title: Patient-reported outcomes during and after definitive chemoradiotherapy for oesophageal cancer.
abstract: BACKGROUND
  Limited data describe patient-reported outcomes (PROs) of localised oesophageal cancer treated with definitive chemoradiotherapy(CRT). The phase 2/3 SCOPE-1 trial assessed the effectiveness of CRT±cetuximab. The trial for the first time provided an opportunity to describe PROs from a multi-centre group of patients treated with CRT that are presented here.
  
  
  METHODS
  Patients undergoing CRT±cetuximab within the SCOPE-1 trial (258 patients from 36 UK centres) completed generic-, disease- and treatment-specific health-related quality of life (HRQL) questionnaires (EORTC QLQ-C30, QLQ-OES18, Dermatology Life-Quality Index (DLQI)) at baseline and at 7, 13, 24, 52 and 104 weeks. Mean EORTC functional scale scores (>15 point change significant), DLQI scores (>4 point change significant) and proportions of patients (>15% significant) with 'minimal' or 'severe' symptoms are presented.
  
  
  RESULTS
  Questionnaire response rates were good. At baseline, EORTC functional scores were high (>75%) and few symptoms were reported except for severe problems with fatigue, insomnia and eating-related symptoms (e.g., appetite loss, dysphagia, dry mouth) in both groups(>15%). Functional aspects of health deteriorated and symptoms increased with treatment and by week 13 global quality of life, physical, role and social function significantly deteriorated and more problems with fatigue, dyspnoea, appetite loss and trouble with taste were reported. Recovery occurred by 6 months (except severe fatigue and insomnia in >15% of patients) and maintained at follow-up with no differences between groups.
  
  
  CONCLUSIONS
  CRT for localised oesophageal cancer has a significant detrimental impact on many aspects of HRQL; however, recovery is achieved by 6 months and maintained with the exception of persisting problems with severe fatigue and insomnia. The data suggest that the HRQL recovery after definitive CRT is quicker, and there is little lasting deficit compared with treatment including surgery. These data need to be compared with HRQL data from studies evaluating treatments including surgery for oesophageal cancer.
authors.affiliation: 1] Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK [2] Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: J
authors.initials: J
authors.lastname: Rees
authors.affiliation: Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: C N
authors.initials: CN
authors.lastname: Hurt
authors.affiliation: North Wales Cancer Treatment Centre, Glan Clwyd Hospital, Rhyl, North Wales, UK.
authors.forename: S
authors.initials: S
authors.lastname: Gollins
authors.affiliation: CRUK/MRC Oxford Institute for Radiation Oncology, Oxford University, Oxford, UK.
authors.forename: S
authors.initials: S
authors.lastname: Mukherjee
authors.affiliation: CRUK/MRC Oxford Institute for Radiation Oncology, Oxford University, Oxford, UK.
authors.forename: T
authors.initials: T
authors.lastname: Maughan
authors.affiliation: Bristol Haematology and Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: S J
authors.initials: SJ
authors.lastname: Falk
authors.affiliation: Institute of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: J
authors.initials: J
authors.lastname: Staffurth
authors.affiliation: Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: R
authors.initials: R
authors.lastname: Ray
authors.affiliation: Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: N
authors.initials: N
authors.lastname: Bashir
authors.affiliation: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham, UK.
authors.forename: J I
authors.initials: JI
authors.lastname: Geh
authors.affiliation: The Royal Marsden Hospital NHS Foundation Trust, London, UK.
authors.forename: D
authors.initials: D
authors.lastname: Cunningham
authors.affiliation: Queen's Centre for Oncology and Haematology, Hull and East Yorkshire NHS Trust, Hull, UK.
authors.forename: R
authors.initials: R
authors.lastname: Roy
authors.affiliation: UCL Cancer Institute, London, UK.
authors.forename: J
authors.initials: J
authors.lastname: Bridgewater
authors.affiliation: 1] Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, UK [2] Faculty of Medicine, University of Southampton, Southampton, UK.
authors.forename: G
authors.initials: G
authors.lastname: Griffiths
authors.affiliation: Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: L S
authors.initials: LS
authors.lastname: Nixon
authors.affiliation: 1] Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK [2] Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Blazeby
authors.affiliation: Velindre Cancer Centre, Velindre Hospital, Cardiff, UK.
authors.forename: T
authors.initials: T
authors.lastname: Crosby
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D000068818:Cetuximab; D059248:Chemoradiotherapy / Q000379:methods; D004938:Esophageal Neoplasms / Q000628:therapy*; D006801:Humans; D063868:Patient Outcome Assessment; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068818:Cetuximab