A combination of subcutaneous recombinant interleukin-2 and recombinant interferon-alpha in the treatment of advanced renal cell carcinoma or melanoma.

In this phase II study, we have evaluated the efficacy and toxicity of low-dose subcutaneous (s.c.) recombinant interleukin-2 (IL-2) and recombinant interferon (IFN)-alpha in 16 patients with advanced renal cell carcinoma (RCC) and in 4 patients with advanced melanoma. The complete course on this protocol comprised 6 weeks of s.c. IL-2 plus IFN-alpha followed by a 2-week rest period. The treatment was moderately strenuous for patients, requiring frequent dose reductions; only eight cycles (30%) could be administered to 75-100% of the projected dose. Main side-effects were fever, fatigue, hypotension, liver toxicity, neurotoxicity and skin reactions. Among the evaluable 17 patients, two responses (one partial, one complete) were seen in patients with RCC. This regimen proved to be rather toxic and yielded a modest response rate of 15% in RCC, but initial findings concerning the duration of survival seem promising.