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复发/难治性B细胞恶性肿瘤住院患者嵌合抗原受体T细胞疗法的管理:一项使用日本诊断程序组合数据库的分析

Management of inpatient chimeric antigen receptor T-cell therapy for relapsed/refractory B-cell malignancies: an analysis using the Japanese Diagnosis Procedure Combination database.

作者信息

Tanaka Keisuke, Kikuchi Hiroaki, Umezawa Yoshihiro, Mori Takehiko, Fushimi Kiyohide, Yamamoto Masahide

机构信息

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.

出版信息

Int J Hematol. 2025 Aug 6. doi: 10.1007/s12185-025-04043-8.


DOI:10.1007/s12185-025-04043-8
PMID:40770123
Abstract

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.

摘要

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。

相似文献

[1]
Management of inpatient chimeric antigen receptor T-cell therapy for relapsed/refractory B-cell malignancies: an analysis using the Japanese Diagnosis Procedure Combination database.

Int J Hematol. 2025-8-6

[2]
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[3]
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[5]
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[6]
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[7]
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[8]
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[10]
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本文引用的文献

[1]
Current Activity Trends and Outcomes in Hematopoietic Cell Transplantation and Cellular Therapy - A Report from the CIBMTR.

Transplant Cell Ther. 2025-5-19

[2]
Real-world Outcomes of Commercial Tisagenlecleucel for Children, Adolescents, and Young Adults With Acute Lymphoblastic Leukemia in Japan.

Transplant Cell Ther. 2025-2

[3]
Best Practice Considerations by The American Society of Transplant and Cellular Therapy: Infection Prevention and Management After Chimeric Antigen Receptor T Cell Therapy for Hematological Malignancies.

Transplant Cell Ther. 2024-10

[4]
Optimizing the post-CAR T monitoring period in recipients of axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel.

Blood Adv. 2024-10-22

[5]
Hematopoietic cell transplantation and cellular therapies in Europe 2022. CAR-T activity continues to grow; transplant activity has slowed: a report from the EBMT.

Bone Marrow Transplant. 2024-6

[6]
Safety and efficacy of tisagenlecleucel in patients with relapsed or refractory B-cell lymphoma: the first real-world evidence in Japan.

Int J Clin Oncol. 2023-6

[7]
CD19 CAR T cells are an effective therapy for posttransplant relapse in patients with B-lineage ALL: real-world data from Germany.

Blood Adv. 2023-6-13

[8]
Cytomegalovirus reactivation after CD19 CAR T-cell therapy is clinically significant.

Haematologica. 2023-2-1

[9]
A real-world comparison of tisagenlecleucel and axicabtagene ciloleucel CAR T cells in relapsed or refractory diffuse large B cell lymphoma.

Nat Med. 2022-10

[10]
Patterns of Use, Outcomes, and Resource Utilization among Recipients of Commercial Axicabtagene Ciloleucel and Tisagenlecleucel for Relapsed/Refractory Aggressive B Cell Lymphomas.

Transplant Cell Ther. 2022-10

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