Subcutaneous Recombinant Interleukin-2 and a-Interferon in Patients with Advanced Renal Cell Carcinoma: Results of a Multicenter Phase II Study

A phase II multiinstitutional clinical trial was conducted to evaluate the safety and efficacy of the subcutaneous outpatient administration of recombinant human interleukin-2 and a-interferon in patients with progressive metastatic renal cell carcinoma. One hundred and forty-five patients were entered on this study between October 1989 and May 1991. Among 134 patients evaluable for treatment response, there were six complete (4.5%) and twenty partial (14.9%) responders, with an overall response rate of 19.4% (95% confidence interval, 13-26%). The median duration of complete remissions was 228 (range 51+ - 520+) days; the median duration of partial tumor regressions was calculated at 226 (range 112 - 473+) days. The overall median survival from start of therapy was 14.2 (range 1 -23+) months. Fever, chills and general fatigue occurred in the majority of patients treated and were measured at grade II, III and IV in up to 55%, 24% and 3% of all evaluable patients, respectively. Three patients each developed...