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Intergroup LEAP trial (S1612): A randomized phase 2/3 platform trial to test novel therapeutics in medically less fit older adults with acute myeloid leukemia.国际协作组LEAP试验（S1612）：一项随机2/3期平台试验，旨在测试针对身体状况较差的老年急性髓系白血病患者的新型疗法。
Am J Hematol. 2018 Feb;93(2):E49-E52. doi: 10.1002/ajh.24980. Epub 2017 Dec 4.
2
A 5-day outpatient regimen of azacitidine is effective and well tolerated in patients with acute myeloid leukemia unsuitable for intensive chemotherapy.对于不适宜进行强化化疗的急性髓系白血病患者，阿扎胞苷5天门诊治疗方案疗效显著且耐受性良好。
Leuk Lymphoma. 2014 Dec;55(12):2950-1. doi: 10.3109/10428194.2014.904512. Epub 2014 Apr 22.
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A multicenter phase II trial of decitabine as first-line treatment for older patients with acute myeloid leukemia judged unfit for induction chemotherapy.一项多中心二期临床试验，评估地西他滨作为不适合诱导化疗的老年急性髓系白血病患者的一线治疗药物。
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Azacytidine for acute myeloid leukemia in elderly or frail patients: a phase II trial (SAKK 30/07).阿扎胞苷治疗老年或虚弱的急性髓系白血病患者的Ⅱ期临床试验（SAKK 30/07）。
Leuk Lymphoma. 2014 Jan;55(1):87-91. doi: 10.3109/10428194.2013.790540. Epub 2013 May 2.
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Induction therapy for elderly patients with acute myeloid leukemia.老年急性髓系白血病患者的诱导治疗
Blood Rev. 2008 Nov;22(6):311-20. doi: 10.1016/j.blre.2008.04.004. Epub 2008 Jun 9.
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J Clin Oncol. 2012 Nov 20;30(33):4061-3. doi: 10.1200/JCO.2012.44.2962. Epub 2012 Sep 24.
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Azacitidine as the post-remission therapy for elderly patients with acute myeloid leukemia.阿扎胞苷作为老年急性髓系白血病患者缓解后的治疗方法。
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Phase I study of clofarabine in adult patients with acute myeloid leukemia in Japan.日本成人急性髓系白血病患者中克拉屈滨的 I 期研究。
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Decitabine in older adults with acute myeloid leukemia: why was the dream broken?地西他滨用于老年急性髓系白血病患者：梦想为何破灭？
J Clin Oncol. 2013 May 10;31(14):1795-6. doi: 10.1200/JCO.2012.48.1465. Epub 2013 Apr 1.
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Leukemia. 2012 May;26(5):1106-7. doi: 10.1038/leu.2011.342. Epub 2011 Nov 29.

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Front Pediatr. 2024 Jan 10;11:1358139. doi: 10.3389/fped.2023.1358139. eCollection 2023.
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Ex Vivo Drug Sensitivity Correlates with Clinical Response and Supports Personalized Therapy in Pediatric AML.体外药物敏感性与临床反应相关，并支持儿童急性髓系白血病的个性化治疗。
Cancers (Basel). 2022 Dec 18;14(24):6240. doi: 10.3390/cancers14246240.
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A randomized phase II/III study of 'novel therapeutics' versus azacitidine in newly diagnosed patients with acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML), age 60 or older: a report of the comparison of azacitidine and nivolumab to azacitidine: SWOG S1612.一项针对60岁及以上新诊断的急性髓系白血病（AML）、高危骨髓增生异常综合征（MDS）或慢性粒单核细胞白血病（CMML）患者，比较“新型疗法”与阿扎胞苷的随机II/III期研究：阿扎胞苷与纳武单抗对比阿扎胞苷的报告：SWOG S1612。
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Hypomethylating agent-based therapies in older adults with acute myeloid leukemia - A joint review by the Young International Society of Geriatric Oncology and European Society for Blood and Marrow Transplantation Trainee Committee.基于低甲基化剂的治疗在老年急性髓系白血病中的应用 - 老年肿瘤学的青年国际学会和欧洲血液和骨髓移植协会学员委员会的联合综述。
J Geriatr Oncol. 2023 Apr;14(3):101406. doi: 10.1016/j.jgo.2022.11.005. Epub 2022 Nov 23.
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Early mortality risk with non-intensive acute myeloid leukemia (AML) therapies: analysis of 1336 patients from MRC/NCRI and SWOG.非强化急性髓系白血病（AML）治疗的早期死亡风险：对来自MRC/NCRI和SWOG的1336例患者的分析
Leuk Lymphoma. 2023 Jan;64(1):250-252. doi: 10.1080/10428194.2022.2131416. Epub 2022 Oct 13.
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Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials.多臂非随机序贯分配队列设计在肿瘤学 II 期临床试验中的优势。
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Stratified randomization for platform trials with differing experimental arm eligibility.分层随机化用于具有不同实验组合格条件的平台试验。
Clin Trials. 2021 Oct;18(5):562-569. doi: 10.1177/17407745211028872. Epub 2021 Aug 21.
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Older adults with cancer and their caregivers - current landscape and future directions for clinical care.癌症老年患者及其照护者——临床照护的现状和未来方向。
Nat Rev Clin Oncol. 2020 Dec;17(12):742-755. doi: 10.1038/s41571-020-0421-z. Epub 2020 Sep 2.
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Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols.系统评价篮子试验、伞式试验和平台试验：主方案的全景分析。
Trials. 2019 Sep 18;20(1):572. doi: 10.1186/s13063-019-3664-1.
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Reporting of master protocols towards a standardized approach: A systematic review.关于采用标准化方法的主方案报告：一项系统评价。
Contemp Clin Trials Commun. 2019 Jul 4;15:100406. doi: 10.1016/j.conctc.2019.100406. eCollection 2019 Sep.

