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Brief Summary

GUIDELINE TITLE

Advanced breast cancer. Diagnosis and treatment.

BIBLIOGRAPHIC SOURCE(S)

  • National Collaborating Centre for Cancer. Advanced breast cancer: diagnosis and treatment. London (UK): National Institute for Health and Clinical Excellence (NICE); 2009 Feb. 25 p. (NICE clinical guideline; no. 81).

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates previous versions: National Institute for Clinical Excellence (NICE). Guidance on the use of capecitabine for the treatment of locally advanced or metastatic breast cancer. London (UK): National Institute for Clinical Excellence (NICE); 2003 May. 24 p. (Technology appraisal; no. 62).

National Institute for Clinical Excellence (NICE). Guidance on the use of vinorelbine for the treatment of advanced breast cancer. London (UK): National Institute for Clinical Excellence (NICE); 2002 Dec. 14 p. (Technology appraisal guidance; no. 54).

BRIEF SUMMARY CONTENT

 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Collaborating Centre for Cancer (NCC-C) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Diagnosis and Assessment

Imaging Assessment

  • Assess the presence and extent of visceral metastases using a combination of plain radiography, ultrasound, computed tomography (CT) scans and magnetic resonance imaging (MRI).
  • Assess the presence and extent of metastases in the bones of the axial skeleton using bone windows on a CT scan or MRI or bone scintigraphy.
  • Assess proximal limb bones for the risk of pathological fracture in patients with evidence of bone metastases elsewhere, using bone scintigraphy and/or plain radiography.
  • Use MRI to assess bony metastases if other imaging is equivocal for metastatic disease or if more information is needed (for example, if there are lytic metastases encroaching on the spinal canal).
  • Positron emission tomography fused with computed tomography (PET-CT) should only be used to make a new diagnosis of metastases for patients with breast cancer whose imaging is suspicious but not diagnostic of metastatic disease.

Pathological Assessment

  • Patients with tumours of known oestrogen receptor (ER) status whose disease recurs should not have a further biopsy just to reassess ER status.
  • Patients with tumours of known human epidermal growth factor receptor 2 (HER2) status whose disease recurs should not have a further biopsy just to reassess HER2 status.
  • Assess ER and HER2 status at the time of disease recurrence if receptor status was not assessed at the time of initial diagnosis. In the absence of tumour tissue from the primary tumour, and if feasible, obtain a biopsy of a metastasis to assess ER and HER2 status.

Monitoring Disease Status

  • Do not use bone scintigraphy to monitor the response of bone metastases to treatment.
  • Do not use PET-CT to monitor advanced breast cancer.

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.
  • Be aware of the value of decision aids and the range available. Make the most appropriate decision aid available to the patient.

Systemic Disease-Modifying Therapy

  • Offer endocrine therapy as first-line treatment for the majority of patients with ER-positive advanced breast cancer.
  • Offer chemotherapy as first-line treatment for patients with ER-positive advanced breast cancer whose disease is imminently life-threatening or requires early relief of symptoms because of significant visceral organ involvement, providing they understand and are prepared to accept the toxicity.
  • For patients with ER-positive advanced breast cancer who have been treated with chemotherapy as their first-line treatment, offer endocrine therapy following the completion of chemotherapy.

Endocrine Therapy

  • Offer an aromatase inhibitor (either non-steroidal or steroidal) to:
    • Postmenopausal women with ER-positive breast cancer and no prior history of endocrine therapy
    • Postmenopausal women with ER-positive breast cancer previously treated with tamoxifen
  • Offer tamoxifen and ovarian suppression as first-line treatment to premenopausal and perimenopausal women with ER-positive advanced breast cancer not previously treated with tamoxifen.
  • Offer ovarian suppression to premenopausal and perimenopausal women who have previously been treated with tamoxifen and then experience disease progression.
  • Offer tamoxifen as first-line treatment to men with ER-positive advanced breast cancer.

