试验结果不一致后复杂的监管决策：伊布替尼治疗套细胞淋巴瘤的问题 - Suppr | 超能文献

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Complicated regulatory decision-making following inconsistent trial results: the issue with ibrutinib for mantle cell lymphoma.试验结果不一致后复杂的监管决策：伊布替尼治疗套细胞淋巴瘤的问题

Nat Rev Clin Oncol. 2024 Jan;21(1):1-2. doi: 10.1038/s41571-023-00821-7.

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A phase 1 trial of copanlisib plus ibrutinib in relapsed/refractory mantle cell lymphoma.Copanlisib联合依鲁替尼治疗复发/难治性套细胞淋巴瘤的1期试验。

Blood Adv. 2022 Sep 27;6(18):5262-5266. doi: 10.1182/bloodadvances.2021006555.

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[Mantle cell lymphoma with central nervous system relapse successfully treated with nasogastric-tube administration of ibrutinib].[经鼻胃管给予伊布替尼成功治疗中枢神经系统复发的套细胞淋巴瘤]

Rinsho Ketsueki. 2020;61(10):1508-1510. doi: 10.11406/rinketsu.61.1508.

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Concurrent ibrutinib plus venetoclax in relapsed/refractory mantle cell lymphoma: the safety run-in of the phase 3 SYMPATICO study.在复发/难治性套细胞淋巴瘤中联合使用伊布替尼和维奈托克：3 期 SYMPATICO 研究的安全性预试验。

J Hematol Oncol. 2021 Oct 30;14(1):179. doi: 10.1186/s13045-021-01188-x.

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Real-world outcomes of ibrutinib therapy in Korean patients with relapsed or refractory mantle cell lymphoma: a multicenter, retrospective analysis.伊布替尼治疗韩国复发或难治性套细胞淋巴瘤患者的真实世界疗效：一项多中心回顾性分析。

Cancer Commun (Lond). 2021 Mar;41(3):275-278. doi: 10.1002/cac2.12150. Epub 2021 Feb 24.

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Ibrutinib for mantle cell lymphoma at first relapse: a United Kingdom real-world analysis of outcomes in 211 patients.伊布替尼治疗套细胞淋巴瘤首次复发：211 例英国真实世界研究结果分析。

Br J Haematol. 2021 Apr;193(2):290-298. doi: 10.1111/bjh.17363. Epub 2021 Feb 23.

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Rapid progression after ibrutinib discontinuation in a patient with mantle cell lymphoma who has severe coronavirus disease 2019 infection.一名患有套细胞淋巴瘤且感染严重2019冠状病毒病的患者在停用依鲁替尼后病情迅速进展。

Balkan Med J. 2021 Mar;38(2):141-142. doi: 10.4274/balkanmedj.galenos.2020.2020.9.106.

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Does Ibrutinib impact outcomes of viral infection by SARS-CoV-2 in mantle cell lymphoma patients?伊布替尼对套细胞淋巴瘤患者感染新型冠状病毒肺炎的预后有影响吗？

Curr Res Transl Med. 2021 Jan;69(1):103273. doi: 10.1016/j.retram.2020.103273. Epub 2020 Nov 25.

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Diagnostically challenging immunophenotypic shift in mantle cell lymphoma following ibrutinib and venetoclax therapy.依鲁替尼和维奈托克治疗后套细胞淋巴瘤中具有诊断挑战性的免疫表型转变

Pathology. 2021 Dec;53(7):926-929. doi: 10.1016/j.pathol.2021.01.013. Epub 2021 May 1.

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[Five year experience in ibrutinib therapy for relapsed and refractory mantle cell lymphoma in real world Russian clinical practice].[俄罗斯真实世界临床实践中依鲁替尼治疗复发难治性套细胞淋巴瘤的五年经验]

Ter Arkh. 2021 Jul 23;93(7):770-777. doi: 10.26442/00403660.2021.07.200930.

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Predictors of withdrawal of anticancer drug indications granted accelerated approval: a retrospective cohort study.获批加速批准的抗癌药物适应症撤销的预测因素：一项回顾性队列研究。

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Regulatory flexibilities balancing unmet needs, benefits and risks in the approvals of imported cancer drugs in China: a cohort study from 2012 to 2021.中国进口抗癌药物审批中平衡未满足需求、益处和风险的监管灵活性：一项2012年至2021年的队列研究

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本文引用的文献

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Irreconcilable Differences: The Divorce Between Response Rates, Progression-Free Survival, and Overall Survival.不可调和的差异：缓解率、无进展生存期和总生存期之间的脱节

J Clin Oncol. 2023 May 20;41(15):2706-2712. doi: 10.1200/JCO.23.00225. Epub 2023 Mar 17.

2

Treatment of Mantle-Cell Lymphoma.套细胞淋巴瘤的治疗

N Engl J Med. 2022 Sep 22;387(12):1146-1147. doi: 10.1056/NEJMc2209904.

3

Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma.伊布替尼联合苯达莫司汀和利妥昔单抗治疗未经治疗的套细胞淋巴瘤。