Treatment of patients with metastatic renal carcinoma with a combination of subcutaneous interleukin-2 and interferon alfa with or without fluorouracil

Purpose: Subcutaneous recombinant interleukin-2 (rIL-5) and recombinant int erferon alfa-29 (rIFN alpha -2a) have been used extensively in the treatmen t of metastatic renal cancer. Most results, coming from noncontrolled phase II trials, showed inconsistent rates of response. More recently, the addit ion of fluorouracil (FU) was proposed to improve the efficacy of these regi mens. Patients and Methods: The role of a subcutaneous combination of rIL-2 and r IFN alpha -2a with or without FU was investigated. Patients were randomly a ssigned to receive a combination of rIL-2 and rIFN alpha -2a at weeks 1, 3, 5, and 7 or the same combination together with a continuous infusion of FU at weeks 1 and 5, The major end points of this multicenter, randomized tri al were progression-free survival, response rate, and toxicity. Overall sur vival was a secondary end point, Tumor responses were reviewed by an indepe ndent committee, Analysis of the results was performed on an intention-to-t reat basis. Results: One hundred thirty-one patients were enrolled. There was no differ ence in toxicity between the arms, and no toxic death was observed. One par tial response was observed in arm A and five in arm B. Progression-free sur vival did not differ between the arms, and rates at 1 year were 12% and 15% in arms A and B, respectively. No statistically significant differences we re detected in any end point, Conclusion: The subcutaneous combination of rIL-2 and rIFN alpha -2a with o r without FU does not benefit patients with metastatic renal carcinoma, Nei ther of these regimens can be recommended as standard treatment, The result s of the subcutaneous cytokine regimen seem disappointing, J Clin Oncol 18: 4009-4015. (C) 2000 by American Society of Clinical Oncology.