PHASE-II STUDY OF INTERFERON-GAMMA VERSUS INTERLEUKIN-2 AND INTERFERON-ALPHA-2B IN METASTATIC RENAL-CELL CARCINOMA

Purpose: In a randomized phase II study we evaluated response, surviva l and side effects of low dose recombinant interferon-gamma in 30 pati ents (group 1) versus recombinant interleukin-2 and interferon-alpha 2 b in 30 (group 2) with metastatic renal cell carcinoma. Materials and Methods: Group 1 received 200 mu g. interferon-gamma subcutaneously on ce a week. Group 2 received 4 x 4.8 x 10(6) IU/m.(2) interleukin-2 sub cutaneously on days 1 and 22, 2 x 4.8 x 10(6) IU/m.(2) on days 2 and 2 3, and 2 x 2.4 X 10(6) IU/m.(2) combined with interferon-alpha 2b subc utaneously at 3 x 10(6) IU/m.(2) on days 3, 5, 24 and 26, and 6 x 10(6 ) 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 fol lowup of 13 months there was no remission in group 1 compared to 7 rem issions in group 2, with 23 cases of progressive disease detected. Con clusions: Combination therapy showed an objective response rate of 23% (p = 0.01). Although survival was not a primary aim of the study, the re was a tendency toward no significant difference in survival when ev aluating these relatively small groups (p = 0.49).