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

• Published in: British journal of cancer 2001-10, Vol.85 (8), p.1130-1136
• Main Authors: Atzpodien, J, Kirchner, H, Illiger, H J, Metzner, B, Ukena, D, Schott, H, Funke, P J, Gramatzki, M, Jürgenson, S von, Wandert, T, Patzelt, T, Reitz, M
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic agents; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Cancer Research; Carcinoma, Renal Cell - drug therapy; Carcinoma, Renal Cell - mortality; Combined treatments (chemotherapy of immunotherapy associated with an other treatment); Drug Resistance; Epidemiology; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Humans; Interferon-alpha - administration & dosage; Interferon-alpha - adverse effects; Interleukin-2 - administration & dosage; Interleukin-2 - adverse effects; Kidney Neoplasms - drug therapy; Kidney Neoplasms - mortality; Male; Medical sciences; Middle Aged; Molecular Medicine; Neoplasm Metastasis; Oncology; Pharmacology. Drug treatments; Prospective Studies; Regular; regular-article; Tamoxifen - adverse effects; Tamoxifen - therapeutic use
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1054/bjoc.2001.2076

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 × 10 6 IU m –2 day 1 weeks 1 + 4; days 1, 3, 5 weeks 2 + 3; 10 × 10 6 IU m –2 days 1, 3, 5 weeks 5–8; interleukin-2 10 × 10 6 IU m –2 twice daily days 3–5 weeks 1 + 4; 5 × 10 6 IU m –2 days 1, 3, 5 weeks 2 + 3; and 5-fluorouracil 1000 mg m –2 day 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