RECIST 1.1 - Standardisation and disease-specific adaptations: Perspectives from the RECIST Working Group.
RECIST 1.1 - Standardisation and disease-specific adaptations: Perspectives from the RECIST Working Group.
复制标题
DOI：
10.1016/j.ejca.2016.03.082
复制
发表时间：
2016-07
期刊：
影响因子：
--
通讯作者：
de Vries E
中科院分区：
文献类型：
--
作者：
Schwartz LH;Seymour L;Litière S;Ford R;Gwyther S;Mandrekar S;Shankar L;Bogaerts J;Chen A;Dancey J;Hayes W;Hodi FS;Hoekstra OS;Huang EP;Lin N;Liu Y;Therasse P;Wolchok JD;de Vries E
疾病部位的放射成像在癌症患者的管理中起着关键作用。实体瘤疗效评价标准（RECIST）于2000年推出，并于2009年修订，已成为临床试验中实体瘤患者疗效评估的事实标准。RECIST工作组认为，全球肿瘤学界及时实施和采用RECIST更新的能力至关重要。RECIST的更新必须以标准化、系统化的方式进行测试、验证和实施，以应对治疗和成像技术的进步以及用户获得的经验。RECIST 1.1的开发就是这种情况，其中开发了扩展的数据仓库来测试和验证修改。类似的计划正在进行中，在评价对非细胞毒性药物、免疫疗法以及特定疾病的反应时测试RECIST。RECIST工作组此前已概述了正式和全面验证新成像标志物作为临床试验适当终点所需的证据水平。达到所需的最佳证据水平对于III期试验来说是一项艰巨的任务;这涉及到对多个前瞻性、随机多中心临床试验的荟萃分析。还应考虑修改的基本原理;修改可能是为了改善替代性，提供更机械的成像技术，或旨在改善成像生物标志物的重现性。在这里，我们提出了通常描述的RECIST修改，每一个都与不同级别的证据和验证相关。
Radiologic imaging of disease sites plays a pivotal role in the management of patients with cancer. Response Evaluation Criteria in Solid Tumours (RECIST), introduced in 2000, and modified in 2009, has become the de facto standard for assessment of response in solid tumours in patients on clinical trials. The RECIST Working Group considers the ability of the global oncology community to implement and adopt updates to RECIST in a timely manner to be critical. Updates to RECIST must be tested, validated and implemented in a standardised, methodical manner in response to therapeutic and imaging technology advances as well as experience gained by users. This was the case with the development of RECIST 1.1, where an expanded data warehouse was developed to test and validate modifications. Similar initiatives are ongoing, testing RECIST in the evaluation of response to non-cytotoxic agents, immunotherapies, as well as in specific diseases. The RECIST Working Group has previously outlined the level of evidence considered necessary to formally and fully validate new imaging markers as an appropriate end-point for clinical trials. Achieving the optimal level of evidence desired is a difficult feat for phase III trials; this involves a meta-analysis of multiple prospective, randomised multicentre clinical trials. The rationale for modifications should also be considered; the modifications may be proposed to improve surrogacy, to provide a more mechanistic imaging technique, or be designed to improve reproducibility of the imaging biomarker. Here, we present the commonly described modifications of RECIST, each of which is associated with different levels of evidence and validation.
登录
查看更多内容
影响因子：
8.4
作者：
Liu, Yan;Litiere, Saskia;Seymour, Lesley
通讯作者：
Seymour, Lesley
影响因子：
158.5
作者：
Parker, C.;Nilsson, S.;Sartor, O.
通讯作者：
Sartor, O.
影响因子：
158.5
作者：
Scher, Howard I.;Fizazi, Karim;de Bono, Johann S.
通讯作者：
de Bono, Johann S.
影响因子：
45.3
作者：
MACDONALD, DR;CASCINO, TL;CAIRNCROSS, JG
通讯作者：
CAIRNCROSS, JG
影响因子：
8.4
作者：
Sargent, D. J.;Rubinstein, L.;Shankar, L. K.
通讯作者：
Shankar, L. K.