IMMUNOCHEMOTHERAPY WITH INTERFERON-α, INTERLEUKIN-2, 5-FLUOROURACIL, AND CIMETIDINE FOR PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

Abstract

Introduction. We prospectively evaluated the efficacy and safety of immunochemotherapy using INF-α, IL-2, 5-fluorouracil (5-FU), and cimetidine in patients with metastatic renal cell carcinoma (RCC). Patients and Methods. Twenty-two patients with metastatic RCC were given 4 weeks of initial therapy consisting of IFN-α (3-6x10^6 IU/day 3 times/week), IL-2 (0.7-1.4x10^6 JRU/day for 5 consecutive days/week), 5-FU (150 mg/m2/day for 5 consecutive days/week), and cimetidine (800 mg/day), followed by maintenance therapy with IFN-α, IL-2, and cimetidine. The response rate, overall and progression-free survivals, and adverse events were analyzed. Results. The median periods of therapy and follow-up were 4.4 months (range: 0.4 33) and 28.8 months (range: 1-65), respectively. The early anti-tumor effect was a complete response in one (4.5%), a partial response in 3 (13.6%), no change in 9 (40.9%), and progressive disease in 9 (40.9%). The 2-year progression-free and overall survival rates were 31% and 76%, respectively. The overall survival of cytokine-naive group was higher than that of cytokine-resistant group (p＜0.032). Adverse events of grade ≦3 occurred in 5 patients, and 9 discontinued this therapy due to adverse events. Conclusion. The present regimen had a low response rate despite the high incidence of adverse events and should be limited to patients with cytokine-naive metastatic RCC.