title: Mature autologous dendritic cell vaccines in advanced non-small cell lung cancer: a phase I pilot study.
abstract: BACKGROUND
  Overall therapeutic outcomes of advanced non-small-cell lung cancer (NSCLC) are poor. The dendritic cell (DC) immunotherapy has been developed as a new strategy for the treatment of lung cancer. The purpose of this study was to evaluate the feasibility, safety and immunologic responses in use in mature, antigen-pulsed autologous DC vaccine in NSCLC patients.
  
  
  METHODS
  Five HLA-A2 patients with inoperable stage III or IV NSCLC were selected to receive two doses of 5 × 107 DC cells administered subcutaneous and intravenously two times at two week intervals. The immunologic response, safety and tolerability to the vaccine were evaluated by the lymphoproliferation assay and clinical and laboratorial evolution, respectively.
  
  
  RESULTS
  The dose of the vaccine has shown to be safe and well tolerated. The lymphoproliferation assay showed an improvement in the specific immune response after the immunization, with a significant response after the second dose (p = 0.005). This response was not long lasting and a tendency to reduction two weeks after the second dose of the vaccine was observed. Two patients had a survival almost twice greater than the expected average and were the only ones that expressed HER-2 and CEA together.
  
  
  CONCLUSIONS
  Despite the small sample size, the results on the immune response, safety and tolerability, combined with the results of other studies, are encouraging to the conduction of a large clinical trial with multiples doses in patients with early lung cancer who underwent surgical treatment.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN45563569.
authors.affiliation: Department of Internal Medicine, Faculty of Medical Sciences, State University of Campinas, Campinas, Brazil.
authors.forename: Maurício W
authors.initials: MW
authors.lastname: Perroud
authors.forename: Helen N
authors.initials: HN
authors.lastname: Honma
authors.forename: Aristóteles S
authors.initials: AS
authors.lastname: Barbeiro
authors.forename: Simone Co
authors.initials: SC
authors.lastname: Gilli
authors.forename: Maria T
authors.initials: MT
authors.lastname: Almeida
authors.forename: José
authors.initials: J
authors.lastname: Vassallo
authors.forename: Sara To
authors.initials: ST
authors.lastname: Saad
authors.forename: Lair
authors.initials: L
authors.lastname: Zambon
mesh_terms: D000368:Aged; D019496:Cancer Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D003713:Dendritic Cells / Q000276:immunology*; D005260:Female; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000009:adverse effects / Q000379:methods*; D008175:Lung Neoplasms / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D019496:Cancer Vaccines