Chemotherapy

  • On disease progression, offer systemic sequential therapy to the majority of patients with advanced breast cancer who have decided to be treated with chemotherapy.
  • Consider using combination chemotherapy to treat patients with advanced breast cancer for whom a greater probability of response is important and who understand and are likely to tolerate the additional toxicity.
  • For patients with advanced breast cancer who are not suitable for anthracyclines (because they are contraindicated or because of prior anthracycline treatment either in the adjuvant or metastatic setting), systemic chemotherapy should be offered in the following sequence:
    • First line: single-agent docetaxel
    • Second line: single-agent vinorelbine or capecitabine
    • Third line: single-agent capecitabine or vinorelbine (whichever was not used as second-line treatment)
  • Gemcitabine in combination with paclitaxel, within its licensed indication, is recommended as an option for the treatment of metastatic breast cancer only when docetaxel monotherapy or docetaxel plus capecitabine are also considered appropriate.a

Biological Therapy

Supportive Care

  • Healthcare professionals involved in the care of patients with advanced breast cancer should ensure that the organisation and provision of supportive care services comply with the recommendations made in 'Improving outcomes in breast cancer: manual update' (NICE cancer service guidance [2002]) and Improving supportive and palliative care for adults with cancer' (NICE cancer service guidance [2004]), in particular the following two recommendations:
    • 'Assessment and discussion of patients' needs for physical, psychological, social, spiritual and financial support should be undertaken at key points (such as diagnosis; at commencement, during, and at the end of treatment; at relapse; and when death is approaching).'
    • 'Mechanisms should be developed to promote continuity of care, which might include the nomination of a person to take on the role of "key worker" for individual patients.'

Managing Complications

Lymphoedema

  • Assess patients with lymphoedema for treatable underlying factors before starting any lymphoedema management programme.
  • Offer all patients with lymphoedema complex decongestive therapy (CDT) as the first stage of lymphoedema management.
  • Consider using multilayer lymphoedema bandaging (MLLB) for volume reduction as a first treatment option before compression hosiery.
  • Provide patients with lymphoedema with at least two suitable compression garments. These should be of the appropriate class and size, and a choice of fabrics and colours should be available.
  • Provide patients with lymphoedema with clear, written information and the contact details of local and national lymphoedema support groups.

Cancer-Related Fatigue

  • Offer all patients with advanced breast cancer for whom cancer-related fatigue is a significant problem an assessment to identify any treatable causative factors, and offer appropriate management as necessary.
  • Provide clear, written information about cancer-related fatigue, organisations that offer psychosocial support and patient-led groups.
  • Provide information about and timely access to an exercise programme for all patients with advanced breast cancer experiencing cancer-related fatigue.

Uncontrolled Local Disease

  • A breast cancer multidisciplinary team should assess all patients presenting with uncontrolled local disease and discuss the therapeutic options for controlling the disease and relieving symptoms.
  • A wound care team should see all patients with fungating tumours to plan a dressing regimen and supervise management with the breast care team.
  • A palliative care team should assess all patients with uncontrolled local disease in order to plan a symptom management strategy and provide psychological support.

Bone Metastases

  • Consider offering bisphosphonates to patients newly diagnosed with bone metastases to prevent skeletal-related events and reduce pain.
  • The choice of bisphosphonate for patients with bone metastases should be a local decision, taking into account patient preference and limited to preparations licensed for this indication.
  • Use external beam radiotherapy in a single fraction of 8Gy to treat patients with bone metastases and pain.
  • An orthopaedic surgeon should assess all patients at risk of a long bone fracture, to consider prophylactic surgery.

Brain Metastases

  • Offer surgery followed by whole brain radiotherapy to patients who have a single or small number of potentially resectable brain metastases, a good performance status and who have no or well-controlled other metastatic disease.
  • Offer whole brain radiotherapy to patients for whom surgery is not appropriate, unless they have a very poor prognosis.
  • Offer active rehabilitation to patients who have surgery and/or whole brain radiotherapy.
  • Offer referral to specialist palliative care to patients for whom active treatment for brain metastases would be inappropriate.

CLINICAL ALGORITHM(S)

There is a care pathway for advanced breast cancer in the quick reference guide, available at www.nice.org.uk/CG81quickrefguide. The care pathway includes algorithms for:

  • Diagnosis and assessment - imaging assessment and pathological assessment
  • Sequential systemic therapy - endocrine therapy - women
  • Chemotherapy and biological therapy
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EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically stated.

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IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Collaborating Centre for Cancer. Advanced breast cancer: diagnosis and treatment. London (UK): National Institute for Health and Clinical Excellence (NICE); 2009 Feb. 25 p. (NICE clinical guideline; no. 81).

