Comparative Effectiveness of Tumor Response Assessment Methods: Standard of Care Versus Computer-Assisted Response Evaluation
Comparative Effectiveness of Tumor Response Assessment Methods: Standard of Care Versus Computer-Assisted Response Evaluation
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DOI：
10.1200/cci.17.00026
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发表时间：
2017-01-01
影响因子：
4.2
通讯作者：
Smith, Andrew D.
中科院分区：
文献类型：
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作者：
Allen, Brian C.;Florez, Edward;Smith, Andrew D.
目的比较计算机辅助CT与手工方法评估转移性肿瘤反应的有效性。材料与方法在这项机构审查委员会批准的符合健康保险携带和责任法案的回顾性研究中，来自10个不同机构的11名阅片人根据三种不同的治疗反应标准，使用配对的基线和初始治疗后反应对肿瘤反应进行独立分类。治疗计算机断层扫描研究，从20例随机选择的转移性肾细胞癌患者接受舒尼替尼治疗，作为已完成的III期多机构研究的一部分。采用手动肿瘤缓解评价方法（标准治疗）和计算机辅助缓解评价（CARE）评价图像，包括逐步指导、交互式错误识别和纠正方法、自动肿瘤度量提取、计算、缓解分类以及数据和图像存档。交叉设计、患者随机化和2周洗脱期用于减少回忆偏倚。比较有效性指标包括错误率和平均患者评估时间。结果平均而言，标准治疗方法与30.5%（6.1/20）的患者中的一个或多个错误相关，而CARE的错误率为0.0%（0.0/20）（P< .001）。最常见的错误与数据传输和算术计算有关。在发生错误的患者中，错误类型的中位数为1（范围，1 - 3）。CARE的平均患者评估时间是标准治疗方法的两倍（6.4分钟对13.1分钟; P <0.001）。结论CARE减少了错误和评估时间，这表明总体有效性优于目前标准治疗的手动肿瘤反应评估方法。(C)2017年美国临床肿瘤学会
Purpose To compare the effectiveness of metastatic tumor response evaluation with computed tomography using computer-assisted versus manual methods.Materials and Methods In this institutional review board-approved, Health Insurance Portability and Accountability Act-compliant retrospective study, 11 readers from 10 different institutions independently categorized tumor response according to three different therapeutic response criteria by using paired baseline and initial post-therapy computed tomography studies from 20 randomly selected patients with metastatic renal cell carcinoma who were treated with sunitinib as part of a completed phase III multi-institutional study. Images were evaluated with a manual tumor response evaluation method (standard of care) and with computer-assisted response evaluation (CARE) that included stepwise guidance, interactive error identification and correction methods, automated tumor metric extraction, calculations, response categorization, and data and image archiving. A crossover design, patient randomization, and 2-week washout period were used to reduce recall bias. Comparative effectiveness metrics included error rate and mean patient evaluation time.Results The standard-of-care method, on average, was associated with one or more errors in 30.5% (6.1 of 20) of patients, whereas CARE had a 0.0% (0.0 of 20) error rate (P< .001). The most common errors were related to data transfer and arithmetic calculation. In patients with errors, the median number of error types was 1 (range, 1 to 3). Mean patient evaluation time with CARE was twice as fast as the standard-of-care method (6.4 minutes v 13.1 minutes; P < .001).Conclusion CARE reduced errors and time of evaluation, which indicated better overall effectiveness than manual tumor response evaluation methods that are the current standard of care. (C) 2017 by American Society of Clinical Oncology