title: Up to 15-year clinical follow-up of a pilot Phase III immunotherapy study in stage II breast cancer patients using oxidized mannan-MUC1.
abstract: BACKGROUND
  Targeting antigens to dendritic cell receptors has recently become a popular approach to inducing effective immune responses against cancer antigens. Almost 20 years ago, however, we demonstrated that targeting the mannose receptor on macrophages and dendritic cells leads to strong cellular immune responses. We conducted numerous human clinical trials demonstrating the effectiveness of oxidized mannan-MUC1 (M-FP) in MUC1(+) adenocarcinoma patients. In one trial, the 5-8-year follow-up of breast cancer patients vaccinated with M-FP was published previously; we now report here the 12-15-year follow-up. Details regarding the preparation of the vaccine, inclusion and exclusion criteria, immunotherapy and follow-up schedule, were published previously.
  
  
  RESULTS
  The follow-up at 12-15 years showed that the recurrence rate in patients receiving placebo was 60% (nine of 15). In those receiving immunotherapy (M-FP), the rate was 12.5% (two of 16). The time of recurrence in the placebo group ranged from 7 to 180 months (mean: 65.8 months) and in the two patients of the vaccine group, the recurrence appeared at 95 and 141 months (mean: 118 months) after surgery. These findings are statistically significant (p = 0.02 for survival and p = 0.009 for percentage of patients cancer-free). All patients injected with M-FP showed no evidence of toxic effects or signs of autoimmunity during the 12-15-year follow-up.
  
  
  CONCLUSIONS
  The preliminary evidence indicates that M-FP is beneficial in the overall survival of early-stage breast cancer patients. This long-term clinical follow-up of patients strongly supports the necessity for a large Phase III study of direct M-FP injection in early-stage breast cancer patients, to evaluate immunotherapy as an adjuvant treatment for breast cancer.
authors.affiliation: Prolipsis Medical Centre, Athens, Greece.
authors.forename: Stamatis
authors.initials: S
authors.lastname: Vassilaros
authors.forename: Anastasios
authors.initials: A
authors.lastname: Tsibanis
authors.forename: Annivas
authors.initials: A
authors.lastname: Tsikkinis
authors.forename: Geoffrey A
authors.initials: GA
authors.lastname: Pietersz
authors.forename: Ian F C
authors.initials: IF
authors.lastname: McKenzie
authors.forename: Vasso
authors.initials: V
authors.lastname: Apostolopoulos
mesh_terms: D000230:Adenocarcinoma / Q000276:immunology / Q000401:mortality / Q000628:therapy; D000368:Aged; D001943:Breast Neoplasms / Q000276:immunology / Q000401:mortality / Q000628:therapy; D019496:Cancer Vaccines / Q000008:administration & dosage / Q000276:immunology; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007167:Immunotherapy; D008351:Mannans / Q000008:administration & dosage / Q000276:immunology; D008875:Middle Aged; D018396:Mucin-1 / Q000008:administration & dosage / Q000276:immunology; D010084:Oxidation-Reduction; D015996:Survival Rate
chemical_list: D019496:Cancer Vaccines; D008351:Mannans; D018396:Mucin-1