Abstract
BackgroundEsophageal squamous cell carcinoma (ESCC) is a major cause of cancer morbidity and mortality in Eastern Africa. The majority of patients with ESCC in Eastern Africa present with advanced disease at the time of diagnosis. Several palliative interventions for ESCC are currently in use within the region, including chemotherapy, radiation therapy with and without chemotherapy, and esophageal stenting with self-expandable metallic stents; however, the comparative effectiveness of these interventions in a low resource setting has yet to be examined.MethodsThis prospective, observational, multi-center, open cohort study aims to describe the therapeutic landscape of ESCC in Eastern Africa and investigate the outcomes of different treatment strategies within the region. The 4.5-year study will recruit at a total of six sites in Kenya, Malawi and Tanzania (Ocean Road Cancer Institute and Muhimbili National Hospital in Dar es Salaam, Tanzania; Kilimanjaro Christian Medical Center in Moshi, Tanzania; Tenwek Hospital in Bomet, Kenya; Moi Teaching and Referral Hospital in Eldoret, Kenya; and Kamuzu Central Hospital in Lilongwe, Malawi). Treatment outcomes that will be evaluated include overall survival, quality of life (QOL) and safety. All patients (≥18 years old) who present to participating sites with a histopathologically-confirmed or presumptive clinical diagnosis of ESCC based on endoscopy or barium swallow will be recruited to participate. Key clinical and treatment-related data including standardized QOL metrics will be collected at study enrollment, 1 month following treatment, 3 months following treatment, and thereafter at 3-month intervals until death. Vital status and QOL data will be collected through mobile phone outreach.DiscussionThis study will be the first study to prospectively compare ESCC treatment strategies in Eastern Africa, and the first to investigate QOL benefits associated with different treatments in sub-Saharan Africa. Findings from this study will help define optimal management strategies for ESCC in Eastern Africa and other resource-limited settings and will serve as a benchmark for future research.Trial registrationThis study was retrospectively registered with the ClinicalTrials.gov database on December 15, 2021, NCT05177393.
Highlights
Esophageal squamous cell carcinoma (ESCC) is a major cause of cancer morbidity and mortality in Eastern Africa
This study will be the first study to prospectively compare ESCC treatment strategies in Eastern Africa, and the first to investigate quality of life (QOL) benefits associated with different treatments in sub-Saharan Africa
80% of all Esophageal cancer (EC) cases occur in low- and middle-income countries (LMICs), where esophageal squamous cell carcinoma (ESCC) is the dominant histology [2]
Summary
Study objectives The goals of the TOEC-Eastern Africa study are: 1) To describe the treatment patterns for ESCC at referral hospitals in Eastern Africa. Cochran-Armitage test will be used to compare symptom metrics assessed using the ‘Modified Rosenblatt Index’ (Dysphagia, Odynophagia, ‘Chest and/or Back pain,’ WHO performance status, and ‘Overall Well-being’ since starting treatment) between each of the different palliative EC treatments (chemotherapy, radiotherapy, chemoradiation, esophageal stenting, basic supportive care) at each time point: 1 month after initiation of treatment, 3 months after the initiation of treatment and every 3 months thereafter. Findings from this study have potential to improve our understanding of optimal treatment strategies for ESCC in Eastern Africa and other resource-limited settings This coordinated prospective cohort study across six sites in three countries is novel and, if successful, may serve as a pragmatic approach to generate context-specific data regarding cancer therapies in subSaharan Africa.
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