title: Interleukin-2, interferon-alpha and medroxyprogesterone acetate in metastatic renal cell carcinoma.
abstract: BACKGROUND
  Interleukin-2 (IL-2) and interferon-alpha (IFN-alpha) are the main immuno-biological agents used in the therapy of metastatic renal cell carcinoma (RCC). Unfortunately the promising results obtained in biological studies have not yet been confirmed in clinical studies. One reason is linked to the immunosuppression of metastatic patients which is caused by macrophage products. IL-6 in particular is considered a growth factor for RCC. Medroxyprogesterone acetate (MPA) may interfere with IL-6 macrophage production, possibly causing a synergistic effect in association with IL-2 and IFN-alpha. Therefore the purpose of our study was to evaluate the toxicity and the efficacy of the association between IL-2, IFN-alpha and MPA.
  
  
  METHODS
  Forty-two consecutive patients with metastatic RCC were enrolled. IL-2 was administered subcutaneously at doses of 4.5 million UI on days 1-5, 8-12, 15-19 and 22-26; IFN-alpha was administered s.c. at a dose of 3 million t.t.w; MPA was administered orally at a dose of 1000 mg daily. This schedule was repeated after a rest of 2 weeks.
  
  
  RESULTS
  Toxicity was mild: the main symptoms observed were fatigue and fever. Six CR (14%), five PR (12%), thirteen SD (31%) and seventeen PD (41%) were observed for an overall response rate of 26%. Patients with good PS and low levels of CRP had a better prognosis.
  
  
  CONCLUSIONS
  Considering both the good activity and the low toxicity of this scheme, we think that it could be carried out in normal clinical practice.
authors.affiliation: Medical and Experimental Oncology Department, Oncology Institute, Via Amendola 209, 70126 Bari, Italy. onmes2@libero.it
authors.forename: Emanuele
authors.initials: E
authors.lastname: Naglieri
authors.forename: Massimo
authors.initials: M
authors.lastname: Lopez
authors.forename: Giorgio
authors.initials: G
authors.lastname: Lelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Morelli
authors.forename: Antonella
authors.initials: A
authors.lastname: Amodio
authors.forename: Pasquale
authors.initials: P
authors.lastname: Di Tonno
authors.forename: Nicola
authors.initials: N
authors.lastname: Gebbia
authors.forename: Marisa
authors.initials: M
authors.lastname: Di Seri
authors.forename: Maria Concetta
authors.initials: MC
authors.lastname: Chetri
authors.forename: Pietro
authors.initials: P
authors.lastname: Rizzo
authors.forename: Ines
authors.initials: I
authors.lastname: Abbate
authors.forename: Addolorata
authors.initials: A
authors.lastname: Casamassima
authors.forename: Francesco Paolo
authors.initials: FP
authors.lastname: Selvaggi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000378:metabolism; D002292:Carcinoma, Renal Cell / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D004357:Drug Synergism; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects; D015850:Interleukin-6 / Q000097:blood; D007680:Kidney Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011994:Recombinant Proteins; D015996:Survival Rate
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D007376:Interleukin-2; D015850:Interleukin-6; D011994:Recombinant Proteins; D002097:C-Reactive Protein; D017258:Medroxyprogesterone Acetate