Table 5 Summary of currently relevant ethical issues in ASCT in breast cancer patients

Health technology

Harm: Introduction of ASCT into clinical practice took place without further evaluation in clinical trials.

Harm: Incidence of severe side effects, risk of mortality and some negative impact on quality of life in the survivors

Trust: The only two trials which showed benefit in overall survival were found to be fraudulent (Bezwoda fraud). This caused significant effects on further research and the doctor-patient relationship as well as a lack of trust in oncology and the trial investigators. In consequence ASCT in breast cancer remains a stigmatized technology and of great symbolic value.

Uncertainty: It is unknown to date whether there is any evidence of a benefit of ASCT for some subgroups of breast cancer patients and, if so, whether this group would benefit more from an existing alternative.

External validity: The trials are only representative for highly specialised centres.

Alternatives: Safer procedures than ASCT do exist

Patients

Last chance therapy in metastatic breast cancer: As a consequence of this status patients postpone preparing for death. Attention is drawing away from more appropriate efforts to minimize symptoms and enhance the quality of life for terminally ill patients and their families. Recent publications discuss the right of patients to aggressive, toxic and expensive treatment - even untested with insufficient evidence on effectiveness and safety if it is potentially life-saving or life-prolonging.

Patient autonomy: Patients were faced with the decision to consent to a hopefully life prolonging but also potentially fatal treatment. There are some suggestions that patients are insufficiently informed and patient understanding is not always ensured.

Technological imperative: ASCT with the potential to benefit women with a life-threatening disease raises new hope for patients and physicians.