{"title":"CAR-T 细胞疗法在 B 细胞淋巴瘤中的应用：随机对照试验荟萃分析。","authors":"Xiao-Jing Yu, Chang Liu, Shi-Zhi Hu, Zhan-Yuan Yuan, Hai-Yan Ni, Sheng-Jia Sun, Cheng-Yang Hu, He-Qin Zhan","doi":"10.1007/s12094-024-03774-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>This study aims to compare the efficacy and safety of chimeric antigen receptor T-cell (CAR-T) immunotherapy with standard treatment for B-cell lymphoma, providing evidence-based support for the more efficient use of CAR-T cell immunotherapy.</p><p><strong>Methods: </strong>We conducted a comprehensive literature search of high-quality randomized controlled trials (RCTs) on CAR-T therapy for B-cell lymphoma in the following databases: Wanfang, Web of Science, CNKI, VIP database, and PubMed, up to February 2024. The outcome measures included objective remission rate (ORR), complete remission rate (CRR), and incidence of adverse reactions. Subgroup analysis was performed based on the differences in co-stimulatory domains. Meta-analysis was conducted using Review Manager 5.4 and Stata software.</p><p><strong>Results: </strong>A total of five RCTs involving 1670 patients were included in this meta-analysis. The results showed that the CAR-T treatment group had significantly higher ORR (RR: 1.47, 95% CI 1.23-1.76, I<sup>2</sup> = 80%, p < 0.0001), CRR (RR: 2.19, 95% CI 2.16-3.79, I<sup>2</sup> = 93%, p = 0.005), cytokine release syndrome (CRS) incidence (RR: 34.51, 95% CI 2.27-523.78, I<sup>2</sup> = 98%, p = 0.01), neurotoxicity (NT) incidence (RR: 6.00, 95% CI 1.82-19.75, I<sup>2</sup> = 80%, p = 0.003), neutropenia incidence (RR: 1.39, 95% CI 1.02-1.88, I<sup>2</sup> = 93%, p = 0.03), leukopenia incidence (RR: 1.39, 95% CI 1.04-1.87, I<sup>2</sup> = 61%, p = 0.03), and headache incidence (RR: 1.56, 95% CI 1.25-1.95, I<sup>2</sup> = 34%, p < 0.0001) compared to the standard treatment group. Subgroup analysis based on co-stimulatory domains revealed that the 4-1BB subgroup had higher incidences of CRR, CRS, NT and leukopenia than the CD28 subgroup; however, the CD28 subgroup exhibited higher ORR and neutropenia than the 4-1BB subgroup.</p><p><strong>Conclusion: </strong>CAR-T cell immunotherapy demonstrates superior efficacy compared to standard therapy in treating B-cell lymphoma. However, CAR-T treatment can lead to adverse reactions such as CRS and NT. Infusion of an appropriate dose of CAR-T cells (e.g., 100 × 10<sup>6</sup>) may be a strategy to mitigate the risk of CRS and NT.</p>","PeriodicalId":50685,"journal":{"name":"Clinical & Translational Oncology","volume":" ","pages":""},"PeriodicalIF":2.8000,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Application of CAR-T cell therapy in B-cell lymphoma: a meta-analysis of randomized controlled trials.\",\"authors\":\"Xiao-Jing Yu, Chang Liu, Shi-Zhi Hu, Zhan-Yuan Yuan, Hai-Yan Ni, Sheng-Jia Sun, Cheng-Yang Hu, He-Qin Zhan\",\"doi\":\"10.1007/s12094-024-03774-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>This study aims to compare the efficacy and safety of chimeric antigen receptor T-cell (CAR-T) immunotherapy with standard treatment for B-cell lymphoma, providing evidence-based support for the more efficient use of CAR-T cell immunotherapy.</p><p><strong>Methods: </strong>We conducted a comprehensive literature search of high-quality randomized controlled trials (RCTs) on CAR-T therapy for B-cell lymphoma in the following databases: Wanfang, Web of Science, CNKI, VIP database, and PubMed, up to February 2024. The outcome measures included objective remission rate (ORR), complete remission rate (CRR), and incidence of adverse reactions. Subgroup analysis was performed based on the differences in co-stimulatory domains. Meta-analysis was conducted using Review Manager 5.4 and Stata software.</p><p><strong>Results: </strong>A total of five RCTs involving 1670 patients were included in this meta-analysis. The results showed that the CAR-T treatment group had significantly higher ORR (RR: 1.47, 95% CI 1.23-1.76, I<sup>2</sup> = 80%, p < 0.0001), CRR (RR: 2.19, 95% CI 2.16-3.79, I<sup>2</sup> = 93%, p = 0.005), cytokine release syndrome (CRS) incidence (RR: 34.51, 95% CI 2.27-523.78, I<sup>2</sup> = 98%, p = 0.01), neurotoxicity (NT) incidence (RR: 6.00, 95% CI 1.82-19.75, I<sup>2</sup> = 80%, p = 0.003), neutropenia incidence (RR: 1.39, 95% CI 1.02-1.88, I<sup>2</sup> = 93%, p = 0.03), leukopenia incidence (RR: 1.39, 95% CI 1.04-1.87, I<sup>2</sup> = 61%, p = 0.03), and headache incidence (RR: 1.56, 95% CI 1.25-1.95, I<sup>2</sup> = 34%, p < 0.0001) compared to the standard treatment group. Subgroup analysis based on co-stimulatory domains revealed that the 4-1BB subgroup had higher incidences of CRR, CRS, NT and leukopenia than the CD28 subgroup; however, the CD28 subgroup exhibited higher ORR and neutropenia than the 4-1BB subgroup.