Mawalla William Frank, Achola Caroline, Nabalende Hadijah, Otim Isaac, Legason Ismail D, Ogwang Martin D, Aol Pamella M, Sandi Godlove, Mwamtemi Hadija, Mahawi Salama, Mkwizu Elifuraha, Lyamuya Philomena G, Kamanga Jacqueline P, Schroeder Kristin, Ntemi Paul, Chamba Clara, Vavoulis Dimitris, Morrell Liz, Chirande Lulu, Schuh Anna
Department of Haematology and Blood Transfusion, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Oncology Unit, St Mary's Hospital Lacor, Gulu, Uganda.
Blood Adv. 2025 May 27;9(10):2393-2401. doi: 10.1182/bloodadvances.2024015234.
The addition of rituximab to the chemotherapy backbone was shown to significantly improve outcomes of children with aggressive high-grade lymphomas in high-income countries. However, data on its safety and efficacy in children with Epstein-Barr virus (EBV)-positive Burkitt lymphoma (BL) are limited. We conducted a prospective nonrandomized observational study in East African patients aged ≤25 years with confirmed BL. Patients received either the International Network for Cancer Treatment and Research (INCTR)-based standard chemotherapy (cyclophosphamide, vincristine, and methotrexate [COM]) or rituximab plus standard chemotherapy (R-COM). The primary end point was safety. The secondary outcomes were event-free and overall survival and cost-effectiveness of incorporating rituximab. Primary analyses were conducted in the intention-to-treat population. The median follow-up was 23 months. Safety analyses included 72 patients: 32 in the COM group and 40 in the R-COM group. Grade ≥3 adverse events occurred in 18% of R-COM patients and 16% of COM patients. With respect to treatment outcomes at 12 months, 5 events were observed in the R-COM group and 14 in the COM group. The 12-month event-free survival was 67% with R-COM and 43% with COM (hazard ratio [HR], 0.49; 95% confidence interval [CI], 0.24-0.98; P = .045). There were 8 deaths in the R-COM group, whereas 16 patients died in the COM group (HR, 0.32; 95% CI, 0.14-0.75; P = .009). R-COM was particularly effective in advanced-stage disease. The addition of rituximab to the INCTR-based protocol (COM) for EBV-positive BL has been observed to be safe and feasible in experienced centers in East Africa and saves lives.
在高收入国家，在化疗基础上加用利妥昔单抗已被证明可显著改善侵袭性高级别淋巴瘤患儿的预后。然而，关于其在爱泼斯坦-巴尔病毒（EBV）阳性伯基特淋巴瘤（BL）患儿中的安全性和疗效的数据有限。我们对东非年龄≤25岁的确诊BL患者进行了一项前瞻性非随机观察性研究。患者接受基于国际癌症治疗和研究网络（INCTR）的标准化疗（环磷酰胺、长春新碱和甲氨蝶呤[COM]）或利妥昔单抗加标准化疗（R-COM）。主要终点是安全性。次要结局是无事件生存期和总生存期以及加用利妥昔单抗的成本效益。主要分析在意向性治疗人群中进行。中位随访时间为23个月。安全性分析纳入了72例患者：COM组32例，R-COM组40例。≥3级不良事件在18%的R-COM组患者和16%的COM组患者中发生。关于12个月时的治疗结局，R-COM组观察到5例事件，COM组观察到14例。R-COM组12个月无事件生存率为67%，COM组为43%（风险比[HR]，0.49；95%置信区间[CI]，0.24 - 0.98；P = 0.045）。R-COM组有8例死亡，而COM组有16例患者死亡（HR，0.32；95% CI，0.14 - 0.75；P = 0.009）。R-COM在晚期疾病中特别有效。在东非经验丰富的中心，在基于INCTR的方案（COM）中加用利妥昔单抗治疗EBV阳性BL已被观察到是安全可行的，且可挽救生命。
