Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE Guidance 41
Author: J.L. Cartwright, SpR Public Health
Date: 19/06/08 / Version: 2
Status: Final Version
Intended Audience: Cancer Services Coordinating Group - breast
Applicability: Screening Services
Meeting Date: CSCG, 20/06/08 / Review Date: N/A
Relevant Previous Documents: N/A
Purpose of Document:
To provide advice to Welsh Assembly Government regarding the implementation of NICE clinical guidance 41 for Wales.
Publication/Distribution:
· Publication in NPHS Document Database (Specify Database)
· Link from NPHS e-Bulletin
Table of Contents
Executive Summary 6
1 Introduction 9
2 Aim 9
3 Objectives 9
4 Methods 10
5 Background 11
5.1 Familial Breast cancer 11
5.2 Clinical genetics service 12
5.2.1 Referral criteria 12
5.2.2 Calculation of breast cancer risk 15
5.3 NICE clinical guidance 17
5.3.1 Summary of NICE Clinical Guidance 41 recommendations on MRI breast surveillance 18
6 Results 21
6.1 Current surveillance system 21
Epidemiology of women currently offered surveillance. 23
6.1.1 Age range 23
6.1.2 Area of residence 24
6.1.3 Trends over time 25
6.2 Expected number of women registered in the Family History Programme following NICE guidance implementation 27
6.3 Current MRI scanners in Wales 29
6.3.1 Ability of current MRI Scanners to meet identified need 29
6.4 Comparative surveillance systems 32
7 Options for provision 33
7.1 MRI in Breast Test Wales 33
7.2 Acute Trusts 34
7.3 Breast Test Wales/ Acute trust hybrid 34
8 Appraisal 35
8.1 Call/recall 35
8.2 Radiology expertise 36
8.3 Staffing 37
8.4 MR capacity 37
8.5 Standards and quality assurance 38
8.6 Access 39
9 Recommendations 39
10 Reference List 41
Appendix 1.UK MRI Breast screening protocol 43
Appendix 2.Stakeholders consulted 48
© 2008 National Public Health Service for Wales
Material contained in this document may be reproduced without prior permission provided it is done so accurately and is not used in a misleading context. Acknowledgement to the National Public Health Service for Wales to be stated.
Executive Summary
Breast cancer is the most common cancer in women and accounts for between 18-25% of all female malignancies world-wide. The lifetime risk (to 85 years of age) of developing breast cancer in more developed countries world-wide has been estimated in the UK at 11% (1 in 9 women). It has been estimated that up to 27% of women may have an inherited predisposition to breast cancer.
Breast screening by mammography is provided by Breast Test Wales (BTW) for women aged 50 and over. Women under 50 years with a family history of breast cancer who were assessed by the All Wales medical genetics services (AWMGS) as having a moderate or high risk of developing the disease are also offered annual mammography by BTW, although this is not formally commissioned or funded.
The BTW Family History Programme began in 2001. Since then 2363 women have been registered in the programme, women are aged between 30 and 65 years, and distributed across the whole of Wales. The number of mammographic screens performed per year for women on the family history programme has risen across all divisions to 1431 in 2006.
NICE Clinical guidance 41, Familial breast cancer. The classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care, recommends when, dependant on a woman’s age and risk of breast cancer, women would benefit from magnetic resonance imaging, MRI, breast surveillance. This is in addition to, or as an alternative to, mammography as per previous recommendations. All women currently registered with the family history programme meet the NICE guidance criteria for annual MRI breast surveillance.
In total for Wales there would be a need for 1700 MRI scans per annum for women known to the Family History Programme at present, and between 2000 and 2200 MRI scans per annum if women not currently known to the programme were recruited.
Identified need for breast MRI can not be met within the existing MRI resource. The recent review of diagnostic imaging concluded that there is not the capacity in Wales to meet current targets without investment in workforce and equipment. The review specifically states that additional further investment would be necessary for provision of new services such as breast MRI surveillance.
