Focused Workshop on Breast Cancer

This workshop took place on December 17-18, 2008 and was part of a larger workshop on cancer control held jointly by the WHO Eastern Mediterranean Region Office, INCTR and Lalla Salma.

Plenary Session

The plenary session consisted of a series of presentations designed to provide background to the working group discussions.
These are provided below:
Introduction to Breast Cancer in the Eastern Mediterranean Region
Importance of Early Detection and Treatment
Early Detection: Pros and Cons of Different Methods
Ensuring Rapid and Accurate Diagnosis
Management of Breast Cancer
Evaluating Breast Cancer Control Programs
The Lalla Salma Screening Program

Working Groups

Instructions provided to the working groups

The purpose of the working groups is to address specific issues that are relevant to breast cancer control in the EMR. Its focus is how best to translate existing evidence into action, to create needed evidence where this is lacking, and if possible, to provide specific tools to organizations or countries planning to establish breast cancer control programs – i.e., to move beyond – and complement – existing “guidelines.” A summary of the BHGI guidelines is provided.

In particular, the groups should identify existing barriers to effective care, encompassing all aspects of breast cancer control, and covering diverse issues such as the education/knowledge level of the public and of primary, secondary and tertiary care physicians; the nature and degree of resource limitations, including, in addition to human and material resources, health system structural issues, referral and patient navigation, the ability and need to evaluate programs, the effectiveness of communication between the various disciplines involved in breast cancer control and the interplay of politics (in its broadest sense) versus evidence in decision making. Account should be taken of the fact that the incidence of breast cancer is much lower in the EMR than in, for example, the USA or Europe, and that the age-specific incidence curves differ markedly, such that the mean age of women with breast cancer is much lower in the EMR. Moreover, the age-specific incidence curves from EMR countries plateau at around 50 years, i.e., just at the age at which most authorities in high income countries consider there is evidence for the value of mammography in reducing breast cancer related mortality. Nevertheless, breast cancer is the commonest cancer in women in the region and its incidence is increasing. Thus, planning for the future with regard to expanding existing resources, human and otherwise, and establishing referral networks, where appropriate linked to educational (for the public and primary health care providers) and/or screening programs are appropriate topics for discussion. The potential impact of digital tools for education, diagnosis and treatment, which will undoubtedly play an increasingly important role in cancer control, should also be considered.

There will be four working groups, each with a chairperson, whose role is to lead the discussion and to try to ensure that answers to as many of the questions posed to each group are answered, and a co-chairman/rapporteur, who will both assist the chairman in his role while keeping concise records of the conclusions reached and recommendations made. The rapporteur will also be responsible for presenting the report of his/her working group on the last day of the meeting. Each group will also include outside experts who may form a panel, along with the chairman and rapporteur, and should be provided opportunities to express their views. The four groups and major discussion topics for each are listed below:

1. Access to Care/Patient tracking and registration; organized versus opportunistic screening; public education; education of primary health care providers; ensuring screen positive patients are appropriately informed, referred and keep appointments; and developing systems of data collection that can be used both in the management of breast cancer control projects (e.g., tracking of screen positive women) and their evaluation.

2. Screening approaches to early diagnosis; the feasibility and priority of screening approaches in the context of available resources; pros and cons of mammography versus clinical breast examination in countries in the region. Relevant experience from ongoing programs and the need for more evidence on the value of various screening approaches in EMR countries.

3. Diagnosis and pathology; biopsy and lymph node sampling; quality and promptness of pathologic diagnosis; diagnostic imaging; required staging studies.

4. Treatment approaches; ensuring appropriate surgery and prompt initiation of radiation and systemic therapy; developing a multidisciplinary approach to treatment; potential for and difficulties relating to standardized therapy at institutional or national levels; resource sparing treatment approaches; breast conservation.

Guidelines for the discussion areas and questions to be addressed are provided below. There may not be time to address all of these issues, in which case the chairperson, after consultation with the group, can has the prerogative to decide which the most important questions are. Similarly, if the chairperson feels that a major topic area has been omitted, and the group is in agreement, he or she may add this to the list of discussion topics. Every effort should be made to provide specific recommendations relating to the establishment of breast cancer control programs.

The outcome of the workshops will be a report that summarizes the discussion relating to practical realities relevant to breast cancer control in the region and lists recommendations that identify specific actions that might be taken, including the design of breast cancer screening programs and research studies (particularly operational research studies) that may be needed to better assess the present situation. Some suggestions for the formulation of recommendations are made, but the recommendations should be based on the group discussions and consensus.

Since reports presented at the meeting will be preliminary, core group members should be identified who are willing to work on finalizing the reports by the end of January 2009.

