SUBCUTANEOUS LOW-DOSE RECOMBINANT INTERLEUKIN-2 AND ALPHA-INTERFERON IN PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA

A double-institution phase II study was performed in patients with met astatic renal cell carcinoma treated subcutaneously (s.c.) with interl eukin 2 (IL-2) and alpha-interferon (INF-alpha). Thirty-eight patients were treated over a course of 7 weeks. Initially (day 1 + 2) patients received s.c. IL-2 at 18 x 10(6) IU m(-2). During the following 6 wee ks, patients received s.c. IL-2 at 3.6 x 10(6) IU m(-2) for 5 days per week and s.c. INF-alpha at 5 x 10(6) for 3 days per week. Thirty-eigh t patients were evaluated for response. An objective response was seen in seven patients (18.4 +/- 12.3%), with one complete response and si x partial responses. Median duration of response was 6.7 months. Toxic ity could be evaluated in 38 patients and was limited. Mild to moderat e toxicity included fever (97%), fatigue or malaise (76%), nausea or v omiting (50%), anorexia (32%), hypotension (26%), neurological disturb ances (26%) and hypercreatininaemia (39%). In addition, four grade IV haematological toxicities were noted. No cardiac side-effects were see n. IL-2 and INF-alpha given by this schedule can be safely administere d in an outpatient setting. The objective response rate was similar to our previous treatments with high-dose IL-2 given as a continuous inf usion.