title: Symptom and quality of life results of an international randomised phase III study of adjuvant vaccination with Bec2/BCG in responding patients with limited disease small-cell lung cancer.
abstract: OBJECTIVE
  This study reports the symptom and HRQOL results in which standard treatment was compared to standard therapy plus Bec2, an anti-idiotypic antibody that mimics GD3, a ganglioside antigen.
  
  
  METHODS
  Five hundred and fifteen LD SCLC patients were randomised to receive five vaccinations of Bec2 (2.5mg)/BCG vaccine arm (VA) or an observational arm (OA) administered over a 10-week period. Survival was the primary end-point; HRQOL was a secondary end-point, assessed using the EORTC QLQ-C30/LC 13.
  
  
  RESULTS
  There was no improvement in survival or progression-free survival in the vaccination arm. At baseline patients in both arms demonstrated significantly impaired scores on the global QOL scale, when compared to a normative population. However, HRQOL and symptom scores between the two treatment arms were not statistically different at any time point.
  
  
  CONCLUSIONS
  We found no benefits to patient HRQOL by additional vaccination with Bec2/BCG to LD SCLC for patients who have been undergoing standard therapy.
authors.affiliation: Quality of Life Department, European Organisation for Research and Treatment of Cancer, EORTC Headquarters,AISBL-IVZW, Avenue E. Mounierlaan, 83/11, Brussel 1200, Bruxelles, Belgium. andrew.bottomley@eortc.be
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
authors.forename: Channa
authors.initials: C
authors.lastname: Debruyne
authors.forename: Enriqueta
authors.initials: E
authors.lastname: Felip
authors.forename: Michael
authors.initials: M
authors.lastname: Millward
authors.forename: Luc
authors.initials: L
authors.lastname: Thiberville
authors.forename: Giannicola
authors.initials: G
authors.lastname: D'Addario
authors.forename: Lisa
authors.initials: L
authors.lastname: Rome
authors.forename: Petr
authors.initials: P
authors.lastname: Zatloukal
authors.forename: Corneel
authors.initials: C
authors.lastname: Coens
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Giaccone
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000009:adverse effects / Q000627:therapeutic use*; D019496:Cancer Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D051638:Ether-A-Go-Go Potassium Channels / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009419:Nerve Tissue Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D010349:Patient Compliance; D011788:Quality of Life; D055752:Small Cell Lung Carcinoma / Q000473:pathology / Q000628:therapy*; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods
chemical_list: D001500:BCG Vaccine; D019496:Cancer Vaccines; D051638:Ether-A-Go-Go Potassium Channels; C121382:KCNH4 protein, human; D009419:Nerve Tissue Proteins