Department of Pediatrics, St. Marianna University School of Medicine, Kanagawa, Japan.
Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan.
Eur J Haematol. 2024 Apr;112(4):585-593. doi: 10.1111/ejh.14148. Epub 2023 Dec 19.
The benefit of adding rituximab to standard lymphomes malins B (LMB) chemotherapy for children with high-risk mature B-cell non-Hodgkin lymphoma (B-NHL) has previously been demonstrated in an international randomized phase III trial, to which the Japanese Pediatric Leukemia/Lymphoma Study Group could not participate.
To evaluate the efficacy and safety of rituximab in combination with LMB chemotherapy in Japanese patients, we conducted a single-arm multicenter trial.
In this study, 45 patients were enrolled between April 2016 and September 2018. A total of 33 (73.3%), 5 (11.1%), and 6 (13.3%) patients had Burkitt lymphoma/leukemia, diffuse large B-cell lymphoma, and aggressive mature B-NHL, not otherwise specified, respectively. Ten (22.2%) and 21 (46.7%) patients had central nervous system disease and leukemic disease, respectively. The median follow-up period was 47.5 months. Three-year event-free survival and overall survival were 97.7% (95% confidence interval, 84.9-99.7) and 100%, respectively. The only event was relapse, which occurred in a patient with diffuse large B-cell lymphoma. Seven patients (15.6%) developed Grade 4 or higher non-hematologic adverse events. Febrile neutropenia was the most frequent Grade 3 or higher adverse event after the pre-phase treatment, with a frequency of 54.5%.
The efficacy and safety of rituximab in combination with LMB chemotherapy in children with high-risk mature B-NHL was observed in Japan.
在一项国际随机 III 期试验中，已经证明在高危成熟 B 细胞非霍奇金淋巴瘤（B-NHL）患儿中，利妥昔单抗联合标准淋巴瘤改良方案（LMB）化疗的获益优于单纯 LMB 化疗，而日本儿科白血病/淋巴瘤研究组未能参与该试验。
为了评估利妥昔单抗联合 LMB 化疗在日本患者中的疗效和安全性，我们开展了一项单臂多中心试验。
在这项研究中，共有 45 例患者于 2016 年 4 月至 2018 年 9 月入组。分别有 33 例（73.3%）、5 例（11.1%）和 6 例（13.3%）患者患有伯基特淋巴瘤/白血病、弥漫性大 B 细胞淋巴瘤和侵袭性成熟 B-NHL （未特指）。10 例（22.2%）和 21 例（46.7%）患者分别患有中枢神经系统疾病和白血病。中位随访时间为 47.5 个月。3 年无事件生存率和总生存率分别为 97.7%（95%置信区间，84.9-99.7）和 100%。唯一的事件是复发，发生于 1 例弥漫性大 B 细胞淋巴瘤患者。7 例（15.6%）患者发生 4 级或更高级别的非血液学不良事件。发热性中性粒细胞减少症是前阶段治疗后最常见的 3 级或更高级别的不良事件，发生率为 54.5%。
在日本，高危成熟 B-NHL 患儿中利妥昔单抗联合 LMB 化疗的疗效和安全性得到了观察。
