Systemic Treatment of Patients With Metastatic Breast Cancer: ASCO Resource-Stratified Guideline.

PURPOSE: To guide clinicians and policymakers in three global resource-constrained settings on treating patients with metastatic breast cancer (MBC) when Maximal setting-guideline recommended treatment is unavailable. METHODS: A multidisciplinary, multinational panel reviewed existing ASCO guidelines and conducted modified ADAPTE and formal consensus processes. RESULTS: Four published resource-agnostic guidelines were adapted for resource-constrained settings; informing two rounds of formal consensus; recommendations received ≥75% agreement. RECOMMENDATIONS: Clinicians should recommend treatment according to menopausal status, pathological and biomarker features when quality results are available. In first-line, for hormone receptor (HR)-positive MBC, when a non-steroidal aromatase inhibitor and CDK 4/6 inhibitor combination is unavailable, use hormonal therapy alone. For life-threatening disease, use single-agent chemotherapy or surgery for local control. For premenopausal patients, use ovarian suppression or ablation plus hormone therapy in Basic settings. For human epidermal growth factor receptor 2 (HER2)-positive MBC, if trastuzumab, pertuzumab, and chemotherapy are unavailable, use trastuzumab and chemotherapy; if unavailable, use chemotherapy. For HER2-positive, HR-positive MBC, use standard first-line therapy, or endocrine therapy if contraindications. For triple-negative MBC with unknown PD-L1 status, or if PD-L1-positive and immunotherapy unavailable, use single-agent chemotherapy. For germline BRCA1/2 mutation-positive MBC, if poly(ADP-ribose) polymerase inhibitor is unavailable, use hormonal therapy (HR-positive MBC) and chemotherapy (HR-negative MBC). In second-line, for HR-positive MBC, Enhanced setting recommendations depend on prior treatment; for Limited, use tamoxifen or chemotherapy. For HER2-positive MBC, if trastuzumab deruxtecan is unavailable, use trastuzumab emtansine; if unavailable, capecitabine and lapatinib; if unavailable, trastuzumab and/or chemotherapy (hormonal therapy alone for HR-positive MBC).Additional information is available at www.asco.org/resource-stratified-guidelines. It is ASCO's view that healthcare providers and system decision-makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

Action for Increasing Diversity, Market Access, and Capacity in Oncology Registration Trials-Is Africa the Answer? Report From a Satellite Session of the Accelerating Anti-Cancer Agent Development and Validation Workshop.

Patients of African ancestry are not well-represented in cancer clinical trials despite bearing a disproportionate share of mortality both in United States and Africa. We describe key stakeholder perspectives and priorities related to bringing early-stage cancer clinical trials to Africa and outline essential action steps. Increasing Diversity, Market Access, and Capacity in Oncology Registration Trials-Is Africa the Answer? satellite session was organized at 2021 Accelerating Anti-Cancer Agent Development and Validation Workshop. Panelists included representatives of African Organization for Research and Training in Cancer, Uganda Cancer Institute, Uganda Women's Cancer Support Organization, BIO Ventures for Global Health, Bill & Melinda Gates Foundation, the US Food and Drug Administration, Nigeria's National Agency for Food and Drug Administration and Control, Bayer, and Genentech, with moderators from ASCO and American Cancer Society. Key discussion themes and resulting action steps were agreed upon by all participants. Panelists agreed that increasing diversity in cancer clinical trials by including African patients is key to ensuring novel drugs are safe and effective across populations. They underscored the importance of equity in clinical trial access for patients in Africa. Panelists discussed their values related to access and barriers to opening clinical trials in Africa and described innovative solutions from their work aimed at overcoming these obstacles. Multisectoral collaboration efforts that allow leveraging of limited resources and result in sustainable capacity building and mutually beneficial long-term partnerships were discussed as key to outlined action steps. The panel discussion resulted in valuable insights about key stakeholder values and priorities related to bringing early-stage clinical trials to Africa, as well as specific actions for each stakeholder group.

Breast cancer early detection and diagnostic capacity in Uganda.

