LACK OF EFFICACY OF RECOMBINANT HUMAN INTERLEUKIN-6 IN PATIENTS WITH ADVANCED RENAL-CELL CANCER - RESULTS OF A PHASE-II STUDY

The present phase II study was undertaken to assess antitumoral activi ty, safety and tolerability of recombinant human interleukin-6 (rh IL- 6) in patients with advanced renal cell cancer. Rh IL-6 was administer ed as a daily subcutaneous injection at a fixed dose of 150 mu g/day f or a maximum of 42 consecutive days. 12 patients with metastatic renal cell cancer without previous immunotherapy were enrolled and were eva luated for response. No objective clinical responses were observed in the trial. Toxicity was moderate and reversible and mainly comprised f ever, influenza-like symptoms, fatigue and moderate hepatotoxicity. An aemia, leucocytosis, thrombocytosis and induction of an acute phase re sponse were observed in most patients. In conclusion, prolonged subcut aneous administration of rh IL-6 on an outpatient basis is safe and fe asible. However, rh IL-6 exhibited no antitumoral activity in patients with metastastic renal cell cancer. Profound regulatory effects on ha ematopoiesis and inflammatory response of rh IL-6 were observed. (C) 1 998 Elsevier Science Ltd. All rights reserved.