title: Biochemotherapy with low doses of subcutaneous interleukin-2 in patients with melanoma: results of a phase II trial.
abstract: BACKGROUND
  Metastatic melanoma has an ominous prognosis. Bio-chemotherapy regimens can increase the response rate but with a high degree of toxicity due, mainly, to the use of high-dose intravenous interleukin-2.
  
  
  OBJECTIVE
  To test the feasibility and activity profile of a bio-chemotherapy regimen of low-dose subcutaneous interleukin-2.
  
  
  METHODS
  Administration scheme: dacarbazine at 200 mg/m2/d on days 1-4, cisplatin at 20 mg/m2/d intravenous on days 1-4, vinblastine at 1.5 mg/m2/d on days 1-4, IL-2 at 4.5 MUI/m2/d subcutaneous on days 5-8, IFN-alpha at 5 MU subcutaneous on days 5-9, 11, 13, 15 of every 21-day cycle.
  
  
  RESULTS
  Objective response was obtained in 11 patients (39.3%; 95%CI: 21-59) including 4 with complete response (14.3%; 95%CI: 4-33). With an extended follow-up of 49 months and 60 months, respectively, 2 patients continue with complete response. The main toxicities were haematological: grade 3-4 neutropenia in 8.2% of cycles, thrombocytopenia in 1.2% and anaemia in 3.2%.
  
  
  CONCLUSIONS
  The regimen is safe and has a good activity profile. The presence of long-term survivors, despite the use of lower doses and subcutaneous IL-2, is encouraging.
authors.affiliation: Servicio de Oncología Médica (ICHMO), Hospital Clinic, Barcelona, IDIBAPS, Spain.
authors.forename: María
authors.initials: M
authors.lastname: González Cao
authors.forename: Susana
authors.initials: S
authors.lastname: Puig
authors.forename: Josep
authors.initials: J
authors.lastname: Malvehy
authors.forename: Josep Eugeni
authors.initials: JE
authors.lastname: Herrero
authors.forename: Rosa María
authors.initials: RM
authors.lastname: Martí
authors.forename: Carlos
authors.initials: C
authors.lastname: Conill
authors.forename: Marcelo
authors.initials: M
authors.lastname: Sánchez
authors.forename: Begoña
authors.initials: B
authors.lastname: Mellado
authors.forename: Pere
authors.initials: P
authors.lastname: Gascón
authors.forename: Teresa
authors.initials: T
authors.lastname: Castel
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003606:Dacarbazine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D016898:Interferon-alpha / Q000008:administration & dosage; D007376:Interleukin-2 / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D012878:Skin Neoplasms / Q000188:drug therapy / Q000473:pathology; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D007155:Immunologic Factors; D016898:Interferon-alpha; D007376:Interleukin-2; D014747:Vinblastine; D003606:Dacarbazine; D002945:Cisplatin