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Women's Health

Journal supplement focuses on guidelines for international breast health and cancer control-implementation

The "Global Summit on International Breast Health Implementation," an international conference convened by the Breast Health Global Initiative (BHGI), a group of breast cancer experts and advocates, was held in Budapest, Hungary in October 2007. The conference was cosponsored by the Agency for Healthcare Research and Quality (HS17218). An October 15, 2008, supplemental issue of Cancer 113(Suppl 8) included a series of 15 papers on the conference topics by researchers and constituent groups affiliated with the BHGI. The first paper introduces the overall aims of BHGI. Four subsequent papers discuss guideline implementation in the context of resource allocation for early detection, diagnosis, and treatment, and breast health care programs. Three papers discuss guideline implementation for breast pathology, breast radiation therapy, and locally advanced breast cancer. Other papers discuss breast cancer prevention, strategic health communication, re-establishing a surgical pathology service, revision surgery for breast cancer, effective but cost-prohibitive drugs in breast cancer treatment, and breast cancer in Latin America. The final paper in the supplement focuses on defining a global research agenda for breast cancer. Brief summaries of the papers follow.

Hortobagyi, G. N. "A time for creative collaboration," pp. 2217-2220.

BHGI is a group of carefully selected breast cancer and public health professionals and advocates. It has developed a guideline structure that defines the minimal components of a breast health program. Without these basic components, there is no breast health program. In addition, three increasingly sophisticated levels of care are defined that can substitute for or improve the results of the basic level of care. The expertise of the BHGI can provide an impartial assessment of the existing evidence for best practices in the diagnosis, prevention, and treatment of breast diseases. By disseminating their guidelines and principles, the BHGI hopes to recruit a broader constituency around the world that understands that the burden of breast cancer morbidity and mortality does not have to remain unchanged. There are tools and strategies to reduce both, even with relatively limited resources.

Yip, C-H., Smith, R. A., Anderson, B. O., and others. "Guideline implementation for breast healthcare in low- and middle-income countries," pp. 2244-2256.

The objective of BHGI's third Global Summit held in Budapest in 2007 was to address resource allocation, specifically focusing on guideline implementation in low- and middle-income countries. The BHGI Early Detection Panel of multidisciplinary experts addressed the implementation of BHGI guidelines for the early detection of disease as they related to resource allocation for public education and awareness, cancer detection methods, and evaluation goals. Public education and awareness are the critical first steps, because early detection programs cannot succeed if the public is unaware of their value. Screening methods, including mammography, clinical breast examination, and breast self-examination, were reviewed for efficiency and effectiveness in the context of resource availability and population-based need. The most critical need may be for carefully designed and conducted studies on barriers to early detection.

Shyyan, R., Sener, S. F., Anderson, B. O., and others. "Guideline implementation for breast healthcare in low- and middle-income countries: Diagnosis resources allocation," pp. 2257-68.

The BHGI Diagnosis Panel reviewed diagnosis guideline tables. Core implementation issues and process indicators based on the resource allocation guidelines were discussed. The evaluation by the Diagnosis Panel was divided into six parts: (1) clinical assessment, (2) diagnostic breast imaging, (3) tissue sampling, (4) surgical pathology, (5) laboratory tests and metastatic imaging, and (6) health care system issues related to diagnosis. Process indicators were developed based on the priorities established in the guideline stratification. For each level of resources (basic, limited, enhanced, and maximal) the panel set forth diagnostic guidelines. For example, pathology tumor marker assays, starting with estrogen receptor testing, should be available to support limited-level treatment, because the test results by immunohistochemistry determine key questions regarding therapy choices for endocrine therapy.

Eniu, A., Carlson, R. W., El Saghir, N. S., and others. "Guideline implementation for breast healthcare in low- and middle-income countries: Treatment resource allocation," pp. 2269-2281.

The BHGI Treatment Panel expanded on prior guidelines to examine how key therapeutic interventions can be integrated to form a functional treatment program in low- to middle-income countries given differing levels of available resources. The panel expanded previous guidelines to include process metrics that can be used by medical professionals and health care authorities to assess the functionality of their breast health programs. The evaluation of the Treatment Panel was considered in the context of required resources (surgery, radiation therapy, and systemic therapy), which were then stratified based on cancer stage at presentation. The panel provides checklists for a number of different therapies. Each entry consists of a specific therapy (e.g., breast cancer surgery with axillary dissection), its strengths and weaknesses, and resources required. Also presented is a treatment resource allocation and process metrics table for stage I breast cancer.

