Jia Ru, Liu Ningning, Cai Guoxiang, Zhang Yun, Xiao Haijuan, Zhou Lihong, Ji Qing, Zhao Ling, Zeng Puhua, Liu Huaimin, Huo Jiege, Yue Xiaoqiang, Zhang Yi, Wu Chaojun, Sun Xiaoting, Feng Yuanyuan, Liu Hongjie, Liu Hui, Han Zhifen, Lai Youying, Zhang Yanbo, Han Gang, Gong Hangjun, Wang Yan, Li Qi
Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Academy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Front Oncol. 2021 Mar 3;11:618793. doi: 10.3389/fonc.2021.618793. eCollection 2021.
Chemotherapy is the standard adjuvant treatment for colon cancer. Chinese herbal formula PRM1201 improves the efficacy of chemotherapy when used in combination with Cetuximab or Bevacizumab in patients with metastatic colorectal cancer. This study aims to explore the benefits of treatment with chemotherapy plus PRM1201 in the postoperative adjuvant setting.
In this parallel-group study, patients who had undergone curative resection for stage III colon cancer were randomly assigned to receive adjuvant chemotherapy (FOLFOX q2w for 6 months, or CapeOx q3w for 6 months) plus PRM1201 (chemo+PRM1201 group) or adjuvant chemotherapy plus placebo (chemo+placebo group). The primary endpoint was disease-free survival (DFS), and the secondary endpoints were quality of life (QOL) and toxicity.
A total of 370 patients were randomly assigned to chemotherapy plus PRM1201 group (n = 184) and chemotherapy plus placebo group (n = 186). Up to October 30, 2019, 96 events of recurrence, metastasis, or death had been reported, of which 38 events were in the group of chemotherapy plus PRM1201 and 58 events in the chemo+placebo group. The 3-year DFS rate was 77.1 and 68.6% in the chemo+PRM1201 and chemo+placebo group, respectively (hazard ratio [HR], 0.63; 95% CI, 0.42 to 0.94). The QOL of patients in the chemo+PRM1201 group were significantly improved in terms of global quality of life, physical functioning, role functioning, emotional functioning, fatigue, and appetite loss. The incidence of grade 3 or 4 treatment-related adverse event (TRAEs) were similar between the two arms.
Chemotherapy in combination with PRM1201 improved the adjuvant treatment of colon cancer. PRM1201 can be recommended as an effective option in clinical practice.
Chinese Clinical Trials Registry, identifier ChiCTR-IOR-16007719.
化疗是结肠癌的标准辅助治疗方法。中药配方PRM1201与西妥昔单抗或贝伐单抗联合用于转移性结直肠癌患者时，可提高化疗疗效。本研究旨在探讨化疗联合PRM1201在术后辅助治疗中的益处。
在这项平行组研究中，对III期结肠癌行根治性切除的患者被随机分配接受辅助化疗（FOLFOX方案每2周1次，共6个月，或CapeOx方案每3周1次，共6个月）联合PRM1201（化疗+PRM1201组）或辅助化疗联合安慰剂（化疗+安慰剂组）。主要终点为无病生存期（DFS），次要终点为生活质量（QOL）和毒性。
共有370例患者被随机分配至化疗联合PRM1201组（n = 184）和化疗联合安慰剂组（n = 186）。截至2019年10月30日，共报告96例复发、转移或死亡事件，其中化疗联合PRM1201组38例，化疗+安慰剂组58例。化疗+PRM1201组和化疗+安慰剂组的3年DFS率分别为77.1%和68.6%（风险比[HR]，0.63；95%CI，0.42至0.94）。化疗+PRM1201组患者的生活质量在总体生活质量、身体功能、角色功能、情感功能、疲劳和食欲减退方面均有显著改善。两组3/4级治疗相关不良事件（TRAEs）的发生率相似。
化疗联合PRM1201改善了结肠癌的辅助治疗。PRM1201可作为临床实践中的有效选择推荐。
中国临床试验注册中心，标识符ChiCTR-IOR-16007719。
