With emerging new drugs in myelofibrosis (MF), a robust and harmonized framework for defining the severity of anemia and response to treatment will enhance clinical investigation and facilitate interstudy comparisons. Accordingly, the lead authors on the 2013 edition of the International Working Group–European LeukemiaNet (IWG-ELN) response criteria in MF were summoned to revise their document with the intent to (1) account for gender-specific differences in determining hemoglobin levels for eligibility criteria; (2) revise the definition of transfusion-dependent anemia (TDA) based on current restrictive transfusion practices; and (3) provide a structurally simple and easy to apply response criteria that are sensitive enough to detect efficacy signals (minor response) and also account for major responses. The initial draft of the 2024 IWG-ELN proposed criteria was subsequently circulated around a wider group of international experts and their feedback incorporated. The proposed articles include new definitions for TDA (≥3 units in the 12 weeks before study enrollment) and hemoglobin thresholds for eligibility criteria (<10 g/dL for women and <11 g/dL for men). The revised document also provides separate (TDA vs non-TDA) and graded (major vs minor response) response criteria while preserving the requirement for a 12-week period of screening and observation on treatment.

中文翻译：

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修订国际工作组-欧洲白血病网骨髓纤维化贫血反应标准的提案


随着骨髓纤维化 （MF） 新药的出现，用于定义贫血严重程度和对治疗反应的强大而协调的框架将加强临床研究并促进研究间比较。因此，2013 年版国际工作组-欧洲白血病网 （IWG-ELN） MF 反应标准的主要作者被召集修订他们的文件，目的是 （1） 在确定资格标准的血红蛋白水平时考虑性别特异性差异;（2） 根据当前的限制性输血做法修订输血依赖性贫血 （TDA） 的定义;（3） 提供结构简单且易于应用的反应标准，该标准足够敏感以检测疗效信号（次要反应）并解释主要反应。2024 IWG-ELN 拟议标准的初稿随后在更广泛的国际专家群体中分发，并纳入了他们的反馈。拟议的文章包括 TDA 的新定义（研究入组前 12 周内 ≥3 个单位）和资格标准的血红蛋白阈值（女性 <10 g/dL 和男性 <11 g/dL）。修订后的文件还提供了单独的（TDA 与非 TDA）和分级（主要与次要反应）反应标准，同时保留了 12 周的筛查和观察治疗的要求。