HIGH-DOSE INTERLEUKIN-2 2 DAYS A WEEK FOR METASTATIC RENAL-CELL CARCINOMA - A FNCLCC MULTICENTER STUDY

The purpose of this study was to determine the efficacy and safety of a new high-dose interleukin (IL)-2 regimen, given two days a week for renal cell carcinoma. One hundred and four patients received IL2 as a continous i.v. infusion for 48 h at a daily dose of 24 x 10(6) IU/m(2) /day for 5 consecutive weeks. Patients were assessed for efficacy 4 an d 8 weeks after the end of therapy, and patients who stabilized or res ponded received maintenance therapy with the same regimen. An objectiv e clinical response was observed in 20 patients (complete in four, par tial in 16). The dose of infused IL2 was significantly higher in the r esponders than in the nonresponders (p < 0.005). Clinical responses we re significantly associated with a sedimentation rate of <20 (p = 0.02 ), but no other prognostic factor was identified. Mean survival was 13 months. Grade 3 and 4 toxicities were rare, except for hypotension (5 8% of patients), the main dose-limiting toxic effect. Overall, 83% of the planned dose of IL-2 was given. IL-2 given 2 days a week is active in metastatic renal cell carcinoma and well tolerated.