National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIb. The 2020 Preemptive Therapy Working Group Report.
National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIb. The 2020 Preemptive Therapy Working Group Report.
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DOI：
10.1016/j.jtct.2021.03.029
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发表时间：
2021-08
影响因子：
3.2
通讯作者：
Hill G
中科院分区：
文献类型：
--
作者：
Pidala J;Kitko C;Lee SJ;Carpenter P;Cuvelier GDE;Holtan S;Flowers ME;Cutler C;Jagasia M;Gooley T;Palmer J;Randolph T;Levine JE;Ayuk F;Dignan F;Schoemans H;Tkaczyk E;Farhadfar N;Lawitschka A;Schultz KR;Martin PJ;Sarantopoulos S;Inamoto Y;Socie G;Wolff D;Blazar B;Greinix H;Paczesny S;Pavletic S;Hill G
慢性移植物抗宿主病(GVHD)通常发生在异基因造血细胞移植(HCT)后，尽管有标准的预防性免疫抑制。强化的普遍预防方法是有效的，但可能存在过度治疗的风险，并可能干扰移植物抗肿瘤免疫反应。在这里，我们总结了关于慢性GVHD预防性治疗的概念和实践方面的考虑，即基于发生慢性GVHD的风险高于先前认识的证据，在HCT后应用的干预措施。这种风险可以通过临床因素或风险分配生物标记物来预测，也可以通过不完全符合美国国立卫生研究院诊断标准的慢性移植物抗宿主病的早期迹象和症状来指示。然而，目前还不存在真正先发制人的、个性化的和有针对性的慢性GVHD疗法。在这份报告中，我们(1)回顾关于慢性GVHD临床危险因素的现有知识，(2)回顾关于慢性GVHD风险分配生物标记物的已知情况，(3)研究慢性GVHD的发病机制如何与现有的靶向治疗药物相交，以及(4)总结慢性GVHD预防性治疗的考虑因素，强调试验发展，包括试验设计和统计学考虑。我们的结论是，稳健的风险分配模型能够准确预测HCT和早期预防性治疗试验后的慢性GVHD，是推进这一新研究领域的最紧迫的优先事项。
Chronic graft-versus-host disease (GVHD) commonly occurs after allogeneic hematopoietic cell transplantation (HCT) despite standard prophylactic immune suppression. Intensified universal prophylaxis approaches are effective but risk possible overtreatment and may interfere with the graft-versus-malignancy immune response. Here we summarize conceptual and practical considerations regarding preemptive therapy of chronic GVHD, namely interventions applied after HCT based on evidence that the risk of developing chronic GVHD is higher than previously appreciated. This risk may be anticipated by clinical factors or risk assignment biomarkers or may be indicated by early signs and symptoms of chronic GVHD that do not fully meet National Institutes of Health diagnostic criteria. However, truly preemptive, individualized, and targeted chronic GVHD therapies currently do not exist. In this report, we (1) review current knowledge regarding clinical risk factors for chronic GVHD, (2) review what is known about chronic GVHD risk assignment biomarkers, (3) examine how chronic GVHD pathogenesis intersects with available targeted therapeutic agents, and (4) summarize considerations for preemptive therapy for chronic GVHD, emphasizing trial development, including trial design and statistical considerations. We conclude that robust risk assignment models that accurately predict chronic GVHD after HCT and early-phase preemptive therapy trials represent the most urgent priorities for advancing this novel area of research.
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影响因子：
7.3
作者：
Cuvelier GDE;Li A;Drissler S;Kariminia A;Abdossamadi S;Rozmus J;Chanoine JP;Ng B;Mostafavi S;Brinkman RR;Schultz KR
通讯作者：
Schultz KR
DOI：
10.1007/s12032-018-1127-2
发表时间：
2018-04-25
期刊：
Medical oncology (Northwood, London, England)
影响因子：
--
作者：
Afram G;Simón JAP;Remberger M;Caballero-Velázquez T;Martino R;Piñana JL;Ringden O;Esquirol A;Lopez-Corral L;Garcia I;López-Godino O;Sierra J;Caballero D;Ljungman P;Vazquez L;Hägglund H
通讯作者：
Hägglund H
影响因子：
20.3
作者：
Abu Zaid, Mohammad;Wu, Juan;Choi, Sung Won
通讯作者：
Choi, Sung Won
影响因子：
8
作者：
Forcade, Edouard;Paz, Katelyn;Blazar, Bruce R.
通讯作者：
Blazar, Bruce R.
影响因子：
7.5
作者：
Awan, Farrukh T.;Schuh, Anna;Byrd, John C.
通讯作者：
Byrd, John C.