Harford, J., Azavedo, E., and Fischietto, M., on behalf of the Breast Health Global Initiative Healthcare Systems Panel. "Guideline implementation for breast healthcare in low- and middle-income countries: Breast healthcare program resource allocation," pp. 2282-2296.

The Healthcare Systems Panel agreed that it is the responsibility of the health care system (HCS), defined either locally or nationally, to ensure that human resources are appropriate in the areas of early detection, diagnosis, and treatment. The HCS Panel guidelines on human resource allocation include the personnel needed for patient and family education, capacity building, and patient navigation. The HCS Panel guidelines on support systems resource allocation address issues faced by breast cancer program managers who must work within a given HCS to determine which services to provide, records to keep, and facilities to invest in developing. Because all of the guidelines from each of the other panels will need to be implemented in the context of a given HCS, the two guideline tables developed by the HCS Panel, in a sense, must be derivative of the work of the other panels that define the stratified needs in each of their respective thematic areas.

Masood, S., Vass, L., Ibarra, J. A., and others on behalf of the Breast Health Global Initiative Pathology Focus Group. "Breast pathology guideline implementation in low- and middle-income countries," pp. 2297-2304.

The BHGI designated a number of interested pathologists, breast cancer clinician specialists, and patient advocates to form the Breast Pathology Focus Group (BPFG). The BPFG was charged with assessing how to adapt the previous resource-stratified guideline tables into real world implementation in low- and middle-income countries, to develop process indicators for each of the four levels of resources, and to identify system changes necessary for implementation. The BPFG made specific recommendations on the training of pathology personnel, interdisciplinary coordination and teamwork, and adequate tissue sampling. It also provided guidelines on pathology diagnosis and reporting and the use of immunohistochemical testing. In addition, the group agreed on seven process indicators in breast pathology to be integrated in all anatomic pathology laboratories.

Bese, N. S., Munshi, A., Budrukkar, A., and others on behalf of the Breast Health Global Initiative Radiation Therapy Focus Group. "Breast radiation guideline implementation in low- and middle-income countries," pp. 2269-2281.

The BHGI's Radiation Therapy Focus Group reviewed the components needed for implementing a successful radiation therapy program, focusing on specific radiation therapy techniques and strategies for expanding the use of radiation therapy for breast cancer in countries with limited resources. For example, they discussed the advantages and disadvantages of a cobalt-69 machine versus a linear accelerator for countries with limited resources. Their recommendations covered whole-breast radiation therapy and accelerated partial breast irradiation for early-stage breast cancer (stages I and II) as well as postmastectomy radiation therapy. There were also recommendations for the treatment of metastatic breast cancer. Finally, the authors discussed quality-assurance and cost issues.

El Saghir, N. S., Eniu, A., Carlson, R. W., and others on behalf of the Breast Health Global Initiative Systemic Therapy Focus Group. "Locally advanced breast cancer: Treatment guideline implementation with particular attention to low- and middle-income countries," pp. 2315-2324.

Systemic therapy for breast cancer incorporates chemotherapy, targeted therapy, and hormone manipulation. It is used for metastatic disease, as postoperative adjuvant therapy for primary breast cancer, and as neoadjuvant (preoperative) therapy for locally advanced breast cancer (LABC). The BHGI's Systemic Therapy Focus Group discussed the management and implementation of primary systemic therapy (PST) for LABC. Systemic therapy for LABC involves the use of a wide range of medications, from tamoxifen to more expensive, targeted agents such as trastuzumab and lapatinib. The Focus Group encourages the conduct of clinical trials in low-resource countries, since breast cancers observed in such countries frequently exhibit different and more aggressive biologic behavior than those found in industrialized countries.

McTiernan, A., Porter, P., and Potter, J. D. "Breast cancer prevention in countries with diverse resources," pp. 2325-2330.

The authors review several lifestyle factors and interventions that have been shown or are postulated to reduce breast cancer risk. The emphasis is on interventions, including lactation, physical activity, weight control, diet, alcohol use, and avoidance of specific carcinogens, which could be implemented in countries with low or moderate levels of health care resources. This review is not comprehensive, but instead includes studies to illustrate particular issues. For example, 1 collaborative study on breastfeeding with over 147,000 patients found that the risk of developing invasive breast cancer decreased 4.3 percent for every 12 months of breastfeeding. Other studies pertaining to the role of physical activity, weight control, and diet are also discussed. The authors caution that applicability of various strategies to low-income countries has yet to be adequately studied.

Kreps, G. L., and Sivaram, R. "Strategic health communication across the continuum of breast cancer care in limited-resource countries," pp. 2331-2337.

