Interleukin-2- and interferon alfa-2a-based immunochemotherapy in advanced renal cell carcinoma:: A prospectively German cooperative renal randomized trial of the carcinoma chemoimmunotherapy group (DGCIN)

Purpose We conducted a prospectively randomized clinical trial to compare the efficacy of three outpatient therapy regimens in 341 patients with progressive metastatic renal cell carcinoma. Patients and Methods Patients were stratified according to known clinical predictors and were subsequently randomly assigned. Treatment arms were: arm A (n = 132), subcutaneous interferon alfa-2a (sc-IFN-alpha-2a), subcutaneous interieukin-2 (sc-IL-2), and intravenous (IV) fluorouracil; arm B (n = 146): arm A treatment combined with per oral 13-cis-retinoic acid; and arm C (n 63), sc-IFN-a-2a and IV vinblastine. Results Treatment (according to the standard 8-week Hannover Atzpodien regimen) arms A, B, and C yielded objective response rates of 31%, 26%, and 20%, respectively. Arm B, but not arm A, showed a significantly improved progression-free survival (PFS) compared with arm C (P = .0248). Both arm A (median overall survival, 25 months; P = .0440) and arm B (median overall survival, 27 months; P = .0227) led to significantly improved overall survival (OS) compared with arm C (median OS, 16 months). All three sc-IFN-alpha-2a- based therapies were moderately or well tolerated. Conclusion Our results established the safety and improved long-term therapeutic efficacy of sc-IL-2 plus sc-INF-alpha-2a-based outpatient immunochemotherapies, compared with sc-INF-alpha-2a/IV vinblastine. (C) 2004 by American Society of Clinical Oncology.