Objective: We conducted a phase II trial in metastatic renal cell cancer of outpatient subcutaneous (s.c.) interferon-α2b (IFN), followed by an inpatient hybrid schedule of bolus and continuous interleukin-2 (IL- 2). Methods: Treatment consisted of monthly IFN 10 MU/m2 s.c. for 4 consecutive days, followed by 36 MIU/m2 bolus IL-2, then 72-hour continuous intravenous (i.v.) infusion of 18 MIU/m2 IL-2 per day. Between May 1997 and June 2000, 25 men and 11 women enrolled, with a median age of 57 years (range, 42–77), including 9 patients over 65. Prior treatment included nephrectomy (31), radiation (8), biotherapy(7), and chemotherapy (4). Sites of disease included 26 lung, 13 lymph node, 9 bone, 8 liver, 4 kidney, and 4 adrenal locations. Patients received an average of 3.1 treatment cycles (range, 1–6). Results: There was 1 complete and 3 partial responses, for a response rate of 11% (3% to 27%; 95% confidence interval [CI]); 40% had stable disease. Median failure-free survival was 2.5 months; median overall survival was 15.0 months. The 1-, 2-, and 5-year survival rates were 53%, 30%, and 12%, respectively. Only 8 patients required a reduction in IL-2 dose. The most frequent grade 3 or 4 toxicities were 11% fatigue, 9% renal insufficiency, and 7% hypotension. Conclusions: Response and survival rates were similar to those seen in other multicenter trials using inpatient high-dose IL-2.
