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. 2001 Oct;85(8):1130–1136. doi: 10.1054/bjoc.2001.2076

IL-2 in combination with IFN-αand 5-FU versus tamoxifen in metastatic renal cell carcinoma: long-term results of a controlled randomized clinical trial

J Atzpodien 1,2, H Kirchner 3, H J Illiger 4, B Metzner 4, D Ukena 5, H Schott 6, P J Funke 7, M Gramatzki 8, S von Jürgenson 1, T Wandert 2, T Patzelt 2, M Reitz 2; D. G. C. I. N. (German Cooperative Renal Carcinoma Chemo-Immunotherapy Trials Group)2
PMCID: PMC2375150  PMID: 11710825

Abstract

We conducted a prospectively randomized clinical trial to compare the efficacy and safety of subcutaneous interferon-α2a, subcutaneous interleukin-2 and intravenous 5-fluorouracil as home therapy against oral tamoxifen in 78 patients with progressive metastatic renal cell carcinoma. Treatment courses consisted of interferon-α2a 5 × 106 IU m−2day 1 weeks 1 + 4; days 1, 3, 5 weeks 2 + 3; 10 × 106 IU m−2days 1, 3, 5 weeks 5–8; interleukin-2 10 × 106 IU m−2twice daily days 3–5 weeks 1 + 4; 5 × 106 IU m−2days 1, 3, 5 weeks 2 + 3; and 5-fluorouracil 1000 mg m−2day 1 weeks 5–8. The tamoxifen group received tamoxifen 80 mg twice daily over 8 weeks. Among 41 patients treated with interleukin-2, interferon-α2a and 5-fluorouracil there were 7 complete (17.1%) and 9 partial responders (21.9%), with an overall objective response rate of 39.1% (95% CI, 24.2–55.5). An additional 15 patients (36.6%) were stable throughout therapy. The overall survival was 24 months (range 5–76+). In 37 patients receiving tamoxifen no objective remissions occurred. 13 patients (35.1%) had stable disease and 24 patients (64.9%) showed continued disease progression. The overall survival was 13 months (range 3–73+). In summary, this home-based therapy regimen of interferon-α2a, interleukin-2 and 5-fluorouracil demonstrated significant therapeutic efficacy in patients with progressive renal cell carcinoma when compared to hormonal therapy. © 2001 Cancer Research Campaign  http://www.bjcancer.com

Keywords: renal cancer, interleukin-2, interferon-alpha, tamoxifen

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Footnotes

The first author is supported by grants of Deutsche Krebshilfe, Wilhelm-Sander-Stiftung and Gesellschaft zur Förderung immunologischer Krebstherapien e.V.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

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