标准化辅助结肠癌试验中的数据收集:IDEA 和 ACCENT 国际联盟和国家专家的共识项目。
Standardizing data collection in adjuvant colon cancer trials: A consensus project from the IDEA and ACCENT international consortia and national experts.
发表日期:2024 May 15
作者:
Julien Taieb, Debora Basile, Jenny Seligmann, Guillem Argiles, Thierry André, Claire Gallois, Richard M Goldberg, Greg Yothers, Alberto Sobrero, Jeffrey A Meyerhardt, John Souglakos, Roberto Labianca, Tim Iveson, David N Church, Dirk Arnold, Jeanne Tie, Sharlene Gill, Pierre Laurent-Puig, Takayuki Yoshino, Sara Lonardi, Qian Shi
来源:
MOLECULAR & CELLULAR PROTEOMICS
摘要:
尽管最近的临床试验做出了贡献,但辅助结肠癌(CC)的一些问题和挑战仍未解决。因此,应该计划进一步的研究,以更好地完善风险评估,并在辅助环境中建立最佳治疗策略。然而,有必要要求充分的、当代的和相关的变量,并均匀地报告它们,以便在分析其预后价值时带来最大的信息。该项目的设计是为了获得参与第二阶段的规划、应计和分析的专家的共识。 III CC 临床试验,以确定强制性和推荐的基线变量,以便 i) 协调全球范围内专门用于 CC 辅助治疗的临床试验的未来数据收集; ii) 为此类情况下临床试验中使用的病例报告表提出指南。总共72个与辅助临床试验中应报告的变量以及如何报告这些变量相关的问题获得批准,然后由小组成员投票达成最终共识。有关患者相关因素、组织病理学特征、分子概况、循环生物标志物的数据项整个专家组对血液分析进行了分析和讨论。对于每个项目,我们都会报告支持所达成的共识和讨论的相关问题的数据。对于已切除的 III 期患者,有 19 项被认为是强制性的,对于已切除的 II 期患者,有 24 项被认为是强制性的。此外,分别有9个和4个项目被判断为III期和II期推荐。我们认为,随着研究小组设计未来辅助结肠癌领域的临床试验,这28个变量应该在更全面的CRF中使用和统一报告.版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。
Despite contributions provided by the recent clinical trials, several issues and challenges still remain unsolved in adjuvant colon cancer (CC). Hence, further studies should be planned to better refine risk assessment as well as to establish the optimal treatment strategy in the adjuvant setting. However, it is necessary to request adequate, contemporary and relevant variables and report them homogeneously in order to bring maximal information when analyzing their prognostic value.The project was devised to gain a consensus from experts engaged in the planning, accrual and analyses of stage II and III CC clinical trials, to identify mandatory and recommended baseline variables in order to i) harmonize future data collection worldwide in clinical trials dedicated to adjuvant treatment of CC; ii) propose guidance for Case Report Forms to be used for clinical trials in this setting. A total of 72 questions related to variables that should be reported and how to report them in adjuvant clinical trials were approved and then voted to reach a final consensus from panelists.Data items on patient-related factors, histopathological features, molecular profile, circulating biomarkers and blood analyses were analyzed and discussed by the whole expert panel. For each item, we report data supporting the acquired consensus and the relevant issues that were discussed. Nineteen items were deemed to be mandatory for resected stage III patients and 24 for resected stage II disease. In addition, 9 and 4 items were judged as recommended for stage III and II, respectively.In our opinion, these 28 variables should be used and uniformly reported in more comprehensive CRFs as research groups design future clinical trials in the field of adjuvant colon cancer.Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.