实体瘤疗效评估标准 (RECIST) 基于这样的假设：靶病灶选择是客观的，并且代表治疗期间总肿瘤负荷 (TTB) 的变化。设计了一个计算机模拟模型来挑战这一假设，重点关注主观性的一个特定方面：目标病变选择。读者之间的分歧以及个别读者测量结果和 TTB 之间的分歧被分析为病变总数、受影响器官、当病变数量增加、病变集中在少数器官上、以及病变生长接近进行性疾病和部分缓解的阈值时，分歧就会增加。通过 RECIST 1.1 估计 TTB 存在固有的方法学错误，该错误取决于病变的数量及其分布。例如，对于固定数量的 5 个和 15 个病变，分布在最多 4 个器官上，观察到的错误率分别为 7.8% 和 17.3%。我们的结果表明，RECIST 可以准确估计 TTB局部疾病，但在远端转移和多器官受累的情况下失败。 “最大病变的选择”使这种情况变得更糟，它引入了偏差，使得几乎不可能对 TTB 进行准确的估计。在肿瘤负荷的定量分析中包括更多（如果不是全部）病变是可取的。版权所有 © 2023 作者。由 Wolters Kluwer Health, Inc. 出版

Response Evaluation Criteria in Solid Tumors (RECIST) is grounded on the assumption that target lesion selection is objective and representative of the change in total tumor burden (TTB) during therapy. A computer simulation model was designed to challenge this assumption, focusing on a particular aspect of subjectivity: target lesion selection.Disagreement among readers and the disagreement between individual reader measurements and TTB were analyzed as a function of the total number of lesions, affected organs, and lesion growth.Disagreement rises when the number of lesions increases, when lesions are concentrated on a few organs, and when lesion growth borders the thresholds of progressive disease and partial response. There is an intrinsic methodological error in the estimation of TTB via RECIST 1.1, which depends on the number of lesions and their distributions. For example, for a fixed number of lesions at 5 and 15, distributed over a maximum of 4 organs, the error rates are observed to be 7.8% and 17.3%, respectively.Our results demonstrate that RECIST can deliver an accurate estimate of TTB in localized disease, but fails in cases of distal metastases and multiple organ involvement. This is worsened by the "selection of the largest lesions," which introduces a bias that makes it hardly possible to perform an accurate estimate of the TTB. Including more (if not all) lesions in the quantitative analysis of tumor burden is desirable.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.