Effect of 5 years of CT-scan and CEA follow-up on survival endpoints in patients with colorectal cancer.

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology Pub Date : 2025-09-17 DOI:10.1016/j.annonc.2025.09.004

C Lepage, J-M Phelip, L Cany, E Barbier, S Manfredi, P Deguiral, M Laly, M Baconnier, M Jary, J-P Latrive, E Terrebonne, A Lièvre, M Jafari, M Ben Abdelghani, J-F Ain, G Breysacher, I Boillot-Benedetto, A Pelaquier, P Prost, J Ezenfis, Y Rinaldi, C Le Foll, O Berthelet, A Darut-Jouve, L Dahan, T Piche, J-P Lagasse, F Bibeau, P Laurent-Puig, O Bouché

{"title":"Effect of 5 years of CT-scan and CEA follow-up on survival endpoints in patients with colorectal cancer.","authors":"C Lepage, J-M Phelip, L Cany, E Barbier, S Manfredi, P Deguiral, M Laly, M Baconnier, M Jary, J-P Latrive, E Terrebonne, A Lièvre, M Jafari, M Ben Abdelghani, J-F Ain, G Breysacher, I Boillot-Benedetto, A Pelaquier, P Prost, J Ezenfis, Y Rinaldi, C Le Foll, O Berthelet, A Darut-Jouve, L Dahan, T Piche, J-P Lagasse, F Bibeau, P Laurent-Puig, O Bouché","doi":"10.1016/j.annonc.2025.09.004","DOIUrl":null,"url":null,"abstract":"Background: Intensive follow-up of patients after curative surgery for colorectal cancer is recommended by various scientific societies. 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.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)/CT-scan/3m) versus standard monitoring (US/3m and thoracic radiography/6m) 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 post-surgical investigation in France and Belgium. The primary endpoint was 5-year overall survival (OS).Results: Altogether, 2009 patients were randomized. Among them, 16% had rectal cancer, and 44% left colon cancer; 75.9% were less than 75 years old. 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%). The 5-year OS rates were 82.1% (95%CI [78.5;85.2]) in group A (intensive imaging + CEA) vs. 84.1% (95%CI [80.5;87.0]) in group B (intensive imaging alone), vs. 83.6%, (95%CI [80.1;86.6]) in group C (standard imaging+ CEA) vs. 79.5% (95%CI [75.7;82.8]) in group D (standard imaging alone) (p(logrank)= 0.170. Median OS was not reached in the four groups, Five-year relapse-free survival (RFS) was 73.8% in the CT-scan surveillance group vs. 69.3% in the no-CT-scan group (HR 0.89 [0.76;1.03]; p=0.108). Five-year RFS was 71.3% in the CEA surveillance group vs. 71.8% in the no-CEA group (HR 1.00 [0.86;1.16]; 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 overall survival for the overall population of the study.","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4000,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.annonc.2025.09.004","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Intensive follow-up of patients after curative surgery for colorectal cancer is recommended by various scientific societies. 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.

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)/CT-scan/3m) versus standard monitoring (US/3m and thoracic radiography/6m) 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 post-surgical investigation in France and Belgium. The primary endpoint was 5-year overall survival (OS).

Results: Altogether, 2009 patients were randomized. Among them, 16% had rectal cancer, and 44% left colon cancer; 75.9% were less than 75 years old. 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%). The 5-year OS rates were 82.1% (95%CI [78.5;85.2]) in group A (intensive imaging + CEA) vs. 84.1% (95%CI [80.5;87.0]) in group B (intensive imaging alone), vs. 83.6%, (95%CI [80.1;86.6]) in group C (standard imaging+ CEA) vs. 79.5% (95%CI [75.7;82.8]) in group D (standard imaging alone) (p(logrank)= 0.170. Median OS was not reached in the four groups, Five-year relapse-free survival (RFS) was 73.8% in the CT-scan surveillance group vs. 69.3% in the no-CT-scan group (HR 0.89 [0.76;1.03]; p=0.108). Five-year RFS was 71.3% in the CEA surveillance group vs. 71.8% in the no-CEA group (HR 1.00 [0.86;1.16]; 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 overall survival for the overall population of the study.

查看原文本刊更多论文

5年ct扫描和CEA随访对结直肠癌患者生存终点的影响。

背景：大肠癌根治性手术后患者的强化随访是各科学学会推荐的。然而，这些建议主要基于专家意见，而少数临床试验的结果是有争议的。此外，到目前为止，还没有证据表明对生存有好处。患者及方法：PRODIGE-13是一项合作的前瞻性多中心对照III期试验，通过因子计划评估1)强化放射监测（交替腹部超声（US)/ ct扫描/3m）与标准监测（US/3m和胸部x线摄影/6m）和ii）癌胚抗原（CEA）评估与不评估的影响。在法国和比利时对切除的II期或III期结直肠癌进行随访，在基线术后调查中没有残留疾病的证据。主要终点是5年总生存期（OS）。结果：共纳入2009例患者。其中16%的人患有直肠癌，44%的人患有结肠癌；75.9%年龄在75岁以下。中位随访7.8年，22.3%的患者癌症复发（局部10.5%，转移性72.9%，两者均为16.6%）。A组（强化影像+ CEA） 5年OS为82.1% (95%CI [78.5;85.2])， B组（单独强化影像）84.1% (95%CI [80.5;87.0])， C组（标准影像+ CEA） 5年OS为83.6% (95%CI [80.1;86.6])， D组（单独标准影像）5年OS为79.5% (95%CI [75.7;82.8]) （p(logrank)= 0.170）。四组患者的中位OS均未达到，ct扫描监测组5年无复发生存率（RFS）为73.8%，未扫描组为69.3% （HR 0.89 [0.76;1.03]; p=0.108）。CEA监测组5年RFS为71.3%，无CEA监测组为71.8% （HR 1.00[0.86;1.16]; 0.959）。结论：在II期或III期结直肠癌患者中，在根治性手术后，CEA和/或ct扫描监测的实施并没有为该研究的总体人群的5年总生存率提供任何益处。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Annals of Oncology 医学-肿瘤学

CiteScore

63.90

自引率

1.00%

发文量

3712

审稿时长

2-3 weeks

期刊介绍： Annals of Oncology, the official journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, offers rapid and efficient peer-reviewed publications on innovative cancer treatments and translational research in oncology and precision medicine. The journal primarily focuses on areas such as systemic anticancer therapy, with a specific emphasis on molecular targeted agents and new immune therapies. We also welcome randomized trials, including negative results, as well as top-level guidelines. Additionally, we encourage submissions in emerging fields that are crucial to personalized medicine, such as molecular pathology, bioinformatics, modern statistics, and biotechnologies. Manuscripts related to radiotherapy, surgery, and pediatrics will be considered if they demonstrate a clear interaction with any of the aforementioned fields or if they present groundbreaking findings. Our international editorial board comprises renowned experts who are leaders in their respective fields. Through Annals of Oncology, we strive to provide the most effective communication on the dynamic and ever-evolving global oncology landscape.