Detailed Guidelines for Working Group Discussions

Working Group 1: Access to Care

This group should discuss all aspects of access to breast cancer care at all stages of care, including the possibility of early detection and access to prompt diagnosis and appropriate treatment (in the local context). In particular, it should attempt to identify some of the existing barriers to access to care, such as limited knowledge about cancer in both potential patients and in primary care (even secondary care) providers, limited available resources and lack of organized approaches at regional or national levels with respect to all aspects of breast cancer control. Patient navigation and triage, and communication among the broad range of health professionals involved with breast cancer control also fall into this groups purview, and recommendations regarding avoidance of the potential divide between those interested in education and early detection on the one hand, and diagnosis and treatment on the other should be addressed, as this may be critical with respect to access to care for screen positive women. An important issue is why many women refuse treatment for breast cancer, whether identified by screening or not and approaches to overcoming this problem. This group should also address the need for record keeping in both with respect to the management of projects addressing breast cancer control, which may extend to cancer registration, particularly in the context of breast cancer.

Specific Questions

1. What obstacles exist in the EMR to the prompt and accurate diagnosis of breast cancer and prompt access to appropriate therapy?
a. Is there a need for further research in this area? If so, what methods should be used?
b. Is there a need for further research on why many women with suspected or proven breast cancer refuse investigations and therapy; if not, what actions should be taken to address this issue?
2. How should countries decide on the priority to be assigned to breast cancer prevention and early detection (e.g., incidence of breast cancer, mortality rates, trends in incidence and mortality rates, available resources, etc.) both now and in the future?
a. Would it be helpful for a set of criteria to be developed for use in the EMR and possibly other regions to assist countries or regions in determining the priority of screening for breast cancer and the screening approach to be used?
b. If so, what factors should be taken into consideration (e.g., incidence, available resources for early detection, pathology and treatment, possible negative impact upon other cancer and health priorities)?
3. Are there core elements of effective and cost-effective public and professional education about breast cancer that either already exist, or could be developed in template form which could then provide the basis for this aspect of national programs in the EMR?
4. What implications for early detection programs does the lower overall incidence of breast cancer and the difference in the age-specific incidence curve (“plateau” after the age of 45-50) have for breast cancer screening?
5. What are the pros and cons of opportunistic versus organized programs for early detection in the EMR?
6. Would it be helpful to countries to have access to model templates for data collection (such as those created by INCTR) relating to access to care?

Sample model templates provided: 1-3

Suggested recommendations

The group should attempt to develop a set of recommendations related to assessing obstacles to access to care, (including approaches to identifying such obstacles) recommendations on overcoming already recognized obstacles and methods of continuously evaluating access to care, not just at the point of detection of a patient with suspected breast cancer, but throughout her journey to a center capable of providing treatment and beyond (i.e., treatment delivery and outcome). It should make recommendations regarding education of the public and primary or secondary health care providers about breast cancer and list the factors that should be considered in deciding the priority of breast cancer control.

Working Group 2: Screening approaches to early diagnosis

This group should discuss all aspects of breast cancer screening, including the pros and cons of available methods and the evaluation of the success of programs that are instituted. It should identify the reasons for the lack of success of screening programs in developing countries, such as quality of screening, the limited size of screened populations, treatment refusal etc. It should address the need for the evaluation of the effectiveness of programs, outcome measures and, to the extent possible, cost benefit considerations, including the increased demands on currently available health services and the potential for the diversion of health care workers from other tasks that screening programs will inevitably create.

Specific questions

1. Does the group agree, in view of the lack of evidence for an effect on mortality of breast cancer by breast cancer screening in developing countries that all early detection programs should only be instituted in a research context, e.g., evaluated at least with regard to stage distribution and possibly survival and/or mortality rates in screened women compared to an appropriate control group?
a. If so, what are the pros and cons of various control groups (e.g., unscreened women presenting to the same treatment centers, women randomized to education only, etc.)?
b. If not, how should countries or regions decide on the method to be used for early detection (e.g., education alone, breast self-examination, clinical breast examination, mammography or a combination of these). What is the role of ultrasound examination?
c. Would it be helpful for a set of criteria to be developed for use in the EMR and possibly other regions to assist countries or regions in deciding on the appropriate screening method to be used?
2. Given that breast cancer is increasing in the EMR, to what extent should programs undertaken today be considered pilot or research studies primarily designed to prepare for the future, e.g., to provide training in mammography in at least some centers even when clinical examination is selected as the primary screening method?
3. What are the relative priorities of educating the public and primary care providers about breast cancer versus establishing screening programs?
4. What impact is digital mammography likely to have on mammography programs now and in the future (with respect to training and consultation, both nationally and internationally)?
5. Would it be helpful to countries to have access to templates for data collection (such as those created by INCTR) in breast cancer screening programs that can be modified according to need?

Sample model templates provided: 4, 5

Suggested recommendations

The group should attempt to develop recommendations on how to determine the priority of breast cancer screening programs in the overall context of cancer control and with the increasing incidence of breast cancer in mind. It should provide guidance on how to decide whether early detection programs should be established, which approaches, if any, beyond education, should be used (clinical breast examination, mammography) and how to ensure efficient linkage with diagnostic and treatment programs.

Working Group 3: Diagnosis and Investigations

This group should consider all aspects of diagnosis, including biopsy, pathological examination of breast mass and regional nodes and imaging procedures relating to the investigation of women with a possible or confirmed diagnosis of breast cancer, whether identified via the primary health care system or via screening programs.

