Measuring response in solid tumors: Unidimensional versus bidimensional measurement
Measuring response in solid tumors: Unidimensional versus bidimensional measurement
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DOI：
10.1093/jnci/91.6.523
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发表时间：
1999-03-17
期刊：
影响因子：
--
通讯作者：
Therasse, P
中科院分区：
文献类型：
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作者：
James, K;Eisenhauer, E;Therasse, P
背景：肿瘤缩小是筛选新型细胞毒性药物的常见终点。部分缓解的标准世界卫生组织标准是单个肿瘤的两个测量值（肿瘤的最大直径和垂直于该最大直径的最大直径）的乘积之和减少50%或更多。然而，理论上，单个肿瘤的最大直径的简单和与细胞杀伤的线性相关性比二维乘积的和更高。已经假设二维乘积的计算是不必要的，并且提出单个肿瘤的最大直径总和减少30%（假设球形并且等同于二维乘积总和减少50%）作为新标准。我们将标准缓解和新缓解标准应用于相同数据，以确定是否会在相同患者中产生相同数量的缓解。方法：对8项不同癌症研究中的569例患者的数据进行重新分析。分别应用两个响应标准，并使用kappa统计量比较结果。验证性测量的重要性和非球形肿瘤的频率也进行了检查。此外，对于128例患者的子集，应用疾病进展的一维标准（最大直径总和增加30%），并与二维乘积总和增加25%的标准定义进行比较。结果：一维和二维标准之间的协议一般被认为是好的。总体缓解一致性的kappa统计量为0.95。结论：我们得出结论，肿瘤最大直径的一维测量可能足以评估实体肿瘤的变化。
Background: Tumor shrinkage is a common end point used in screening new cytotoxic agents. The standard World Health Organization criterion for partial response is a 50% or more decrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of individual tumors. However, 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. It has been hypothesized that the calculation of bidimensional products is unnecessary, and a 30% decrease in the sum of maximum diameters of individual tumors (assuming spherical shape and equivalence to a 50% reduction in the sum of the bidimensional products) was proposed as a new criterion. We have applied the standard response and the new response criteria to the same data to determine whether the same number of responses in the same patients would result. Methods: Data from 569 patients included in eight studies of a variety of cancers were reanalyzed. The two response criteria were separately applied, and the results were compared using the kappa statistic. The importance of confirmatory measurements and the frequency of nonspherical tumors were also examined. In addition, for a subset of 128 patients, a unidimensional criterion for disease progression (30% increase in the sum of maximum diameters) was applied and compared with the standard definition of a 25% increase in the sum of the bidimensional products. Results: Agreement between the unidimensional and bidimensional criteria was generally found to be good. The kappa statistic for concordance for overall response was 0.95. Conclusion: We conclude that one dimensional measurement of tumor maximum diameter may be sufficient to assess change in solid tumors.