High-dose aldesleukin in renal cell carcinoma: long-term survival update

This article updates response duration and survival data for patients with metastatic renal cell carcinoma receiving high-dose recombinant interleukin-2 (rIL-2).

Two hundred fifty-five assessable renal cell carcinoma patients were entered into seven phase II clinical trials. They were administered 600,000 or 720,000 IU/kg rIL-2 by 15-minute intravenous infusion every 8 hours for up to 14 consecutive doses over 5 days as clinically tolerated with maximal support. A second identical cycle of treatment was scheduled following 5 to 9 days of rest, and courses could be repeated every 6 to 12 weeks in stable or responding patients. All data have been updated as of June 1996 with report forms completed by the clinical investigators.

Objective overall responses have now been achieved in 37 of 255 patients (15%) with 17 complete (7%) and 20 partial (8%) responses. Median response duration for all objective responders is 54 months with a range of 3 to 107+ months. Median response duration for all complete responses has not been reached, with a range of 7 to 107+ months. Median response duration for all partial responses is 20 months, with a range of 3 to 97+ months. Median survival for all 255 patients was 16.3 months, and 10% to 20% of patients were estimated to be alive 5 to 10 years following treatment.

Treatment with high-dose rIL-2 is extremely effective for a subset of patients with metastatic renal cell carcinoma.