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Recommendations for Clinical Trial Development in Mantle Cell Lymphoma.套细胞淋巴瘤临床试验开发建议
J Natl Cancer Inst. 2016 Dec 31;109(1). doi: 10.1093/jnci/djw263. Print 2017 Jan.
2
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Cancer Treat Rev. 2017 Jul;58:51-60. doi: 10.1016/j.ctrv.2017.05.008. Epub 2017 Jun 13.
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Refining the Mantle Cell Lymphoma Paradigm: Impact of Novel Therapies on Current Practice.完善套细胞淋巴瘤治疗模式:新型疗法对当前实践的影响。
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Management of Older Adults with Mantle Cell Lymphoma.老年人套细胞淋巴瘤的治疗。
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Diagnosis and treatment of mantle cell lymphoma.套细胞淋巴瘤的诊断与治疗。
Swiss Med Wkly. 2013 Nov 13;143:w13868. doi: 10.4414/smw.2013.13868. eCollection 2013.
7
Transplantation for mantle cell lymphoma: is it the right thing to do?套细胞淋巴瘤的移植治疗:这样做是否正确?
Hematology Am Soc Hematol Educ Program. 2013;2013:568-74. doi: 10.1182/asheducation-2013.1.568.
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Treatment strategies in mantle cell lymphoma.套细胞淋巴瘤的治疗策略
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Is hematopoietic cell transplantation still a valid option for mantle cell lymphoma in first remission in the chemoimmunotherapy-era?在化疗免疫治疗时代,对于处于缓解期的套细胞淋巴瘤患者,造血细胞移植仍然是一种有效的选择吗?
Bone Marrow Transplant. 2013 Nov;48(12):1489-96. doi: 10.1038/bmt.2013.56. Epub 2013 Apr 15.

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Cancer therapy by cyclin-dependent kinase inhibitors (CDKIs): bench to bedside.细胞周期蛋白依赖性激酶抑制剂(CDKIs)用于癌症治疗:从 bench 到 bedside。 (注:“bench to bedside”直译为“从实验室到临床应用”,这里保留英文表述更能体现原文专业性和特定语境含义)
EXCLI J. 2024 Jun 4;23:862-882. doi: 10.17179/excli2024-7076. eCollection 2024.
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Recommendations for cellular and molecular pathology input into clinical trials: a systematic review and meta-aggregation.推荐细胞和分子病理学在临床试验中的应用:系统评价和荟萃分析。
J Pathol Clin Res. 2021 May;7(3):191-202. doi: 10.1002/cjp2.199. Epub 2021 Feb 26.
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Management of Drug Resistance in Mantle Cell Lymphoma.套细胞淋巴瘤耐药性的管理
Cancers (Basel). 2020 Jun 12;12(6):1565. doi: 10.3390/cancers12061565.
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An open-label phase 2 trial of entospletinib in indolent non-Hodgkin lymphoma and mantle cell lymphoma.依鲁替尼治疗惰性非霍奇金淋巴瘤和套细胞淋巴瘤的开放性 2 期临床试验。
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Maintenance Therapy in Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma.弥漫性大 B 细胞淋巴瘤和套细胞淋巴瘤的维持治疗。
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Current trials for frontline therapy of mantle cell lymphoma.当前用于治疗套细胞淋巴瘤的一线疗法的临床试验。
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Mantle cell lymphoma initial therapy with abbreviated R-CHOP followed by Y-ibritumomab tiuxetan: 10-year follow-up of the phase 2 ECOG-ACRIN study E1499.采用简化R-CHOP方案序贯钇-伊布替尼单抗进行套细胞淋巴瘤初始治疗:ECOG-ACRIN 2期研究E1499的10年随访结果
Leukemia. 2017 Feb;31(2):517-519. doi: 10.1038/leu.2016.305. Epub 2016 Oct 26.

