作者
Rongxin Zhang,Rongxin Zhang,Rongxin Zhang,Xiaojun Wu,Xiaojun Wu,Xiaojun Wu,Desen Wan,Desen Wan,Desen Wan,Junzhong Lin,Junzhong Lin,Junzhong Lin,Pei-Rong Ding,Pei-Rong Ding,Pei-Rong Ding,Leen Liao,Leen Liao,Leen Liao,Jian Lei,Lu Zhang,Lu Zhang,Lu Zhang,Liren Li,Liren Li,Liren Li,Gong Chen,Gong Chen,Gong Chen,Ling-Heng Kong,Ling-Heng Kong,Ling-Heng Kong,Fulong Wang,Fulong Wang,Fulong Wang,Jian Zhang,Wenhua Fan,Wen Fan,Wen Fan,Jiang Wu,Wenjuan Jiang,Wenjuan Jiang,Wenhao Zhou,Wenhao Zhou,Wenhao Zhou,Cong Liu,Cong Liu,Cong Liu,Yuan Li,Yuan Li,Yuan Li,Xueying Li,Xueying Li,Xueying Li,Jianhong Peng,Jianhong Peng,Jianhong Peng,Zhizhong Pan,Zhizhong Pan,Zhizhong Pan
摘要
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.