UICC World Cancer Congress 2006

Globally, breast cancer is the most common cancer among women and is the most likely reason that a woman will die of cancer. Each year, breast cancer is newly diagnosed in more than 1.1 million women, representing more than 10% of all new cancer cases. With over 410,000 deaths each year, breast cancer accounts for over 1.6% of all female deaths worldwide (1,2). Countries with established and adequately funded health care systems not only have higher breast cancer diagnosis rates, but also have improved breast cancer survival (3). Breast cancer is becoming an increasingly urgent problem in low resource regions where incidence rates have been rising by up to 5% per year (4). Despite the common impression that breast cancer is a disease of wealthy countries, the majority of breast cancer deaths occur in developing countries (5).

Physicians working in a limited resources environment may be forced to make decisions contrary to their best medical knowledge. Despite knowing the optimal management for a patient, less-than-optimal solutions are offered to patients because diagnostic and/or treatment resources are lacking. Lack of radiotherapy facilities, for instance, prevents the use of breast conserving therapy (BCT) (6) and lack of available chemotherapy agents and infrastructure may make it impossible or unsafe to deliver cytotoxic chemotherapy in the adjuvant setting (7).

The constraint of limited resources generates tension for the clinician who is unable to offer “gold standard” treatments to any or all of the patients. This tension is amplified by the clinicians' added responsibility of having to manage an inadequate, fixed amount of resources from an insufficient cancer program budget. Does a clinician decide to treat ten patients with an older, less expensive chemotherapy regimen, or to treat two patients, with a newer, more efficacious but also more expensive regimen? For this reason, it is important to ask questions about which resources commonly applied in resource-abundant countries are actually needed in limited resource populations, where patients commonly present with more advanced disease at diagnosis.

THE ROLE OF GUIDELINES FOR LIMITED RESOURCE COUNTRIES

In most of the world, rational care requires rationing of resources. To Westerners, this concept may seem Draconian or unethical. Does the Hippocratic Oath not drive us to provide everything that we can for our patients? This perspective might suggest that defining guidelines for care in limited resource environments resembles the authorization of substandard care. Nothing could be further from the truth. The first attempts at establishing a cancer treatment program require treatment recommendations that favor simple and highly efficacious therapies. Key treatment alternatives are discussed, considering both relative costs of the interventions, efficacy differences, and the expected availability of resources and personnel to implement the program. Flexibility in the recommendations are important, as social, economic and health system development heterogeneity exists among countries and often among regions of the same country making universal, uniform recommendations impractical.

It would be easy to assume that methods of breast cancer diagnosis and treatment that have evolved in the West should directly translate into application in countries with limited resources—low- and middle-income countries. This assumption is not necessarily correct, and forgets the historic development of modern techniques. Some tools considered indispensable by Western standards are less useful in limited resource environments, because the more advanced stage of disease at diagnosis makes their findings less relevant. Standards of care are defined by the environment in which they are practiced. Similarly, the requirement for tools depends on the population in which the tools are being used. The degree to which detection technology is useful depends in part on the prevalence and stage of disease at presentation.

Early detection and comprehensive cancer treatment play synergistic roles in creating improved breast cancer outcomes. In economically developed countries, guidelines outlining optimal approaches to early detection, diagnosis and treatment of breast cancer are defined and have been disseminated (8-10). However, in 2002 the World Health Organization (WHO) pointed out that these guidelines have limited utility in resource-constrained countries (11). They fail to include implementation costs and provide no guidance as to how an existing system could be improved incrementally toward an ideal delivery system based on available resources. The guidelines development process for countries with limited resources tries to offer a practical solution to the implausibility of applying breast cancer guidelines developed for high resource-countries to countries with limited resources. Guidelines from high-resource countries may be inappropriate for a number of reasons, including inadequate numbers of trained health care providers; inadequate diagnostic and treatment infrastructure such as pathology, pharmacy, infusion centers, and microbiology laboratories; lack of drugs; lack of radiographic film; and inadequate transportation systems. Thus, in a country with limited resources, many barriers lie between the average patient and the level of care dictated by guidelines applicable to high-resource settings.

THE BREAST HEALTH GLOBAL INITIATIVE

Established in 2002, the Breast Health Global Initiative (BHGI) created an international health alliance to develop evidence-based guidelines for countries with limited resources—low- and middle-income countries—to improve breast health outcomes. The BHGI serves as a program for international guideline development, and as a hub for linkage and alliance among clinicians and governmental health agencies and advocacy groups to translate guidelines into policy and practice. BHGI cosponsors, The Fred Hutchinson Cancer Research Center and the Susan G. Komen Breast Cancer Foundation, collaborated with 12 national and international health organizations, cancer societies and non-governmental organizations (NGOs) to hold two BHGI international summits. The evidence-based BHGI Guidelines, developed at the 2002 summit, were first published in 2003 as a theoretical treatise on international breast health care. Following the 2005 summit the guidelines were updated and expanded into a fully comprehensive framework to permit step-by-step improvement in care. The Guidelines provide a flexible framework for quality improvement in health care delivery based upon outcomes, cost, cost-effectiveness and use of health care services.