本文引用的文献

1
Prognostic Value of Ki-67 Index, Cytology, and Growth Pattern in Mantle-Cell Lymphoma: Results From Randomized Trials of the European Mantle Cell Lymphoma Network.Ki-67 指数、细胞学和生长模式在套细胞淋巴瘤中的预后价值:来自欧洲套细胞淋巴瘤网络的随机试验结果。
J Clin Oncol. 2016 Apr 20;34(12):1386-94. doi: 10.1200/JCO.2015.63.8387. Epub 2016 Feb 29.
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Postibrutinib outcomes in patients with mantle cell lymphoma.套细胞淋巴瘤患者接受伊布替尼治疗后的结局。
Blood. 2016 Mar 24;127(12):1559-63. doi: 10.1182/blood-2015-10-673145. Epub 2016 Jan 13.
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Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study.依鲁替尼对比替西罗莫司治疗复发或难治性套细胞淋巴瘤患者:一项国际性、随机、开放标签、3 期研究。
Lancet. 2016 Feb 20;387(10020):770-8. doi: 10.1016/S0140-6736(15)00667-4. Epub 2015 Dec 7.
4
Rituximab plus hyper-CVAD alternating with MTX/Ara-C in patients with newly diagnosed mantle cell lymphoma: 15-year follow-up of a phase II study from the MD Anderson Cancer Center.利妥昔单抗联合强化环磷酰胺、长春新碱、阿霉素和地塞米松(hyper-CVAD)与甲氨蝶呤/阿糖胞苷(MTX/Ara-C)交替用于新诊断的套细胞淋巴瘤患者:来自MD安德森癌症中心一项II期研究的15年随访
Br J Haematol. 2016 Jan;172(1):80-8. doi: 10.1111/bjh.13796. Epub 2015 Dec 9.
5
A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies.选择性布鲁顿酪氨酸激酶(BTK)抑制剂ONO/GS-4059用于复发和难治性成熟B细胞恶性肿瘤的1期临床试验。
Blood. 2016 Jan 28;127(4):411-9. doi: 10.1182/blood-2015-08-664086. Epub 2015 Nov 5.
6
Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for newly diagnosed mantle cell lymphoma: SWOG S0601.R-CHOP方案联合硼替佐米诱导治疗继以硼替佐米维持治疗初诊套细胞淋巴瘤的II期试验:SWOG S0601
Br J Haematol. 2016 Jan;172(2):208-18. doi: 10.1111/bjh.13818. Epub 2015 Oct 22.
7
Maintenance rituximab after autologous stem cell transplantation in patients with mantle cell lymphoma.套细胞淋巴瘤患者自体干细胞移植后维持使用利妥昔单抗。
Ann Oncol. 2015 Nov;26(11):2323-8. doi: 10.1093/annonc/mdv364. Epub 2015 Sep 7.
8
A phase II, single-arm, open-label, multicenter study to evaluate the efficacy and safety of P276-00, a cyclin-dependent kinase inhibitor, in patients with relapsed or refractory mantle cell lymphoma.一项II期、单臂、开放标签、多中心研究,旨在评估细胞周期蛋白依赖性激酶抑制剂P276-00在复发或难治性套细胞淋巴瘤患者中的疗效和安全性。
Clin Lymphoma Myeloma Leuk. 2015 Jul;15(7):392-7. doi: 10.1016/j.clml.2015.02.021. Epub 2015 Mar 5.
9
Phase I study of ABT-199 (GDC-0199) in patients with relapsed/refractory non-Hodgkin lymphoma: responses observed in diffuse large B-cell (DLBCL) and follicular lymphoma (FL) at higher cohort doses.ABT-199(GDC-0199)用于复发/难治性非霍奇金淋巴瘤患者的I期研究:在较高队列剂量下弥漫性大B细胞淋巴瘤(DLBCL)和滤泡性淋巴瘤(FL)中的观察到的反应。
Clin Adv Hematol Oncol. 2014 Aug;12(8 Suppl 16):18-9.
10
Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma.硼替佐米为基础的治疗新诊断的套细胞淋巴瘤。
N Engl J Med. 2015 Mar 5;372(10):944-53. doi: 10.1056/NEJMoa1412096.