BACKGROUND: Greater than 80% of women presenting for breast cancer treatment in Uganda have late-stage disease, which is attributable to a dysfunctional referral system and a lack of recognition of the early signs and symptoms among primary health care providers, and compounded by the poor infrastructure and inadequate human capacity. Improving the breast health care system requires a systemic approach beginning with situational analysis to identify systematic gaps that prevent sustainable improvements in outcome. METHODS: The authors performed a situational analysis of the breast health care system using methods developed by the Breast Health Global Initiative. Based on their findings, they developed a series of recommendations for strengthening the health system for the early diagnosis of breast cancer based on clinical detection, referral, tissue sampling, and diagnosis. RESULTS: Deficits in the recognition of breast cancer signs and symptoms, the underuse of clinical breast examination as a diagnostic and/or screening tool, the centralization of diagnostic tests (radiology and pathology), reliance on excisional biopsies rather than needle biopsies, and a lack of trained professionals and knowledge of the referral system all contribute to significant health system delays. CONCLUSIONS: To strengthen referral networks and improve the early diagnosis of breast cancer in Uganda, national referral hospitals should provide educational programs to primary health care providers in community health centers (CHCs), at which the majority of women first present with symptoms. At secondary district-level facilities in which imaging and tissue sampling can be performed, the capacity for diagnostic testing could be increased through task shifting of basic interpretation (abnormal vs normal) from specialists to nonspecialists using networking technology to facilitate remote oversight from specialists at the national referral hospitals.

Breast cancer patient advocacy: A qualitative study of the challenges and opportunities for civil society organizations in low-income and middle-income countries.

BACKGROUND: Breast cancer advocacy movements, driven by advocate-led civil society organizations (CSOs), have proven to be a powerful force for the advancement of cancer control in high-income countries (HICs). However, although patient advocacy movements are growing in low-income and middle-income countries (LMICs) in response to an increasing cancer burden, the experiences and needs of advocate-led breast cancer CSOs in LMICs is understudied. METHODS: The authors conducted a qualitative study using in-depth interviews and focus group discussions with 98 participants representing 23 LMICs in Eastern Europe, Central Asia, East and Southern Africa, and Latin America. RESULTS: Despite geographic, cultural, and socioeconomic differences, the common themes that emerged from the data across the 3 regions are strikingly similar: trust, knowledge gaps, stigma, sharing experiences, and sustainability. The authors identified common facilitators (training/education, relationship building/networking, third-party facilitators, and communication) and barriers (mistrust, stigma, organizational fragility, difficulty translating HIC strategies) to establishing trust, collaboration, and advancing cancer advocacy efforts. To the authors' knowledge, the current study is the first to describe the role that coalitions and regional networks play in advancing breast cancer advocacy in LMICs across multiple regions. CONCLUSIONS: The findings of the current study corroborate the importance of investing in 3-way partnerships between CSOs, political leaders, and health experts. When provided with information that is evidence-based and resource appropriate, as well as opportunities to network, advocates are better equipped to achieve their goals. The authors propose that support for CSOs focuses on building trust through increasing opportunities for engagement, disseminating best practices and evidence-based information, and fostering the creation of platforms for partnerships and networks.

Breast cancer treatment: A phased approach to implementation.

Optimal treatment outcomes for breast cancer are dependent on a timely diagnosis followed by an organized, multidisciplinary approach to care. However, in many low- and middle-income countries, effective care management pathways can be difficult to follow because of financial constraints, a lack of resources, an insufficiently trained workforce, and/or poor infrastructure. On the basis of prior work by the Breast Health Global Initiative, this article proposes a phased implementation strategy for developing sustainable approaches to enhancing patient care in limited-resource settings by creating roadmaps that are individualized and adapted to the baseline environment. This strategy proposes that, after a situational analysis, implementation phases begin with bolstering palliative care capacity, especially in settings where a late-stage diagnosis is common. This is followed by strengthening the patient pathway, with consideration given to a dynamic balance between centralization of services into centers of excellence to achieve better quality and decentralization of services to increase patient access. The use of resource checklists ensures that comprehensive therapy or palliative care can be delivered safely and effectively. Episodic or continuous monitoring with established process and quality metrics facilitates ongoing assessment, which should drive continual process improvements. A series of case studies provides a snapshot of country experiences with enhancing patient care, including the implementation of national cancer control plans in Kenya, palliative care in Romania, the introduction of a 1-stop clinic for diagnosis in Brazil, the surgical management of breast cancer in India, and the establishment of a women's cancer center in Ghana.

