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

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

Int J Surg. 2024 Apr 9. doi: 10.1097/JS9.0000000000001301. Online ahead of print.

Authors

Rong-Xin Zhang^{1

2

3}, Xiao-Jun Wu^{1

2

3}, De-Sen Wan^{1

2

3}, Jun-Zhong Lin^{1

2

3}, Pei-Rong Ding^{1

2

3}, Le-En Liao^{1

2

3}, Jian Lei⁴, Zhen-Hai Lu^{1

2

3}, Li-Ren Li^{1

2

3}, Gong Chen^{1

2

3}, Ling-Heng Kong^{1

2

3}, Fu-Long Wang^{1

2

3}, Jian Zhang⁵, Wen-Hua Fan^{1

2

3}, Wu Jiang^{1

2

3}, Wen-Hao Zhou^{1

2

3}, Cong Li^{1

2

3}, Yuan Li^{1

2

3}, Xue-Ying Li^{1

2

3}, Jian-Hong Peng^{1

2

3}, Zhi-Zhong Pan^{1

2

3}

Affiliations

¹ Departments of Colorectal Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, Guangdong, P.R. China, Zip 510060.
² State Key Laboratory of Oncology in South China, Guangzhou 510060, Guangdong, People's Republic of China.
³ Collaborative Innovation Center of Cancer Medicine, Guangzhou 510060, Guangdong, People's Republic of China.
⁴ Department of General Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510060, Guangdong, People's Republic of China.
⁵ State Key Laboratory of Ophthalmology, Zhongshan Ophthalmology, Sun Yat-sen University, Guangzhou, People's Republic of China.

PMID: 38652147
DOI: 10.1097/JS9.0000000000001301

Abstract

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

Methods: We 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 actualization 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 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 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.