Cost-effectiveness analysis of first-line chemotherapies in metastatic colorectal cancer: Results of the Fédération Francophone de Cancérologie Digestive (FFCD) 9601 randomized trial

Background: The De Gramont regimen (or high-dose LV5FU2, HD-LV5FU2) is considered a standard treatment for metastatic colorectal cancer. The aim of the study was to evaluate the efficacy and the costs of three regimens as compared to HD-LV5FU2: raltitrexed (R), LV5FU2 with a lower dose of folinic acid (LD-LV5FU2), and weekly infusional 5FU (WI-FU). Methods: An economic analysis was performed prospectively as part of a randomized trial comparing first-line chemotherapy regimens in 294 patients with unresectable metastatic colorectal cancer. The primary endpoint was event-free survival (EFS). Direct medical costs were computed from the health system viewpoint using 2001 unit costs. Results: None of the three regimens improved EFS as compared to HD-LV5FU2. R was less effective and more toxic. The mean total cost per patient was € 15,970 for HD-LV5FU2. The cost of R (€ 10,687) was lower than that of HD-LV5FU2 (p = 0.008). The cost of LD-LV5FU2 (€ 14,888) and of WI-FU (€ 13,760) was not significantly different from that of HD-LV5FU2. Conclusion: The lower efficacy and increased toxicity of R made it a clinically inferior regimen despite its easy administration and lower cost. The HD-LV5FU2 protocol remains a better treatment. LD-LV5FU2 appeared a good alternative regimen because it reduced costs without jeopardizing its efficacy. The WI-FU regimen did not show a significant difference in terms of efficacy, but suggested toxicity to be slightly increased.