1. 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).
- Author
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Atzpodien, J., Schmitt, E., Gertenbach, U., Fornara, P., Heynemann, H., Maskow, A., Ecke, M., Wöltjen, H. H., Jentsch, H., Wieland, W., Wandert, T., Reitz, M., Wöltjen, H H, and German Cooperative Renal Carcinoma Chemo-Immunotherapy Trials Group (DGCIN)
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ADJUVANT treatment of cancer , *RENAL cancer , *INTERLEUKIN-2 , *INTERFERONS , *ANTINEOPLASTIC agents , *IMMUNOTHERAPY , *CANCER patients , *FLUOROURACIL , *THERAPEUTIC use of proteins , *COMPARATIVE studies , *KIDNEY tumors , *RESEARCH methodology , *MEDICAL cooperation , *METASTASIS , *PROGNOSIS , *RECOMBINANT proteins , *RENAL cell carcinoma , *RESEARCH , *STATISTICAL sampling , *SURVIVAL analysis (Biometry) , *EVALUATION research , *RANDOMIZED controlled trials , *NEPHRECTOMY , *SURGERY , *THERAPEUTICS - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2005
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