Specific questions

1. What obstacles exist in the EMR to the prompt, accurate and complete evaluation of women with a possible diagnosis of breast cancer?
a. Is there a need for further research in this area? If so, what methods should be used?
b. What is the relative importance and availability of studies of hormone and Her2/Neu receptor status and what quality control methods exist?
2. What approaches might be considered in order to overcome, at least in part, identified obstacles to prompt diagnosis and staging studies?
3. Are there possibilities within the EMR to compensate for differences in available resources for diagnosis and pathology – e.g., via training or consultation programs in resource rich countries, possibly utilizing teleradiology and/or telepathology.
4. Would it be useful or feasible to provide models/standard procedures for the region with respect to breast cancer diagnosis and staging - relating to biopsy, node status, receptor status and evaluation of local, regional and distant spread?
5. Would the development of standardized report formats be of value?
a. If so, what difficulties might be encountered in ensuring their use?
b. How might these difficulties be overcome?
6. What educational and training programs should be considered for health professionals involved in diagnosis and evaluation in order to cope with the increasing burden of breast cancer in the region?
7. Would it be helpful to countries to have access to templates for data collection (such as those created by INCTR) relating to breast diagnosis and investigations can be modified according to need?

Sample model templates provided: 9, 15, 17

Suggested recommendations

This group should provide recommendations regarding the minimal pathological and staging studies required for accurate diagnosis and appropriate treatment decisions. It should identify obstacles or suggest how to identify obstacles to accurate diagnosis and staging, and recommend approaches to overcoming such obstacles, e.g., accreditation programs/quality assurance and continuing education. It should make recommendations regarding standardized reporting and communication of findings to oncologists (including multidisciplinary meetings).

Working Group 4: Treatment Approaches

This group should consider all aspects of the management of breast cancer, including the health system structure and cost of care that may create obstacles to the most effective care feasible in different socioeconomic contexts. Particular emphasis should be given to obstacles to communication among the oncological disciplines (especially surgeons, medical and radiation oncologists), the links to other vital specialties, including pathology and medical imaging and how these can be overcome. Consideration should be given as to how clinical record keeping, including treatment outcome (requiring improved patient follow up) can be improved.

Specific questions

1. What obstacles exist to the effective collaboration among surgical, radiation and medical oncologists in the treatment of women with breast cancer in the region and what recommendations does the group have to overcome existing obstacles?
2. To what extent are treatment approaches standardized in major cancer institutes and hospitals in the EMR and to what extent can more standard approaches be introduced, especially in large cancer institutions in order to better evaluate the impact of screening on survival/mortality?
3. Is there a need for the conduct of more research studies to explore the relative merits of various treatment approaches in countries with limited resources?
4. If so, what treatment elements would the group give the highest priority to (e.g., optimal therapy for early stage breast cancer, breast conservation, limiting radiation, simple approaches in the lowest resource settings, such as mastectomy and oophorectomy etc.)
5. Is there effective collaboration among those involved with early detection and those involved with diagnosis and treatment in the region or at least some programs that can serve as models for countries or regions where there is less communication? If so, how can these models be introduced or evaluated in other regions?
6. What obstacles exist with respect to following up patients in order to accurately measure survival and how might these be overcome?
7. Are there possibilities for (or already existing) exchange/training programs in the management of breast cancer between the higher and lower resourced countries in the region? If so, how might such programs be introduced or expanded?
8. Would it be helpful to countries to have access to templates for data collection (such as those created by INCTR) relating to breast cancer treatment and follow up that can be modified according to need?

Sample model templates: 17, 18

Suggested recommendations

This group should provide recommendations regarding the identification and overcoming of obstacles to collaboration among surgeons, radiotherapists and chemotherapists, the advisability and feasibility of developing standardized treatment approaches, outside research studies, within institutions or even at a national level. It should identify high priority research questions that are relevant to countries at different socioeconomic levels in the region. It should provide recommendations as to how follow up might be improved such that accurate survival data can be collected and followed over years. It should provide suggestions as to how regional cooperation might be enhanced to the benefit of women with breast cancer.

Report

Workshop on Breast Cancer Control at EMRO, Cairo, 17th-18th December

PLENARY SESSION

Introduction: Purpose and Structure of the Workshop Dr I. Magrath

Breast cancer is the most important cancer in the EMR region, with about half those diagnosed dying from the disease. Post-menopausal women have lower incidence than in the West. There are many steps that influence the outcome of breast cancer, including presence or absence of early detection, stage of diagnosis, referral for therapy, acceptance of therapy and outcome of therapy. Without effective treatment, early detection will not be effective.

Objectives of workshop:
• To promote actions directed to breast cancer control.
• To identify obstacles to effective action that exist in the EMR or areas where more research is needed
• To propose approaches to overcoming known obstacles
• To emphasise the value of an integrated approach from early detection to treatment and to discuss how this might be achieved at least in the context of pilot projects
• To emphasise the need to evaluate programme outcomes and to consider how best this can be done:
–Cost: financial, human capital, potential negative impact
–Benefit: increased survival/decreased mortality
• To identify tools that aid decision making re: priorities, methodologies, data collection and programme evaluation

INCTR has developed templates for model data collection forms (modules) that can be used or adapted as required. There is one summary module (19). These could be incorporated in a system for data flow from screening, diagnostic and treatment centres to the data centre – both for research and evaluating the impact of projects.

