PHASE-II STUDY OF CONTINUOUS INTRAVENOUS-INFUSION OF RECOMBINANT INTERLEUKIN-2 IN PATIENTS WITH ADVANCED RENAL-CELL CARCINOMA

Background: The goal of this study was to evaluate the therapeutic eff icacy and toxicity of recombinant interleukin-2 (rIL-2) administered b y continuous intravenous (CIV) infusion to patients with metastatic re nal cell cancer (RCC). Patients and methods: Thirty patients with RCC were given rIL-2 18 MIU/m2/d CTV. The schedule consisted of two induct ion cycles and four maintenance cycles with a 3-week rest period betwe en cycles. Each induction cycle consisted of two infusion periods last ing 120 and 108 hours, respectively, separated by a 6-day rest period. Each maintenance cycle consisted of a 120-hour infusion period. Resul ts: Among 29 assessable patients, the objective response rate was 14% (95% confidence interval, 2% to 26%); one patient achieved a complete response, and 3 partial responses. Ten patients (34%) had stable disea se (SD). Median survival was 11 months. Toxicity was generally managea ble. Hypotension was universal, but required dose reduction in only 2 patients. Increase in serum creatinine levels was observed in 20 patie nts, and returned to normal in all but 4 patients after discontinuatio n of treatment. Conclusion: Results confirm the efficacy of rIL-2 in p atients with RCC and the feasibility of the treatment in a normal onco logy ward. However, responses are observed in a minority of patients, and treatment-related toxicity, as well as technical problems, may be troublesome to many patients.