In 2002, the BHGI hosted and held its first Global Summit, “International Breast Health Care Guidelines for Countries with Limited Healthcare Resources”, to define approaches by which countries of low and mid-level income could foster programmatic improvement in early detection, diagnosis and treatment of breast cancer. The first evidence-based guidelines were developed at this summit and published in 2003 as a theoretical treatise on international breast health care. These guidelines outline principles for programmatic improvement in breast health services as applied to low and middle income countries (7,12-14).

At the 2002 Global Summit, two axioms were adopted as principles for guideline development. First, it was assumed that all women have the right to access to health care, but that considerable challenges exist in implementing breast health care programs when resources are limited. Second, it was assumed that all women have the right to education about breast cancer, but that it must be culturally appropriate, and targeted and tailored to the specific population. While some countries of the world may not fully accept these axioms, the panelists felt that adoption of these principles represented a key starting point in guideline development.

In countries with limited resources, most women have advanced or metastatic breast cancer at the time of diagnosis. Based upon evidence-based review and consensus discussion, four core observations were made in 2002:

• Because advanced breast cancer has the poorest survival and is the most resource-intensive to treat, efforts aimed at early detection can reduce the stage at diagnosis, potentially improving the odds of survival and cure, and enabling simpler and more cost-effective treatment;.

• There is a need to build programs that are specific to each country's unique situation;

• The development of cancer centers can be a cost-effective way to deliver breast cancer care to some women when it is not yet possible to deliver such care to women nationwide;

• Collecting data on breast cancer is imperative for deciding how best to apply resources and for measuring progress.

2005 BHGI GLOBAL SUMMIT - UPDATED RESULTS

The BHGI guidelines were reexamined, revised and extended at the second Global Summit in 2005. Held from January 12–15, 2005, and hosted by the Office of International Affairs of the National Cancer Institute in Bethesda, Maryland, this summit convened 67 international experts representing 33 countries and five continents to define specific “best practices with limited resources”. The 2005 Guidelines addressed 1) Early Detection and Access to Care (15), 2) Diagnosis and Pathology (16), 3) Cancer Treatment and Allocation of Resources (17), and 4) Health Care Systems and Public Policy (18). The 2005 Guidelines define a comprehensive pathway for step-by-step quality improvement in health care delivery based upon outcomes, cost, cost-effectiveness and use of health care services.

To update and expand on the BHGI guidelines published in 2003, the 2005 BHGI panels outlined a stepwise, systematic approach to health care improvement. A tiered system of resource allotment was defined using four levels—basic, limited, enhanced, and maximal—based on the contribution of each resource toward improving clinical outcomes. During this analysis, a number of key points were identified and/or demonstrated:

• Early breast cancer detection improves outcome in a cost effective fashion assuming treatment is available;

• The effectiveness of early detection programs require public education to foster active patient participation in diagnosis and treatment;

• Clinical breast examination combined with diagnostic breast imaging (breast ultrasound with our without diagnostic mammography) can facilitate cost-effective tissue sampling techniques for cytological or histological diagnosis;

• Breast conserving therapy with partial mastectomy and radiation requires more health care resources and infrastructure than mastectomy, but can be provided in a thoughtfully designed limited resource setting;

• The availability and administration of systemic therapy are critical to improving breast cancer survival;

• Estrogen receptor testing allows patient selection for hormonal treatments (tamoxifen, oophorectomy) which is both better for patient care and allows proper distribution of services;

• Chemotherapy, which requires some allocation of resources and infrastructure, is needed to treat node-positive, locally advanced breast cancers, which represent the most common clinical presentation of disease in low-resource countries;

• When chemotherapy is unavailable, patients presenting with locally advanced, hormone receptor negative cancers can only receive palliative therapy.

The BHGI guidelines can be used to communicate programmatic needs to hospital administrations, government officials and/or health care ministries. It is the thesis of the BHGI that these works create a framework for change, by defining practical pathways through which breast cancer care can be improved in an incremental and cost-effective fashion (19). However, guidelines do not in-and-of themselves improve outcome for women. Implementation is the critical step by which the value of the guidelines may be measured. The results of pilot research projects and demonstration projects need to be studied and reported, both to determine the effectiveness of the guidelines, and to create evidence that will allow guideline implementation in other places. In this way, the BHGI endeavors to help women cope with and survive the ravages of the most common cancer and most common cancer killer among women.

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