Originally published as JCO Early Release 10.1200/JCO.2004.06.155 on February 23 2004

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Interleukin-2- and Interferon Alfa-2a-Based Immunochemotherapy in Advanced Renal Cell Carcinoma: A Prospectively Randomized Trial of the German Cooperative Renal Carcinoma Chemoimmunotherapy Group (DGCIN)

From the Medizinische Hochschule Hannover, Hämatologie und Onkologie Hannover; Klinikum Hannover Siloah Hämatologie/Onkologie, Hannover; Europäisches Institut für Tumor Immunologie und Prävention; Medizinische Einrichtungen der Universität Bonn, Urologische Universitätsklinik, Bonn; Fachklinik Hornheide an der Universität Münster Internistische Onkologie, Münster; Universitätsklinik Ulm, Innere Medizin 3, Ulm; Klinikum Ernst-von-Bergmann Urologische Klinik, Potsdam; Klinikum der Martin-Luther-Universität Urologische Klinik, Halle; Charité Berlin Urologische Klinik, Berlin; Klinikum Minden, Hämatologie/Onkologie, Minden; Universitätsklinikum Heidelberg, Urologische Klinik, Heidelberg; Städtische Kliniken Oldenburg Hämatologie/Onkologie, Oldenburg; Krankenhaus der Anhaltischen Diakonissenanstalten, Urologische Klinik, Dessau; Klinikum Planegg, Urologische Klinik, Planegg; Ludwig-Maximilians-Universität München; Urologische Klinik, München; and Universitätsklinik Frankfurt, Hämatologie und Onkologie, Frankfurt, Germany

Address reprint requests to Jens Atzpodien, MD, PhD, Fachklinik Hornheide an der Universität Münster, Dorbaumstraße, 300 D-48157 Münster, Germany; e-mail: Sekrprofatzpodien{at}yahoo.de

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--2a), subcutaneous interleukin-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--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--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--2a–based outpatient immunochemotherapies, compared with sc-INF--2a/IV vinblastine.

Supported by grants from Deutsche Krebshilfe, Wilhelm-Sander-Stiftung, and Deutsche Gesellschaft zur Förderung immunologischer Krebstherapien eingetragener Verein (J.A.).

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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