Outcome of workshop:
• Learning from each other
• Identification of obstacles and potential solutions as well as areas where more assessment is required
• Exploration of possibilities for regional cooperation in breast cancer control
• Promotion of pilot programmes in breast cancer control that are integrated and effectively evaluated
• Identify tools that could help, e.g., the draft model data collection templates created by INCTR
• Preparation of a report of the group discussions and recommendations and eventual dissemination, as a basis for future actions and assessment of progress.

Overview of Breast Cancer Control: Importance of Early Detection and Treatment Dr R. Burton

Survival from breast cancer in women has improved in many countries, much of this, especially in North America, Europe and Australasia, is a result of improved awareness resulting in reduction in tumour size and improved treatment. The room for further improvement of survival in technically advanced countries is now very small. The first aim of an early detection programme in Low and Middle Income countries is to promote diagnosis at an earlier stage, move from detection in stage 3 and 4 to detection in stages 1 and 2. Mammography cannot do this, as its objective is to find impalpable breast cancers in stage 1, and it misses many invasive breast cancers in younger women. Therefore we need methods to downstage.

Treatment must be the optimal possible according to stage, ER/PR and EGF status. Reduction in breast cancer mortality in the UK seems almost entirely due to treatment. In Australia reduction in breast cancer mortality occurred most in women age 40-49, the group not targeted for breast screening by mammography. In contrast, improvement in therapy in response to National Clinical Practice Guidelines was substantial.

Recruitment versus opportunistic screening Dr R. Bekkali

In Morocco the target group for screening is 45-65 as many cases are identified in women age 45-49, a target group of over 2 million women. The mean age of detection of incident cases is 48. Morocco has higher reported breast cancer incidence than Tunisia and Algeria, but a much lower incidence than in the West. In a telemammography pilot project using digital mammography, with second reading of images in Brussels, 2200 women were screened in 1 year. Among the first 1000 women 5 cases of breast cancer were found; 3 would also have been diagnosed clinically. Following a recommendation by the Scientific Board of the Lalla Salma Association, a decision was made to start screening by clinical breast examination; because of the cost and high proportion of late stages in the population, mammography would not be cost-effective. Screening is initiated through the primary health care system, women are invited to be screened by CBE, the physicians and nurses having received training in CBE. Diagnosis is carried out at the secondary health care level– CBE and mammography are offered, with ultrasound, biopsy and pathology, if necessary. If breast cancer is confirmed, treatment is performed at the tertiary level.

There is a cultural barrier that has to be overcome, to persuade women without symptoms to be examined. A media campaign was initiated in May 2008 to provide the necessary health education. This is the first time in Morocco that breast cancer has been talked about in public - women affected by breast cancer were leaders in this process and a singer acted as a celebrity advocate; print media and television were used.

In the campaign, 2,300 GPs were trained, 120,654 CBEs performed, and 1284 women identified as suspected of having breast cancer. This was in the public system. In the private system (40% of women) opportunistic screening is performed, with no clear definition of age group.

Early Detection: pros and cons of different methodologies: education alone, BE/BSE, mammography Dr A.B. Miller

Mammography screening is less effective in women under age 50, and the technical and personnel requirements for population-based mammography screening are very substantial. An IARC working group (2002) determined that the reduction in risk of death from breast cancer by mammography screening was 12% in women aged 40–49 and 25% in women aged 50–69. In a large more recent UK trial among women age 39-41 on entry, the ratio of breast cancer deaths at mean follow-up of 10.7 years in the intervention arm relative to the control was 0.83 (95% CI 0.66-1.04), i.e. a non-significant 17% reduction in breast cancer mortality.

There has been only one trial that was specifically designed to evaluate the role of mammography over and above annual breast examinations and the teaching of breast self-examination (BE) - the Canadian National Breast Screening Trial among women age 50-59. In this trial, no breast cancer mortality reduction was found in the mammography-containing arm. A model-based analysis however suggested a benefit from BE of 20% compared to no screening, and an extension of this shows that BE is far more cost-effective than mammography screening.

In a number of western countries, breast cancer mortality has been falling. The timing of this recent fall is compatible with improvements in therapy, but is not compatible with an effect of mammography screening. However, the lack of any fall prior to 1990 suggests that early detection is not effective in the absence of effective treatment.

In Cairo, a trial with an initial pilot phase of 4000 women, and subsequent cluster randomization of 10,000 women in two other areas, has shown high breast cancer detection rates from BE, with good compliance with diagnosis, and preliminary evidence of a stage shift to an earlier stage at diagnosis in the BE group. The experience is now being replicated in Khartoum, Sana’a and Yazd (Iran), with projects designed to be compatible with local resources. Our experience suggests that BSE should be taught as part of BE, not used on its own, but as contributing to breast awareness.

WHO’s recommendations for LMI countries are:
• Evaluate importance of breast cancer
• Evaluate available resources
• Ensure availability of early diagnosis
• Ensure availability of therapy
• Introduce early detection based upon evidence
• If insufficient evidence-base, introduce screening as demonstration project first

The available evidence on BE now supports its use in population-based projects in the EMR.

