Abstract：
BACKGROUND: 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.
METHODS: To evaluate the efficacy and safety of rituximab in combination with LMB chemotherapy in Japanese patients, we conducted a single-arm multicenter trial.
RESULTS: 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%.
CONCLUSIONS: The efficacy and safety of rituximab in combination with LMB chemotherapy in children with high-risk mature B-NHL was observed in Japan.
METHODS: To evaluate the efficacy and safety of rituximab in combination with LMB chemotherapy in Japanese patients, we conducted a single-arm multicenter trial.
RESULTS: 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%.
CONCLUSIONS: The efficacy and safety of rituximab in combination with LMB chemotherapy in children with high-risk mature B-NHL was observed in Japan.
摘要：
背景：先前在一项国际随机III期试验中已经证明，在标准的淋巴瘤malinsB（LMB）化疗中添加利妥昔单抗对高危成熟B细胞非霍奇金淋巴瘤（B-NHL）儿童的益处。日本小儿白血病/淋巴瘤研究组无法参与。
方法：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，我们进行了一项单臂多中心试验.
结果：在这项研究中，在2016年4月至2018年9月之间招募了45名患者。共33人（73.3%），5（11.1%），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,和激进的成熟B-NHL，未指定，分别。10例（22.2％）和21例（46.7％）患者患有中枢神经系统疾病和白血病，分别。中位随访期为47.5个月。三年无事件生存率和总生存率为97.7%(95%置信区间,84.9-99.7)和100%，分别。唯一的事件是复发，发生在弥漫性大B细胞淋巴瘤患者中。7名患者（15.6%）出现4级或更高的非血液学不良事件。发热性中性粒细胞减少症是前期治疗后最常见的3级或更高级别不良事件，频率为54.5%。
结论：在日本观察到利妥昔单抗联合LMB化疗对高危成熟B-NHL患儿的疗效和安全性。
方法：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，我们进行了一项单臂多中心试验.
结果：在这项研究中，在2016年4月至2018年9月之间招募了45名患者。共33人（73.3%），5（11.1%），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,和激进的成熟B-NHL，未指定，分别。10例（22.2％）和21例（46.7％）患者患有中枢神经系统疾病和白血病，分别。中位随访期为47.5个月。三年无事件生存率和总生存率为97.7%(95%置信区间,84.9-99.7)和100%，分别。唯一的事件是复发，发生在弥漫性大B细胞淋巴瘤患者中。7名患者（15.6%）出现4级或更高的非血液学不良事件。发热性中性粒细胞减少症是前期治疗后最常见的3级或更高级别不良事件，频率为54.5%。
结论：在日本观察到利妥昔单抗联合LMB化疗对高危成熟B-NHL患儿的疗效和安全性。
