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FACS 随机临床试验中用于诊断结直肠癌复发的血清癌胚抗原趋势。

Serum carcinoembryonic antigen trends for diagnosing colorectal cancer recurrence in the FACS randomized clinical trial.

机构信息

Test Evaluation Group, Academic Unit of Health Economics, University of Leeds, Leeds, UK.

University Surgery, University of Southampton, Southampton, UK.

出版信息

Br J Surg. 2018 May;105(6):658-662. doi: 10.1002/bjs.10819. Epub 2018 Mar 26.

Abstract

BACKGROUND

Most guidelines recommend that patients who have undergone curative resection for primary colorectal cancer are followed up for 5 years with regular blood carcinoembryonic antigen (CEA) tests to trigger further investigation for recurrence. However, CEA may miss recurrences, or patients may have false alarms and undergo unnecessary investigation.

METHODS

The diagnostic accuracy of trends in CEA measurements for recurrent colorectal cancer, taken as part of the FACS (Follow-up After Colorectal Surgery) trial (2003-2014), were analysed. Investigation to detect recurrence was triggered by clinical symptoms, scheduled CT or colonoscopy, or a CEA level of at least 7 μg/l above baseline. Time-dependent receiver operating characteristic (ROC) curve analysis was used to compare the diagnostic accuracy of CEA trends with single measurements. CEA trends were estimated using linear regression.

RESULTS

The area under the ROC curve (AUC) for CEA trend was at least 0·820 across all 5 years of follow-up. In comparison, the AUCs for single measurements ranged from 0·623 to 0·749. Improvement was most marked at the end of the first year of follow-up, with the AUC increasing from 0·623 (95 per cent c.i. 0·509 to 0·736) to 0·880 (0·814 to 0·947). However, no individual trend threshold achieved a sensitivity above 70 per cent (30 per cent missed recurrences).

CONCLUSION

Interpreting trends in CEA measurements instead of single CEA test results improves diagnostic accuracy for recurrence, but not sufficiently to warrant it being used as a single surveillance strategy to trigger further investigation. In the absence of a more accurate biomarker, monitoring trends in CEA should be combined with clinical, endoscopic and imaging surveillance for improved accuracy.

摘要

背景

大多数指南建议,接受原发性结直肠癌根治性切除术的患者应在 5 年内定期进行血液癌胚抗原(CEA)检测,以触发进一步的复发检查。然而,CEA 可能会漏掉复发,或者患者可能会出现假警报并进行不必要的检查。

方法

分析了 FACS(结直肠手术后随访)试验(2003-2014 年)中部分患者 CEA 测量值趋势作为复发结直肠癌的诊断准确性。通过临床症状、计划进行 CT 或结肠镜检查或 CEA 水平比基线升高至少 7μg/l 来触发复发检测。使用时间依赖性接受者操作特征(ROC)曲线分析比较 CEA 趋势与单次测量的诊断准确性。CEA 趋势使用线性回归进行估计。

结果

在整个 5 年随访期间,ROC 曲线下面积(AUC)对于 CEA 趋势至少为 0.820。相比之下,单次测量的 AUC 范围为 0.623 至 0.749。在随访的第一年结束时,改善最为明显,AUC 从 0.623(95%置信区间 0.509 至 0.736)增加到 0.880(0.814 至 0.947)。然而,没有单个趋势阈值的灵敏度超过 70%(30%的复发被漏掉)。

结论

解读 CEA 测量值的趋势而不是单次 CEA 测试结果可以提高复发的诊断准确性,但不足以使其成为触发进一步检查的单一监测策略。在缺乏更准确的生物标志物的情况下,监测 CEA 的趋势应与临床、内镜和影像学监测相结合,以提高准确性。

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