title: Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial.
abstract: OBJECTIVE
  To present an updated survival analysis of an open-label, parallel-group, phase IIB trial of BLP25 liposome vaccine (L-BLP25) in patients with stage IIIB or IV non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Patients were randomized to either L-BLP25 plus best supportive care (BSC) or BSC alone. Patients in the L-BLP25 arm received subcutaneous vaccinations of L-BLP25 930 μg weekly for 8 weeks, followed by maintenance vaccinations at 6-week intervals.
  
  
  RESULTS
  Median survival time was 4.2 months longer in patients receiving L-BLP25 plus BSC (n = 88) than in those receiving BSC alone (n = 83; 17.2 months vs. 13.0 months, respectively; hazard ratio [HR] 0.745, 95% confidence interval [CI] 0.533-1.042). The 3-year survival rate was 31% in patients receiving L-BLP25 plus BSC and 17% in those receiving BSC (P = 0.035). In the stratified subset of patients with stage IIIB loco-regional (LR) disease, median survival time was 17.3 months longer in patients receiving L-BLP25 plus BSC (n = 35) than in those receiving BSC (n = 30; 30.6 months vs. 13.3 months, respectively; HR 0.548, 95% CI 0.301-0.999). In this subgroup, 3-year survival was 49% in patients receiving L-BLP25 plus BSC and 27% in those receiving BSC (P = 0.070).
  
  
  CONCLUSIONS
  Confirming the initial results, further follow-up continues to show that survival time for patients with stage IIIB/IV NSCLC was longer with L-BLP25 plus BSC compared with BSC alone, with the greatest difference seen in patients with stage IIIB LR disease.
authors: Cross Cancer Institute, 11560 University Avenue, Edmonton, AB, T6G 1Z2, Canada. charles.butts@albertahealthservices.ca
authors: Charles
authors: C
authors: Butts
authors: Andrew
authors: A
authors: Maksymiuk
authors: Glenwood
authors: G
authors: Goss
authors: Denis
authors: D
authors: Soulières
authors: Ernie
authors: E
authors: Marshall
authors: Yvon
authors: Y
authors: Cormier
authors: Peter M
authors: PM
authors: Ellis
authors: Allan
authors: A
authors: Price
authors: Ravinder
authors: R
authors: Sawhney
authors: Frank
authors: F
authors: Beier
authors: Martin
authors: M
authors: Falk
authors: Nevin
authors: N
authors: Murray
mesh_terms: D019496:Cancer Vaccines / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000276:immunology / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D008081:Liposomes; D008175:Lung Neoplasms / Q000276:immunology / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D008297:Male; D008562:Membrane Glycoproteins / Q000008:administration & dosage*; D008875:Middle Aged; D009367:Neoplasm Staging; D016019:Survival Analysis; D015996:Survival Rate
chemical_list: D019496:Cancer Vaccines; C518273:L-BLP25; D008081:Liposomes; D008562:Membrane Glycoproteins