title: Health-related quality of life in patients with glioblastoma: a randomised controlled trial.
abstract: BACKGROUND
  A randomised controlled trial of radiotherapy alone versus radiotherapy with concomitant and adjuvant temozolomide for patients with glioblastoma showed that survival was higher for patients assigned combination treatment compared with those assigned standard radiotherapy alone. This paper reports the health-related quality of life (HRQOL) of the patients in this trial.
  
  
  METHODS
  573 patients with newly diagnosed glioblastoma were randomly allocated either radiotherapy alone or radiotherapy and temozolomide. The primary endpoint was survival, and HRQOL was a secondary endpoint. We assessed HRQOL at baseline and at every 3 months during treatment until progression using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 (QLQ-C30) and the EORTC brain cancer module (EORTC BN-20). We calculated changes from baseline score for seven predefined HRQOL measures (fatigue, overall health, social function, emotional function, future uncertainty, insomnia, and communication deficit) and differences between groups for these measures at every time point. The significance of, and proportions of patients with, improved HRQOL scores--defined as a change of 10 points or more--were recorded. This trial is registered on the US National Cancer Institute website http://www.cancer.gov/search/NewClinicalTrials, NCT00006353.
  
  
  RESULTS
  Baseline questionnaires were available for 490 (86%) patients. Baseline HRQOL scores did not differ between groups. At first follow-up, groups differed only in social functioning, favouring the radiotherapy-only group (mean score 79.0 [SD 3.2] for patients assigned radiotherapy vs 67.4 [2.7] for those assigned radiotherapy and temozolomide; difference between groups 11.6 points [95% CI 3.5-19.7], p=0.0052). Over subsequent assessments, HRQOL was much the same between treatment groups.
  
  
  CONCLUSIONS
  Addition of temozolomide during and after radiotherapy for patients with newly diagnosed glioblastoma significantly improved survival without a negative effect on HRQOL.
authors.affiliation: Medical Centre Haaglanden, The Hague, The Netherlands. m.taphoorn@mchaaglanden.nl
authors.forename: Martin J B
authors.initials: MJ
authors.lastname: Taphoorn
authors.forename: Roger
authors.initials: R
authors.lastname: Stupp
authors.forename: Corneel
authors.initials: C
authors.lastname: Coens
authors.forename: David
authors.initials: D
authors.lastname: Osoba
authors.forename: Rolf
authors.initials: R
authors.lastname: Kortmann
authors.forename: Martin J
authors.initials: MJ
authors.lastname: van den Bent
authors.forename: Warren
authors.initials: W
authors.lastname: Mason
authors.forename: René O
authors.initials: RO
authors.lastname: Mirimanoff
authors.forename: Brigitta G
authors.initials: BG
authors.lastname: Baumert
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Eisenhauer
authors.forename: Peter
authors.initials: P
authors.lastname: Forsyth
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000150:complications* / Q000188:drug therapy / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004644:Emotions; D005221:Fatigue; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012919:Social Behavior; D013315:Stress, Psychological; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide