Clinical Study

British Journal of Cancer (2005) 92, 843–846. doi:10.1038/sj.bjc.6602443 www.bjcancer.com
Published online 8 March 2005

Adjuvant treatment with interleukin-2- and interferon-alpha2a-based chemoimmunotherapy in renal cell carcinoma post tumour nephrectomy: Results of a prospectively randomised Trial of the German Cooperative Renal Carcinoma Chemoimmunotherapy Group (DGCIN)

J Atzpodien1,2, E Schmitt3, U Gertenbach4, P Fornara5, H Heynemann5, A Maskow6, M Ecke7, H H Wöltjen8, H Jentsch9, W Wieland10, T Wandert2 and M Reitz2 DGCIN – German Cooperative Renal Carcinoma Chemo-Immunotherapy Trials Group

  1. 1Fachklinik Hornheide an der Universität Münster, Internistische Onkologie, Dorbaumstr. 300, 48157 Münster, Germany
  2. 2Europäisches Institut für Tumor Immunologie und Prävention, Gotenstr. 152, 53175 Bonn, Germany
  3. 3Kreiskrankenhaus Aschersleben, Urologische Klinik, Eislebender Str. 7a, 06449 Aschersleben, Germany
  4. 4Allgemeines Krankenhaus der Stadt Hagen, Urologische Klinik, Grünstr. 35, 58095 Hagen, Germany
  5. 5Klinikum der Martin-Luther-Universität, Urologische Klinik, Ernst-Grube-Str. 40, 06120 Halle a.d. Saale, Germany
  6. 6Universitätsklinikum Leipzig, Klinik und Poliklinik für Urologie, Liebigstr. 21, 04103 Leipzig, Germany
  7. 7Städtisches Klinikum Magdeburg, Urologie, Birkenallee 34, 39002 Magdeburg, Germany
  8. 8Klinikum Minden, Hämatologie/Onkologie, Portastr. 7–9, 32423 Minden, Germany
  9. 9Klinikum Ernst-von Bergmann, Klinik für Urologie, Charlottenstr. 72, 14467 Potsdam, Germany
  10. 10Caritas Krankenhaus St Josef, Urologie, Landshuterstr. 65, 93053 Regensburg, Germany

Correspondence: Professor J Atzpodien, E-mail: SekrProfAtzpodien@yahoo.de

Received 11 October 2004; Revised 6 January 2005; Accepted 6 January 2005.

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Abstract

We conducted a prospectively randomised clinical trial to investigate the role of adjuvant outpatient immunochemotherapy administered postoperatively in high-risk patients with renal cell carcinoma. In total, 203 renal carcinoma patients' status post radical tumour nephrectomy were stratified into three risk groups: patients with tumour extending into renal vein/vena cava or invading beyond Gerota's fascia (pT3b/c pN0 or pT4pN0), patients with locoregional lymph node infiltration (pN+), and patients after complete resection of tumour relapse or solitary metastasis (R0). Patients were randomised to undergo either (A) 8 weeks of outpatient subcutaneous interleukin-2 (sc-rIL-2), subcutaneous interferon-alpha2a (sc-rIFN-alpha2a), and intravenous 5-fluorouracil (iv-5-FU) according to the standard Atzpodien regimen (Atzpodien et al, 2004) or (B) observation. Two-, 5-, and 8-year survival rates were 81, 58, and 58% in the treatment arm, and 91, 76, and 66% in the observation arm (log rank P=0.0278), with a median follow-up of 4.3 years. Two, 5-, and 8-year relapse-free survival rates were calculated at 54, 42, and 39% in the treatment arm, and at 62, 49, and 49% in the observation arm (log rank P=0.2398). Stage-adapted subanalyses revealed no survival advantages of treatment over observation, as well. Our results established that there was no relapse-free survival benefit and the overall survival was inferior with an adjuvant 8-week-outpatient sc-rIL-2/sc-rIFN-alpha2a/iv-5-FU-based immunochemotherapy compared to observation in high-risk renal cell carcinoma patients following radical tumour nephrectomy.

Keywords:

adjuvant, immunotherapy, renal cell carcinoma