Merck Research Laboratories, West Point, PA, USA.
Transl Oncol. 2012 Feb;5(1):19-25. doi: 10.1593/tlo.11232. Epub 2012 Feb 1.
This study was designed to characterize the reproducibility of measurement for tumor volumes and their longest tumor diameters (LDs) and estimate the potential impact of using changes in tumor volumes instead of LDs as the basis for response assessments.
We studied patients with advanced lung cancer who have been observed longitudinally with x-ray computed tomography in a multinational trial. A total of 71 time points from 10 patients with 13 morphologically complex target lesions were analyzed. A total of 6461 volume measurements and their corresponding LDs were made by seven independent teams using their own work flows and image analysis tools. Interteam agreement and overall interrater concurrence were characterized.
Interteam agreement between volume measurements was better than between LD measurements (ı = 0.945 vs 0.734, P = .005). The variability in determining the nadir was lower for volumes than for LDs (P = .005). Use of standard thresholds for the RECIST-based method and use of experimentally determined cutoffs for categorizing responses showed that volume measurements had a significantly greater sensitivity for detecting partial responses and disease progression. Earlier detection of progression would have led to earlier changes in patient management in most cases.
Our findings indicate that measurement of changes in tumor volumes is adequately reproducible. Using tumor volumes as the basis for response assessments could have a positive impact on both patient management and clinical trials. More authoritative work to qualify or discard changes in volume as the basis for response assessments should proceed.
本研究旨在描述肿瘤体积及其最长径(LD)测量的可重复性,并评估使用肿瘤体积变化代替 LD 作为反应评估基础的潜在影响。
我们对在一项多国试验中通过 X 射线计算机断层扫描进行纵向观察的晚期肺癌患者进行了研究。对 10 名患者的 13 个形态复杂的靶病变进行了 71 个时间点的分析。共有 7 个独立团队使用自己的工作流程和图像分析工具,对 6461 次体积测量及其相应的 LD 进行了测量。对体积测量的组间一致性和总体组内一致性进行了描述。
体积测量的组间一致性优于 LD 测量(ı=0.945 与 0.734,P=0.005)。确定最低点的可变性,体积比 LD 小(P=0.005)。使用 RECIST 基于方法的标准阈值和实验确定的分类反应截止值表明,体积测量对检测部分反应和疾病进展具有更高的敏感性。在大多数情况下,更早地检测到进展将导致更早地改变患者的管理。
我们的研究结果表明,肿瘤体积变化的测量具有足够的可重复性。使用肿瘤体积作为反应评估的基础,可能对患者管理和临床试验都产生积极影响。应进行更权威的工作,以确定或排除体积变化作为反应评估的基础。