title: Supportive care for patients with gastrointestinal cancer.
abstract: BACKGROUND
  Supportive care has traditionally been given to optimise the comfort of patients and their ability to function, as well as to minimise the side-effects of anti-cancer treatments. The scope of modern comprehensive supportive care however is broadening and covers not only specific palliative treatment but non-tumour specific treatment such as social, psychological and spiritual support. In oncology, best supportive care (BSC) has been used as a comparator arm of randomised controlled trials in chemotherapy. However the BSC arm is usually not well defined and its evaluation is therefore difficult because of the heterogeneity of the definitions. A systematic review was undertaken of the evidence from all RCTs of gastrointestinal cancers (includes gastrointestinal/gastric, colorectal/colon cancer but excludes pancreatic cancer trials) which include a BSC/SC arm.
  
  
  OBJECTIVE
  1. To examine the effectiveness/outcomes of best supportive care interventions versus cancer therapies for gastrointestinal cancer trials;2. To determine whether trials containing best supportive care include a definition of this.
  
  
  METHODS
  Electronic databases, grey literature sources, citation searching and reference checking, handsearches of journals and discussion with experts were used to identify potentially eligible trials from both published and unpublished sources.
  
  
  METHODS
  RCTs comparing BSC/SC versus anticancer therapies in patients with gastrointestinal cancers.
  
  
  METHODS
  Four RCTs were found and reviewed. Because of the heterogeneity of studies, a meta-analysis was not attempted. Data was extracted from the included papers and the quality of each included study was assessed using the Jadad 1996 and Rinck 1997 methods of assessing the quality of RCTs.
  
  
  RESULTS
  Data from four trials (483 patients) were included. Due to the heterogeneity of studies (in terms of populations studied, the interventions used, the variety of outcomes and assessments used) it was not possible to make direct comparisons between the studies. The primary outcome in all four trials was survival, in spite of patients with advanced/metastatic gastrointestinal cancer having a poor prognosis, and the interventions being primarily palliative.
  
  
  CONCLUSIONS
  Overall the results show that for most of the trials included in this review, certain forms of chemotherapy plus supportive care improve both survival and quality of life in patients with gastrointestinal cancer (gastric and colorectal cancers) compared to receiving supportive care alone. Trials involving BSC/SC in patients with advanced gastrointestinal cancer require careful evaluation. Oncologists and researchers alike should strive for improvements in trial design and reporting. Future trials should focus on clearer definitions of supportive care. The EORTC definition of supportive care can be used as a guide. BSC/SC trials should use standardised validated outcome measures for symptom control, quality of life, toxicity and other useful palliative measures.
authors.affiliation: Division of Clinical Sciences, Section of Surgical and Anaesthetic Sciences, Palliative Medicine, University of Sheffield, Royal Hallamshire Hospital, K floor, Glossop Road, Sheffield, South Yorkshire, UK, S10 2JF.
authors.forename: N
authors.initials: N
authors.lastname: Ahmed
authors.forename: S
authors.initials: S
authors.lastname: Ahmedzai
authors.forename: V
authors.initials: V
authors.lastname: Vora
authors.forename: S
authors.initials: S
authors.lastname: Hillam
authors.forename: S
authors.initials: S
authors.lastname: Paz
mesh_terms: D005770:Gastrointestinal Neoplasms / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D010166:Palliative Care; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic