Interferon-alpha and 5-fluorouracil therapy in patients with metastatic renal cell cancer: An open multicenter trial

Objectives. Recent clinical trials have implied the cytotoxic and antiproli ferative effects of combining 5-fluorouracil and interferon-alpha in the tr eatment of metastatic renal cell cancer. We therefore conducted an open mul ticenter trial to test the efficacy of such a combination on this cancer. Methods. Human lymphoblastoid interferon (3 MIU per patient) was administer ed subcutaneously three times weekly for 12 weeks, while S-fluorouracil was administered (600 mg/m(2)/day) as a continuous infusion for the first 5 da ys, followed by an intravenous bolus infusion of 600 mg/m(2) once a week fr om the 3rd week until the 12th week. Results. Of the 63 patients entered into the trial, 55 were eligible and ev aluable for systemic toxicities, and 53 were evaluable for their response. All patients had undergone a prior nephrectomy, and their European Cooperat ive Oncology Group (ECOG) performance status ranged from 0 to 3 (median 0). Three complete and eight partial responses were induced, with an overall r esponse rate of 20.0%. The median time to progression and the median surviv al time were 11 and 33 months, respectively. World Health Organization grad e 3 toxicities were observed in 8 patients; however, no grade 4 toxicities or toxicity-related deaths were noted. Conclusions. Combination therapy of interferon-alpha plus 5-fluorouracil at the above-described dosage and schedule produced no better responses than interferon monotherapies. Prolongation of survival could be attributable to the fair performance status of the patients. This regimen has limited valu e for the treatment of patients with advanced renal cell cancer. UROLOGY 53 : 53-59, 1999. (C) 1999, Elsevier Science Inc. All rights reserved.