title: Health-Related Quality of Life in SCALOP, a Randomized Phase 2 Trial Comparing Chemoradiation Therapy Regimens in Locally Advanced Pancreatic Cancer.
abstract: OBJECTIVE
  Chemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT.
  
  
  METHODS
  Patients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26).
  
  
  RESULTS
  A total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity.
  
  
  CONCLUSIONS
  Although there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT.
authors.affiliation: Wales Cancer Trials Unit, College of Biomedical and Life Sciences, Cardiff University, Cardiff, Wales, United Kingdom. Electronic address: hurtcn@cardiff.ac.uk.
authors.forename: Christopher N
authors.initials: CN
authors.lastname: Hurt
authors.affiliation: Cancer Research UK/MRC Oxford Institute for Radiation Oncology, Oxford University, NIHR Biomedical Research, Oxford, United Kingdom.
authors.forename: Somnath
authors.initials: S
authors.lastname: Mukherjee
authors.affiliation: UCL Cancer Institute, London, United Kingdom.
authors.forename: John
authors.initials: J
authors.lastname: Bridgewater
authors.affiliation: Bristol Haematology and Oncology Centre, Bristol, United Kingdom.
authors.forename: Stephen
authors.initials: S
authors.lastname: Falk
authors.affiliation: Velindre Cancer Centre, Velindre Hospital, Cardiff, Wales, United Kingdom.
authors.forename: Tom
authors.initials: T
authors.lastname: Crosby
authors.affiliation: Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom.
authors.forename: Alec
authors.initials: A
authors.lastname: McDonald
authors.affiliation: Velindre Cancer Centre, Velindre Hospital, Cardiff, Wales, United Kingdom.
authors.forename: George
authors.initials: G
authors.lastname: Joseph
authors.affiliation: Institute of Cancer and Genetics, Cardiff University, Cardiff, Wales, United Kingdom.
authors.forename: John
authors.initials: J
authors.lastname: Staffurth
authors.affiliation: Department of Radiation Oncology, Rush University Medical Center, Chicago, Illinois.
authors.forename: Ross A
authors.initials: RA
authors.lastname: Abrams
authors.affiliation: Division of Surgery, Head and Neck, University Hospitals Bristol National Health Service Foundation Trust, Bristol and School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
authors.affiliation: Wales Cancer Trials Unit, College of Biomedical and Life Sciences, Cardiff University, Cardiff, Wales, United Kingdom.
authors.forename: Sarah
authors.initials: S
authors.lastname: Bridges
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: Dutton
authors.affiliation: Southampton Clinical Trials Unit, Faculty of Medicine, Southampton University, Southampton General Hospital, Southampton, United Kingdom.
authors.forename: Gareth
authors.initials: G
authors.lastname: Griffiths
authors.affiliation: Cancer Research UK/MRC Oxford Institute for Radiation Oncology, Oxford University, NIHR Biomedical Research, Oxford, United Kingdom.
authors.forename: Tim
authors.initials: T
authors.lastname: Maughan
authors.affiliation: University Surgical Unit, Faculty of Medicine, University Hospital Southampton, Southampton, United Kingdom.
authors.forename: Colin
authors.initials: C
authors.lastname: Johnson
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine / Q000008:administration & dosage; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005221:Fatigue / Q000209:etiology; D001068:Feeding and Eating Disorders / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000209:etiology; D006304:Health Status; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects / Q000379:methods; D008297:Male; D010190:Pancreatic Neoplasms / Q000473:pathology* / Q000628:therapy*; D011788:Quality of Life; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D006113:United Kingdom; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D000093542:Gemcitabine