Jan Brijs, Jonas Van Ham, Benedicte Dubois, Franky Sinap, Vibeke Vergote, Daan Dierickx, Peter Vandenberghe
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Two CAR-T cell products, tisagenlecleucel (tisa-cel,) and axicabtagene ciloleucel (axi-cel), are reimbursed in Belgium for R/R LBCL beyond second line.</p><p><strong>Objectives and methods: </strong>We conducted a retrospective cohort study to report the outcome with tisa-cel and axi-cel for R/R LBCL beyond second line in the years 2019-2023 at the University Hospitals Leuven for 79 patients selected for apheresis and CAR-T infusion.</p><p><strong>Results: </strong>Eleven patients (14%) did not proceed to CAR-T cell infusion. For infused patients (<i>n</i> = 68), the best overall response rate (ORR)/complete response (CR) rate was 64%/49% for tisa-cel and 88%/66% for axi-cel (<i>p</i> = 0.04 for ORR). After a median follow-up of 13.8 months, progression-free survival (PFS) and overall survival (OS) at 1 year were 30% and 43% for tisa-cel and 48% and 62% for axi-cel. Cytokine release syndrome (CRS) (all grades/grade ≥3) occurred in 82%/9% after tisa-cel and in 97%/0% after axi-cel. Immune effector cell-associated neurotoxicity syndrome (ICANS) (all grades/grade ≥3) occurred in 24%/18% after tisa-cel and in 54%/40% after axi-cel. The non-relapse mortality in the infusion cohort was 13%.</p><p><strong>Conclusion: </strong>Our real-world data show high and durable response rates, with a non-significant trend towards a higher efficacy and higher toxicity for axi-cel compared to tisa-cel. Our results are in line with other real-world registries except for a shorter median OS and more high-grade ICANS.</p>","PeriodicalId":48865,"journal":{"name":"Acta Clinica Belgica","volume":"79 4","pages":"276-284"},"PeriodicalIF":1.1000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Single center, real-world retrospective study of CAR-T cell therapy for relapsed/refractory large B-cell lymphoma beyond second line: five-year results at the University Hospitals Leuven.\",\"authors\":\"Jan Brijs, Jonas Van Ham, Benedicte Dubois, Franky Sinap, Vibeke Vergote, Daan Dierickx, Peter Vandenberghe\",\"doi\":\"10.1080/17843286.2024.2399365\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Large B-cell lymphomas (LBCL) are the most frequently aggressive B-cell non-Hodgkin lymphomas. Anti-CD19 chimeric antigen receptor (CAR)-T cell therapy has emerged as a new, powerful treatment for relapsed or refractory (R/R) disease. Two CAR-T cell products, tisagenlecleucel (tisa-cel,) and axicabtagene ciloleucel (axi-cel), are reimbursed in Belgium for R/R LBCL beyond second line.</p><p><strong>Objectives and methods: </strong>We conducted a retrospective cohort study to report the outcome with tisa-cel and axi-cel for R/R LBCL beyond second line in the years 2019-2023 at the University Hospitals Leuven for 79 patients selected for apheresis and CAR-T infusion.</p><p><strong>Results: </strong>Eleven patients (14%) did not proceed to CAR-T cell infusion. For infused patients (<i>n</i> = 68), the best overall response rate (ORR)/complete response (CR) rate was 64%/49% for tisa-cel and 88%/66% for axi-cel (<i>p</i> = 0.04 for ORR). After a median follow-up of 13.8 months, progression-free survival (PFS) and overall survival (OS) at 1 year were 30% and 43% for tisa-cel and 48% and 62% for axi-cel. Cytokine release syndrome (CRS) (all grades/grade ≥3) occurred in 82%/9% after tisa-cel and in 97%/0% after axi-cel. Immune effector cell-associated neurotoxicity syndrome (ICANS) (all grades/grade ≥3) occurred in 24%/18% after tisa-cel and in 54%/40% after axi-cel. The non-relapse mortality in the infusion cohort was 13%.</p><p><strong>Conclusion: </strong>Our real-world data show high and durable response rates, with a non-significant trend towards a higher efficacy and higher toxicity for axi-cel compared to tisa-cel. 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引用次数: 0
