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Is unmeasurable residual disease (uMRD) the best surrogate endpoint for clinical trials, regulatory approvals and therapy decisions in chronic lymphocytic leukaemia (CLL)?

作者信息

Yang Shenmiao, Kay Neil E, Shi Min, Hanson Curtis A, Gale Robert Peter

机构信息

Peking University Peoples Hospital, Peking University Institute of Hematology, Beijing, China.

Mayo Clinic, Department of Medicine, Division of Hematology, Rochester, MN, USA.

出版信息

Leukemia. 2022 Nov;36(11):2743-2747. doi: 10.1038/s41375-022-01699-7. Epub 2022 Sep 13.

DOI:10.1038/s41375-022-01699-7
PMID:36100641
Abstract
摘要

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Is unmeasurable residual disease (uMRD) the best surrogate endpoint for clinical trials, regulatory approvals and therapy decisions in chronic lymphocytic leukaemia (CLL)?在慢性淋巴细胞白血病（CLL）中，不可测量的残留疾病（uMRD）是临床试验、监管批准和治疗决策的最佳替代终点吗？
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2
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Impacts of early therapy response, interval to therapy interruption, and cumulative therapy interruption duration on outcome of ibrutinib therapy in relapsed/refractory chronic lymphocytic leukemia.

本文引用的文献

1
Biased Evaluation in Cancer Drug Trials-How Use of Progression-Free Survival as the Primary End Point Can Mislead.癌症药物试验中的偏倚评估——将无进展生存期用作主要终点如何会产生误导。
JAMA Oncol. 2022 May 1;8(5):679-680. doi: 10.1001/jamaoncol.2021.8206.
2
Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort.固定疗程伊布替尼联合维奈托克治疗初治 CLL： CAPTIVATE FD 队列的主要分析。
Blood. 2022 Jun 2;139(22):3278-3289. doi: 10.1182/blood.2021014488.
3
First-line treatment of chronic lymphocytic leukemia with ibrutinib plus obinutuzumab chlorambucil plus obinutuzumab: final analysis of the randomized, phase III iLLUMINATE trial.
早期治疗反应、治疗中断间隔时间和累积治疗中断时间对复发/难治性慢性淋巴细胞白血病伊布替尼治疗结果的影响。
Ann Hematol. 2023 Aug;102(8):2181-2188. doi: 10.1007/s00277-023-05309-z. Epub 2023 Jul 1.
4
Measurable Residual Disease in Chronic Lymphocytic Leukemia: Current Understanding and Evolving Role in Clinical Practice.慢性淋巴细胞白血病中的可测量残留疾病：当前的理解和在临床实践中的不断发展的作用。
Curr Treat Options Oncol. 2023 Aug;24(8):907-928. doi: 10.1007/s11864-023-01103-1. Epub 2023 May 17.
伊布替尼联合奥滨尤妥珠单抗、苯丁酸氮芥联合奥滨尤妥珠单抗一线治疗慢性淋巴细胞白血病：随机、III 期 iLLUMINATE 试验的最终分析。
Haematologica. 2022 Sep 1;107(9):2108-2120. doi: 10.3324/haematol.2021.279012.
4
Zanubrutinib, obinutuzumab, and venetoclax with minimal residual disease-driven discontinuation in previously untreated patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: a multicentre, single-arm, phase 2 trial.泽布替尼、奥滨尤妥珠单抗和维奈托克联合治疗慢性淋巴细胞白血病或小淋巴细胞淋巴瘤初治患者：基于微小残留病灶驱动停药的多中心、单臂、2 期临床试验。
Lancet Haematol. 2021 Dec;8(12):e879-e890. doi: 10.1016/S2352-3026(21)00307-0.
5
Minimal Residual Disease Dynamics after Venetoclax-Obinutuzumab Treatment: Extended Off-Treatment Follow-up From the Randomized CLL14 Study.维奈托克联合奥滨尤妥珠单抗治疗后的微小残留病动态：来自随机 CLL14 研究的延长治疗后随访。
J Clin Oncol. 2021 Dec 20;39(36):4049-4060. doi: 10.1200/JCO.21.01181. Epub 2021 Oct 28.
6
Ibrutinib Plus Venetoclax for First-Line Treatment of Chronic Lymphocytic Leukemia: Primary Analysis Results From the Minimal Residual Disease Cohort of the Randomized Phase II CAPTIVATE Study.伊布替尼联合维奈托克用于慢性淋巴细胞白血病的一线治疗：随机、II 期 CAPTIVATE 研究微小残留病灶队列的主要分析结果。
J Clin Oncol. 2021 Dec 1;39(34):3853-3865. doi: 10.1200/JCO.21.00807. Epub 2021 Oct 7.
7
Measurable residual disease testing in chronic lymphocytic leukaemia: hype, hope neither or both?慢性淋巴细胞白血病中的可测量残留病检测：炒作、希望，还是两者皆非或兼而有之？
Leukemia. 2021 Dec;35(12):3364-3370. doi: 10.1038/s41375-021-01419-7. Epub 2021 Sep 27.
8
Acalabrutinib, venetoclax, and obinutuzumab as frontline treatment for chronic lymphocytic leukaemia: a single-arm, open-label, phase 2 study.阿卡替尼、维奈托克和奥滨尤妥珠单抗作为慢性淋巴细胞白血病的一线治疗：一项单臂、开放标签、2 期研究。
Lancet Oncol. 2021 Oct;22(10):1391-1402. doi: 10.1016/S1470-2045(21)00455-1. Epub 2021 Sep 14.
9
Measurable residual disease does not preclude prolonged progression-free survival in CLL treated with ibrutinib.在接受伊布替尼治疗的 CLL 患者中，可测量的残留疾病并不能排除无进展生存期延长。
Blood. 2021 Dec 30;138(26):2810-2827. doi: 10.1182/blood.2020010146.
10
Measurable residual disease in chronic lymphocytic leukemia: expert review and consensus recommendations.慢性淋巴细胞白血病的可测量残留病：专家综述与共识建议。
Leukemia. 2021 Nov;35(11):3059-3072. doi: 10.1038/s41375-021-01241-1. Epub 2021 Jun 24.