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

作者：Rongxin Zhang, Xiaojun Wu, Desen Wan, Junzhong Lin, Peirong Ding, Leen Liao, Jian Lei, Zhenhai Lu, Li Li, Gong Chen, Ling-Heng Kong, Fulong Wang, Jiän Zhang, Wenhua Fan, Jiang Wu, Wenhao Zhou, Cong Li, Yuan Li, Xueying Li, Jianhong Peng, Zhizhong Pan · 发表于：International Journal of Surgery · 年份：2024 · DOI：10.1097/js9.0000000000001301 · 被引用次数：6 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal Cancer Treatments and Studies、Intraperitoneal and Appendiceal Malignancies

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,...