title: Biochemotherapy in the treatment of metastatic melanoma in selected patients.
abstract: BACKGROUND
  Bioimmunochemotherapy (BCT) is a combination of biological agents and cytostatics that has shown an increase in response rate (RR) in metastatic melanoma patients. The aim of the study is to evaluate RR, progression- free survival (PFS), overall survival (OS) and treatment toxicity.
  
  
  METHODS
  Retrospective analysis of 11 metastatic melanoma patients treated from January 2002 to June 2008 with cisplatin 20 mg/m(2) i.v. days 1.4, dacarbazine 800 mg/m(2) i.v. day 1, vinblastine 1.5 mg/m(2) i.v. days 1.4, interleukin (IL)-2 9 MIU/m(2) s.c. 5.8 days and interferon (IFN)-alpha-2b 5 MIU/m2 s.c. days 5.9, 11, 13 and 15, with the support of granulocyte colony-stimulating factor (G-CSF) and antibiotics. Patients with ECOG 0, age < or = 65 years and with measurable disease were included. The planned number of courses was 4. RR was measured by Revised Evaluation Criteria in Solid Tumour (RECIST) criteria (computed tomography [CT]+/-proton emission tomography [PET]). Toxicity was measured according to the National Cancer Institute (NCI) common toxicity criteria.
  
  
  RESULTS
  Observed RRs were 18% complete response (CR), 27% partial response (PR), 9% stable disease (SD) and 46% disease progression. The median PFS was 4 months (95% CI, 0.10 m), with a 23% one-year PFS. Median OS was 4.6 months (95% CI, 0.9.19 m), with a 29% one-year OS. Eighty-three percent of patients experienced grade 3-4 toxicity, mainly due to neutropenia, thrombocytopenia and flu-like syndrome.
  
  
  CONCLUSIONS
  Treatment with BCT shows an increase in RR, some achieving durable CR; nevertheless it cannot be considered a standard treatment and should be employed only in selected patients.
authors.affiliation: Medical Oncology Service, Virgen de las Nieves University Hospital, ES-18014 Granada, Spain. bea_astorga@hotmail.com
authors.forename: Beatriz
authors.initials: B
authors.lastname: González Astorga
authors.forename: Berta
authors.initials: B
authors.lastname: Jiménez Rubiano
authors.forename: Juan Ramón
authors.initials: JR
authors.lastname: Delgado Pérez
authors.forename: Javier
authors.initials: J
authors.lastname: Valdivia Bautista
authors.forename: Carmen
authors.initials: C
authors.lastname: Sánchez Toro
authors.forename: Encarnación
authors.initials: E
authors.lastname: González Flores
authors.forename: Raquel
authors.initials: R
authors.lastname: Luque Caro
authors.forename: Victoria
authors.initials: V
authors.lastname: Castellón Rubio
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D017326:Clinical Trials, Phase III as Topic; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D007167:Immunotherapy; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary* / Q000628:therapy; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000401:mortality / Q000556:secondary* / Q000628:therapy; D015201:Meta-Analysis as Topic; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D011994:Recombinant Proteins; D012074:Remission Induction; D012189:Retrospective Studies; D012983:Soft Tissue Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary* / Q000628:therapy; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D007155:Immunologic Factors; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D014747:Vinblastine; D003606:Dacarbazine; D002945:Cisplatin