Ahn S H, Garewal H S, Dragovich T
Department of Medicine, Section of Hematology-Oncology, University of Arizona, Tucson, AZ 85724, USA.
J BUON. 2008 Jul-Sep;13(3):359-62.
The Response Evaluation Criteria in Solid Tumors (RECIST) have largely replaced the World Health Organization (WHO) criteria as a preferred method for assessing tumor response in clinical trials. We hypothesized that due to frequent asymmetric growth pattern, as well as somewhat diffuse margins of pancreatic cancer, the use of WHO vs. RECIST criteria may result in significantly different tumor response assessments. The purpose of this retrospective study was to compare the WHO (bidimensional) to RECIST (unidimensional) in assessing treatment response in pancreatic cancer patients enrolled in clinical trials.
We have evaluated the contrast- enhanced computed tomography (CT) images from 12 pancreatic cancer patients with measurable disease enrolled in two phase I/II clinical trials at the Arizona Cancer Center, between July 2000 and July 2003. The tumor measurements were re-calculated by RECIST and WHO criteria and were compared.
In 3 out of the 12 patients (25%) there was discordant response categorization when WHO criteria were used instead of RECIST. Clinical presentations in all 3 patients were more consistent with WHO categorization.
Our retrospective data analysis suggests that use of different tumor response criteria (RECIST vs. WHO) may result in different assessments of treatment efficacy in patients with pancreatic cancer on clinical trials. This finding warrants further confirmation in a larger prospectively designed trial.
实体瘤疗效评价标准（RECIST）已在很大程度上取代了世界卫生组织（WHO）的标准，成为临床试验中评估肿瘤反应的首选方法。我们推测，由于胰腺癌常见的不对称生长模式以及其边界略显弥散，使用WHO标准与RECIST标准可能会导致肿瘤反应评估结果存在显著差异。这项回顾性研究的目的是比较WHO（二维）与RECIST（一维）标准在评估参加临床试验的胰腺癌患者治疗反应中的差异。
我们评估了2000年7月至2003年7月期间在亚利桑那癌症中心参加两项I/II期临床试验的12例患有可测量病灶的胰腺癌患者的增强计算机断层扫描（CT）图像。按照RECIST和WHO标准重新计算肿瘤测量值并进行比较。
12例患者中有3例（25%）在使用WHO标准而非RECIST标准时出现了反应分类不一致的情况。所有3例患者的临床表现与WHO分类更为一致。
我们的回顾性数据分析表明，在临床试验中，使用不同的肿瘤反应标准（RECIST与WHO）可能会导致对胰腺癌患者治疗疗效的评估结果不同。这一发现有待在更大规模的前瞻性设计试验中进一步证实。
