etoposide (CE) in patient s with advanced non-small cell lung cancer (NSCLC), using resource utilizat ion data collected in conjunction with the first randomized clinical trial comparing both combinations. Methods: Efficacy and medical care resource ut ilization 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 wi th Stage IIIB or IV NSCLC. There were no differences between both regimens when survival was used as primary end-point. so a cost-minimization analysi s was used to compare them. In addition, cost-effectiveness analyses were c onducted when percentage of responses and time to progression were used as secondary end-points. Results: There were no differences between both regim ens when survival was selected as the efficacy end-point. Despite the highe r chemotherapy cost of GC when compared to CE, there were no differences in total direct costs (584 523 pts for GC and 589 630 pts For CE; P = NS) bet ween both regimens. Potential savings with GC were mainly associated with a decrease in hospitalization rate. There were differences in favor of GC wh en response rate (40.6% for CC and 21.9% for CE; P < 0.05) and lime to dise ase progression (8.7 months for GC and 7.2 months for CE; P < 0.05) were us ed as clinical end-points. GC presented a Favorable cost-effectiveness prof ile when compared to CE. Conclusions: This prospective economic evaluation conducted alongside a clinical trial offers valuable preliminary informatio n on the potential efficiency of the combination gemcitabine-cisplatin in N SCLC. Future assessments based on larger clinical trials focused on surviva l and naturalistic economic studies conducted in real clinical practice set tings are necessary to confirm these findings. (C) 2000 Elsevier Science Ir eland Ltd. All rights reserved.