套细胞淋巴瘤临床试验开发建议

Recommendations for Clinical Trial Development in Mantle Cell Lymphoma.

作者信息

Spurgeon Stephen E, Till Brian G, Martin Peter, Goy Andre H, Dreyling Martin P, Gopal Ajay K, LeBlanc Michael, Leonard John P, Friedberg Jonathan W, Baizer Lawrence, Little Richard F, Kahl Brad S, Smith Mitchell R

机构信息

Affiliations of authors: Division of Hematology and Medical Oncology, Oregon Health and Science (OHSU) University Knight Cancer Institute, Portland, OR (SES); Clinical Research Division, Fred Hutchinson Cancer Research Center/ Department of Medicine, Division of Medical Oncology, University of Washington, Seattle, WA (BGT, AKG); Department of Medicine, Weill Cornell Medicine, New York, NY (PM, JPL); John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ (AHG); Department of Medicine III, Klinikum der Universität München, Campus Grosshadern, Munich, Germany (MPD); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (ML); Wilmot Cancer Center and Division of Hematology/Oncology, University of Rochester, Rochester, NY (JWF); Coordinating Center for Clinical Trials, National Cancer Institute, National Institutes of Health, Bethesda, MD (LB); HIV and AIDS Malignancy Branch, Center for Cancer Research, and Clinical Investigations Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD (RFL); Department of Medicine, Oncology Division, Washington University, St. Louis, MO (BSK); Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (MRS).

出版信息

J Natl Cancer Inst. 2016 Dec 31;109(1). doi: 10.1093/jnci/djw263. Print 2017 Jan.

DOI:10.1093/jnci/djw263
PMID:28040733
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6059122/
Abstract

Mantle cell lymphoma (MCL) comprises around 6% of all non-Hodgkin's lymphoma (NHL) diagnoses. In younger patients, age less than 60 to 65 years, aggressive induction often followed by consolidation with autologous stem cell transplant has suggested improved outcomes in this population. Less intensive therapies in older patients often followed by maintenance have been studied or are under active investigation. However, despite recent advances, MCL remains incurable, with a median overall survival of around five years. Patients with high-risk disease have particularly poor outcomes. Treatment varies widely across institutions, and to date no randomized trials comparing intensive vs less intensive approaches have been reported. Although recent data have highlighted the heterogeneity of MCL outcomes, patient assessment for treatment selection has largely been driven by patient age with little regard to fitness, disease biology, or disease risk. One critical advance is the finding that minimal residual disease status (MRD) after induction correlates with long-term outcomes. As such, its use as a potential end point could inform clinical trial design. In order to more rapidly improve the outcomes of MCL patients, clinical trials are needed that prospectively stratify patients on the basis of MCL biology and disease risk, incorporate novel agents, and use MRD to guide the need for additional therapy.

摘要

套细胞淋巴瘤(MCL)约占所有非霍奇金淋巴瘤(NHL)诊断病例的6%。在年龄小于60至65岁的年轻患者中,积极诱导治疗后常继以自体干细胞移植巩固治疗,这表明该人群的预后有所改善。对老年患者采用强度较低的治疗并常继以维持治疗的方案已得到研究或正在积极探索中。然而,尽管最近取得了进展,MCL仍然无法治愈,总体中位生存期约为五年。高危疾病患者的预后尤其差。各机构的治疗方法差异很大,迄今为止,尚未有比较强化治疗与低强度治疗方法的随机试验报告。尽管最近的数据突出了MCL预后的异质性,但在选择治疗方案时,对患者的评估很大程度上是由患者年龄驱动的,而很少考虑身体状况、疾病生物学特性或疾病风险。一项关键进展是发现诱导治疗后的微小残留病状态(MRD)与长期预后相关。因此,将其用作潜在的终点指标可为临床试验设计提供参考。为了更快地改善MCL患者的预后,需要开展临床试验,根据MCL生物学特性和疾病风险对患者进行前瞻性分层,纳入新型药物,并使用MRD来指导是否需要额外治疗。