Atzpodien, J. and Schmitt, E. and Gertenbach, U. and Fornara, P. and Heynemann, H. and Maskow, A. and Ecke, M. and Woltjen, H. H. and Jentsch, H. and Wieland, Wolf and Wandert, T. and Reitz, M. (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). BRITISH JOURNAL OF CANCER, 92 (5). pp. 843-846. ISSN 0007-0920, 1532-1827
Full text not available from this repository. (Request a copy)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-alpha 2a), 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-alpha 2a/iv-5-FU-based immunochemotherapy compared to observation in high-risk renal cell carcinoma patients following radical tumour nephrectomy.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DOSE BOLUS INTERLEUKIN-2; INTERFERON-ALPHA; RADICAL NEPHRECTOMY; PHASE-III; 5-FLUOROURACIL; CANCER; COMBINATION; VACCINE; RISK; adjuvant; immunotherapy; renal cell carcinoma |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Urologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 18 May 2021 10:12 |
| Last Modified: | 18 May 2021 10:12 |
| URI: | https://pred.uni-regensburg.de/id/eprint/36372 |
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