Effect of 3 to 5 Years of Scheduled CEA and CT Follow-up to Detect Recurrence of Colorectal Cancer The FACS Randomized Clinical Trial
Effect of 3 to 5 Years of Scheduled CEA and CT Follow-up to Detect Recurrence of Colorectal Cancer The FACS Randomized Clinical Trial
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DOI：
10.1001/jama.2013.285718
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发表时间：
2014-01-15
影响因子：
120.7
通讯作者：
Mant, David
中科院分区：
文献类型：
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作者：
Primrose, John N.;Perera, Rafael;Mant, David
重要的结直肠癌术后强化随访是常见的做法，但基于有限的证据。目的评估定期血癌胚抗原(CEA)和计算机断层扫描(CT)作为随访对检测复发的结直肠癌的疗效。设计、设置和参与者在英国39家国家卫生服务医院进行的随机临床试验；在2003年1月至2009年8月期间招募了1202名符合条件的参与者，他们接受了原发结直肠癌的根治性手术，包括有指征的辅助治疗，在研究中没有残留疾病的证据。干预参与者被随机分配到4组中的1组：仅CEA组(n=300)、仅CT组(n=299)、CEA+CT组(n=302)或最低随访组(n=301)。连续2年每3个月测一次血CEA，连续3年每6个月测一次CEA，连续2年每6个月行一次胸部、腹部、盆腔CT扫描，连续3年每年复查一次，最低随访组在出现症状后进行随访期。结果经过平均4.4年(SD，0.8)的观察，199名参与者中发现癌症复发(16.6%；95%CI，14.5%-18.7%)；1202名参与者中有71名(5.9%；95%CI，4.6%-7.2%)接受了有治疗意图的复发治疗，根据Dukes分期(A期，5.1%[13/254])，差异无统计学意义；B阶段，6.1%[34/553]；C阶段，6.2%[22/354])。随访率最低组为2.3%(7/301)，CEA组为6.7%(20/300)，CT组为8%(24/299)，CEA+CT组为6.6%(20/302)。与最低随访期相比，CEA组有治疗意向的患者百分比的绝对差异为4.4%(95%CI，1.0%-7.9%；调整后的优势比[OR]，3.00；95%的CI，1.23-7.33)；CT组的绝对差异为5.7%(95%的CI，2.2%-9.5%；调整的OR，3.63；CEA+CT组为4.3%(95%CI，1.0%~7.9%；调整后OR为3.10；95%CI为1.10~8.71)。联合强化监测组(CEA、CT和CEA+CT；18.2%[164/901])与最少随访组(15.9%[48/301]；差异2.3%；95%CI，-2.6%~7.1%)之间的死亡人数无显著差异。结论在接受过结直肠癌根治性手术、强化成像或CEA筛查的患者中，与最少随访相比，CEA和CT联合应用均可提高手术治疗的复发率。如果任何一种战略都有生存优势，那很可能是微不足道的。
IMPORTANCE Intensive follow-up after surgery for colorectal cancer is common practice but is based on limited evidence.OBJECTIVE To assess the effect of scheduled blood measurement of carcinoembryonic antigen (CEA) and computed tomography (CT) as follow-up to detect recurrent colorectal cancer treatable with curative intent.DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial in 39 National Health Service hospitals in the United Kingdom; 1202 eligible participants were recruited between January 2003 and August 2009 who had undergone curative surgery for primary colorectal cancer, including adjuvant treatment if indicated, with no evidence of residual disease on investigation.INTERVENTIONS Participants were randomly assigned to 1 of 4 groups: CEA only (n = 300), CT only (n = 299), CEA+CT (n = 302), or minimum follow-up (n = 301). Blood CEA was measured every 3 months for 2 years, then every 6 months for 3 years; CT scans of the chest, abdomen, and pelvis were performed every 6 months for 2 years, then annually for 3 years; and the minimum follow-up group received follow-up if symptoms occurred.MAIN OUTCOMES AND MEASURES The primary outcome was surgical treatment of recurrence with curative intent; secondary outcomes were mortality (total and colorectal cancer), time to detection of recurrence, and survival after treatment of recurrence with curative intent.RESULTS After a mean 4.4 (SD, 0.8) years of observation, cancer recurrence was detected in 199 participants (16.6%; 95% CI, 14.5%-18.7%) overall; 71 of 1202 participants (5.9%; 95% CI, 4.6%-7.2%) were treated for recurrence with curative intent, with little difference according to Dukes staging (stage A, 5.1% [13/254]; stage B, 6.1% [34/553]; stage C, 6.2% [22/354]). Surgical treatment of recurrence with curative intent was 2.3% (7/301) in the minimum follow-up group, 6.7%(20/300) in the CEA group, 8%(24/299) in the CT group, and 6.6% (20/302) in the CEA+CT group. Compared with minimum follow-up, the absolute difference in the percentage of patients treated with curative intent in the CEA group was 4.4%(95% CI, 1.0%-7.9%; adjusted odds ratio [OR], 3.00; 95% CI, 1.23-7.33), in the CT groupwas 5.7% (95% CI, 2.2%-9.5%; adjusted OR, 3.63; 95% CI, 1.51-8.69), and in the CEA+CT groupwas 4.3% (95% CI, 1.0%-7.9%; adjusted OR, 3.10; 95% CI, 1.10-8.71). The number of deaths was not significantly different in the combined intensive monitoring groups (CEA, CT, and CEA+CT; 18.2% [164/901]) vs the minimum follow-up group (15.9% [48/301]; difference, 2.3%; 95% CI, -2.6% to 7.1%).CONCLUSIONS AND RELEVANCE Among patients who had undergone curative surgery for primary colorectal cancer, intensive imaging or CEA screening each provided an increased rate of surgical treatment of recurrence with curative intent compared with minimal follow-up; there was no advantage in combining CEA and CT. If there is a survival advantage to any strategy, it is likely to be small.