Objectives: To compare the feasibility and reliability of manual versus software-assisted assessments of computed tomography scans according to iRECIST in patients undergoing immune-based cancer treatment. Methods: Computed tomography scans of 30 tumor patients undergoing cancer treatment were evaluated by four independent radiologists at baseline (BL) and two follow-ups (FU), resulting in a total of 360 tumor assessments (120 each at BL/FU1/FU2). After image interpretation, tumor burden and response status were either calculated manually or semi-automatically as defined by software, respectively. The reading time, calculated sum of longest diameter (SLD), and tumor response (e.g., “iStable Disease”) were determined for each assessment. After complete data collection, a consensus reading among the four readers was performed to establish a reference standard for the correct response assignments. The reading times, error rates, and inter-reader agreement on SLDs were statistically compared between the manual versus software-assisted approaches. Results: The reading time was significantly longer for the manual versus software-assisted assessments at both follow-ups (median [interquartile range] FU1: 4.00 min [2.17 min] vs. 2.50 min [1.00 min]; FU2: 3.75 min [1.88 min] vs. 2.00 min [1.50 min]; bothp< 0.001). Regarding reliability, 2.5% of all the response assessments were incorrect at FU1 (3.3% manual; 0% software-assisted), which increased to 5.8% at FU2 (10% manual; 1.7% software-assisted), demonstrating higher error rates for manual readings. Quantitative SLD inter-reader agreement was inferior for the manual compared to the software-assisted assessments at both FUs (FU1: ICC = 0.91 vs. 0.93; FU2: ICC = 0.75 vs. 0.86). Conclusions: Software-assisted assessments may facilitate the iRECIST response evaluation of cancer patients in clinical routine by decreasing the reading time and reducing response misclassifications.
目的：比较在接受免疫治疗的肿瘤患者中，依据iRECIST标准进行计算机断层扫描评估时，人工测量与软件辅助测量的可行性与可靠性。方法：由四位独立放射科医师对30例接受治疗的肿瘤患者基线期及两次随访期的CT扫描图像进行评估，共完成360次肿瘤评估（基线期、随访1、随访2各120次）。图像判读后，分别通过人工计算和软件半自动计算方式测定肿瘤负荷及反应状态。每次评估均记录阅片时间、最长径总和及肿瘤反应（如“i疾病稳定”）。数据收集完成后，四位医师进行共识阅片以建立正确反应判定的参考标准。对人工与软件辅助两种方法的阅片时间、错误率及最长径总和的阅片者间一致性进行统计学比较。结果：两次随访评估中，人工测量的阅片时间均显著长于软件辅助测量（随访1中位数[四分位距]：4.00分钟[2.17分钟] vs 2.50分钟[1.00分钟]；随访2：3.75分钟[1.88分钟] vs 2.00分钟[1.50分钟]；p值均<0.001）。在可靠性方面，随访1期总反应评估错误率为2.5%（人工3.3%，软件辅助0%），随访2期升至5.8%（人工10%，软件辅助1.7%），显示人工测量的错误率更高。两次随访评估中，人工测量的最长径总和阅片者间一致性均低于软件辅助测量（随访1：组内相关系数0.91 vs 0.93；随访2：0.75 vs 0.86）。结论：软件辅助评估可通过缩短阅片时间、减少反应误判，为临床常规工作中肿瘤患者的iRECIST反应评估提供便利。
肿瘤(癌症)患者之家