摘要
统一的疗效评价标准在淋巴瘤新药的临床研究中至关重要,有可比性的研究结果有助于监管部门的审批。自2007年开始,含PET(PET-CT)的淋巴瘤疗效评价标准使淋巴瘤的分期和疗效评价更为精确,并广泛应用于临床研究中。然而,由于淋巴瘤的异质性特点,临床研究中使用统一的评价标准仍然会产生一些争议。因此,本文将从淋巴瘤疗效评价标准的变迁,临床研究中的应用以及常见问题作一综述。
Uniformly adopted response criteria are crucial for the design and implementation of lymphoma novel drug clinical studies, conducing to reviewing and approval by health authority with its comparability. From 2007, the criteria incorporating PET (PET-CT) has been widely used in lymphoma clinical studies, for accurate staging and assessing of lymphomas. Nonetheless, the heterogeneity of lymphomas has been presenting a few of critical controversies regarding its optimal use in practice. Thus, the aim of this paper is to review the trajectory of lymphoma response criteria, the adoption in lymphoma studies, and the common questions.
作者
徐应永
XU Yingyong(Department of Clinical R&D,Celgene Corporation,Shanghai 200020,China)
出处
《临床肿瘤学杂志》
CAS
北大核心
2019年第3期256-261,共6页
Chinese Clinical Oncology
关键词
淋巴瘤
临床研究
疗效评价
Lymphoma
Clinical study
Response criteria
