Access to and Affordability of World Health Organization Essential Medicines for Cancer in Sub-Saharan Africa: Examples from Kenya, Rwanda, and Uganda.

BACKGROUND: Cancer mortality is high in sub-Saharan Africa (SSA), partly due to inadequate treatment access. We explored access to and affordability of cancer treatment regimens for the top 10 cancers utilizing examples from Kenya, Uganda, and Rwanda. MATERIALS AND METHODS: Population, healthcare financing, minimum wage, and cancer incidence and mortality data were obtained from the WHO, World Bank, public sources, and GLOBOCAN. National Essential Medicines List (NEML) alignment with 2019 WHO EML was assessed as a proportion. Cancer regimen pricing was calculated using public and proprietary sources and methods from prior studies. Affordability through universal healthcare coverage (UHC) was assessed as 1-year cost <3× gross national income per capita; and to patients out-of-pocket (OOP), as 30-day treatment course cost <1 day of minimum wage work. RESULTS: A total of 93.4% of the WHO EML cancer medicines were listed on the 2019 Kenya NEML, and 70.5% and 41.1% on Uganda (2016) and Rwanda (2015) NEMLs, respectively. Generic chemotherapies were available and affordable to governments through UHC to treat non-Hodgkin's lymphoma, cervical, breast, prostate, colorectal, ovarian cancers, and select leukemias. Newer targeted agents were not affordable through government UHC purchasing, while some capecitabine-based regimens were not affordable in Uganda and Rwanda. All therapies were not affordable OOP. CONCLUSION: All cancer treatment regimens were not affordable OOP and some were not covered by governments. Newer targeted drugs were not affordable to all 3 governments. UHC of cancer drugs and improving targeted therapy affordability to LMIC governments in SSA are key to improving treatment access and health outcomes.

Perspectives of Zambian Clinical Oncology Trainees in the MD Anderson and Zambia Virtual Clinical Research Training Program (MOZART).

BACKGROUND: African countries are underrepresented in cancer research, partly because of a lack of structured curricula on clinical research during medical education. To address this need, the MD Anderson and Zambia Virtual Clinical Research Training Program (MOZART) was developed jointly by MD Anderson Cancer Center (MDA) and the Cancer Diseases Hospital in Zambia (CDH) for Zambian clinical oncology trainees. We explored participant perspectives to provide insight for implementation of similar efforts. MATERIALS AND METHODS: The MD Anderson and Zambia Virtual Clinical Research Training Program consisted of weekly virtual lectures and support of Zambian-led research protocols through longitudinal mentorship groups that included CDH faculty and MDA peer and faculty mentors. Participants were contacted via email to take part in semi-structured interviews, which were conducted via teleconference and audio-recorded, transcribed, and coded. Emergent themes were extracted and are presented with representative verbatim quotations. RESULTS: Thirteen of the 14 (93%) trainees were interviewed. Emergent themes included (1) participants having diverse educational backgrounds but limited exposure to clinical research, (2) importance of cancer research specific to a resource-constrained setting, (3) complementary roles of peer mentors and local and international faculty mentors, (4) positive impact on clinical research skills but importance of a longitudinal program and early exposure to clinical research, and (5) challenges with executing research protocols. CONCLUSION: To our knowledge, this is the first qualitative study of African clinical oncology trainees participating in a virtual clinical research training program. The lessons learned from semi-structured interviews with participants in MOZART provided valuable insights that can inform the development of similar clinical research training efforts and scale-up.

Building Capacity for Cancer Research in the Era of COVID-19: Implementation and Results From an International Virtual Clinical Research Training Program in Zambia.

PURPOSE: The incidence of cancer in sub-Saharan Africa is increasing rapidly, yet cancer research in the region continues to lag. One contributing factor is limited exposure to clinical research among trainees. We describe implementation and results of a virtual clinical research training program for Zambian clinical oncology fellows developed jointly by the Cancer Diseases Hospital in Zambia and the MD Anderson Cancer Center to address this need. METHODS: The clinical research training program consisted of 14 weekly virtual lectures, development of research questions by Zambian clinical oncology fellows, assignment of faculty and peer mentors, longitudinal mentorship of research protocols, and anonymous precourse and postcourse surveys. The paired t-test was used to analyze the change in academic self-efficacy scores. RESULTS: Fourteen Zambian clinical oncology fellows participated. Senior fellows were paired with research mentors, leading to the development of eight research protocols. A total of 70 meetings and 126 hours of mentorship occurred with a median of seven meetings and 15 hours per pairing. The precourse and postcourse survey response rates were 86% and 79%, respectively. There were statistically significant increases in nine of 12 academic self-efficacy domains. The largest gains were in ability to independently perform research (P < .001) and research mentorship (P = .02) with an average increase of 1.5 points on a five-point scale in both domains. CONCLUSION: The Cancer Diseases Hospital MD Anderson Cancer Center clinical research training program for Zambian clinical oncology fellows led to increases in multiple academic self-efficacy domains among participants, formation of longitudinal mentorship groups with both faculty and peer mentors, and development of Zambian-led research protocols, demonstrating the feasibility of implementing a virtual model. This may be especially relevant because of shifting international collaboration paradigms after the COVID-19 pandemic.

