A NEW SCHEDULE OF INTERLEUKIN-2 FOR METASTATIC RENAL-CELL CARCINOMA -THE INSTITUT GUSTAVE-ROUSSY STUDY

Treatment of metastatic renal cell carcinoma with interleukin 2 (IL2) remains controversial despite the authorisation from the French govern ment for IL2 with the West schedule in this disease. We report herein the study of the Institut Gustave-Roussy of 73 patients, who received from 1989 to 1991 a new schedule of high dose IL2. Seventy three patie nts received high dose IL2 according to the following schedule: IL2 by continuous infusion at 24 10(6) IU/m(2)/d, on 2 consecutive days per week, during 5 weeks. This treatment was associated in the first 33 pa tients with gamma interferon at a dose of 5 10(6) IU/m(2)/d subcutaneo usly the days of IL2 infusion, during the 5 weeks of therapy. Immunoth erapy was further continued in responding patients, either as an assoc iation of IL2 and LANAK (lymphokine-activated naturel killer) cells, o r as IL2 alone. Finally, when possible, surgery was performed on resid ual masses. Twenty five percent of objective responses (PR + CR) have been observed. Moreover, 12.3% CR has been obtained after the overall therapy. The global mean survival is 15 months, with a mean survival o f 8, 18 and 24 + months depending on the status of the disease (progre ssive, stable or responsing) after initial treatment with IL2. Toleran ce of this schedule was good with an actual received dose of 90% of th e planned doses, and patients could leave the hospital within 2 hours after the end of IL2 in 87% of the cycles. No toxic death was observed . Among the parameters observed for correlation with the clinical resp onse, only performance status and level of sTNF-alpha R were significa ntly associated with the response.