title: Subcutaneous interleukin-2, interferon alpha-2b and 5-fluorouracil in metastatic renal cell carcinoma as second-line treatment after failure of previous immunotherapy: a phase II trial.
abstract: The association of interleukin-2 (IL-2), interferon alpha-2a (IFNalpha), 5-fluorouracil (5-FU) has been reported to induce response in metastatic renal cell carcinoma (MRCC). This study evaluated IL-2, IFNalpha and 5FU as second-line treatment after failure under immunotherapy. A total of 35 patients received IL-2, at 9 x 10(6) IU m(-2), once or t.i.d, 5 days a week, every other week. Interferon alpha was administered at 6 MUI, TIW along with IL-2 every week. 5-Fluorouracil was given at 750 mg m(-2) day(-1) on days 1-5 every 4 weeks. One cycle lasted 8 weeks. All patients were evaluable for response and toxicity. There were two objective responses (5.7%) and 14 stable diseases (40%). Survival was 14 months. In all, 17 patients experienced grade 3 toxicity. The predictive factor for progression to second-line immunotherapy was the results of first-line immunotherapy, and performance status, delay from primary tumour to metastases and response or stabilisation to chemo-immunotherapy for survival. IL-2, IFNalpha and 5-FU induce low objective response but stabilisation in patients with MRCC having failed with immunotherapy, and may be considered only in selected patients on performance status, stabilisation or response after first-line immunotherapy and interval from their primary tumour to metastases.
authors.affiliation: Department of Medicine, Institut Bergonié, Bordeaux, France. alain.ravaud@chu-bordeaux.fr
authors.forename: A
authors.initials: A
authors.lastname: Ravaud
authors.forename: N
authors.initials: N
authors.lastname: Trufflandier
authors.forename: J M
authors.initials: JM
authors.lastname: Ferrière
authors.forename: M
authors.initials: M
authors.lastname: Debled
authors.forename: J
authors.initials: J
authors.lastname: Palussière
authors.forename: L
authors.initials: L
authors.lastname: Cany
authors.forename: R
authors.initials: R
authors.lastname: Gaston
authors.forename: S
authors.initials: S
authors.lastname: Mathoulin-Pélissier
authors.forename: B N
authors.initials: BN
authors.lastname: Bui
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D018450:Disease Progression; D004357:Drug Synergism; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D007376:Interleukin-2 / Q000008:administration & dosage; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011994:Recombinant Proteins; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D007376:Interleukin-2; D011994:Recombinant Proteins; D005472:Fluorouracil