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利妥昔单抗联合标准化疗及其对CD20阳性儿童急性淋巴细胞白血病诱导缓解期微小残留病的影响:一项前瞻性随机对照试验。

Rituximab added to standard chemotherapy and its effect on minimal residual disease during induction in CD20 positive pediatric acute lymphoblastic leukemia: a pilot RCT.

作者信息

Gupta Aditya Kumar, Chopra Anita, Meena Jagdish Prasad, Singh Jay, Pandey Ravindra Mohan, Bakhshi Sameer, Seth Rachna

机构信息

Division of Pediatric Oncology, Department of Pediatrics, All India Institute of Medical Sciences New Delhi 110029, India.

Department of Laboratory Oncology, Institute Rotary Cancer Centre, All India Institute of Medical Sciences New Delhi 110029, India.

出版信息

Am J Blood Res. 2021 Dec 15;11(6):571-579. eCollection 2021.

PMID:35103111
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8784647/
Abstract

The use of rituximab in the treatment of pediatric acute lymphoblastic leukemia (ALL) has been evaluated but mostly this has been done in the setting of a relapsed or refractory disease. Addition of rituximab to the initial treatment regimen improves the outcomes in adult CD20 positive ALL. This study was done to study its effect on newly diagnosed CD20 positive pediatric ALL patients. Twenty pediatric patients with CD20 positive ALL were randomly assigned to receive rituximab along with standard-chemotherapy [Intervention-arm (IA)] or standard-chemotherapy alone [Standard-arm (SA)]. The absolute blast count (ABC) on day 8, flowcytometry-MRD levels in the peripheral blood (PB) on day-8, day-15 and in the bone marrow (BM) at end of induction (EOI) were the outcome variables. Baseline characteristics were comparable between the IA (n=10) and SA (n=10). Significantly lower day-8 ABC was seen in the IA (P=0.005). The day-8 PB-MRD showed lower values for the IA but the difference wasn't significant (P=0.22). There was no difference between the IA and SA for day-15 PB-MRD and EOI BM-MRD. There was no difference in the incidence of adverse effects. Rituximab added to standard-chemotherapy lead to lower day-8 ABC and lower day-8 PB-MRD in CD20 positive pediatric ALL patients. Rituximab may be beneficial in pediatric ALL treatment. Studies with larger sample size are needed for more evidence.

摘要

利妥昔单抗在儿童急性淋巴细胞白血病(ALL)治疗中的应用已得到评估,但大多是在复发或难治性疾病的背景下进行的。在成人CD20阳性ALL的初始治疗方案中添加利妥昔单抗可改善治疗结果。本研究旨在探讨其对新诊断的CD20阳性儿童ALL患者的影响。20例CD20阳性ALL患儿被随机分配接受利妥昔单抗联合标准化疗[干预组(IA)]或仅接受标准化疗[标准组(SA)]。第8天的绝对原始细胞计数(ABC)、第8天、第15天外周血(PB)以及诱导结束时骨髓(BM)中的流式细胞术微小残留病(MRD)水平为观察变量。IA组(n = 10)和SA组(n = 10)的基线特征具有可比性。IA组第8天的ABC显著降低(P = 0.005)。IA组第8天的PB-MRD值较低,但差异不显著(P = 0.22)。IA组和SA组在第15天的PB-MRD和诱导结束时的BM-MRD方面没有差异。不良反应的发生率没有差异。在CD20阳性儿童ALL患者中,在标准化疗中添加利妥昔单抗可降低第8天的ABC和第8天的PB-MRD。利妥昔单抗可能对儿童ALL治疗有益。需要更大样本量的研究以获得更多证据。

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