Results of immunochemotherapy with interleukin-2, interferon-alpha(2) and 9-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 o f a combination therapy with recombinant interleukin-2 (rIL-2), recombinant interferon-alpha(2) (rIFN-alpha(2)) and 5-fluorouracil (5-FU) were evaluat ed. Method: From August 1992 through August 1997, 47 consecutive patients ( 38 men) with metastatic RCC were treated using rIL-2 and rIFN-alpha 2 subcu taneously in combination with intravenous 5-FU. An average of 2.4 cycles/pa tient (range 1-9) was administered. Results: Toxicity grades II and III (Wo rld Health Organization) were observed in 24 and 17 patients, respectively. We achieved 9 major responses (7 complete responses (CR) and 2 partial res ponses (PR)) for an objective response rate of 19.1% (95% confidence interv al 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 n o evidence of disease. The 1- and 3-year survival probability was 70 and 37 %, respectively. In an univariate analysis, two prognostic factors were cor related with disease outcome: Karnofsky performance index (p = 0.01) and th e presence of bone metastases (p = 0.023). Conclusion: This triple-drug com bination therapy was effective in the treatment of progressive RCC in almos t every fifth patient.