Measuring therapeutic response in chronic graft-versus-host disease. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: IV. The 2014 Response Criteria Working Group report.
Measuring therapeutic response in chronic graft-versus-host disease. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: IV. The 2014 Response Criteria Working Group report.
复制标题
DOI：
10.1016/j.bbmt.2015.02.025
复制
发表时间：
2015-06
期刊：
影响因子：
--
通讯作者：
Pavletic S
中科院分区：
文献类型：
--
作者：
Lee SJ;Wolff D;Kitko C;Koreth J;Inamoto Y;Jagasia M;Pidala J;Olivieri A;Martin PJ;Przepiorka D;Pusic I;Dignan F;Mitchell SA;Lawitschka A;Jacobsohn D;Hall AM;Flowers ME;Schultz KR;Vogelsang G;Pavletic S
2005年，美国国立卫生研究院慢性GVHD共识反应标准工作组推荐了几种方法来记录慢性GVHD器官累及的一系列评估。针对每个器官和总体结果提出了完全缓解、部分缓解和进展的临时定义。根据过去九年的出版物，2014年工作组更新了其关于措施和解释机关和总体反应的建议。主要的变化包括从反应的确定中消除几个临床参数，更新或增加新的器官量表来评估反应，以及认识到进展排除了通常不需要改变治疗的最小的、临床不显著的恶化。响应定义已经过修订，以反映这些变化，并有望提高这些措施在临床试验中的可靠性和实用性。澄清了局部或器官靶向治疗后的反应评估。在临床试验中强烈鼓励采取辅助措施。建议进一步研究的领域包括确定不可逆器官损伤的标准和修改后的反应标准的验证，包括在儿科人群中。
In 2005, the NIH Chronic GVHD Consensus Response Criteria Working Group recommended several measures to document serial evaluations of chronic GVHD organ involvement. Provisional definitions of complete response, partial response, and progression were proposed for each organ and for overall outcome. Based on publications over the last nine years, the 2014 Working Group has updated its recommendations for measures and interpretation of organ and overall responses. Major changes include elimination of several clinical parameters from the determination of response, updates to or addition of new organ scales to assess response, and the recognition that progression excludes minimal, clinically insignificant worsening that does not usually warrant a change in therapy. The response definitions have been revised to reflect these changes and are expected to enhance reliability and practical utility of these measures in clinical trials. Clarification is provided about response assessment after the addition of topical or organ-targeted treatment. Ancillary measures are strongly encouraged in clinical trials. Areas suggested for additional research include criteria to identify irreversible organ damage and validation of the modified response criteria, including in the pediatric population.