title: Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: a systematic literature review.
abstract: BACKGROUND
  An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis.
  
  
  METHODS
  We chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments.
  
  
  RESULTS
  Of the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying.
  
  
  CONCLUSIONS
  The questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature.
authors.affiliation: Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany. Sigrid.Droste@iqwig.de
authors.forename: Sigrid
authors.initials: S
authors.lastname: Droste
authors.forename: Annegret
authors.initials: A
authors.lastname: Herrmann-Frank
authors.forename: Fueloep
authors.initials: F
authors.lastname: Scheibler
authors.forename: Tanja
authors.initials: T
authors.lastname: Krones
mesh_terms: D001943:Breast Neoplasms / Q000473:pathology / Q000601:surgery*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D015201:Meta-Analysis as Topic; D009367:Neoplasm Staging; D026684:Personal Autonomy; D028723:Personhood; D011643:Publishing / Q000941:ethics*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000941:ethics; D012107:Research Design; D015871:Scientific Misconduct / Q000941:ethics; D012945:Social Values; D033581:Stem Cell Transplantation / Q000941:ethics* / Q000401:mortality*; D014182:Transplantation, Autologous / Q000941:ethics