title: IL-2 in combination with IFN- alpha and 5-FU versus tamoxifen in metastatic renal cell carcinoma: long-term results of a controlled randomized clinical trial.
abstract: We conducted a prospectively randomized clinical trial to compare the efficacy and safety of subcutaneous interferon-alpha2a, 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-alpha2a 5 x 10(6) IU m(-2), day 1 weeks 1 + 4; days 1, 3, 5 weeks 2 + 3; 10 x 10(6) IU m(-2), days 1, 3, 5 weeks 5-8; interleukin-2 10 x 10(6) IU m(-2), twice daily days 3-5 weeks 1 + 4; 5 x 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-alpha2a 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-alpha2a, interleukin-2 and 5-fluorouracil demonstrated significant therapeutic efficacy in patients with progressive renal cell carcinoma when compared to hormonal therapy.
authors.affiliation: Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, Hannover, 30625, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Atzpodien
authors.forename: H
authors.initials: H
authors.lastname: Kirchner
authors.forename: H J
authors.initials: HJ
authors.lastname: Illiger
authors.forename: B
authors.initials: B
authors.lastname: Metzner
authors.forename: D
authors.initials: D
authors.lastname: Ukena
authors.forename: H
authors.initials: H
authors.lastname: Schott
authors.forename: P J
authors.initials: PJ
authors.lastname: Funke
authors.forename: M
authors.initials: M
authors.lastname: Gramatzki
authors.forename: S
authors.initials: S
authors.lastname: Jürgenson
authors.forename: T
authors.initials: T
authors.lastname: Wandert
authors.forename: T
authors.initials: T
authors.lastname: Patzelt
authors.forename: M
authors.initials: M
authors.lastname: Reitz
mesh_terms: D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D016898:Interferon-alpha; D007376:Interleukin-2; D013629:Tamoxifen; D005472:Fluorouracil