title: Quality-of-life outcomes for adjuvant chemotherapy in early-stage non-small-cell lung cancer: results from a randomized trial, JBR.10.
abstract: OBJECTIVE
  Adjuvant chemotherapy for early stage non-small-cell lung cancer (NSCLC) is now the standard of care, but there is little information regarding its impact on quality of life (QOL). We report the QOL results of JBR.10, a North American, intergroup, randomized trial of adjuvant cisplatin and vinorelbine compared with observation in patients who have completely resected, stages IB to II NSCLC.
  
  
  METHODS
  QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and a trial-specific checklist at baseline and at weeks 5 and 9 for those who received chemotherapy and at follow-up months 3, 6, 9, 12, 18, 24, 30 and 36. A 10-point change in QOL scores from baseline was considered clinically significant.
  
  
  RESULTS
  Four hundred eighty-two patients were randomly assigned on JBR.10. A total of 173 patients (82% of the expected) in the observation arm and 186 (85% of expected) in the chemotherapy arm completed baseline QOL assessments. The two groups were comparable, with low global QOL scores and significant symptom burden, especially pain and fatigue, after thoracotomy. Changes in QOL during chemotherapy were relatively modest; fatigue, nausea, and vomiting worsened, but there was a reduction in pain and no change in global QOL. Patients in the observation arm showed considerable improvements in QOL by 3 months. QOL, except for symptoms of sensory neuropathy and hearing loss, in those treated with chemotherapy returned to baseline by 9 months.
  
  
  CONCLUSIONS
  The findings of this trial indicate that the negative effects of adjuvant chemotherapy on QOL appear to be temporary, and that improvements (with a return to baseline function) are likely in most patients.
authors.affiliation: National Cancer Institute of Canada Clinical Trials Group, Cancer Centre of Southeastern Ontario, Kingston, ON, Canada. andrea.bezjak@rmp.uhn.on.ca
authors.forename: Andrea
authors.initials: A
authors.lastname: Bezjak
authors.forename: Christopher W
authors.initials: CW
authors.lastname: Lee
authors.forename: Keyue
authors.initials: K
authors.lastname: Ding
authors.forename: Michael
authors.initials: M
authors.lastname: Brundage
authors.forename: Timothy
authors.initials: T
authors.lastname: Winton
authors.forename: Barbara
authors.initials: B
authors.lastname: Graham
authors.forename: Marlo
authors.initials: M
authors.lastname: Whitehead
authors.forename: David H
authors.initials: DH
authors.lastname: Johnson
authors.forename: Robert B
authors.initials: RB
authors.lastname: Livingston
authors.forename: Lesley
authors.initials: L
authors.lastname: Seymour
authors.forename: Frances A
authors.initials: FA
authors.lastname: Shepherd
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002170:Canada; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D016014:Linear Models; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D019370:Observation; D010349:Patient Compliance; D011013:Pneumonectomy; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine