扎鲁替尼联合阿糖胞苷治疗难治性/复发性原发性中枢神经系统淋巴瘤患者。

IF 1.7 4区医学 Q3 HEMATOLOGY

Acta Haematologica Pub Date : 2024-01-01 Epub Date: 2024-02-26 DOI:10.1159/000537995

Zhiguang Lin, Jingjing Ma, Yan Ma, Qing Li, Hui Kang, Mengxue Zhang, Bobin Chen

{"title":"扎鲁替尼联合阿糖胞苷治疗难治性/复发性原发性中枢神经系统淋巴瘤患者。","authors":"Zhiguang Lin, Jingjing Ma, Yan Ma, Qing Li, Hui Kang, Mengxue Zhang, Bobin Chen","doi":"10.1159/000537995","DOIUrl":null,"url":null,"abstract":"Introduction: Primary central nervous system lymphoma (PCNSL) is a rare subtype of aggressive extranodal non-Hodgkin lymphoma. Currently, there is no standard of care for the treatment of refractory or relapsed PCNSL (r/r PCNSL). We conducted a prospective single-arm phase II study to evaluate zanubrutinib plus cytarabine for r/r PCNSL.Methods: Using Simon's two-stage design, we analyzed 34 patients who received high-dose cytarabine (3.0 g/m2 once daily) for 2 days and zanubrutinib (160 mg twice daily) for 21 days each cycle for up to 6 cycles. The study was registered at <ext-link ext-link-type=\"uri\" xlink:href=\"http://www.chictr.org.cn\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">www.chictr.org.cn</ext-link> as #ChiCTR2000039229.Results: The median follow-up was 19 months. The overall response rate was 64.7% (95% confidence interval [CI], 47.9-78.5%) with a complete remission or unconfirmed complete remission rate of 47.1% (16/34) and a partial remission rate of 17.6% (6/34). The median progression-free survival was 4.5 months (95% CI, 1.5-9.4), and the median OS was 18 months (95% CI, 9.5 to not estimable). The median duration of the response was 9 months (95% CI, 3.2 to not estimable). The most common treatment-emergent adverse events were thrombocytopenia (55.9%). No treatment-related death occurred.Conclusion: Zanubrutinib and cytarabine showed efficacy in r/r PCNSL with an acceptable safety profile.","PeriodicalId":6981,"journal":{"name":"Acta Haematologica","volume":" ","pages":"555-563"},"PeriodicalIF":1.7000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11441377/pdf/","citationCount":"0","resultStr":"{\"title\":\"Zanubrutinib plus Cytarabine in Patients with Refractory/Relapsed Primary Central Nervous System Lymphoma.\",\"authors\":\"Zhiguang Lin, Jingjing Ma, Yan Ma, Qing Li, Hui Kang, Mengxue Zhang, Bobin Chen\",\"doi\":\"10.1159/000537995\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction: Primary central nervous system lymphoma (PCNSL) is a rare subtype of aggressive extranodal non-Hodgkin lymphoma. Currently, there is no standard of care for the treatment of refractory or relapsed PCNSL (r/r PCNSL). We conducted a prospective single-arm phase II study to evaluate zanubrutinib plus cytarabine for r/r PCNSL.Methods: Using Simon's two-stage design, we analyzed 34 patients who received high-dose cytarabine (3.0 g/m2 once daily) for 2 days and zanubrutinib (160 mg twice daily) for 21 days each cycle for up to 6 cycles. The study was registered at <ext-link ext-link-type=\\\"uri\\\" xlink:href=\\\"http://www.chictr.org.cn\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\">www.chictr.org.cn</ext-link> as #ChiCTR2000039229.Results: The median follow-up was 19 months. The overall response rate was 64.7% (95% confidence interval [CI], 47.9-78.5%) with a complete remission or unconfirmed complete remission rate of 47.1% (16/34) and a partial remission rate of 17.6% (6/34). The median progression-free survival was 4.5 months (95% CI, 1.5-9.4), and the median OS was 18 months (95% CI, 9.5 to not estimable). The median duration of the response was 9 months (95% CI, 3.2 to not estimable). The most common treatment-emergent adverse events were thrombocytopenia (55.9%). No treatment-related death occurred.Conclusion: Zanubrutinib and cytarabine showed efficacy in r/r PCNSL with an acceptable safety profile.\",\"PeriodicalId\":6981,\"journal\":{\"name\":\"Acta Haematologica\",\"volume\":\" \",\"pages\":\"555-563\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11441377/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Acta Haematologica\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000537995\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/2/26 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta Haematologica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000537995","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/26 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"HEMATOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

简介原发性中枢神经系统淋巴瘤（PCNSL）是侵袭性结节外非霍奇金淋巴瘤的一种罕见亚型。目前，治疗难治性或复发性 PCNSL（r/r PCNSL）尚无标准疗法。我们开展了一项前瞻性单臂II期研究，评估扎鲁替尼联合阿糖胞苷治疗r/r PCNSL的疗效：采用西蒙两阶段设计，我们对34例患者进行了分析，这些患者接受大剂量阿糖胞苷（3.0 g/m2，每日1次）治疗2天，同时接受扎努布替尼（160 mg，每日2次）治疗21天，每个周期最多6个周期。该研究已在 www.chictr.org.cn 注册，注册号为 #ChiCTR2000039229。结果：中位随访时间为19个月。总反应率为64.7%（95%置信区间（CI），47.9%至78.5%），完全缓解或未经证实的完全缓解率为47.1%（16/34），部分缓解率为17.6%（6/34）。无进展生存期中位数为4.5个月（95%CI，1.5至9.4），OS中位数为18个月（95%CI，9.5至无法估计）。中位应答持续时间为9个月（95%CI，3.2至无法估计）。最常见的治疗突发不良事件是血小板减少（55.9%）。没有发生与治疗相关的死亡：结论：扎鲁替尼和阿糖胞苷对r/r PCNSL疗效显著，安全性可接受。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Zanubrutinib plus Cytarabine in Patients with Refractory/Relapsed Primary Central Nervous System Lymphoma.

Introduction: Primary central nervous system lymphoma (PCNSL) is a rare subtype of aggressive extranodal non-Hodgkin lymphoma. Currently, there is no standard of care for the treatment of refractory or relapsed PCNSL (r/r PCNSL). We conducted a prospective single-arm phase II study to evaluate zanubrutinib plus cytarabine for r/r PCNSL.

Methods: Using Simon's two-stage design, we analyzed 34 patients who received high-dose cytarabine (3.0 g/m2 once daily) for 2 days and zanubrutinib (160 mg twice daily) for 21 days each cycle for up to 6 cycles. The study was registered at www.chictr.org.cn as #ChiCTR2000039229.

Results: The median follow-up was 19 months. The overall response rate was 64.7% (95% confidence interval [CI], 47.9-78.5%) with a complete remission or unconfirmed complete remission rate of 47.1% (16/34) and a partial remission rate of 17.6% (6/34). The median progression-free survival was 4.5 months (95% CI, 1.5-9.4), and the median OS was 18 months (95% CI, 9.5 to not estimable). The median duration of the response was 9 months (95% CI, 3.2 to not estimable). The most common treatment-emergent adverse events were thrombocytopenia (55.9%). No treatment-related death occurred.

Conclusion: Zanubrutinib and cytarabine showed efficacy in r/r PCNSL with an acceptable safety profile.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Acta Haematologica 医学-血液学

CiteScore

4.90

自引率

0.00%

发文量

审稿时长

6-12 weeks

期刊介绍： ''Acta Haematologica'' is a well-established and internationally recognized clinically-oriented journal featuring balanced, wide-ranging coverage of current hematology research. A wealth of information on such problems as anemia, leukemia, lymphoma, multiple myeloma, hereditary disorders, blood coagulation, growth factors, hematopoiesis and differentiation is contained in first-rate basic and clinical papers some of which are accompanied by editorial comments by eminent experts. These are supplemented by short state-of-the-art communications, reviews and correspondence as well as occasional special issues devoted to ‘hot topics’ in hematology. These will keep the practicing hematologist well informed of the new developments in the field.