摘要
前言大 B 细胞淋巴瘤(LBCL)是最常见的侵袭性 B 细胞非霍奇金淋巴瘤。抗CD19嵌合抗原受体(CAR)-T细胞疗法已成为治疗复发或难治性(R/R)疾病的一种新的强效疗法。在比利时,两种CAR-T细胞产品--tisagenlecleucel(tisa-cel)和axicabtagene ciloleucel(axi-cel)--可用于治疗二线以上的复发性/难治性LBCL:我们进行了一项回顾性队列研究,以报告鲁汶大学医院在2019-2023年期间对79名被选中进行血液净化和CAR-T输注的R/R LBCL二线以上患者使用tisa-cel和axi-cel的结果:结果:11名患者(14%)未进行CAR-T细胞输注。输注患者(n = 68)的最佳总反应率(ORR)/完全反应率(CR)分别为:tisa-cel 64%/49%,axi-cel 88%/66%(ORR p = 0.04)。中位随访13.8个月后,tisa-cel的无进展生存期(PFS)和1年总生存期(OS)分别为30%和43%,axi-cel为48%和62%。细胞因子释放综合征(CRS)(所有等级/等级≥3)的发生率在 tisa-cel 后为 82%/9%,在 axi-cel 后为 97%/0%。免疫效应细胞相关神经毒性综合征(ICANS)(所有分级/分级≥3)的发生率为24%/18%,阿西凝胶后为54%/40%。输注组的非复发死亡率为13%:我们的真实世界数据显示,阿西凝胶的反应率高且持久,与替萨凝胶相比,阿西凝胶的疗效更高,毒性更强,但趋势并不明显。除了中位OS较短和高级别ICANS较多之外,我们的结果与其他真实世界登记结果一致。
Single center, real-world retrospective study of CAR-T cell therapy for relapsed/refractory large B-cell lymphoma beyond second line: five-year results at the University Hospitals Leuven.
Introduction: Large B-cell lymphomas (LBCL) are the most frequently aggressive B-cell non-Hodgkin lymphomas. Anti-CD19 chimeric antigen receptor (CAR)-T cell therapy has emerged as a new, powerful treatment for relapsed or refractory (R/R) disease. Two CAR-T cell products, tisagenlecleucel (tisa-cel,) and axicabtagene ciloleucel (axi-cel), are reimbursed in Belgium for R/R LBCL beyond second line.
Objectives and methods: We conducted a retrospective cohort study to report the outcome with tisa-cel and axi-cel for R/R LBCL beyond second line in the years 2019-2023 at the University Hospitals Leuven for 79 patients selected for apheresis and CAR-T infusion.
Results: Eleven patients (14%) did not proceed to CAR-T cell infusion. For infused patients (n = 68), the best overall response rate (ORR)/complete response (CR) rate was 64%/49% for tisa-cel and 88%/66% for axi-cel (p = 0.04 for ORR). After a median follow-up of 13.8 months, progression-free survival (PFS) and overall survival (OS) at 1 year were 30% and 43% for tisa-cel and 48% and 62% for axi-cel. Cytokine release syndrome (CRS) (all grades/grade ≥3) occurred in 82%/9% after tisa-cel and in 97%/0% after axi-cel. Immune effector cell-associated neurotoxicity syndrome (ICANS) (all grades/grade ≥3) occurred in 24%/18% after tisa-cel and in 54%/40% after axi-cel. The non-relapse mortality in the infusion cohort was 13%.
Conclusion: Our real-world data show high and durable response rates, with a non-significant trend towards a higher efficacy and higher toxicity for axi-cel compared to tisa-cel. Our results are in line with other real-world registries except for a shorter median OS and more high-grade ICANS.
期刊介绍:
Acta Clinica Belgica: International Journal of Clinical and Laboratory Medicine primarily publishes papers on clinical medicine, clinical chemistry, pathology and molecular biology, provided they describe results which contribute to our understanding of clinical problems or describe new methods applicable to clinical investigation. Readership includes physicians, pathologists, pharmacists and physicians working in non-academic and academic hospitals, practicing internal medicine and its subspecialties.