89O - Long-term outcomes of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection (IOCCRC): A randomized, multicenter, prospective, phase III trial

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 ([1] 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 = 0.573, 95% CI: 0.345-0.953, P = 0.032).[2] 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.

Clinical trial identification

NCT01465451.

Editorial acknowledgement

Legal entity responsible for the study

Sun Yat-sen University Cancer Center.

Funding

Sun Yat-sen University.

Disclosure

All authors have declared no conflicts of interest.