INTENSIVE REGIMEN OF CYTOKINES WITH INTERLEUKIN-2 AND INTERFERON ALFA-2B IN SELECTED PATIENTS WITH METASTATIC RENAL-CARCINOMA

We conducted a Phase II trial using an intensive regimen combining int erleukin-2 (IL2), interferon-alfa-2b (IFN), and lymphokine-activated k iller (LAK) cells. The aim of this study was to evaluate the toxicity and the efficacy of this combination in selected patients with metasta tic renal cell carcinoma. Thirty-one assessable patients were treated with at least one cycle of a regimen consisting of 20 x 10(6) IU/day s .c. IFN for 5 days, followed 2 days later by i.v. injections of 24 x 1 0(6) IU/m(2)/day IL2 every 8 h together with i.v. bolus of 5 x 10(6) I U/m(2)/day IFN every 8 h during 5 days. After a 6-day break, during wh ich four leukophereses were performed, this i.v. combination was admin istered along with the LAK cell reinjections for a maximum of 5 days. Twenty-seven patients underwent the two parts of the first course of t reatment; respectively, 42% and 46% of the planned dose of IL2 and IFN were administered. Several severe toxicities were observed including two treatment-related deaths. Significant tumor responses were observe d in seven patients, including two complete remissions. Two of these p atients remain alive without evidence of disease 36 and 40 months afte r treatment, respectively. This intensive regimen of IL2 together with IFN and LAK cells cannot be recommended even in selected patients wit h metastatic renal cell carcinoma. In addition, our results argue agai nst the concept of a dose-response relationship in this setting.