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Annals of Oncology 4:689-691, 1993
© 1993 European Society for Medical Oncology

other

Phase II study of continuous intravenous infusion of recombinant interleukin-2 in patients with advanced renal cell carcinoma

M. Lopez, S Carpano, A. Cancrini, M. Marcellini, P. Del Medico, M. Rinaldi, P. Vici, G. Paoletti and L. Di Lauro

Regina Elena Istitute for Cancer Research Rome, Italy

Correspondence to: Dr. M. Lopez, Divisione di Oncologia Medica II, Istituto Regjna Elena per lo Studio e la Cura dei Tumori, Viale Regina Elena, 291, 00161 - Roma, Italy

Background: The goal of this study was to evaluate the therapeutic efficacy and toxicity of recombinant interleukin-2 (rIL-2) administered by continuous intravenous (CIV) infusion to patients with metastatic renal cell cancer (RCC).

Patients and methods: Thirty patients with RCC were given rIL-2 18 MIU/m2/d CIV. The schedule consisted of two induction cycles and four maintenance cycles with a 3-week rest period between cycles. Each induction cycle consisted of two infusion periods lasting 120 and 108 hours, respectively, separated by a 6-day rest period. Each maintenance cycle consisted of a 120-hour infusion period.

Results: 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 disease (SD). Median survival was 11 months. Toxicity was generally manageable. Hypotension was universal, but required dose reduction in only 2 patients. Increase in serum creatinine levels was observed in 20 patients, and returned to normal in all but 4 patients after discontinuation of treatment.

Conclusion: Results confirm the efficacy of rIL-2 in patients with RCC and the feasibility of the treatment in a normal oncology 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.

interleukin-2, continuous intravenous infusion, renal cell carcinoma


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