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2003 May (revised 2009 Feb)

GUIDELINE DEVELOPER(S)

National Collaborating Centre for Cancer - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

GUIDELINE COMMITTEE

Guideline Development Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Group Members: Mr John Winstanley (Chair) Consultant Surgeon, Royal Bolton Hospital; Dr Sarah Wilson (Chair) Medical Director, InHealth; Dr Nick Murray (Lead Clinician) Senior Lecturer and Honorary Consultant Medical Oncologist, Cancer Research UK Clinical Centre, University of Southampton; Dr Murray Brunt, Consultant Clinical Oncologist, University Hospital of North Staffordshire NHS Trust; Dr Helen Burrell, Consultant Radiologist, Nottingham University Hospitals NHS Trust; Dr Susan Closs, Lead Consultant in Palliative Medicine/Network Chair in Palliative Care (South West Wales Cancer Network), Swansea NHS Trust; Mrs Debbie Collins, Macmillan Radiotherapy Specialist, Kent Oncology Centre; Dr Dermott Davison, GP, County Antrim, Northern Ireland; Dr Chris Gaffney, Consultant Clinical Oncologist, Velindre Cancer Centre, Cardiff; Mrs Kathleen Jenkins, Retired Clinical Nurse Specialist; Mrs Mary Milne, Nurse Consultant, The Parapet Breast Unit; Mrs Susan Raettig, Patient/carer member, Chair, Hull and East Riding Cancer Patient Involvement Group; Miss Jane Rankin, Lead Cancer Physiotherapist, Belfast City Hospital; Mrs Claire Ryan, Lead Research Nurse, Oncology Clinical Trials, Kent Oncology Research Centre; Mr John Winstanley, Consultant Surgeon, Royal Bolton Hospital; Mrs Netta Wooles, Patient/carer member; Miss Anna Wood, Patient/carer member, Head of Policy and Campaigns, Breast Cancer Care

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

At the start of the guideline development process all Guideline Development Group (GDG) members' interests were recorded on a standard declaration form that covered consultancies, fee-paid work, share-holdings, fellowships and support from the healthcare industry. At all subsequent GDG meetings, members declared new, arising conflicts of interest which were always recorded (see Appendix 6.1 of the full version of the original guideline document for a list of disclosures).

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates previous versions: National Institute for Clinical Excellence (NICE). Guidance on the use of capecitabine for the treatment of locally advanced or metastatic breast cancer. London (UK): National Institute for Clinical Excellence (NICE); 2003 May. 24 p. (Technology appraisal; no. 62).

National Institute for Clinical Excellence (NICE). Guidance on the use of vinorelbine for the treatment of advanced breast cancer. London (UK): National Institute for Clinical Excellence (NICE); 2002 Dec. 14 p. (Technology appraisal guidance; no. 54).

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) format from the National Institute for Health and Clinical Excellence (NICE) Web site.

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N1794. 11 Strand, London, WC2N 5HR.

PATIENT RESOURCES

The following is available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N1795. 11 Strand, London, WC2N 5HR.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

This NGC summary was completed by ECRI on June 26, 2006. This NGC summary was updated by ECRI Institute on August 25, 2009.

The National Institute for Health and Clinical Excellence (NICE) has granted the National Guideline Clearinghouse (NGC) permission to include summaries of their Technology Appraisal guidance with the intention of disseminating and facilitating the implementation of that guidance. NICE has not verified this content to confirm that it accurately reflects the original NICE guidance and therefore no guarantees are given by NICE in this regard. All NICE technology appraisal guidance is prepared in relation to the National Health Service in England and Wales. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The full versions of all NICE guidance can be found at www.nice.org.uk.

COPYRIGHT STATEMENT

The National Institute for Health and Clinical Excellence (NICE) has granted the National Guideline Clearinghouse (NGC) permission to include summaries of their clinical guidelines with the intention of disseminating and facilitating the implementation of that guidance. NICE has not yet verified this content to confirm that it accurately reflects that original NICE guidance and therefore no guarantees are given by NICE in this regard. All NICE clinical guidelines are prepared in relation to the National Health Service in England and Wales. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The full versions of all NICE guidance can be found at www.nice.org.uk.

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DISCLAIMER

NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.
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