Risk factors for bisphosphonate-associated osteonecrosis of the jaw in the prospective randomized trial of adjuvant bisphosphonates for early-stage breast cancer (SWOG 0307).

PURPOSE: Bisphosphonates reduce bone metastases in postmenopausal women with early-stage breast cancer but carry the risk of bisphosphonate-related osteonecrosis of the jaw (BRONJ). We describe risk factors for BRONJ and compare BRONJ provoked by infection or trauma with spontaneous lesions, which carry a better prognosis. METHODS: SWOG 0307 randomized women with stage I-III breast cancer to receive zoledronic acid (ZA), clodronate (CL), or ibandronate (IB) for 3 years, implemented BRONJ prevention guidelines, and collected information about dental health and development of BRONJ. All statistical tests were two-sided. RESULTS: Of 6018 women, 48 developed BRONJ. Infection was present in 21 (43.8%). Median time to BRONJ was 2.1 years for ZA, 2.0 years for IB, and 3.4 years for clodronate (p = 0.04). BRONJ was associated with bisphosphonate type (28/2231 (1.26%) for ZA, 8/2235 (0.36%) for CL, 12/1552 (0.77%) for IB), dental calculus (OR 2.03), gingivitis (OR 2.11), moderate/severe periodontal disease (OR 2.87), and periodontitis > 4 mm (OR 2.20) (p < 0.05). Of 57 lesions, BRONJ occurred spontaneously in 20 (35.1%) and was provoked by dental extraction in 20 (35.1%), periodontal disease in 14 (24.6%), denture trauma in 6 (10.5%), and dental surgery in 2 (3.5%). Spontaneous BRONJ occurred more frequently at the mylohyoid ridge. There were no differences in dental disease, infection, or bisphosphonate type between spontaneous and provoked BRONJ. CONCLUSION: ZA and worse dental health were associated with increased incidence of BRONJ, with a trend toward additive risk when combined. BRONJ incidence was lower than in similar studies, with prevention strategies likely linked to this. CLINICAL TRIAL NUMBER: NCT00127205 REGISTRATION DATE: July 2005.

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.

Patient Advocacy Approaches to Improving Care for Breast and Cervical Cancer in East and Southern Africa.

PURPOSE: Breast and cervical cancer are the most common cancers among women in East and Southern Africa, where mortality remains high because of late diagnosis and limited access to treatment. We explored local approaches to breast and cervical cancer advocacy to identify the most pressing issues and opportunities for increasing the impact of civil society activities in the region. METHODS: Focus group discussions were conducted with participants of the 2016 Women's Empowerment Cancer Advocacy Network (WE CAN) Summit in Nairobi, Kenya. Discussions were audio-recorded, transcribed, coded, and analyzed for emergent themes. Results were presented to participants of 2019 WE CAN summit for cross-validation. RESULTS: Four focus group discussions were conducted with 50 participants. Thirty-six (70%) identified as advocates, 30 (59%) as cancer survivors, 14 (27%) as nongovernmental organization representatives, 13 (25%) as researchers, 4 (8%) as clinicians, and 6 (8%) as policymakers. Although most participants focused on cancer awareness and screening/early detection, some noted that treatment was often unavailable and advocated for a broader strategy to improving access to care. Challenges to designing and implementing such a strategy included knowledge gaps in addressing late diagnosis and access to care, difficulty collaborating with like-minded organizations, approaching policymakers, and addressing treatment financing. Cancer coalitions, although rare, were crucial to building collaborations with ministries of health, policymakers, and international organizations that advanced breast and cervical cancer care. CONCLUSION: Participants indicated that they would benefit from additional training about resource-appropriate best practices for improving breast and cervical cancer care and outcomes. Coalition-building and collaborations, including with oncologists and other medical professionals involved in cancer care, were crucial to leveraging limited resources, sharing lessons learned, and developing local solutions to common challenges.