Effect of 5 years of CT-scan and CEA follow-up on survival endpoints in patients with colorectal cancer: the PRODIGE-13 FFCD phase III trial.

However, these recommendations are based mainly on expert opinions, while the results of the few clinical trials are controversial. Moreover, no survival benefit has been demonstrated to date.

然而，这些推荐主要基于专家意见，而少数临床试验的结果存在争议。此外，迄今为止尚未证明有任何生存益处。

patients_and_methods

PRODIGE-13 is a cooperative prospective multicentre controlled phase III trial evaluating by factorial plan the impact of (i) intensive radiological monitoring [alternating abdominal ultrasound (US)/computed tomography (CT) scan/3 months] versus standard monitoring (US/3 months and thoracic radiography/6 months) and (ii) carcinoembryonic antigen (CEA) assessment versus no assessment, in the follow-up of resected stage II or III colorectal cancer with no evidence of residual disease on baseline postsurgical investigation in France and Belgium.

PRODIGE-13 是一项合作的前瞻性多中心对照 III 期试验，通过因子设计评估了两个方面的影响：(i) 强化影像学监测（交替进行腹部超声/计算机断层扫描/每3个月一次）与标准监测（超声/每3个月一次和胸部X光片/每6个月一次）；(ii) 癌胚抗原（CEA）评估与不评估，在法国和比利时对无残留病灶的 II 或 III 期结直肠癌术后随访中的作用。

The primary endpoint was 5-year overall survival(OS).

主要终点是5年总生存（OS）。

Results

Altogether, 2009 patients were randomly assigned.

共有2009名患者被随机分配。

Among them, 16% had rectal cancer, and 44% left colon cancer; 75.9% were <75 years old.

在这些患者中，16%患有直肠癌，44%患有左半结肠癌；75.9%的患者年龄小于75岁。

With a median follow-up of 7.8 years, cancer recurred in 22.3% of patients (local 10.5%, metastatic 72.9%, both 16.6%).

中位随访时间为7.8年，22.3%的患者出现癌症复发（局部复发10.5%，远处转移72.9%，两者均有16.6%）。

The 5-year OS rates were 82.1% [95% confidence interval(CI) 78.5% to 85.2%] in group A (intensive imaging + CEA) versus 84.1% (95% CI 80.5% to 87.0%) in group B (intensive imaging alone), versus 83.6% (95% CI 80.1% to 86.6%) in group C (standard imaging + CEA) versus 79.5% (95% CI 75.7% to 82.8%) in group D (standard imaging alone) [P (log-rank) = 0.170].

5年总生存率在A组（密集影像+CEA）为82.1%（95%置信区间78.5%至85.2%），B组（仅密集影像）为84.1%（95%置信区间80.5%至87.0%），C组（标准影像+CEA）为83.6%（95%置信区间80.1%至86.6%），D组（仅标准影像）为79.5%（95%置信区间75.7%至82.8%）[P（log-rank）= 0.170]。

Median OS was not reached in the four groups.

四个组中的中位总生存期均未达到。

Five-year relapse-free survival (RFS) was 73.8% in the CT-scan surveillance group versus 69.3% in the no-CT-scan group [hazard ratio(HR) 0.89, 95% CI 0.76-1.03, P = 0.108].

CT扫描监测组的五年无复发生存率为73.8%，而无CT扫描组为69.3% [风险比（HR）0.89，95%置信区间0.76-1.03，P = 0.108]。

Five-year RFS was 71.3% in the CEA surveillance group versus 71.8% in the no-CEA group (HR 1.00, 95% CI 0.86-1.16, P = 0.959).

在CEA监测组中，5年无复发生存率为71.3%，而在无CEA组中为71.8%（HR 1.00，95%置信区间0.86-1.16，P = 0.959）。

Conclusions

Among patients with stage II or III colorectal cancer, after curative surgery, the implementation of CEA and/or CT-scan surveillance did not provide any benefit in 5-year OS for the overall population of the study.

在II期或III期结直肠癌患者中，根治性手术后，实施CEA和/或CT扫描监测并未为研究的总体人群带来5年总生存的任何益处。