The authors examine strategic health communication factors in developing and implementing effective, evidence-based, economically feasible, and culturally appropriate interventions to improve breast cancer outcomes that can be applied in nations with limited health care resources. They discuss communication across the continuum of care from early detection to diagnosis, treatment, and survivorship and the importance of culturally sensitive health communications programs and policies in limited-resource countries. They note the provision of social support as an effective communication strategy for moderating negative psychological reactions to breast cancer. The authors also focus on the role of communication campaign interventions at the group, community, and population levels.

Stalsberg, H., Awuah, B., Ibarra, J. A. and Nsiah-Asare, A. "Re-establishing a surgical pathology service in Kumasi, Ghana," pp. 2338-2346.

The authors present a case report about how a hospital in Norway helped a hospital in Ghana re-establish its surgical pathology service. The proposals, the barriers encountered, and the key elements of the final successful collaboration between the low-resource and high-resource country are described. The first proposal to collaborate with a community hospital in the United States did not work out due to legal, technical, and staff capacity issues. The second proposal to the Norwegian hospital was implemented by the following steps: training two Ghanaian technicians at the Norwegian hospital, restarting slide production at the Ghana hospital, sending specimens to the Norwegian hospital, and training two young physicians at the Norwegian hospital. In addition, the Ghanaian hospital acquired a new pathology building and new equipment. Funding support from the Ghanaian hospital was supplemented by support from the Norwegian hospital and government.

Thorat, M. A., Rangole, A., Nadkarni, M. S., and others. "Revision surgery for breast cancer," pp. 2347-2352.

The researchers studied revision surgery for breast cancer at a hospital in Mumbai, India. To their knowledge, this subject had not previously been studied. In India, most breast surgeries are done by general surgeons, since breast surgery is not a subspecialty. Forty-five percent of the 424 patients who came to the hospital after receiving breast cancer surgery had received incomplete surgery. Completion revision surgery was performed for 153 patients, while 123 patients had residual axillary lymph nodes. The median number of axillary lymph nodes left behind was 8, and 64 patients had metastatic lymph node(s) left behind. The authors conclude that although this is a single institution's experience, the overall situation in India in not likely to be very different. There are very few specialty cancer treatment centers for India's vast population.

Bines, J., and Eniu, A. "Effective but cost-prohibitive drugs in breast cancer treatment," pp. 2353-2358.

New drugs for early-stage breast cancer are effective, but many are cost-prohibitive in low-income countries. The authors of this paper review new and emerging medical treatment with the potential to improve the cost-effectiveness equation. From a medical perspective, studies of effective shortened treatment duration and intermittent administration are needed. Strategies to improve on existing therapies may be able to take advantage of drug interactions with food and other drugs that increase their bioavailability. Through the use of multigene arrays and pharmacogenetics, treatment may be selected for the patients who most likely will benefit from it, avoiding unnecessary toxicity and cost. Older drugs may find their way back and assume new roles as they are selected for the right target patient population.

Cazap, E., Buzaid, A. C., Garbino, C., and others. "Breast cancer in Latin America: Results of the Latin American and Caribbean Society of Medical Oncology/Breast Cancer Research Foundation Expert Survey," pp. 2359-2365.

The researchers surveyed 100 breast cancer experts from 12 Latin American countries. The purpose of the survey was to perform an exploratory analysis on the current state of breast cancer care in these regions. The survey asked 65 questions about care at both the country and the center levels. It found that six countries had country-based cancer registries while another six had only provincial or municipal registries. More than 90 percent of respondents stated that there were no national laws or guidelines in their country for mandatory mammography screening. Access to mammography reportedly was available to 66 percent of patients at the country level. At the center and country levels, the overwhelming majority of patients began their treatment in less than 3 months. Almost all patients started chemotherapy during their first 3 months after surgery.

Love, R. R. "Defining a global research agenda for breast cancer," pp. 2366-2371.

Health care strategies that are effective and efficient in high-income countries may be inappropriate for countries with lower breast cancer incidence, fewer resources, and competing demands from high-incidence health problems such as communicable diseases, notes the author of this paper. He provides background critical to development of a research agenda that can support effective and cost-effective allocation of resources to breast cancer globally, as well as the mechanisms through which this agenda may be accomplished. This research agenda should embrace the following priorities: downstaging by clinical breast examination; performing pharmacogenomic studies of systemic adjuvant therapy to establish and increase efficacy and safety of "standard" hormonal therapies in different populations; performing pharmacogenomic studies to establish and increase efficacy of generic drug-systemic therapy approaches in hormone receptor-negative breast cancer; and developing a model for closing the affordability gap for new systemic targeted therapies. Studies on these and related subjects can best be carried out by research partnerships between organizations in high and low-to-medium income countries.

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