title: Phase II randomized controlled trial of an epidermal growth factor vaccine in advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  We show the result of a randomized phase II clinical trial with an epidermal growth factor (EGF)-based cancer vaccine in advanced non-small-cell lung cancer (NSCLC) patients, evaluating immunogenicity, safety, and effect on survival.
  
  
  METHODS
  Eighty patients with stage IIIB/IV NSCLC after finishing first-line chemotherapy were randomly assigned to receive best supportive care or EGF vaccinations.
  
  
  RESULTS
  Vaccination was safe. Adverse events were observed in less than 25% of cases and were grade 1 or 2 according to National Cancer Institute Common Toxicity Criteria. Good anti-EGF antibody response (GAR) was obtained in 51.3% of vaccinated patients and in none of the control group. Serum EGF concentration showed a major decrease in 64.3% of vaccinated patients. GAR patients survived significantly more than those with poor antibody response (PAR). Also, patients whose serum EGF dropped below 168 pg/mL survived significantly more than the rest. There was a trend to an increased survival for vaccinated patients compared with controls. The survival advantage for vaccinated patients compared with controls was statistically significant in the subgroup of patients with age younger than 60 years.
  
  
  CONCLUSIONS
  Vaccination with EGF was safe and provoked an increase in anti-EGF antibody titers and a decrease in serum EGF. There was a direct correlation between antibody response and survival. There was a direct correlation between decrease in serum EGF and survival. In patients younger than 60 years, vaccination was associated with increased survival.
authors: Hospital Hermanos Ameijeiras, San Lázaro 701, PO Box 10300, Ciudad Habana, Cuba.
authors: Elia
authors: E
authors: Neninger Vinageras
authors: Ana
authors: A
authors: de la Torre
authors: Marta
authors: M
authors: Osorio Rodríguez
authors: Mauricio
authors: M
authors: Catalá Ferrer
authors: Idania
authors: I
authors: Bravo
authors: Mario
authors: M
authors: Mendoza del Pino
authors: Daniel
authors: D
authors: Abreu Abreu
authors: Soraida
authors: S
authors: Acosta Brooks
authors: Rolando
authors: R
authors: Rives
authors: Concepción
authors: C
authors: del Castillo Carrillo
authors: Marta
authors: M
authors: González Dueñas
authors: Carmen
authors: C
authors: Viada
authors: Beatriz
authors: B
authors: García Verdecia
authors: Tania
authors: T
authors: Crombet Ramos
authors: Gisela
authors: G
authors: González Marinello
authors: Agustín
authors: A
authors: Lage Dávila
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000276:immunology; D000328:Adult; D000368:Aged; D019496:Cancer Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000276:immunology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000276:immunology* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000276:immunology; D004815:Epidermal Growth Factor / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D066246:ErbB Receptors / Q000378:metabolism; D005260:Female; D006801:Humans; D016233:Immunotherapy, Active / Q000379:methods; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000276:immunology* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D019496:Cancer Vaccines; D004815:Epidermal Growth Factor; D066246:ErbB Receptors