Effect of PRM1201 Combined With Adjuvant Chemotherapy on Preventing Recurrence and Metastasis of Stage III Colon Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Ru Jia; Ru Jia; Ningning Liu; Ningning Liu; Guoxiang Cai; Yun Zhang; Haijuan Xiao; Lihong Zhou; Qing Ji; Ling Zhao; Puhua Zeng; Huaimin Liu; Jiege Huo; Xiaoqiang Yue; Yi Zhang; Chaojun Wu; Xiaoting Sun; Yuanyuan Feng; Hongjie Liu; Hui Liu; Zhifen Han; Youying Lai; Yanbo Zhang; Gang Han; Hangjun Gong; Yan Wang; Qi Li; Qi Li

doi:10.3389/fonc.2021.618793

Frontiers in Oncology (Mar 2021)

Effect of PRM1201 Combined With Adjuvant Chemotherapy on Preventing Recurrence and Metastasis of Stage III Colon Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Ru Jia,
Ru Jia,
Ningning Liu,
Ningning Liu,
Guoxiang Cai,
Yun Zhang,
Haijuan Xiao,
Lihong Zhou,
Qing Ji,
Ling Zhao,
Puhua Zeng,
Huaimin Liu,
Jiege Huo,
Xiaoqiang Yue,
Yi Zhang,
Chaojun Wu,
Xiaoting Sun,
Yuanyuan Feng,
Hongjie Liu,
Hui Liu,
Zhifen Han,
Youying Lai,
Yanbo Zhang,
Gang Han,
Hangjun Gong,
Yan Wang,
Qi Li,
Qi Li

Affiliations

Ru Jia: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Ru Jia: Academy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Ningning Liu: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Ningning Liu: Academy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Guoxiang Cai: Department of Colorectal Cancer Surgery, Fudan University Shanghai Cancer Center, Shanghai, China
Yun Zhang: Department of Gastrointestinal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Haijuan Xiao: Department of Oncology, Hospital Affiliated to Shaanxi University of Chinese Medicine, Xianyang, China
Lihong Zhou: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Qing Ji: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Ling Zhao: Academy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Puhua Zeng: Department of Medical Oncology, Hunan University of Chinese Medicine Integrated Chinese and Western Medicine Affiliated Hospital, Changsha, China
Huaimin Liu: Department of Integrated Chinese and Western Medicine, Henan Cancer Hospital, Zhengzhou, China
Jiege Huo: Department of Oncology, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China
Xiaoqiang Yue: Department of Traditional Chinese Medicine, Changzheng Hospital, Naval Medical University, Shanghai, China
Yi Zhang: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Chaojun Wu: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Xiaoting Sun: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Yuanyuan Feng: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Hongjie Liu: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Hui Liu: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Zhifen Han: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Youying Lai: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Yanbo Zhang: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Gang Han: Department of Gastrointestinal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Hangjun Gong: Department of Gastrointestinal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Yan Wang: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Qi Li: Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Qi Li: Academy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China

DOI: https://doi.org/10.3389/fonc.2021.618793
Journal volume & issue: Vol. 11

Abstract

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BackgroundChemotherapy 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.MethodsIn 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.ResultsA 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.ConclusionsChemotherapy in combination with PRM1201 improved the adjuvant treatment of colon cancer. PRM1201 can be recommended as an effective option in clinical practice.Clinical Trial RegistrationChinese Clinical Trials Registry, identifier ChiCTR-IOR-16007719.

Published in Frontiers in Oncology

ISSN: 2234-943X (Online)
Publisher: Frontiers Media S.A.
Country of publisher: Switzerland
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.frontiersin.org/journals/oncology/

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