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Results of Immunochemotherapy with Interleukin-2, Interferon-α2 and 5-Fluorouracil in the Treatment of Metastatic Renal Cell Cancer

Objective: In patients with advanced metastatic renal cell carcinoma (RCC) seen at a single institution, the toxicity and long-term clinical effects of a combination therapy with recombinant interleukin-2 (rIL-2), recombinant interferon-α2 (rIFN-α2) and 5-fluorouracil (5-FU) were evaluated. Method: From August 1992 through August 1997, 47 consecutive patients (38 men) with metastatic RCC were treated using rIL-2 and rIFN-α2 subcutaneously in combination with intravenous 5-FU. An average of 2.4 cycles/patient (range 1–9) was administered. Results: Toxicity grades II and III (World Health Organization) were observed in 24 and 17 patients, respectively. We achieved 9 major responses (7 complete responses (CR) and 2 partial responses (PR)) for an objective response rate of 19.1% (95% confidence interval 9.1–33.3%). A further 13 patients (27.7%) had a stabilization of disease. After a mean follow-up of 17.9 (2–53) months, 4 patients are alive with no evidence of disease. The 1- and 3-year survival probability was 70 and 37%, respectively. In an univariate analysis, two prognostic factors were correlated with disease outcome: Karnofsky performance index (p = 0.01) and the presence of bone metastases (p = 0.023). Conclusion: This triple-drug combination therapy was effective in the treatment of progressive RCC in almost every fifth patient.