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

• Published in: International journal of surgery (London, England)
• Main Authors: Zhang, Rong-Xin, Wu, Xiao-Jun, Wan, De-Sen, Lin, Jun-Zhong, Ding, Pei-Rong, Liao, Le-En, Lei, Jian, Lu, Zhen-Hai, Li, Li-Ren, Chen, Gong, Kong, Ling-Heng, Wang, Fu-Long, Zhang, Jian, Fan, Wen-Hua, Jiang, Wu, Zhou, Wen-Hao, Li, Cong, Li, Yuan, Li, Xue-Ying, Peng, Jian-Hong, Pan, Zhi-Zhong
• Format: Journal Article
• Language: English
• Published: United States 09.04.2024
• ISSN: 1743-9159; 1743-9159
• DOI: 10.1097/JS9.0000000000001301

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