Park Joon Oh, Lee Soon Il, Song Seo Young, Kim Kihyun, Kim Won Seog, Jung Chul Won, Park Young Suk, Im Young-Hyuk, Kang Won Ki, Lee Mark Hong, Lee Kyung Soo, Park Keunchil
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Jpn J Clin Oncol. 2003 Oct;33(10):533-7. doi: 10.1093/jjco/hyg093.
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.
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.
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.
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.
客观肿瘤反应是日常实践以及临床试验中评估抗癌药物疗效的常用终点指标。传统上，这些情况下采用的是世界卫生组织（WHO）的标准标准。然而，新型抗癌药物的不断发展以及成像技术的进步，需要新的方法来评估治疗反应。最近，实体瘤反应评估标准（RECIST）小组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的线性关系比二维乘积的总和更强。为了验证这些新指南，我们在同一患者群体中比较了WHO标准反应标准与新的RECIST指南。
回顾性重新分析了三星医疗中心八项前瞻性II期研究中79例患者的数据，以确定两种反应标准之间的一致性。分别应用两种反应标准，并使用kappa统计量比较结果，以检验总体反应率的一致性。
根据WHO标准，总体反应率为31.6%。使用RECIST标准，9例患者被重新分类，总体反应率为30.4%。25例反应中有23例（92%）的一维和二维标准之间具有极好的一致性。总体反应一致性的kappa统计量为0.91。
我们得出结论，新的RECIST指南在评估实体瘤反应方面与旧的反应标准相当。此外，新指南在日常实践中测量反应时与在临床试验中一样简单且可重复。
