Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 3532
© 2005 American Society of Clinical Oncology

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Abstract

Cost-effectiveness analysis of oxaliplatin/5-FU/LV in adjuvant treatment of stage III colon cancer in the U.S

Innovus Research (UK) Ltd., High Wycombe, United Kingdom; London Sch of Economics, London, United Kingdom; Innovus Research (UK) Ltd, High Wycombe, United Kingdom; Innovus Research Inc, Medford, MA; Sanofi-Aventis, Bagneux, France; Royal Free and Univ Coll Medcl Sch, London, United Kingdom

3532

Background: The MOSAIC trial demonstrated that oxaliplatin/5-FU/LV (FOLFOX4) as adjuvant treatment of stage II/III colon cancer significantly improves disease-free survival (DFS) at 3 years, compared to 5-FU/LV (78.7% vs 73.3%, p<0.001).[1] FOLFOX4 has become the new standard in stage III. This analysis evaluates the long-term cost-effectiveness of using FOLFOX4 in this setting, from a US Medicare perspective. Methods: We estimated the cost per life-year (LY) gained over a lifetime. Using stage III patient data from the MOSAIC trial (median follow-up 44.2 months), we estimated DFS and overall survival (OS) up to 4 years from randomization. We extrapolated DFS from 4 to 5 years by fitting a Weibull model, and thereafter using a life table for the US general population. We assumed no relapse occurred beyond 5 years. We predicted OS beyond 4 years using the extrapolated DFS estimates and observed survival after relapse. Costs were calculated from trial data up to relapse, accounting for censoring; while for periods after relapse or 4 years they were estimated using literature. Uncertainty was explored using a bootstrap approach. Results: The extrapolated life-expectancy of stage III patients on FOLFOX4 was 19.99 years vs. 18.33 years for patients on 5-FU/LV. The lifetime extrapolated incremental disease-free survival between FOLFOX4 and 5-FU/LV was 2.31 years (95% CI: 0.72, 3.89). The expected cost of treatment following relapse was estimated at $54,000. Total lifetime disease-related costs were $55,525 with oxaliplatin vs. $38,093 with 5-FU/LV. The resulting incremental cost-effectiveness ratio for FOLFOX4 compared to 5-FU/LV was $17,900 per LY gained, after discounting costs and outcomes at 3% per annum. Conclusions: Adjuvant chemotherapy with FOLFOX4 has shown a significant DFS benefit over 5-FU/LV in the MOSAIC trial. We extrapolated the within-trial data to estimate a 1.66 (0.10, 3.22) year benefit in overall life expectancy in patients with stage III disease. If this benefit is confirmed, we estimate that FOLFOX4 would cost $17,900 per LY gained, which compares favorably with other accepted interventions in oncology. [1]André T NEJM 2004; 350:2343–51

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration sanofi-aventis

Abstract presentation from the 2005 ASCO Annual Meeting