Discussion
Ensuring compliance with screening is very important to achieve the impact expected in the population, this requires an organised approach; opportunistic screening has been shown to be ineffective. In Bahrain, 15,000 women were screened by mammography out of 65,000 invited, 65 breast cancers were found, but this had a small impact upon the total number of breast cancers and no impact upon breast cancer mortality has yet been seen. In Jordan, with health education alone there has been some impact upon advanced stage at detection (65% to 53%). Proper diagnosis is essential, and trained primary practitioners are necessary in order to reduce delay in diagnosis, which is often due to failure to recognize the early signs of breast cancer. The trials of BSE did not evaluate this approach in a routine population - in the Shanghai study, a large proportion of women were already being diagnosed at an early stage while in St Petersburg, BSE was evaluated in women already receiving annual CBE. However, there are good observational studies suggesting benefit of BSE.

There are detriments from early detection and screening, and we need to ensure they are not hidden, and that women are not coerced into screening.

Ensuring rapid and accurate diagnosis –Role of pathology Dr M. Ahmed

Breast cancers in this region are often triple negative (ER, PR, HER2). Multidisciplinary teams involved in treating breast cancer should include pathologists, to ensure clinical diagnosis is confirmed by pathology. Pathology should ensure timely and accurate diagnosis, distinguish between benign and malignant lesions, and convey as much information as possible to facilitate planning the most appropriate treatment. Pathology covers many disciplines in addition to anatomic pathology. Pathology findings should be correlated with clinical findings. There should be quality assurance and standardization of practices. Minimally invasive biopsy is simple and inexpensive, can be done as an outpatient but requires carefully trained people. Fine needle aspiration can be performed by many, if trained. Core-needle biopsy provides more information, and has the advantage that it can be used for hormone receptor determination.

Communication between surgeon and pathologist is critical. Specimens should be processed as soon as possible. Poor-quality specimens often result in problems in interpretation.

Pathology reports should include, size, margins, nodal involvement etc. Inaccuracies in diagnosis can be reduced by supervision, better training, and academic involvement.

Management of Breast Cancer - Dr H. Khalid

Ultrasound is preferred for diagnosis in women under age 30, mammography for older women, with ultrasound if necessary, and tissue diagnosis for all. In Egyptian women with early stage disease breast conserving surgery is preferred. Systemic treatment is necessary for locally advanced breast cancers. Neoadjuvant (pre-operative) treatment also improves outcome. In technically advanced countries, survival of advanced breast cancers has improved with combination regimens. Guidelines have been produced by the Breast Global Health Initiative, and recently updated (2008). Local guidelines have also been produced. Inflammatory breast cancer comprises 8% of breast cancers in Egypt. Multidisciplinary care is essential, as it formalises discussions about diagnosis, stage and plans for the right combination and sequence of treatment modalities. It thus diminishes the negative impact of modality-specific bias and anecdotal experience. In Port Said, stage shift has been demonstrated as a result of a comprehensive awareness, diagnosis and treatment programme, while an integrated diagnosis and treatment programme has increased social awareness and acceptance of early diagnosis and treatment.

Evaluating breast cancer control programmes Dr R. Sankaranarayanan

Process measures that can be used for evaluation include:
• Participation in screening
• Screening quality
• Screen positivity
• Compliance with referral
• Breast cancer/benign tumour detection rates

For screening test quality for mammography, the following criteria are used:
• % with radiographically acceptable mammograms (should be ≥97%)
• % undergoing a technical repeat screening test (should be <3%)
• % undergoing additional imaging at the time of screening (should be <5%)
• % of women recalled for further assessment
o Should be < 7% for initial screening round
o < 5% for repeat rounds

Intermediate outcome measures:
• % screen-detected cancers that are invasive (~90%)
• Stage distribution
• Proportion of women with breast cancer ≤ 2 cms
• Proportion of node-negative breast cancers
• Proportion of ER +ve tumours
• Proportion of patients completing the prescribed course of treatment
• Proportion of cancers treated with breast conservation
• Case fatality rate
• 2 and 5 year survival rates

Final outcome measures:
• Incidence of early and advanced breast cancer
• Mortality from breast cancer
• Adverse effects
• Quality of life

Obtaining these indicators requires a programme database. The quality of the programme can be assessed by linking with an appropriate (population-based) registry. Official death records often need to be supplemented with data from other sources (e.g. church and other registers) in order to obtain as complete information as possible.

In the Trivandrum cluster randomized breast cancer screening study, designed to evaluate the extent of stage shift, survival improvement and mortality reduction were observed as a result of a package of interventions consisting of breast awareness, CBE and improving public and professional awareness on breast cancer, its early clinical diagnosis and prompt treatment. Over 90,000 women were divided between the two arms. In the control group, education on cervix cancer, and cervix cancer detection is offered in clinics. In the intervention arm, education on BSE, early detection of breast cancer, CBE, FNAC, biopsy, staging and treatment is offered. 34 breast cancers have been detected in the intervention arm, and 26 in the control arm, of which 60% and 42% are stage I and IIa, respectively. The findings are now being used to inform the regional breast screening programme of breast screening.

