Diagnosis and treatment of advanced breast cancer: summary of NICE guidance

This is one of a series of BMJ summaries of new guidelines, which are based on the best available evidence; they highlight important recommendations for clinical practice, especially where uncertainty or controversy exists.

## Why read this summary?
Breast cancer is the most common cancer in women and the second most common cause of death from cancer in women in the United Kingdom. Each year in the UK more than 12 300 women and 70 men will die from advanced breast cancer having lived with this condition for an average of two to three years before death. 1-4 Management of advanced breast cancer requires the input of a wide range of healthcare professionals, usually in primary, secondary, and tertiary healthcare settings. Clinical practice and availability of certain treatments and procedures are known to vary across the UK. This article summarises the most recent recommendations from the National Institute for Health and Clinical Excellence (NICE) on the diagnosis and treatment of advanced breast cancer. 5
Recommendations NICE recommendations are based on systematic reviews of best available evidence. When minimal evidence is available, recommendations are based on the Guideline Development Group's opinion of what constitutes good practice. Evidence levels for the recommendations are given in italic in square brackets.

## Diagnosis and assessment
Imaging assessment - Assess the presence and extent of metastases in the bones of the axial skeleton using bone windows on a computed tomography (CT) scan or magnetic resonance imaging (MRI) or using bone scintigraphy.

## Providing information and support for decision making
- Assess the patient's individual preference for the level and type of information. Reassess this as circumstances change.
- On the basis of this assessment, offer patients consistent, relevant information and clear explanations, and provide opportunities for patients to discuss issues and ask questions.
- Assess the patient's individual preference for how much they wish to be involved in decision making. Reassess this as circumstances change.
- 

## Managing complications lymphoedema
- Offer all patients with lymphoedema complex decongestive therapy 7 as the first stage of lymphoedema management.
- Consider using multilayer lymphoedema bandaging for volume reduction as a first treatment option before compression hosiery.

## Overcoming barriers
Some of these recommendations have cost implications and/or will require provision of services not previously provided in many areas of Britain. Breast cancer has not previously been listed as an approved indication for PET-CT in the NHS, but the number of patients needing this procedure in any given healthcare trust is likely to be small. Provision of lymphoedema services is patchy around the UK, and the recommendations are likely to require an increase in staff and facilities. Currently very few areas are likely to provide access to an exercise programme for cancer related fatigue, so providers will need to consider how best to provide this. Timeliness of access to appropriate neurosurgical services may vary, and implementing the recommendations may require new protocols in some cancer networks. The use of trastuzumab beyond disease progression in HER-2 positive disease varies widely around the UK. Providers should ensure they have processes that provide complete transparency about the indication for prescribing trastuzumab. Processes should be in place to ensure that trastuzumab is used only in accordance with the indications agreed by purchasers.

## Further information on the guidance
Breast cancer is an important condition causing substantial mortality and morbidity in the United Kingdom, with heavy use of healthcare resources. Introduction of newer and more costly treatments has often proved controversial, with widespread variation in levels of provision between different areas (so called postcode variation), which has been reduced since the establishment of NICE. Although some of the more pressing controversies about availability of treatments were managed using the technology appraisal processes (the appraisal process used by NICE to make binding recommendations about the adoption (or not) of new therapies by the NHS), it is logical to have a single guideline incorporating recommendations about currently available treatments.
Little is new in this guideline, and the Guideline Development Group believes that it reflects what should be current best practice around the UK. As outlined in the main text, some cancer centres and units may need to introduce changes to comply with some guideline recommendations.
The use of trastuzumab at the time of disease progression is thought to vary considerably around the UK. This use is an unlicensed indication, for which no formal cost effectiveness analysis has been submitted to NICE. The Guideline Development Group feels that in the interests of equity, trastuzumab beyond progression is not a treatment that should be used in the NHS unless and until a proper appraisal has been performed.

# Methods
The development of this guideline was based on methods outlined by the NICE guidelines manual. 8
Management of advanced breast cancer involves different treatments over time. Limited information was available in the published literature about comparisons of different sequences of treatments, in particular chemotherapy. In the light of this the development group and health economists from the London School of Hygiene and Tropical Medicine developed a new health economic model for chemotherapy, to incorporate the available data from published randomised trials in a manner that permitted a cost effectiveness evaluation. The development group was aware of the potential limitations of such a model but believed that this model represented a substantial step forward for considering the "whole of life" treatment of a cancer that will ultimately cause death. It will undoubtedly be refined by others in the future. It was reassuring that the final output of the model was consistent with what the development group believes to be the most common practices of oncologists treating breast cancer around the UK.

## Future research and remaining uncertainties
The quality of evidence with which to formulate recommendations for managing advanced breast cancer was surprisingly poor. Many published randomised trials on advanced breast cancer are, in isolation, of an acceptable quality regarding the questions they pose about the population eligible for the trial. However, it is extremely difficult to put the results of such trials into the context of a whole of life treatment plan. Substantial further research is required in this area. The quality of health economic information available from most trials is also poor, and this too needs to be resolved.
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