Open Access Highly Accessed Research article

Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: A systematic literature review

Sigrid Droste1*, Annegret Herrmann-Frank1, Fueloep Scheibler1 and Tanja Krones2

Author Affiliations

1 Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany

2 Institute of Biomedical Ethics, University Hospital, Zurich, Switzerland

For all author emails, please log on.

BMC Medical Ethics 2011, 12:6  doi:10.1186/1472-6939-12-6

Published: 15 April 2011

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.