Tanaka Keisuke, Kikuchi Hiroaki, Umezawa Yoshihiro, Mori Takehiko, Fushimi Kiyohide, Yamamoto Masahide
Department of Hematology, Institute of Science Tokyo Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan.
Department of Nephrology, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan.
Int J Hematol. 2025 Aug 6. doi: 10.1007/s12185-025-04043-8.
Chimeric antigen receptor T-cell (CAR-T) therapy has shown remarkable efficacy in treating relapsed/refractory B-cell malignancies, as supported by real-world evidence (RWE). However, limited RWE exists on the management of adverse events during the perioperative period following CAR-T infusion. This study was conducted to obtain RWE on perioperative management using the Japanese Diagnosis Procedure Combination database, a comprehensive repository of Japanese health and medical service data. Between November 2019 and March 2022, 388 patients received CAR-T therapy. Of these, 312 had large B-cell lymphoma (LBCL) and 76 had B-cell acute lymphoblastic leukemia (B-ALL). The number of CAR-T infusions increased every 6-month interval, correlating with the rise in LBCL cases. Tocilizumab was administered for cytokine release syndrome in 56.1% of LBCL and 42.1% of B-ALL patients. Steroids were used for 22.9% and 81.3%, respectively. Prophylaxis for fungal infections was administered during CAR-T infusion in most LBCL and B-ALL patients. Treatment intensity was escalated in 2.8% of LBCL and 7.0% of B-ALL patients, and treatment for cytomegalovirus infection was initiated in approximately 7% of patients. This analysis elucidated perioperative management strategies based on patients' medication histories.
嵌合抗原受体T细胞(CAR-T)疗法在治疗复发/难治性B细胞恶性肿瘤方面已显示出显著疗效,真实世界证据(RWE)支持这一点。然而,关于CAR-T输注后围手术期不良事件管理的真实世界证据有限。本研究旨在利用日本诊断程序组合数据库(一个日本健康和医疗服务数据的综合存储库)获取围手术期管理的真实世界证据。在2019年11月至2022年3月期间,388例患者接受了CAR-T治疗。其中,312例患有大B细胞淋巴瘤(LBCL),76例患有B细胞急性淋巴细胞白血病(B-ALL)。CAR-T输注次数每6个月增加一次,与LBCL病例数的增加相关。56.1%的LBCL患者和42.1%的B-ALL患者接受托珠单抗治疗细胞因子释放综合征。分别有22.9%和81.3%的患者使用了类固醇。大多数LBCL和B-ALL患者在CAR-T输注期间接受了真菌感染预防。2.8%的LBCL患者和7.0%的B-ALL患者治疗强度升级,约7%的患者开始治疗巨细胞病毒感染。该分析阐明了基于患者用药史的围手术期管理策略。
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