SUBCUTANEOUS INTERLEUKIN-2, INTERFERON ALPHA-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 t he tolerance of interleukin-2 (IL-2), interferon alfa-2a (IFN alpha), and fluorouracil (5-FU) in patients with metastatic renal cell carcino ma. Patients and Methods: One hundred eleven patients were included. P atients received subcutaneous IL-2 9 x 10(6) IU daily for 6 days and I FN 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) f or 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 even ts and two deaths related to treatment. Conclusion: This regimen of IL -2, IFN alpha, and 5-FU in patients with metastatic renal cell carcino ma was ineffective. The results raise the question of the dose and sch edule 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.