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Clinical Trial
. 2024 Oct 1;110(10):6622-6631.
doi: 10.1097/JS9.0000000000001301.

Long-term outcomes of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection (IOCCRC): a randomized, multicenter, prospective, phase III trial

Rong-Xin Zhang  1 , Xiao-Jun Wu  1 , De-Sen Wan  1 , Jun-Zhong Lin  1 , Pei-Rong Ding  1 , Le-En Liao  1 , Jian Lei  2 , Zhen-Hai Lu  1 , Li-Ren Li  1 , Gong Chen  1 , Ling-Heng Kong  1 , Fu-Long Wang  1 , Jian Zhang  3 , Wen-Hua Fan  1 , Wu Jiang  1 , Wen-Hao Zhou  1 , Cong Li  1 , Yuan Li  1 , Xue-Ying Li  1 , Jian-Hong Peng  1 , Zhi-Zhong Pan  1
Affiliations
Clinical Trial

Long-term outcomes of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection (IOCCRC): a randomized, multicenter, prospective, phase III trial

Rong-Xin Zhang et al. Int J Surg. .

Abstract

Background: The authors aimed to compare combined intraoperative chemotherapy and surgical resection with curative surgical resection alone in colorectal cancer patients.

Methods: The authors performed a multicenter, open-label, randomized, phase III trial. All eligible patients were randomized and assigned to intraoperative chemotherapy and curative surgical resection or curative surgical resection alone (1:1). Survival after long-term follow-up was performed in patients analyzed on an intention-to-treat basis.

Results: From January 2011 to January 2016, 696 colorectal cancer patients were enrolled and randomly assigned to intraoperative chemotherapy and radical surgical resection ( n =341) or curative surgical resection alone ( n =344). Intraoperative chemotherapy with surgical resection showed no significant survival benefit over surgical resection alone in colorectal cancer patients [3-year disease-free survival (DFS): 91.1 vs. 90.0%, P =0.328; 3-year OS: 94.4 vs. 95.9%, P =0.756). However, colon cancer patients benefitted from intraoperative chemotherapy, with a relative 4% reduction in liver and peritoneal metastasis (HR=0.336, 95% CI: 0.148-0.759, P =0.015) and a 6.5% improvement in 3-year DFS (HR=0.579, 95% CI: 0.353-0.949, P =0.032). Meanwhile, patients with colon cancer and abnormal pretreatment carcinoembryonic antigen (CEA) levels achieved significant survival benefits from intraoperative chemotherapy (DFS: HR=0.464, 95% CI: 0.233-0.921, P =0.029 and OS: HR=0.476, 95% CI: 0.223-1.017, P =0.049).

Conclusions: Intraoperative chemotherapy showed no significant extra prognostic benefit in total colorectal cancer patients who underwent radical surgical resection; however, in colon cancer patients with abnormal pretreatment serum CEA levels (> 5 ng/ml), intraoperative chemotherapy could improve long-term survival.

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Conflict of interest statement

All the other authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Flow chart of the intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection (IOCCRC) study.
Figure 2
Figure 2
(A) Disease-free survival of all patients with number at risk; (B) Overall survival of all patients with number at risk. HR, hazard ratio.
Figure 3
Figure 3
Forest plot of disease-free survival (A) and overall survival (B) in the intraoperative chemotherapy and control groups in stratification analyses. CEA, carcinoembryonic antigen; CA, glucoprotein antigen; HR, hazard ratio; MMR, mismatch repair; pMMR, mismatch repair proficiency; dMMR, mismatch repair deficiency.
Figure 4
Figure 4
(A) Cumulative hazard of liver and peritoneum metastasis in all patients; (B) Cumulative hazard of liver and peritoneum metastasis in colon cancer patients; (C) Cumulative hazard of liver and peritoneum metastasis in rectal cancer patients. HR, hazard ratio.
Figure 5
Figure 5
(A) Disease-free survival of colon cancer patients; (B) Overall survival of colon cancer patients. (C) Disease-free survival of colon cancer patients with abnormal CEA levels; (D) Overall survival of colon cancer patients with abnormal CEA levels. HR, hazard ratio.
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