• Dexiang Zhu, Jianguo Xia, Yan Gu, Jianjiang Lin, Kefeng Ding, Bo Zhou, Fei Liang, Tianshu Liu, Chunzhi Qin, Ye Wei, Li Ren, Yunshi Zhong, Jianhua Wang, Zhiping Yan, Jiemin Cheng, Jingwen Chen, Wenju Chang, Shaokang Zhan, Yongbin Ding, Haizhong Huo, Fanlong Liu, Junhui Sun, Xinyu Qin, and Jianmin Xu.
• Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
• Ann. Surg. 2021 Jun 1; 273 (6): 1066-1075.

ObjectiveTo evaluate the effects of the addition of preoperative hepatic and regional arterial chemotherapy (PHRAC) on prognosis of stage II and III colorectal cancer (CRC) in a multicenter setting.Summary Of Background DataOur previous single-center pilot trial suggested that PHRAC in combination with surgical resection could reduce the occurrence of liver metastasis (LM) and improve survival in CRC patients.MethodsA prospective multi-center randomized controlled trial was conducted from December 2008 to December 2012 at 5 hospitals in China. Eligible patients with clinical stage II or III CRC who underwent curative resection were randomized to receive PHRAC plus adjuvant therapy (PHRAC arm) or adjuvant therapy alone (control arm). The primary endpoint was DFS. Secondary endpoints were cumulative LM rates, overall survival (OS), and safety (NCT00643877).ResultsA total of 688 patients from 5 centers in China were randomly assigned (1:1) to each arm. The five-year DFS rate was 77% in the PHRAC arm and 65% in the control arm (HR = 0.61, 95% CI 0.46-0.81; P = 0.001). The 5-year LM rates were 7% and 16% in the PHRAC and control arms, respectively (HR = 0.37, 95% CI 0.22-0.63; P < 0.001). The 5-year OS rate was 84% in the PHRAC arm and 76% in the control arm (HR = 0.61, 95% CI 0.43-0.86; P = 0.005). There were no significant differences regarding treatment related morbidity or mortality between the two arms.ConclusionsThe addition of PHRAC could improve DFS in patients with stage II and III CRC. It reduced the incidence of LM and improved OS without compromising patient safety.Trial RegistrationClinicalTrials.gov identifier: NCT00643877.Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

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