How we made the decision

We check our guidelines regularly to ensure they remain up to date. We based the decision on surveillance 8 years after the publication of NICE's guideline on advanced breast cancer (NICE guideline CG81) in 2009.

For details of the process and update decisions that are available, see ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual.

Evidence

We found 43 studies in a search for randomised controlled trials and systematic reviews published between 22 January 2015 and 18 July 2017.

We also considered evidence identified in previous surveillance 3 and 6 years after publication of the guideline. This included 258 studies identified by search and identified in comments received during consultation.

From all sources, we considered 301 studies to be relevant to the guideline.

We also checked for relevant ongoing research, which will be evaluated again at the next surveillance review of the guideline.

See appendix A: summary of evidence from surveillance for details of all evidence considered, and references.

Views of topic experts

We considered the views of topic experts, including those who helped to develop the guideline and other correspondence we have received since the publication of the guideline.

Views of stakeholders

Stakeholders commented on the decision not to update the guideline. Overall, 3 stakeholders commented.

The following 2 stakeholders agreed with the decision to not update the guideline:

  • Novartis Pharmaceuticals Ltd

    • Whilst the stakeholder agreed with the proposal not to update the guideline, they suggested there would be value in incorporating published technology appraisals. To address this feedback, the surveillance review decision is to amend the relevant sections of the guideline to cross-refer to the relevant published NICE technology appraisals. A statement will also be added to the recommendations noting that this is a clinical area in which new technologies are developed and assessed frequently and for clinicians to refer to the NICE Pathway on advanced breast cancer in conjunction with the guideline.

  • Royal College of Nursing

    • This stakeholder agreed with the proposal not to update the guideline. They also commented that they agree with the need for further evidence on lymphoedema management and psychological care.

The following stakeholder disagreed with the decision to not update the guideline:

  • Breast Cancer Care

    • This stakeholder suggested that the guideline should strengthen recommendations on providing information and support to patients with advanced breast cancer. The suggestion is to include: advice on referrals to specific metastatic breast cancer support services, making a diagnosis with a holistic needs assessment, improve communication between services, recommend access to a clinical nurse specialist, and utilisation of multidisciplinary team meetings. On reviewing the comments provided by the stakeholder, there was no anticipated impact on the guideline as these areas were considered to be adequately covered in recommendation 1.4.1, NICE's quality standard on breast cancer (QS12) and NICE's guidelines on improving outcomes in breast cancer (CSG1) and improving supportive and palliative care for adults with cancer (CSG4). NICE guideline CG81 cross-refers to the cancer service guidelines and incorporates the relevant advice within the recommendations. All these recommendations and related NICE guidelines are brought together in the NICE Pathway on advanced breast cancer.

    • This stakeholder suggested that the recommendation to discontinue trastuzumab at disease progression should change to mirror clinical practice as many oncologists continue with treatment at this point. On reviewing recommendation 1.3.12 on trastuzumab, it specifies discontinuation when the disease has progressed outside the central nervous system. The recommendation is based on the evidence that the drug does not cross the blood-brain barrier and is therefore not effective in treating metastatic disease of the central nervous system and progression outside the central nervous system is an indication that the treatment is no longer effective. Guidance on the use of trastuzumab for the treatment of advanced breast cancer is covered in NICE technology appraisal guidance 34. Clinical practice should follow NICE recommendations and any use of trastuzumab outside the summary of product characteristics would be off-label and the responsibility of the prescribing clinician.

    • This stakeholder suggested that consideration should be given to a new recommendation supporting the use of stereotactic radiotherapy for brain metastases. On reviewing the evidence provided by the stakeholder, there was no anticipated impact on the guideline as the references did not provide adequate data in the abstracts to draw sufficient conclusions. NICE guideline CG81 contains a research recommendation calling for the need to compare stereotactic radiotherapy with whole brain radiotherapy in a randomised controlled trial. The management of brain metastases is being covered in a NICE guideline currently in development. If appropriate, the NICE Pathway on advanced breast cancer will cross-refer to the guideline on brain metastases when it publishes.

    • This stakeholder suggested that recommendation 1.5.14 should be updated to reflect the current practice of offering bisphosphonates to all patients with bone metastases. Also, there was a suggestion for guidance on the prescription of bisphosphonates for people with primary breast cancer. Evidence identified at the surveillance review supports the current recommendations to consider offering bisphosphonates to patients newly diagnosed with bone metastases. NICE guideline CG81 does not cover the management of primary or early breast cancer as this population is covered in NICE's guideline on early and locally advanced breast cancer: diagnosis and treatment (CG80).

See appendix B for stakeholders' comments and our responses.

See ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual for more details on our consultation processes.

NICE Surveillance programme project team

Kay Nolan
Associate Director

Jeremy Wight
Consultant Clinical Adviser

Emma McFarlane
Technical Adviser

Omar Moreea
Technical Analyst

The NICE project team would like to thank the topic experts who participated in the surveillance process.

ISBN: 978-1-4731-2123-2


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