Yang Jing, Zhang Jing, Wan Xinyu, Cai Jiaoyang, Wang Tianyi, Yang Xiaomin, Li Wenjie, Ding Lixia, Song Lili, Miao Yan, Wang Xiang, Ma Yani, Luo Chengjuan, Tang Jingyan, Gu Longjun, Chen Jing, Lu Jun, Tang Yanjing, Li Benshang
Department of Cell Immunotherapy, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Child Health Advocacy Institute, China Hospital Development Institute, Shanghai Jiao Tong University, Shanghai, China.
Front Pediatr. 2025 Jan 13;12:1485402. doi: 10.3389/fped.2024.1485402. eCollection 2024.
Corticosteroids are used for toxicity management, raising concerns about whether they may affect the anti-leukemic effects of chimeric antigen receptor (CAR)-T cells.
In this study, we retrospectively analyzed patients (fined two subgroups based on disease burden. Of the 75 cases in the low disease burden (LDB) group (MRD < 5%, no extramedullary disease), there was no significant difference between the use of steroids and event-free survival (EFS) ( = 0.21) and overall survival (OS) ( = 0.26), and the same was found for the 119 cases in the high disease burden (HDB) group. After eliminating the effect of consolidative transplantation on the prognosis, the EFS of the patients who did not use steroids was better ( = 0.037) in the LDB group, but the difference was not significant in the HDB group. The median cumulative dexamethasone-equivalent dose was 0.56 mg/kg, and the EFS and OS were similar in the different cumulative dose groups. Furthermore, there was no difference in the recovery of B cells and the expansion of CAR-T cell copies.
In conclusion, under the guidance of current CRS prevention and control measures, the rational use of corticosteroids does not affect the clinical efficacy and overall survival of CAR-T cell therapy in patients with B-ALL and also does not affect the persistence of CAR-T cells , but the dosage threshold needs further clinical or experimental verification.
皮质类固醇用于毒性管理，这引发了人们对其是否会影响嵌合抗原受体（CAR）-T细胞抗白血病效应的担忧。
在本研究中，我们回顾性分析了患者（根据疾病负担分为两个亚组）。在低疾病负担（LDB）组的75例患者中（微小残留病<5%，无髓外疾病），使用类固醇与无事件生存期（EFS）（P = 0.21）和总生存期（OS）（P = 0.26）之间无显著差异，高疾病负担（HDB）组的119例患者情况相同。在消除巩固性移植对预后的影响后，LDB组未使用类固醇患者的EFS更好（P = 0.037），但HDB组差异不显著。地塞米松等效剂量的中位数为0.56 mg/kg，不同累积剂量组的EFS和OS相似。此外，B细胞恢复和CAR-T细胞拷贝数扩增方面无差异。
总之，在当前细胞因子释放综合征防控措施的指导下，合理使用皮质类固醇不影响B-ALL患者CAR-T细胞治疗的临床疗效和总生存期，也不影响CAR-T细胞的持久性，但剂量阈值需要进一步的临床或实验验证。