In Sarawak it has been possible to demonstrate a stage shift of breast cancer in the population from a health awareness programme (without screening); similar improvements have been noted in South Korea.

Ensuring the quality of screening by CBE requires assessing the quality of diagnosis, and follow-up of screened women for missed cancers.

Prevention and Early Detection of Breast Cancer in Arab Countries
Dr N. Elsaghir

Tertiary prevention – treating advanced disease, is the primary form of cancer control in Arab countries. Given the cost and advanced stages of disease of the majority of patients, there is a need to move to secondary and primary prevention. In Tunisia, approximately 5-7% of newly diagnosed cases are inflammatory breast cancer. In Lebanon and other countries the incidence of breast cancer is increasing, in part from better detection, and also changes in lifestyle: increased fat in the diet, limited exercise among women, the increasing age of the mother at first birth and the frequent use of hormone replacement therapy (HRT) – there is clearly a role for primary prevention. The prevalence of mutations in genes that predispose to breast cancer (BRCA 1 and 2) is unknown. Misdiagnosis, and/or negligence by primary physicians often leads to delays in diagnosis, but other factors contributing to advanced disease at the time of therapy include:
• A low index of suspicion, especially in young women
• “Don’t worry” attitude, infection, engorgement “from pregnancy”, engorgement “from breast feeding”
• Repeated treatment with antibiotics
• Low level of liability and accountability for medical errors in Arab Countries

There is a potential role for husbands in early detection of breast cancer, in terms of general knowledge, and encouraging their wives to participate in early detection programmes.

WORKING GROUPS: OBSTACLES AND SOLUTIONS

1. Access to care/documentation (screening programmes, guidelines, education/public awareness, navigation, data base)

Priority is a Cancer Registry (e.g. hospital-based registry) before a cancer control programme, or some form of data collection. Data on incidence and mortality from breast cancer is needed in order to measure the eventual outcome of the programme.
Obstacles to success include the lack of data, of infrastructure, of trained professionals, and the lack professional and public awareness.

There is a need for further research, though the research questions should be carefully defined. A survey is needed to identify where the obstacles lie and the degree of impact they have in order to design evidence-based interventions. Questionnaires to assess knowledge of males, females and professionals about breast cancer would be very helpful. Examples of such studies include:
• Random interviews of women and men
• Assessment of the level of knowledge of the public about breast cancer
• Assessment of the level of knowledge of primary health care providers about breast cancer

Continuing medical education programmes are needed to increase awareness among professionals and increase their knowledge. However, physicians have time constraints, need new tools to collect relevant data.

Countries should decide on the priority to be assigned to breast cancer prevention and early detection; each country will need to define the size and nature of their own problem. There are four key factors:
• Cancer Incidence,
• Cancer mortality,
• Stage of cancer
• Existence of adequate diagnosis and treatments facilities.

A set of criteria developed for use in the EMR to help determine the priority of screening for breast cancer and screening approach to be used would be helpful.
Several factors need to be taken into consideration including:
• Incidence of advanced breast cancer
• Available resources for early detection, pathology and treatment,
• Possible negative impact upon other cancer and health priorities;
• Ease of implementation,
• Cost
• Economic cost to the country of not introducing more effective breast cancer control measures

There are core elements of effective and cost-effective public and professional education in other disease areas, but we need to create and package them for breast cancer.

The lowere overall incidence of breast cancer and the difference in the age-specific incidence curve compared to those in the West have a number of implications for early detection programmes in the EMR, including:
• The design of screening programmes should take this into consideration.
• 50+ plateau means the use of mammography may not be appropriate and cost effective,
• Mammography is inappropriate if the national priority is to downstage from stage 3-4 to stages 1-2
• CBE may the best option for this region.
• Early detection needs to be organised and linked with health care provision
• Opportunistic screening should not be encouraged as:
–It cannot be determined whether such programs are doing harm or good
–They are more expensive than organized programmes
–No data are collected.

Templates, such as those provided by INCTR can be appropriately modified for use, though a common data format is preferable if they are to be used for data entry at an international level or for comparisons of ongoing projects.

Obstacles at the point of detection:
• Lack of knowledge at the primary health care level
• Incorrect “knowledge”
• Lack of trained providers
• Lack of time and pressure of daily living
• Rarity of the event – breast cancer is uncommon

Research question:
How successfully can a breast cancer detection program be integrated into a horizontal primary health care programme?

Recommendation. Primary health care professionals should be encouraged to refer patients to cancer specialists whenever there is a suspicion that breast cancer may be present.

Obstacles to prompt diagnosis:
• Lack of awareness (public, and professional)
• Lack of a navigation system for patients for guidance and monitoring

Recommendation. To facilitate prompt diagnosis a tracking system supported by unique numerical patient identifiers should be developed.

Lack of awareness (Public, and Professional)

Recommendation. In order to improve public awareness:
• Create modules of breast cancer awareness for senior schools
• Conduct public awareness campaigns
• Encourage establishment of NGOs and charities devoted to breast cancer control.

