title: Assessment of quality of life in the supportive care setting of the big lung trial in non-small-cell lung cancer.
abstract: OBJECTIVE
  The Big Lung Trial (BLT) was a large, pragmatic trial to evaluate the addition of chemotherapy to primary treatment (ie, surgery, radical radiotherapy, or supportive care) in non-small-cell lung cancer (NSCLC). In the supportive care group, there was a small but significant survival benefit in patients treated with chemotherapy compared with supportive care alone (no chemotherapy). A substudy was undertaken to evaluate the quality of life (QoL) implications of the treatment options. QoL was assessed using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30) and LC17, and daily diary cards.
  
  
  METHODS
  EORTC QLQ-C30 and LC17 were collected at 0, 6 to 8, 12, 18, and 24 weeks. Diary cards were completed during the first 12 weeks of the study. The primary end point was global QoL at 12 weeks.
  
  
  RESULTS
  A total of 273 patients were randomly assigned: 138 to no chemotherapy and 135 to chemotherapy. There was no evidence of a large detrimental effect on QoL of chemotherapy. No statistically significant differences in global QoL or physical/emotional functioning, fatigue and dyspnea, and pain were detected at 12 weeks. Higher rates of palliative radiotherapy in the no chemotherapy arm may have lessened differences in QoL. Global QoL, role functioning, fatigue, appetite loss, and constipation were prognostic indicators of survival at 12 weeks.
  
  
  CONCLUSIONS
  There were no important adverse effects of chemotherapy on QoL.
authors.affiliation: Clinical Trials Research Unit, 17 Springfield Mount, Leeds LS2 9NG, United Kingdom. medjmb@leeds.ac.uk
authors.forename: J
authors.initials: J
authors.lastname: Brown
authors.forename: H
authors.initials: H
authors.lastname: Thorpe
authors.forename: V
authors.initials: V
authors.lastname: Napp
authors.forename: D J
authors.initials: DJ
authors.lastname: Fairlamb
authors.forename: N H
authors.initials: NH
authors.lastname: Gower
authors.forename: R
authors.initials: R
authors.lastname: Milroy
authors.forename: M K B
authors.initials: MK
authors.lastname: Parmar
authors.forename: R M
authors.initials: RM
authors.lastname: Rudd
authors.forename: S G
authors.initials: SG
authors.lastname: Spiro
authors.forename: R J
authors.initials: RJ
authors.lastname: Stephens
authors.forename: D
authors.initials: D
authors.lastname: Waller
authors.forename: P
authors.initials: P
authors.lastname: West
authors.forename: M D
authors.initials: MD
authors.lastname: Peake
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010166:Palliative Care; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life; D015996:Survival Rate; D016896:Treatment Outcome