Interleukin-2, interferon-α and 5-fluorouracil immunotherapy for metastatic renal cell carcinoma:: The all Ireland experience

Objective: To analyse the long-term efficacy of combined interferon-alpha (IFN-alpha) and interleukin-2 (IL-2) subcutaneously, with 5-fluorouracil (5-FU) intravenously in a general multicentre setting, as treatment for metastatic renal cell carcinoma (RCC). Methods: Fifty-nine patients with metastatic RCC were scheduled to receive an 8-week cycle of immunotherapy. Karnofsky score ranged from 70 to 100 (median 90). Thirty-one patients at presentation had metastases of which 14 underwent nephrectomy. Metastases occurred in multiple organs (lung 74%, mediastinal lymphadenopathy 22%, bone 21%). Therapeutic response and survival were analysed. Results: Nine patients died from disease progression prior to completion of one full cycle. Six cases (10%) have stable disease at a follow-up of 51 months (range 20-88 months). Currently 11 patients (19%) are alive at a mean follow-up of 45 months (range 18-88 months). Forty-eight patients (81%) died of their disease at a mean follow-up of 10 months (range 0.5-46 months). Survival rate at 1 year was 53%, at 2 years 21%, at 3 years 16% and at 5 years 5%. Overall median survival is 10 months. Conclusion: IL-2 and IFN-alpha with 5-FU based immunotherapy achieve durable survival rates at 3 years in a minority of patients. Addition of 5-FU does not increase survival in our group. This study population is very different to other reported series. However it reflects better the entire population with metastatic RCC though results are subsequently poorer. Identifying patients that will respond is paramount. (C) 2003 Elsevier B.V. All rights reserved.