本文引用的文献

1
Designing Clinical Trials That Accept New Arms: An Example in Metastatic Breast Cancer.设计接受新治疗臂的临床试验：转移性乳腺癌的实例。
J Clin Oncol. 2017 Sep 20;35(27):3160-3168. doi: 10.1200/JCO.2016.70.1169. Epub 2017 May 22.
2
The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia.2016 年版世界卫生组织髓系肿瘤和急性白血病分类。
Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.
3
Relationship between event-free survival and overall survival in acute myeloid leukemia: a report from SWOG, HOVON/SAKK, and MRC/NCRI.急性髓系白血病无事件生存期与总生存期的关系：来自SWOG、HOVON/SAKK及MRC/NCRI的报告
Haematologica. 2016 Jul;101(7):e284-6. doi: 10.3324/haematol.2015.138552. Epub 2016 Mar 24.
4
Emerging innovations in clinical trial design.临床试验设计的新兴创新。
Clin Pharmacol Ther. 2016 Jan;99(1):82-91. doi: 10.1002/cpt.285. Epub 2015 Nov 19.
5
Improving Clinical Trial Efficiency: Thinking outside the Box.提高临床试验效率：跳出框框思考。
Am Soc Clin Oncol Educ Book. 2015:e141-7. doi: 10.14694/EdBook_AM.2015.35.e141.
6
International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts.阿扎胞苷对比传统治疗方案用于新诊断的原始细胞比例>30%的老年急性髓系白血病患者的国际3期研究。
Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18.
7
Acute myeloid leukemia and myelodysplastic syndromes in older adults.老年急性髓系白血病和骨髓增生异常综合征
J Clin Oncol. 2014 Aug 20;32(24):2541-52. doi: 10.1200/JCO.2014.55.1564.
8
Management of older or unfit patients with acute myeloid leukemia.老年或身体状况不佳的急性髓系白血病患者的管理。
Leukemia. 2015 Apr;29(4):770-5. doi: 10.1038/leu.2014.216. Epub 2014 Jul 9.
9
Clofarabine doubles the response rate in older patients with acute myeloid leukemia but does not improve survival.克洛法拉滨可使老年急性髓系白血病患者的反应率翻倍，但不能提高生存率。
Blood. 2013 Aug 22;122(8):1384-94. doi: 10.1182/blood-2013-04-496596. Epub 2013 Jul 9.
10
The addition of gemtuzumab ozogamicin to low-dose Ara-C improves remission rate but does not significantly prolong survival in older patients with acute myeloid leukaemia: results from the LRF AML14 and NCRI AML16 pick-a-winner comparison.在低剂量阿糖胞苷中添加吉妥珠单抗奥佐米星可提高缓解率，但并不能显著延长老年急性髓系白血病患者的生存时间：来自 LRF AML14 和 NCRI AML16 优胜者选择比较的结果。
Leukemia. 2013 Jan;27(1):75-81. doi: 10.1038/leu.2012.229. Epub 2012 Aug 14.

Intergroup LEAP trial (S1612): A randomized phase 2/3 platform trial to test novel therapeutics in medically less fit older adults with acute myeloid leukemia.

作者信息

Walter Roland B, Michaelis Laura C, Othus Megan, Uy Geoffrey L, Radich Jerald P, Little Richard F, Hita Sandi, Saini Lalit, Foran James M, Gerds Aaron T, Klepin Heidi D, Hay Annette E, Assouline Sarit, Lancet Jeffrey E, Couban Stephen, Litzow Mark R, Stone Richard M, Erba Harry P

机构信息

Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.

Department of Medicine, University of Washington, Seattle, Washington.

出版信息

Am J Hematol. 2018 Feb;93(2):E49-E52. doi: 10.1002/ajh.24980. Epub 2017 Dec 4.

DOI:10.1002/ajh.24980
PMID:29164656
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5760282/
Abstract
摘要