Li Danni, Ding Wenwen, Liu Xiaona, Wei Pingping, Zhang Lei, Liang Hui
Objective To analyze the safety profile of blinatumomab in children with B-cell acute lymphoblastic leukemia (ALL). Methods Demographic and clinical data of 33 pediatric B-cell ALL patients treated with blinatumomab in the Women and Children′s Hospital, Qingdao University from January 2022 to November 2024 were retrospectively collected. Demographic data included gender and age, while clinical data comprised leukemia risk stratification, minimal residual disease (MRD) status before blinatumomab use, treatment duration (14 day or 28 day courses), and safety outcomes included drug-related fever, cytokine release syndrome (CRS), tachycardia, blood pressure abnormalities, elevated transaminases, immune effector cell-associated neurotoxicity syndrome (ICANS), oral mucositis, rash, and infections. Patients were stratified by CRS occurrence and transaminase elevation for comparative analysis of demographic/clinical characteristics. Results A total of 33 children with B-cell type ALL who received blinatumomab treatment were included. Among them, 21 were male and 12 were female; the age was 5.2 (4.7, 7.0) years, ranging from 1.7 to 10.0 years. Risk stratification included low (2 cases), intermediate (23 cases), and high (8 cases) risk. Pre-treatment MRD was negative in 16 and positive in 17 patients. Eight patients received a 14 day blinatumomab course, while 25 cases received a 28 day course. The overall adverse events (AEs) rate was 81.8% (27/33). Among the 27 patients who experienced AEs, there were 5 cases (18.5%) of severe adverse events (all grade 3). The specific adverse events that occurred in the 33 patients included drug-related fever in 21 cases (63.6%) [including 16 cases (48.5%) of CRS], elevated transaminases in 10 cases (30.3%), infectious symptoms in 5 cases (15.2%), rash in 4 cases (12.1%), tachycardia in 3 cases (9.1%), ICANS in 2 cases (6.1%), and oral mucositis in 1 case (3.0%). No statistically significant differences were observed in gender, age, risk stratification, pretreatment MRD status, and treatment duration between the CRS and non-CRS groups, transaminase-elevated and normal groups (all P>0.05). Conclusions In pediatric B-cell ALL, the most common AEs related to blinatumomab are CRS and elevated transaminases, but most reactions are mild, with rapid recovery and favorable tolerability.