Modifiable patient-related barriers and their association with breast cancer detection practices among Ugandan women without a diagnosis of breast cancer.

Most women with breast cancer in sub-Saharan Africa (SSA) are diagnosed with late-staged disease. The current study assesses patient-related barriers among women from a general SSA population to better understand how patient-related barriers contribute to diagnostic delays. Using convenience-based sampling, 401 Ugandan women without breast cancer were surveyed to determine how prior participation in cancer detection practices correlate with patient-related barriers to prompt diagnosis. In a predominantly poor (76%) and rural population (75%), the median age of the participants was 38. Of the women surveyed, 155 (46%) had prior exposure to breast cancer education, 92 (27%) performed breast self-examination (BSE) and 68 (20%) had undergone a recent clinical breast examination (CBE), breast ultrasound or breast biopsy. The most commonly identified barriers to prompt diagnosis were knowledge deficits regarding early diagnosis (79%), economic barriers to accessing care (68%), fear (37%) and poor social support (24%). However, only women who reported knowledge deficits-a modifiable barrier-were less likely to participate in cancer detection practices (p<0.05). Women in urban and rural areas were similarly likely to report economic barriers, knowledge deficits and/or poor social support, but rural women were less likely than urban women to have received breast cancer education and/or perform BSE (p<0.001). Women who have had prior breast cancer education (p<0.001) and/or who perform BSE (p = 0.02) were more likely to know where she can go to receive a diagnostic breast evaluation. These findings suggest that SSA countries developing early breast cancer detection programs should specifically address modifiable knowledge deficits among women less likely to achieve a diagnostic work-up to reduce diagnostic delays and improve breast cancer outcomes.

Role of Family Obligation Stress on Ugandan Women's Participation in Preventive Breast Health.

BACKGROUND: The purpose of this study is to determine the role of family obligation stress on Ugandan women's participation in preventive breast health through the receipt of breast cancer education and health check-ups. MATERIALS AND METHODS: A validated survey was conducted on a community sample of Ugandan women, providing a multi-item scale to assess preventive breast-health-seeking behaviors and measure family obligation stress (FO; range 6-18). Univariate and multivariate linear regression was used to assess associations between sociodemographic factors and FO. Univariate and multivariate linear regression (used in conjunction with the robust sandwich estimator for standard errors) and probability differences (PDs) were used to evaluate associations between preventive breast-health-seeking behaviors, sociodemographic factors, and FO. RESULTS: A total of 401 Ugandan women ages 25-74 participated in the survey. Most had three or more children in the home (60%) and were employed full time (69%). Higher FO was associated with increasing number of children and/or adults in the household (p < .05), full-time employment (p < .001), and being single (p = .003). Women with higher FO were less likely to participate in breast cancer education (PD = -0.02 per 1-point increase, p = .008) and preventive health check-ups (PD = -0.02, p = .018), associations that persisted on multivariate analysis controlling for sociodemographic factors. CONCLUSION: Ugandan women with high FO are less likely to participate in preventive breast cancer detection efforts including breast cancer education and preventive health check-ups. Special efforts should be made to reach women with elevated FO, because it may be a risk factor for late-stage presentation among women who develop breast cancer. IMPLICATIONS FOR PRACTICE: High family obligation stress (FO) significantly reduces women's participation in preventive health check-ups and breast cancer education. These findings support research in U.S. Latinas showing high FO negatively affects women's health, suggesting that FO is an important factor in women's health-seeking behavior in other cultures. Addressing family obligation stress by including family members involved in decision-making is essential for improving breast cancer outcomes in low- and middle-income countries, such as Uganda.

Breast Cancer Beliefs as Potential Targets for Breast Cancer Awareness Efforts to Decrease Late-Stage Presentation in Uganda.

