Phase II Study of Interferon-gamma Versus Interleukin-2 and Interferon-alpha 2b in Metastatic Renal Cell Carcinoma

AbstractPurpose: In a randomized phase II study we evaluated response, survival and side effects of low dose recombinant interferon-gamma in 30 patients (group 1) versus recombinant interleukin-2 and interferon-alpha2b in 30 (group 2) with metastatic renal cell carcinoma.Materials and Methods: Group 1 received 200 microgram interferon-gamma subcutaneously once a week. Group 2 received 4 × 4.8 × 106 IU/m.2 interleukin-2 subcutaneously on days 1 and 22, 2 × 4.8 × 106 IU/m.2 on days 2 and 23, and 2 × 2.4 × 106 IU/m.2 combined with interferon-alpha 2b subcutaneously at 3 × 106 IU/m.2 on days 3, 5, 24 and 26, and 6 × 106 IU/m.2 3 times weekly for 6 weeks.Results: Toxicity grades 2 and 3 (World Health Organization) were observed in group 2 only. After followup of 13 months there was no remission in group 1 compared to 7 remissions in group 2, with 23 cases of progressive disease detected.Conclusions: Combination therapy showed an objective response rate of 23 percent (p = 0.01). Although survival was not a prim...