A Phase II Study with 5-Fluorouracil, Folinic Acid and Oxaliplatin (FOLFOX-4 Regimen) in Patients with Metastatic Renal Cell Carcinoma

Purpose: To investigate the efficacy and safety of the FOLFOX-4 regimen for patients with metastatic renal cell carcinoma (MRCC). Patients and Methods: Fifty-nine patients (median age 59 years) pre-treated or not by cytokines (29 vs. 30) received the FOLFOX-4 regimen every 2 weeks. Results: Three minor responses, and no complete or partial responses were obtained. The median progression-free survival was 3 months (95% CI: 2.6–3.4), the median survival 10.6 months (95% CI: 8.7–12.4), with no difference between pre-treated patients and others. Treatment was well tolerated. Conclusion: The FOLFOX-4 regimen is ineffective in patients with MRCC. We believe that oxaliplatin should no longer be explored in renal carcinoma.