The recommendations of this report are:
· Investment in new MRI scanners and the specialist staff to operate a surveillance programme is imperative in order to implement NICE guidance 41.
· The model of provision should combine the experience and expertise of BTW in managing a call/recall system and operating quality assured screening services, with the capacity of the trusts to accommodate new MRI scanners and utilize their full capacity.
· Three centres for breast surveillance are needed to ensure equality of access to the surveillance service. These would ideally be situated in specialist breast units in the North, South and West of Wales, allowing MRI capacity to be utilised in symptomatic breast services.
1 Introduction
Breast screening by mammography is provided by Breast Test Wales (BTW) for women aged 50 and over. Women under 50 years with a family history of breast cancer which suggests they have an increased risk of developing the disease compared with the population as a whole are also offered annual mammography by BTW, although this is not funded. The age at which annual mammography is commenced is determined by the estimated level of risk for the individual from their family history. NICE clinical guidance 41 published in July 2006 recommended these women should receive annual MRI surveillance in addition to mammography. At present there is no system in Wales to provide this level of surveillance. This document explores the options for implementing the NICE guidance across Wales.
2 Aim
To devise and appraise the options for the provision of MRI surveillance to women with a family history of breast cancer across Wales in line with NICE clinical guidance 41(1).
3 Objectives
· Describe current system of surveillance for women with a family history of breast cancer
· Determine the current number of women identified as eligible for breast surveillance and how many would be expected for a population equivalent to Wales
· Describe the location and specification of current MRI scanners, and compare with the UK standards for breast MR imaging(2).
· Identify from the literature and service providers possible options for provision
· Appraise the strengths and weaknesses of identified options
4 Methods
Details of the current system of surveillance for women with a family history of breast cancer were obtained from Screening Services and The All-Wales Cancer Genetics Service. This information was triangulated with the descriptions of the current system from in depth interviews of other stakeholders, and published information.
Anonymised data was obtained from Screening Services, Velindre NHS Trust, for women whose family history had been assessed, broken down by age; Local Health Board; and risk category. The number of quarterly referrals from the cancer genetics service, January 2001 to June 2007, by region was also obtained.
The expected number of families and individuals with an increased risk of breast cancer due to a family history of breast cancer was obtained from peer reviewed published literature.
The location and specification of current MRI scanners in Wales was obtained from the Welsh Health Estates division, and compared with the UK standards for MRI breast imaging published by the Royal College of Radiologists.
A search of peer reviewed literature and scoping of the grey literature was undertaken along with in depth interviews with stakeholders to generate and appraise options for provision of the of MRI surveillance.
5 Background
5.1 Familial Breast cancer
Breast cancer is the most common cancer in women and accounts for between 18-25% of all female malignancies world-wide(3,4). Although breast cancer incidence and mortality varies considerably around the world, the proportion of women who develop breast cancer is higher in western, developed countries. The lifetime risk (to 85 years of age) of developing breast cancer in more developed countries world-wide has been estimated in the UK at 11% (1 in 9 women)(3-5).
It has been estimated that up to 27% of women may have an inherited predisposition to breast cancer(6), although only 3-5% are likely to carry gene faults which conferred a very substantial (>50%) risk of breast cancer(7,8). Media reporting often gives the impression that a greater proportion of cases are linked to genetic inheritance. Since breast cancer is relatively common, it can be difficult for women to know whether any case in a relative indicates a familial inheritance or not. Questions about possible familial breast cancer may be expressed to (or raised by) general practitioners, symptomatic breast clinics, breast screening services and others.
Most women do not develop breast cancer, and of those who do most will not have a known family history of the disease. Some women will have one relative who has had a diagnosis of breast cancer. Often, these affected relatives will be in the older age range when a diagnosis of breast cancer is made. This type of family history does not result in increased risk of breast cancer in relatives and so women in this category are not discussed further in this report.