Recommendation. In order to improve professional awareness:
• Develop curricula for healthcare workers at primary and secondary level
• Develop quality assurance programs

2. Screening approaches: CBE/BSE/mammography, analogue and digital

The need in the EM region is for demonstration projects with full evaluation. Where mammography is possible, that should be used, but with information collected on response to invitations to be screened and how that can be improved. When it is not possible to use mammography for screening, CBE (with BSE) is an appropriate alternative, but comparative studies of the two approaches should be performed when possible. Programmes should be integrated at the primary care level. Ministries of Health should collaborate and ensure that resources are available in the context of the NCCP. There is a need to increase awareness to reduce the knowledge barrier. There is also a need to be conscious of the economic barrier sometimes imposed between screening and diagnosis. Wherever possible diagnosis and treatment should be free, i.e. subsidised by the Ministry of Health. It is important to collaborate with NGOs in knowledge dissemination.

The mammography screening project in Egypt, supported by the Ministry of Health, started from Oct 2007, used 4 mobile vans and 6 fixed units. Digital mammography is used, with images transferred to readers in a centre of excellence. If a woman has a breast complaint they are referred elsewhere. Ten thousand women were examined in the first year and 244 breast cancers were suspected. However, 136 women did not come for diagnosis. 13 women with breast cancer had conservative surgery, 33 modified radical mastectormy, 7 were operated upon privately. In 16% of patients, the breast cancer was >3cm in diameter. It was stated that they “do not have stage 3 and 4 cancers in the screening programme” – presumably because symptomatic women are referred elsewhere. The project is linked to health education and includes screening for diabetes. The programme started in Cairo and expanded to Alexandria in November. The eventual target group are the 8 million women in Egypt age 40 or more.

It is important for diagnosis and treatment centres to be readily accessible to women screened and found to have an abnormality.

It is extremely important that countries that have started mammography screening fully evaluate what has been achieved, publish their findings, and, based on these, make decisions on the future direction of their programme.

Recommendation: Early detection and screening programmes for breast cancer should begin now in all countries in the EM region.
• Public education and education of primary health care practitioners is the first step
• Follow-up diagnosis and treatment must occur
• There should be continuous evaluation of process measures and disease outcomes
• Local research for local questions is important.

3. Diagnosis of breast cancer: imaging and pathology obstacles and solutions

Minimal pathological diagnostic studies should comprise:
• Clinical: history, breast examination by a specialist.
• Imaging and Laboratory tests: ultrasound directed fine needle aspiration cytology (FNAC) of an axillary lymph node
• Pathology: diagnostic FNAC
An accurate histopathological tissue diagnosis

The pathology report should include:
• Tumour size, LN status, type, grade
• Tumour margin status, ductal carcinoma in situ (DCIS) content, lympho-vascular invasion
• Pathological Staging
• Oestrogen receptor (progesterone receptor) status by immunohistochemistry

Other lab tests:
• Complete Blood Profile
• Blood chemistry

TNM staging System should be adopted

Obstacles to accurate diagnosis in the EM region include:
• Stigma pertaining to cancer
• Myths and false beliefs
• Low level of education (ignorance)
• Lack of public health awareness programmes
• Socioeconomic problems preventing symptomatic patients from seeking medical advice
• Paucity of access points to the health care system
• Inadequate number of referral centres
• No training or educational curriculum for primary health care providers
• Inadequate, low-quality recording of patients' epidemiologic & demographic data
• Limited financial resources
• Insufficient health workers e.g. untrained or insufficiently trained personnel (radiologists, radiographers, histopathologists and cytopathologists, laboratory technicians, etc.)
• Unavailability or insufficiency of the required technical resources and equipment (i.e., mammography, ultrasound, sufficiently well-equipped pathology laboratories, tumour marker studies, etc.)
• The pathology report lacks data on the stage of disease at presentation (tumour size, lymph node status) or grade of the disease.
• No information is provided on the results of histopathology after excision of the lump (preventing quality control procedures).

Obstacles to prompt, accurate diagnosis in the EM region:
• Lack of specialized diagnostic breast clinics
• Lack of standardized laboratory and imaging quality control measures.
• Loss of cooperation between the different specialists involved in the diagnosis (i.e., lack of team-work approach).
• No or weak health information system
• Poor follow-up, monitoring or evaluation systems.
• No evidence-based protocol guidelines for pathologists or radiologists.
• Many laboratories in the countries do have centres capable of immunohistochemistry.