</p><p><strong>Conclusion: </strong>CAR-T cell immunotherapy demonstrates superior efficacy compared to standard therapy in treating B-cell lymphoma. However, CAR-T treatment can lead to adverse reactions such as CRS and NT. Infusion of an appropriate dose of CAR-T cells (e.g., 100 × 10<sup>6</sup>) may be a strategy to mitigate the risk of CRS and NT.</p>\",\"PeriodicalId\":50685,\"journal\":{\"name\":\"Clinical & Translational Oncology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2024-11-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical & Translational Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s12094-024-03774-0\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical & Translational Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s12094-024-03774-0","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
研究背景本研究旨在比较嵌合抗原受体T细胞（CAR-T）免疫疗法与B细胞淋巴瘤标准疗法的疗效和安全性，为更有效地使用CAR-T细胞免疫疗法提供循证支持：我们在以下数据库中对CAR-T疗法治疗B细胞淋巴瘤的高质量随机对照试验（RCT）进行了全面的文献检索：万方数据库、Web of Science、CNKI、VIP 数据库和 PubMed（截至 2024 年 2 月）。结果指标包括客观缓解率（ORR）、完全缓解率（CRR）和不良反应发生率。根据共刺激域的差异进行了分组分析。使用Review Manager 5.4和Stata软件进行了Meta分析：本次荟萃分析共纳入了五项RCT研究，涉及1670名患者。结果显示，CAR-T 治疗组的 ORR（RR：1.47，95% CI 1.23-1.76，I2 = 80%，P 2 = 93%，P = 0.005）、细胞因子释放综合征（CRS）发生率（RR：34.51，95% CI 2.27-523.78，I2 = 98%，P = 0.01）、神经毒性（NT）发生率（RR：6.00，95% CI 1.82-19.75，I2 = 80%，P = 0.003）、中性粒细胞减少症发生率（RR：1.39，95% CI 1.02-1.88，I2 = 93%，P = 0.03）、白细胞减少症发生率（RR：1.39，95% CI 1.04-1.87，I2 = 61%，P = 0.03）和头痛发生率（RR：1.56，95% CI 1.25-1.95，I2 = 34%，P 结论：CAR-T 细胞免疫疗法显示出卓越的疗效：与标准疗法相比，CAR-T细胞免疫疗法在治疗B细胞淋巴瘤方面具有更优越的疗效。然而，CAR-T治疗可能会导致CRS和NT等不良反应。输注适当剂量的CAR-T细胞（如100×106）可能是降低CRS和NT风险的一种策略。
Application of CAR-T cell therapy in B-cell lymphoma: a meta-analysis of randomized controlled trials.
Background: This study aims to compare the efficacy and safety of chimeric antigen receptor T-cell (CAR-T) immunotherapy with standard treatment for B-cell lymphoma, providing evidence-based support for the more efficient use of CAR-T cell immunotherapy.
Methods: We conducted a comprehensive literature search of high-quality randomized controlled trials (RCTs) on CAR-T therapy for B-cell lymphoma in the following databases: Wanfang, Web of Science, CNKI, VIP database, and PubMed, up to February 2024. The outcome measures included objective remission rate (ORR), complete remission rate (CRR), and incidence of adverse reactions. Subgroup analysis was performed based on the differences in co-stimulatory domains. Meta-analysis was conducted using Review Manager 5.4 and Stata software.
Results: A total of five RCTs involving 1670 patients were included in this meta-analysis. The results showed that the CAR-T treatment group had significantly higher ORR (RR: 1.47, 95% CI 1.23-1.76, I2 = 80%, p < 0.0001), CRR (RR: 2.19, 95% CI 2.16-3.79, I2 = 93%, p = 0.005), cytokine release syndrome (CRS) incidence (RR: 34.51, 95% CI 2.27-523.78, I2 = 98%, p = 0.01), neurotoxicity (NT) incidence (RR: 6.00, 95% CI 1.82-19.75, I2 = 80%, p = 0.003), neutropenia incidence (RR: 1.39, 95% CI 1.02-1.88, I2 = 93%, p = 0.03), leukopenia incidence (RR: 1.39, 95% CI 1.04-1.87, I2 = 61%, p = 0.03), and headache incidence (RR: 1.56, 95% CI 1.25-1.95, I2 = 34%, p < 0.0001) compared to the standard treatment group. Subgroup analysis based on co-stimulatory domains revealed that the 4-1BB subgroup had higher incidences of CRR, CRS, NT and leukopenia than the CD28 subgroup; however, the CD28 subgroup exhibited higher ORR and neutropenia than the 4-1BB subgroup.
Conclusion: CAR-T cell immunotherapy demonstrates superior efficacy compared to standard therapy in treating B-cell lymphoma. However, CAR-T treatment can lead to adverse reactions such as CRS and NT. Infusion of an appropriate dose of CAR-T cells (e.g., 100 × 106) may be a strategy to mitigate the risk of CRS and NT.
期刊介绍：
Clinical and Translational Oncology is an international journal devoted to fostering interaction between experimental and clinical oncology. It covers all aspects of research on cancer, from the more basic discoveries dealing with both cell and molecular biology of tumour cells, to the most advanced clinical assays of conventional and new drugs. In addition, the journal has a strong commitment to facilitating the transfer of knowledge from the basic laboratory to the clinical practice, with the publication of educational series devoted to closing the gap between molecular and clinical oncologists. Molecular biology of tumours, identification of new targets for cancer therapy, and new technologies for research and treatment of cancer are the major themes covered by the educational series. Full research articles on a broad spectrum of subjects, including the molecular and cellular bases of disease, aetiology, pathophysiology, pathology, epidemiology, clinical features, and the diagnosis, prognosis and treatment of cancer, will be considered for publication.
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