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Draft NICE guidance says more evidence needed on new test to guide breast cancer treatment decisions

Draft guidance from NICE's Diagnostics Assessment Programme on four tests used to guide decisions about the use of chemotherapy in women with early breast cancer is issued today for consultation. The draft guidance recommends that the IHC4 test is used in a research setting to collect evidence about the reproducibility of the test and important outcomes associated with the prognostic ability of the test and to determine the ability of IHC4 to guide clinical decision-making in patients with early breast cancer. The draft guidance produced by the independent Diagnostics Advisory Committee also highlights that it has not been able to support the routine use of the Oncotype DX, MammaPrint or Mammostrat tests in women with oestrogen receptor positive, lymph node negative and human epidermal growth factor receptor 2 negative early breast cancer.

The four tests evaluated in the draft guidance measure the presence of multiple markers within the tumour that may indicate how the tumour is likely to progress. Used in conjunction with other available information such as tumour size and grade, they aim to improve the targeting of chemotherapy in breast cancer by improving the stratification and identification of patients who are most likely to benefit from chemotherapy. The rationale is based on the knowledge that certain biological features of cancers may indicate an increased likelihood of rapid growth and metastatic potential.

Breast cancer is the most commonly diagnosed cancer in women in England and Wales. In 2009 there were 42,305 new cases diagnosed. It is also the second largest cause of cancer death in women after lung cancer - in 2008 breast cancer resulted in 10,716 deaths for women in England and Wales. Some patients with a 'good' prognosis may still have recurrence after curative surgery and adjuvant (additional) chemotherapy. This presents a challenge to clinicians to estimate prognosis and make the most appropriate decisions about the use of adjuvant chemotherapy in women with early stage breast cancer.

Currently factors such as patient age, tumour size, nodal involvement, histological grade, oestrogen receptor (ER) expression, human epidermal growth factor receptor type 2 (HER2) overexpression and comorbidities are assessed and considered alongside patient preference when assessing risk and recommending therapies. In the UK clinicians use local protocols to estimate prognosis based on tools such as the Nottingham Prognostic Index, which takes into account grade as well as size and spread of tumour, or Adjuvant! Online, which uses age of the patient, tumour size, nodal involvement, hormonal receptor status and histological grade to predict disease course and treatment options. However, with use of the current tools, it has been suggested that a proportion of women with early stage breast cancer are over- or under-treated. Over-treatment results in unnecessary use of expensive chemotherapy with its associated adverse effects for women who derive little or no benefit. Under-treatment can result in avoidable deaths in women who had chemotherapy withheld.

The aim of this assessment is to evaluate whether, by streamlining the selection of patients to receive adjuvant chemotherapy, gene expression or protein expression profiling tests improve health outcomes and quality of life in patients with early stage breast cancer compared with currently used decision-making protocols.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "A test that can help predict the likely benefit of adjuvant chemotherapy in women with early breast cancer more accurately than the tools currently used would represent a significant step forward both for patients considering the treatment, and the NHS in terms of allocating resources. However, the Committee concluded that, because the evidence of the ability of the three tests - Oncotype DX, MammaPrint and Mammostrat - to impact clinical decision-making regarding the use of chemotherapy and to predict the level of response to chemotherapy in women with early breast cancer is currently limited, the case was not made for the cost effectiveness of these technologies.

Professor Longson continued: "The Committee noted the IHC4 test is at an earlier stage of development, and could represent an important emerging technology. It has made a number of research recommendations in relation to this technology that seek to establish or provide evidence on a range of potentially important outcomes in patients with early breast cancer. NICE will assess the feasibility of the Committee's research recommendations with a view to facilitating the development of further relevant evidence."

More information on the diagnostics draft guidance consultation for gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat is available hon the webpage. The consultation closes on 24 February 2012.

Ends

Notes to Editors

About the draft guidance

1. The comparator used in this assessment is standard UK practice. Although this varies between hospitals Adjuvant! Online and/or Nottingham Prognostic Index are often used to guide decisions on which patients with early breast cancer should be offered adjuvant chemotherapy.

2. There is local variation in the use of molecular markers (for example, ER and HER2, which are routinely assessed for early invasive breast cancer) in the decision to offer adjuvant chemotherapy. Although some hospitals use Adjuvant! Online and the Nottingham Prognostic Index in their original forms, others use adaptations of these tools. Adjuvant! Online is often used in conjunction with the HER2 score. Management algorithms based on the combined use of the Nottingham Prognostic Index and molecular markers such as ER and HER2 are also used.

3. The cost of the MammaPrint test is £2675, the Oncotype DX test costs £2580, IHC4 was estimated to cost £100-£200 and the Mammostrat test costs between £1120 and £1620.

About the NICE Diagnostics Assessment Programme

1. Further information about the NICE diagnostics assessment programme can be found at: www.nice.org.uk/diagnostics

2. Topics to be considered by the Programme are routed through the related Medical Technologies Assessment Programme. Further information about this can be found at: www.nice.org.uk/mt

About NICE

3. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

4. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

5. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

6. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 02 February 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.