Safety and efficacy of rituximab in Malawi: a case for multicentre oncology clinical trials in Africa?

Abstract

The global burdens of cancer incidence and mortality are increasing at an alarming pace, particularly on the African continent, 1 which is ill-equipped to monitor, respond to, and control these increases. Africa's share of global cancer mortality, which was estimated as 7•2% in 2020, is currently outpacing its share of cancer incidence, which was estimated as 5•7%. 1 This disparity is expected to continue worsening towards, and possibly beyond, 2040. 2 Although the reasons for these negative cancer statistics in Africa are manifold, they can be grouped into system factors (ie, weak economies, underdeveloped health-care infrastructures, and a low trained health-care worker-to-patient ratio); social factors (ie, barriers to treatment access and suspicion toward so-called western medicine); epidemiological factors (ie, demographic shifts in the population, a high prevalence of oncoviruses and HIV, and dynamic comorbidity profiles); and informational factors (ie, the shortage of reliable data to inform policy). 3 In The Lancet Global Health, Stephen Kimani and colleagues 4 report results of their study, which is a small but important step towards addressing the cancer burden in Africa. Given that patients with diffuse large B-cell lymphoma (DLBCL) in Malawi are unlikely to have access to the recommended first-line therapy of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy 5 under routine government programmes, the authors designed a clinical trial to investigate the feasibility, safety, and efficacy of R-CHOP in this population. The authors used a costeffective biosimilar to rituximab from India (known as Reditux; Dr Reddy's Laboratories, Hyderabad, Telangana, India). The study was done at one centre in Lilongwe in Malawi, and screened 76 patients, of whom 37 with confirmed DLBCL were eligible, enrolled, and given up to six cycles of R-CHOP. Of these 37 patients, 27 (83%) were HIV-positive with CD4 counts of more than 100 cells per µL. Baseline characteristics, including sex, median age, and stage of disease, were not significantly different between HIV-positive and HIV-negative patients.Despite a higher frequency of treatment delays in HIV-positive patients than HIV-negative patients, all

Guideline Concordance of Treatment and Outcomes Among Adult Non-Hodgkin Lymphoma Patients in Sub-Saharan Africa: A Multinational, Population-Based Cohort

“…To inform data-driven policy change regarding patient-centered provision of care, eg, further investigating the benefit of rituximab on survival, multicentre studies across the region should be conducted to address these global oncology challenges in SSA. 41 In this context, it is important to note that our study confirms recent findings from SSA not showing the difference in survival between HIV-positive and -negative patients. 16-19 Further, neither stage, ECOG PS, initiation of any treatment nor completion of at least 5 cycles of chemotherapy were influenced by HIV status in our cohort (Chi square test).…”