Subcutaneous interleukin-2, interferon alfa-2a, and continuous infusion of fluorouracil in metastic renal cell carcinoma:: A multicenter phase II trial

Purpose: A phase II trial was designed to determine the efficacy and the tolerance of interleukin-2 (IL-2), interferon alfa-2a (IFN alpha), and fluorouracil (5-FU) in patients with metastatic renal cell carcinoma. Patients and Methods: One hundred eleven patients were included. Patients received subcutaneous IL-2 9 x 10(6) IU daily for 6 days and IFN alpha 6 x 10(6) IU on days 1, 3, and 5 every other week for 8 weeks. 5-FU was administered through a continuous infusion at 600 mg/m(2) for 5 consecutive days for 1 week every 4 weeks. Results: The response rate was 1.8% (95% confidence interval [CI], 0% to 4.3%) with only two partial responses (PRs). Toxicity was moderate with 3.6% grade 4 events and two deaths related to treatment. Conclusion: This regimen of IL-2, IFN alpha, and 5-FU in patients with metastatic renal cell carcinoma was ineffective. The results raise the question of the dose and schedule of subcutaneous cytokines that must be used in metastatic renal carcinoma. J Clin Oncol 16: 2728-2732. (C) 1998 by American Society of Clinical Oncology.