Approaches to overcoming the existing obstacles include:
• Ensure access to breast cancer services (increase access points to primary, secondary and tertiary health care centres).
• Ensure accurate and complete recording of individual demographic & clinico-pathological data
• Develop continuing education for doctors, technicians and nurses
• Improve communication among health professionals (i.e., ensure the multidisciplinary team approach).
• Develop training programmes for involved doctors, technicians and nurses
• Consider collaborative programmes for training and consultation
• Explore and improve quality of diagnostic services (applying technology in low and middle income countries), i.e., breast imaging techniques (ultrasound, diagnostic mammography) and pathology (including cytology, surgical pathology, immunohistochemistry and genetics).
• Develop optimal breast pathology services as a fundamental requirement for the delivery of quality health breast care with emphasis on patients' safety.
• Introduce and disseminate standard care guidelines among pathologists and radiologists
• Develop educational and training curricula tailored to specific resource constraints (e.g. targeted to breast pathology).
• Measure the quality of the offered services (accreditation)
• Develop a basic information system
• Ensure follow-up of the target population
• Organize systems for monitoring and evaluation
• Introduce quality assurance measures
• Develop a regional network of learning laboratories and comprehensive cancer centres.
• Identify institutions willing to collaborate (consider WHO Collaborating Centres).
• Introduce informatics in breast healthcare delivery (low cost communication tools to facilitate transfer of information between partner organizations and to make key information available to the public) e.g. networking of various kinds, telepathology & teleradiology.
• Organize a task force responsible for development of evidence – based guidelines for quality assurance in the EM region.

Development of standardized report formats:
• It would be helpful to countries to have access to templates for data collection modified according to their needs (e.g. based on the INCTR templates).
• However, various difficulties in ensuring their use should be considered:
- Non-compliance of the health care providers in completing the forms and difficulty in ensuring the quality of the recorded information
- Difficulty in ensuring complete follow-up)
• Compliance is more likely to be increased through education, training and institutional support (including the provision of rewards and incentives rather than punishment).

Needs for further research
• Implementation of research to ensure translation of scientific findings into general practice, i.e., evidence-based (questionnaire on situation analysis, case control studies, retrospective, randomized trials, meta-analysis, etc..).
• Her2/Neu receptor studies are important to indicate aggressiveness of the tumour
• Develop standardized quality control methods in the region.

Triage should be carefully studied. If ultrasound were available at the level of the primary health care system, for example, patients with minimal requirements for diagnosis (e.g., with a breast cyst) do not overwhelm the diagnosis system.

Recommendation. The National Cancer Committee in each country should initiate a task force comprising specialists in cancer imaging and pathology, and make recommendations to the government for improving standards in accordance with internationally accepted criteria, as specified in this report.

4. Treatment: developing standard multidisciplinary approaches

Collaboration between surgery, medical oncology and radiation oncology is important to cancer treatment planning. Multidisciplinary teams, comprising: surgery, radiation oncology and medical oncology, pathology, radiology, nursing, social care and psychology, must be promoted, with:
• Weekly or more frequent multidisciplinary clinic to patient evaluation
• Evaluation of all patients in a multidisciplinary setting with “tumor board” review of difficult cases

The development of institutional protocols would do much to avoid unnecessary delays in the institution of treatment, e.g., neoadjuvant (preoperative). Chemotherapy regimens should be standardized within a given institution.

Treatment standardization is fundamental but needs to be adapted to individual patient presentation and existing resources and also needs to be periodically modified to address new information or discoveries. A role for government and international health organisations such as WHO is to reinforce the necessity of conformation to standardized treatment protocols following evidence-based, disease specific guidelines.

Treatment guidelines such as St. Galen, EUSOMA, Breast Health Global Initiative and others are available for review, but must be adapted to specific clinical settings. Not all institutions will choose identical protocols, even within the same country.

WHO and INCTR should promote trials that address therapeutic protocols that are projected to have equivalent outcome as standard protocols, but can be delivered in ways that are more practical, less resource intensive or more cost effective. For example:
–Accelerated partial breast radiation therapy (IAEA)
–Use of less expensive drug protocols
–Use of oophorectomy in place of endocrine therapies among premenopausal women with estrogen receptor positive cancers
–Herceptin for 1 year could improve treatment coverage without creating significant decrement in care.
Trials must be evaluated for therapeutic efficacy to ensure that substandard protocols are not being inadvertently promoted.

Centres of excellence for cancer care (tertiary care) require active collaboration and communication with primary and secondary care facilities.
• Some therapies are limited to tertiary care due to cost and resource limitations, e.g., radiation therapy, sentinel node biopsy using radioactive tracer.
• Primary care facilities can provide critical public education about early cancer detection and properly triage patients to secondary care facilities that provide some level of cancer care, e.g., cancer surgery.
Communication about national cancer treatment protocols from tertiary to secondary care centres is necessary so that proper care is initiated at the secondary level, and also to offload the excessive volume of patients.

Follow-up information systems are not well established. Follow-up is limited by geographical constraints, communication obstacles and patient illiteracy.

Death certification with cancer as a cause of death may be highly inaccurate. As a result, cancer registration and mortality statistics may be flawed. It is worth evaluating the extent to which documentation of available (or administered) treatment and response information can be used to improve decisions on the cause of death. The WHO verbal autopsy process may prove valuable when cause of death is uncertain.

Training opportunities include oncology training for oncologists and for non-oncologists.
• Oncology specialty training is considered a basic requirement of tertiary care facilities and should be supported by governments and WHO.
• Oncology training for non-oncologists such as primary care providers, so that they will properly support early detection programs and post-treatment follow-up.
Collaboration between countries can facilitate this training. Medical school cancer curricula should be developed and included in medical school education.

WHO can facilitate data collection on cancer treatment access in countries and can provide training grants to facilitate cancer education in countries of specific need.

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