title: Patient-reported outcomes evaluating palliative radiotherapy and chemotherapy in patients with oesophageal cancer: a systematic review.
abstract: BACKGROUND
  Patient-reported outcomes (PROs) and assessments of treatment-related toxicity provide important information on the effect of palliative chemotherapy and/or radiotherapy. The aim of this study was to review the effect of palliative radiotherapy and/or chemotherapy on symptoms and quality of life assessed by PROs and measurement of toxicity for patients with oesophageal cancer.
  
  
  METHODS
  The Central, Medline and Embase databases (1990 to November 2011) were systematically searched for prospective studies of palliative chemotherapy and/or radiotherapy in patients with advanced oesophageal cancer with PRO- and/or toxicity outcomes. The risks of bias were assessed.
  
  
  RESULTS
  Of 2677 records identified, only 32 included PROs, of which eight were randomised controlled trials. In studies with sufficient standard of PRO (n = 18), either Health Related Quality of Life (HRQL) (n = 14) or patient-reported dysphagia (n = 4), were assessed. Docetaxel added to cisplatin + fluorouracil (CF) improved HRQL compared to CF only, even though toxicity increased. Epirubicin added to CF resulted in longer preserved HRQL than its comparator in two trials, and non-inferiority in one. All phase II chemotherapy studies reported maintained HRQL or improved dysphagia combined with low level of toxicity. Brachytherapy resulted in better HRQL compared to stent placement in two trials, and external radiotherapy relieved dysphagia. The quality of the HRQL methodology and the interpretation and presentation of the PRO results varied, and clinical significance was seldom discussed.
  
  
  CONCLUSIONS
  PRO endpoints are seldom used and further studies of homogenous patient groups with valid measures and methodology of PROs should be encouraged in the evaluation of palliative treatment. Brachytherapy, external radiotherapy and combination chemotherapy improved HRQL and dysphagia in the few identified studies with sufficient PRO methodology.
authors.affiliation: Department of oncology, Division of Cancer medicine, Surgery and Transplantation, Oslo University Hospital, Oslo, Norway. cecia@ous-hf.no
authors.forename: Cecilie Delphin
authors.initials: CD
authors.lastname: Amdal
authors.forename: Anne-Birgitte
authors.initials: AB
authors.lastname: Jacobsen
authors.forename: Marianne Grønlie
authors.initials: MG
authors.lastname: Guren
authors.forename: Kristin
authors.initials: K
authors.lastname: Bjordal
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001918:Brachytherapy / Q000379:methods / Q000523:psychology; D002277:Carcinoma / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology / Q000532:radiotherapy*; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology / Q000532:radiotherapy*; D006801:Humans; D010166:Palliative Care / Q000523:psychology; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D057566:Self Report; D016896:Treatment Outcome