title: Impact of TG4010 Vaccine on Health-Related Quality of Life in Advanced Non-Small-Cell Lung Cancer: Results of a Phase IIB Clinical Trial.
abstract: BACKGROUND
  This study describes the effect of TG4010 vaccine on Health related Quality of Life (HRQOL) in patients with stage IIIb and IV non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  148 patients with advanced NSCLC expressing MUC1 were randomly assigned to receive TG4010 plus chemotherapy or chemotherapy alone. HRQOL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline and every 6 weeks until disease progression. Time until definitive deterioration (TUDD) of the four well-being dimensions of the FACT-L physical (PWB), functional (FWB), emotional (EWB) and social well-being (SWB) and the Lung Cancer Subscale (LCS) domains were analyzed for a 5-point minimal clinically important difference.
  
  
  RESULTS
  No difference of TUDD of HRQOL has been found between treatment arms. No prognostic factors have been found to have a significant impact on the TUDD of PWB, SWB and LCS domains. The gender, the performance status and the smoking habits seemed to be associated with a shorter TUDD of EWB domain. The smokers and the former smokers seemed to present a shorter TUDD of FWB domain.
  
  
  CONCLUSIONS
  This study suggests that adding therapeutic vaccination with TG4010 to standard chemotherapy in patients with advanced NSCLC is associated with a similar evolution in HRQOL compared to chemotherapy alone.
authors.affiliation: National Quality of Life in Oncology Platform, Nancy, France; INSERM, CIC-EC CIE6, Nancy, France; CHU Nancy, Clinical Epidemiology and Evaluation Department, Nancy, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Rotonda
authors.affiliation: National Quality of Life in Oncology Platform, Nancy, France; Université de Franche-Comté, EA 3181, Besançon, France; CHU Besançon, Methodological and quality of life unit in oncology, Besançon, France.
authors.forename: Amélie
authors.initials: A
authors.lastname: Anota
authors.affiliation: National Quality of Life in Oncology Platform, Nancy, France; Université de Franche-Comté, EA 3181, Besançon, France.
authors.forename: Mariette
authors.initials: M
authors.lastname: Mercier
authors.affiliation: Transgene SA, Illkirch, France.
authors.forename: Bérangère
authors.initials: B
authors.lastname: Bastien
authors.affiliation: Transgene SA, Illkirch, France.
authors.forename: Gisèle
authors.initials: G
authors.lastname: Lacoste
authors.affiliation: Transgene SA, Illkirch, France.
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Limacher
authors.affiliation: Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Quoix
authors.affiliation: National Quality of Life in Oncology Platform, Nancy, France; Université de Franche-Comté, EA 3181, Besançon, France; CHU Besançon, Methodological and quality of life unit in oncology, Besançon, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
mesh_terms: D000368:Aged; D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D002945:Cisplatin / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D008297:Male; D008562:Membrane Glycoproteins / Q000008:administration & dosage* / Q000627:therapeutic use; D008875:Middle Aged; D018396:Mucin-1 / Q000378:metabolism; D011788:Quality of Life / Q000523:psychology; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D019496:Cancer Vaccines; C060192:MUC1 protein, human; D008562:Membrane Glycoproteins; D018396:Mucin-1; C518275:TG4010; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine