The diagnostic accuracy of a single CEA blood test in detecting colorectal cancer recurrence: Results from the FACS trial.
The diagnostic accuracy of a single CEA blood test in detecting colorectal cancer recurrence: Results from the FACS trial.
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DOI：
10.1371/journal.pone.0171810
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发表时间：
2017
期刊：
影响因子：
3.7
通讯作者：
Mant D
中科院分区：
文献类型：
--
作者：
Shinkins B;Nicholson BD;Primrose J;Perera R;James T;Pugh S;Mant D
评价单次CEA（癌胚抗原）血液检测在检测结直肠癌复发中的诊断准确性。接受原发性结直肠癌根治性切除术的患者通常随访5年，定期进行CEA检测。决定进一步调查（通常通过CT成像）是基于单一的测试结果，反映国际准则。对来自FACS试验的数据进行二次分析（两组包括CEA检测）。应用的复合参考标准包括CT-CAP成像、临床评估和结肠镜检查。根据敏感性、特异性、似然比、预测值、ROC曲线下时间依赖性面积和在临床实践中前瞻性使用时的操作性能，评估了检测复发的准确性。在582例患者中，104例（17.9%）在5年随访期间复发。应用推荐阈值5μg/L最多可达到50.0%的灵敏度（95% CI：40.1-59.9%）;在临床实践中的前瞻性使用中，将导致56例复发漏诊（53.8%; 95% CI：44.2-64.4%）和89例假警报（157例转诊患者中的56.7%）。应用较低的阈值2.5μg/L将使漏诊复发的数量减少至36.5%（95% CI：26.5-46.5%），但将使假警报增加至84.2%（924/1097例转诊）。有些患者比其他患者更容易出现错误警报-在5μg/L阈值下，89次不必要的调查集中在29个个体中。我们的研究结果表明CEA的敏感性非常低，这使得人们质疑它是否可以作为一个独立的分类测试。由于工作量和产生的假警报，通过降低推荐的动作阈值来提高单个测试结果的诊断性能是不可行的。目前的国家和国际指南值得重新评估，并应进一步评估改善性能的选项，例如根据CEA趋势做出临床决策。
To evaluate the diagnostic accuracy of a single CEA (carcinoembryonic antigen) blood test in detecting colorectal cancer recurrence. Patients who have undergone curative resection for primary colorectal cancer are typically followed up with scheduled CEA testing for 5 years. Decisions to investigate further (usually by CT imaging) are based on single test results, reflecting international guidelines. A secondary analysis was undertaken of data from the FACS trial (two arms included CEA testing). The composite reference standard applied included CT-CAP imaging, clinical assessment and colonoscopy. Accuracy in detecting recurrence was evaluated in terms of sensitivity, specificity, likelihood ratios, predictive values, time-dependent area under the ROC curves, and operational performance when used prospectively in clinical practice are reported. Of 582 patients, 104 (17.9%) developed recurrence during the 5 year follow-up period. Applying the recommended threshold of 5μg/L achieves at best 50.0% sensitivity (95% CI: 40.1–59.9%); in prospective use in clinical practice it would lead to 56 missed recurrences (53.8%; 95% CI: 44.2–64.4%) and 89 false alarms (56.7% of 157 patients referred for investigation). Applying a lower threshold of 2.5μg/L would reduce the number of missed recurrences to 36.5% (95% CI: 26.5–46.5%) but would increase the false alarms to 84.2% (924/1097 referred). Some patients are more prone to false alarms than others—at the 5μg/L threshold, the 89 episodes of unnecessary investigation were clustered in 29 individuals. Our results demonstrated very low sensitivity for CEA, bringing to question whether it could ever be used as an independent triage test. It is not feasible to improve the diagnostic performance of a single test result by reducing the recommended action threshold because of the workload and false alarms generated. Current national and international guidelines merit re-evaluation and options to improve performance, such as making clinical decisions on the basis of CEA trend, should be further assessed.