Ru Jia1,2, Ningning Liu1,2, Guoxiang Cai3, Yun Zhang4, Haijuan Xiao5, Lihong Zhou1, Qing Ji1, Ling Zhao2, Puhua Zeng6, Huaimin Liu7, Jiege Huo8, Xiaoqiang Yue9, Yi Zhang1, Chaojun Wu1, Xiaoting Sun1, Yuanyuan Feng1, Hongjie Liu1, Hui Liu1, Zhifen Han1, Youying Lai1, Yanbo Zhang1, Gang Han4, Hangjun Gong4, Yan Wang1, Qi Li1,2. 1. Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China. 2. Academy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China. 3. Department of Colorectal Cancer Surgery, Fudan University Shanghai Cancer Center, Shanghai, China. 4. Department of Gastrointestinal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China. 5. Department of Oncology, Hospital Affiliated to Shaanxi University of Chinese Medicine, Xianyang, China. 6. Department of Medical Oncology, Hunan University of Chinese Medicine Integrated Chinese and Western Medicine Affiliated Hospital, Changsha, China. 7. Department of Integrated Chinese and Western Medicine, Henan Cancer Hospital, Zhengzhou, China. 8. Department of Oncology, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China. 9. Department of Traditional Chinese Medicine, Changzheng Hospital, Naval Medical University, Shanghai, China.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Chemotherapy in combination with PRM1201 improved the adjuvant treatment of colon cancer. PRM1201 can be recommended as an effective option in clinical practice. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trials Registry, identifier ChiCTR-IOR-16007719.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Chemotherapy in combination with PRM1201 improved the adjuvant treatment of colon cancer. PRM1201 can be recommended as an effective option in clinical practice. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trials Registry, identifier ChiCTR-IOR-16007719.
Authors: Juan Ignacio Arraras; Javier Suárez; Fernando Arias de la Vega; Ruth Vera; Gemma Asín; Virginia Arrazubi; Mikel Rico; Lucía Teijeira; Jaione Azparren Journal: Clin Transl Oncol Date: 2011-01 Impact factor: 3.405
Authors: Axel Grothey; Alberto F Sobrero; Anthony F Shields; Takayuki Yoshino; James Paul; Julien Taieb; John Souglakos; Qian Shi; Rachel Kerr; Roberto Labianca; Jeffrey A Meyerhardt; Dewi Vernerey; Takeharu Yamanaka; Ioannis Boukovinas; Jeffrey P Meyers; Lindsay A Renfro; Donna Niedzwiecki; Toshiaki Watanabe; Valter Torri; Mark Saunders; Daniel J Sargent; Thierry Andre; Timothy Iveson Journal: N Engl J Med Date: 2018-03-29 Impact factor: 91.245
Authors: Kelley M Kidwell; Greg Yothers; Patricia A Ganz; Stephanie R Land; Clifford Y Ko; Reena S Cecchini; Jacek A Kopec; Norman Wolmark Journal: Cancer Date: 2012-05-08 Impact factor: 6.860