Measuring response in solid tumors: Comparison of RECIST and WHO response criteria
Measuring response in solid tumors: Comparison of RECIST and WHO response criteria
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DOI：
10.1093/jjco/hyg093
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发表时间：
2003-10-01
影响因子：
2.4
通讯作者：
Park, K
中科院分区：
文献类型：
--
作者：
Park, JO;Lee, SI;Park, K
背景：目的肿瘤反应是日常实践和临床试验中评价抗癌药物疗效的共同终点。传统上，在这些情况下采用世界卫生组织(世卫组织)的标准。然而，最近新型抗癌药物的发展和成像技术的进步要求采用新的方法来评估治疗反应。最近，实体肿瘤组的反应评估标准(RECIST)提出了使用一维测量的新指南。从理论上讲，单个肿瘤最大直径的简单总和与细胞杀伤率的关系比二维乘积的总和更线性。为了验证这些新的指南，我们在相同的患者群体中比较了标准的WHO反应标准和新的RECIST指南。方法：对在三星医疗中心参加8项前瞻性II期研究的79名患者的数据进行回顾性重新分析，以确定两种反应标准之间的一致性。结果：符合WHO标准的总有效率为31.6%。按RECIST标准对9例患者进行了重新分类，总有效率为30.4%。在25个回答中，有23个(92%)符合一维和二维标准。总体疗效一致性的Kappa统计量为0.91。结论：新的RECIST指南在评价实体瘤的疗效方面与旧的疗效标准具有可比性。此外，新指南在日常实践中的反应测量方面与在临床试验中一样简单和可重复性。
Background: Objective tumor response is a common endpoint in daily practice as well as in clinical trials to evaluate the efficacy of anti-cancer agents. Traditionally, the standard World Health Organization (WHO) criteria has been adopted in these contexts. However, the recent development of new classes of anti-cancer agents and progress in imaging technology have required new methodology to evaluate response to treatment. Recently, the Response Evaluation Criteria in Solid Tumors Group (RECIST) proposed new guidelines using unidimensional measurement. Theoretically, the simple sum of the maximum diameters of individual tumors is more linearly related to cell kill than is the sum of the bidimensional products. To validate these new guidelines, we have compared the standard WHO response criteria with the new RECIST guidelines in the same patient population.Methods: Data from 79 patients enrolled in eight prospective phase II studies at Samsung Medical Center were retrospectively re-analyzed to determine the concordance between the two response criteria. The two response criteria were applied separately, and the results were compared using the kappa statistic to test concordance for overall response rate.Results: The overall response rate according to the WHO criteria was 31.6%. Using the RECIST criteria, nine patients were reclassified and the overall response rate was 30.4%. There was excellent agreement between the unidimensional and bidimensional criteria in 23 of 25 responses (92%). The kappa statistic for concordance for overall response was 0.91.Conclusions: We conclude that the new RECIST guidelines are comparable to the old response criteria in evaluating response in solid tumors. Moreover, the new guidelines are just as simple and reproducible in the measurement of response in daily practice as they are in clinical trials.