Familial breast cancer typically occurs in women within a family where there have been an unusually high number of family members affected by breast cancer. If there have been more cases of breast or related cancers than would be expected by chance alone, it may be that genes transmitted between generations are sufficient to cause or, more typically, contribute to the development of breast cancer.
The types of family histories pertinent to increased risk are discussed in the relevant sections along with referral criteria.
5.2 Clinical genetics service
5.2.1 Referral criteria
The All Wales Medical Genetics services (AWMGS) was established in 1998.
The AWMGS provides specialist genetic services to individuals and families with, or concerned about, rare genetic conditions. The service is made up of clinical and laboratory services which together provide medical genetics services to the population of Wales. Cardiff and Vale NHS Trust hosts the AWMGS at theUniversity Hospital of Wales (UHW), Heath, Cardiff. Specialistconsultant geneticists, doctors and genetic counselors providegenetic services in all the main hospitals throughout Wales.
The Cancer Genetic Service in Wales (CGSW) is part of the All Medical Wales Genetics service. Its remit is to assess the risk of cancer based on the reported family history and work with the relevant specialists to recommend further screening strategies where appropriate.
The service has referral criteria for clinicians in primary and secondary care which identify those who may be at significantly increased risk of an inherited form of cancer (Figure 1.).
Figure 1. Criteria for referral to the cancer genetics service.
Breast Cancer1 first degree relative diagnosed at 40 years or less
2 first degree relatives at 60 years or less (on the same side of the family)
3 first or second degree relatives any age (on the same side of the family)
1 first degree male breast cancer
A first degree relative with bilateral breast cancer
N.B. breast cancer can also be inherited through the paternal side of the family
Breast/Ovarian Cancer
Minimum: 1 of each cancer in first degree relatives
(If only one of each cancer, the breast cancer diagnosed under 50 years)
A first degree relative who has both breast and ovarian cancer
Source: The Cancer Genetics Service for Wales.
Once women are referred to the service, a detailed family history is taken by postal questionnaire. Confirmation of the type, site and age of onset of their relative’s cancer may be needed. Once accurate and complete information is obtained the family pedigree is drawn and an individuals risk of carrying a faulty gene and risk of developing cancer is calculated.
Individual risk is expressed as:
· the same as background population risk; (less than 15% lifetime risk of breast cancer)
· moderate risk, (a greater than 15% lifetime risk of breast cancer) or
· high risk. (a greater than 15% lifetime risk of breast cancer and a heterozygote risk of 25% or more)
Based upon this risk advice on the need for further surveillance or genetic testing can be given.
Women assessed to be at low or population risk of breast cancer are reassured that, on the information given, their risk is not significantly raised above that of the general population, so extra surveillance is not suggested. It is clearly stated that individuals in this group still have the same risk (or perhaps slightly higher) of cancer as any other individual of the same age in the general population. They should continue the standard health awareness and screening as the general population.
Women assessed as at moderate risk of breast cancer require ongoing management shared between primary care and appropriate specialist (for example the local specialist breast surgeon).
Women assessed to be at high risk of developing breast cancer are referred for specialist surveillance. This group is offered a genetics clinic appointment, and if appropriate, genetic testing.
The genetics clinic offers time to discuss issues at length and genetic counseling regarding the risk of cancer. Where possible, confirmation of diagnoses and histology in the relative with cancer is obtained, and where appropriate arrangements are made for follow up of other family members at high risk; storage of DNA from affected individuals and organisation of molecular genetic testing.
5.2.2 Calculation of breast cancer risk
Calculation of an individual woman’s risk of developing breast cancer is complex. There are breast cancer risks that all women are exposed to (population level); risks that sub-populations (e.g. certain types of family history) are exposed to and the risks for each individual woman. The risks of breast cancer can be expressed in terms of an age-specific risk (e.g. risk over the next five years), or a lifetime risk (e.g. risk to age 80).