RECOMBINANT HUMAN INTERLEUKIN-6 IN METASTATIC RENAL-CELL CANCER - A PHASE-II TRIAL

A phase II trial investigating the anti-tumour effects of recombinant human interleukin 6 (rhlL-6) in patients with metastatic renal cell ca ncer was carried out. RhIL-6 (150 mu g) was administered as a daily su bcutaneous injection for 42 consecutive days on an outpatient basis. F orty-nine patients were studied, 12 with and 37 without previous immun otherapy. Forty patients were evaluable for response. A partial remiss ion was noted in two patients, stable disease in 17 and progressive di sease in 21. Toxicity was moderate and reversible and consisted mainly of fever, flu-like symptoms, nausea, weight loss and hepatotoxicity. Anaemia, leucocytosis and thrombocytosis and induction of acute phase protein synthesis were noted in most patients. In 15% of the patients anti-IL-6 antibodies developed, and were neutralising in only one pati ent. Baseline plasma IL-6 concentrations did not correlate with tumour behaviour before or after rhIL-6 treatment. In conclusion, rhIL-6 can be safely administered on an outpatient basis for a prolonged period of time and has moderate, reversible toxicity. Its administration indu ces IL-6-antibody production in only a minority of patients. Anti-tumo ur effects of rhIL-6 in metastatic renal cancer are limited.