PURPOSE: To assess breast cancer beliefs in Uganda and determine whether these beliefs are associated with factors potentially related to nonparticipation in early detection. METHODS: A survey with open- and close-ended items was conducted in a community sample of Ugandan women to assess their beliefs about breast cancer. Linear regression was used to ascertain associations between breast cancer beliefs and demographic factors potentially associated with early detection, including socioeconomic factors, health care access, prior breast cancer knowledge, and personal detection practices. RESULTS: Of the 401 Ugandan women surveyed, most had less than a primary school education and received medical care at community health centers. Most women either believed in or were unsure about cultural explanatory models for developing breast cancer (> 82%), and the majority listed these beliefs as the most important causes of breast cancer (69%). By comparison, ≤ 45% of women believed in scientific explanatory risks for developing breast cancer. Although most believed that regular screening and early detection would find breast cancer when it is easy to treat (88% and 80%, respectively), they simultaneously held fatalistic attitudes toward their own detection efforts, including belief or uncertainty that a cure is impossible once they could self-detect a lump (54%). Individual beliefs were largely independent of demographic factors. CONCLUSION: Misconceptions about breast cancer risks and benefits of early detection are widespread in Uganda and must be addressed in future breast cancer awareness efforts. Until screening programs exist, most breast cancer will be self-detected. Unless addressed by future awareness efforts, the high frequency of fatalistic attitudes held by women toward their own detection efforts will continue to be deleterious to breast cancer early detection in sub-Saharan countries like Uganda.

Breast Cancer Downstaging Practices and Breast Health Messaging Preferences Among a Community Sample of Urban and Rural Ugandan Women.

PURPOSE: Among a community sample of Ugandan women, we provide information about breast cancer downstaging practices (breast self-examination, clinical breast examination [CBE]) and breast health messaging preferences across sociodemographic, health care access, and prior breast cancer exposure factors. METHODS: Convenience-based sampling was conducted to recruit Ugandan women age 25 years and older to assess breast cancer downstaging practices as well as breast health messaging preferences to present early for a CBE in the theoretical scenario of self-detection of a palpable lump (breast health messaging preferences). RESULTS: The 401 Ugandan women who participated in this survey were mostly poor with less than a primary school education. Of these women, 27% had engaged in breast self-examination, and 15% had undergone a CBE. Greater breast cancer downstaging practices were associated with an urban location, higher education, having a health center as a regular source of care, and receiving breast cancer education (P < .05). Women indicated a greater breast health messaging preference from their provider (66%). This preference was associated with a rural location, having a health center as a regular source of care, and receiving breast cancer education (P < .05). CONCLUSION: Most Ugandan women do not participate in breast cancer downstaging practices despite receipt of breast cancer education. However, such education increases downstaging practices and preference for messaging from their providers. Therefore, efforts to downstage breast cancer in Uganda should simultaneously raise awareness in providers and support improved education efforts in the community.

Exploring stigma as a barrier to cancer service engagement with breast cancer survivors in Kampala, Uganda.

OBJECTIVE: To understand the role of stigma in the delay of cancer service engagement by women with breast cancer in Kampala, Uganda. BACKGROUND: Women in Sub-Saharan African countries are twice as likely to die from cancer as women in high-income countries, which is largely attributable to late diagnosis. While breast cancer-related stigma has been identified in Sub-Saharan Africa, limited research focuses on how stigma impacts the behavior of breast cancer patients in Uganda. METHODS: This qualitative study used a grounded theory approach to examine illness narratives from 20 breast cancer survivors in Uganda, gathered through semistructured interviews. RESULTS: Thematic analysis showed that perceived and internalized stigma associated with breast cancer influenced care engagement throughout illness, delaying engagement and inhibiting treatment completion. Women identified key factors for overcoming stigma including acceptance of diagnosis, social support, and understanding of breast cancer. CONCLUSION: The growing burden of mortality associated with breast cancer in Uganda can be mitigated by improving early detection and treatment engagement through interventions which account for key psychosocial barriers such as stigma.