Background: In advanced renal cell cancer (RCC) interleukin-2 (IL-2) and interferon-α (IFN-α) have shown modest clinical activity as single agents, substantial toxicity being associated with IL-2. For development of a therapeutically active but less toxic regimen a phase II trial of subcutaneous recombinant IL-2 (rIL-2) and low-dose recombinant IFN-α2a (rIFN-α2a) was initiated in unselected patients with advanced RCC. Patients and Methods: From 26 patients stratified to 2 prognostic subsets differing in ECOG status and risk factors, 16 patients were eligible. One treatment cycle consisted of 18×106 IU rIL-2 and 3×106 IU rIFN-α2a on days 1-3 of weeks 1-3 with the 4th week off therapy. Toxicity led to dose reductions of rIL-2 (day 1: 18×106 IU, day 2: 12×106 IU, day 3: 6×106 IU). Circulating cytokines were determined by sandwich enzyme immunoassays during the first 3 days of treatment. Results: 63 treatment cycles were given to 16 patients. The toxicity of the reduced regimen allowed an outpatient therapy (44 treatment cycles). No tumor remission occurred. Stable disease after 2 treatment cycles was observed in 44% of all patients and in 70% of low-risk patients. Median survival was 496 days for low-risk patients and 57 days for high-risk patients. Immunological monitoring revealed a treatment-related enhancement of interleukin-6 serum levels (days 1-3) and of tumor necrosis factor-α and interferon-7 serum levels (day 1). Conclusion: No effect on tumor remission was observed by this treatment regimen of subcutaneous rIL-2 combined with low-dose rIFN-α2a in unselected patients with advanced RCC. Toxicity necessitated a dose reduction of rIL-2 for outpatient therapy.

Keywords:
Interleukin-2, Interferon-α, Interleukin-6, Renal cell cancer
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© 1994 S. Karger AG, Basel
1994
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