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

Abstract

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.

Efficacy and safety of Xian-Lian-Jie-Du optimization decoction as an adjuvant treatment for prevention of recurrence in patients with stage IIIB/IIIC colon cancer: study protocol for a multicentre, randomized controlled trial

“…Surveys indicate that approximately 80 percent of patients in China had used TCM, particularly CHM, during cancer treatment [ 48 , 49 ]. Mounting evidence, meanwhile, suggests that Chinese medicine prescriptions have significant effect of colon cancer progression control [ 16 , 20 , 50 – 53 ]. XLJDOD is an empirical prescription used as an adjuvant treatment of colorectal cancer for more than 10 years in China.…”

“…A retrospective cohort study indicated that adherence to medication of TCM after surgery could significantly improve disease-free survival in colorectal patients with stage III disease [ 19 ]. Furthermore, a randomized controlled trial of 370 patients showed that Chinese herbal formula composed of seven herbs (PRM1201) in combination with adjuvant chemotherapy in the treatment of stage III colon cancer could effectively increase the 3-year DFS rate and improve their life quality [ 20 ].…”

Traditional Chinese Medicine in Regulating Tumor Microenvironment

“… 8 More and more studies have confirmed that TCM can enhance anti-tumor effects by regulating the immune system. 9 , 10 The aim of this study is to introduce how immune cells and non-immune cells in TME promote tumor progression, and to summarize the research progress of TCM in regulating TME.…”

Single-cell RNA sequencing reveals that the immunosuppression landscape induced by chronic stress promotes colorectal cancer metastasis

“…A pioneering study arranged CRC survivors into clusters by four emotion regulation patterns and suggested that health care professionals should be aware of the individual differences in the emotions of these CRC patients [ 7 ]. Our previous randomized controlled clinical study in CRC showed that disease-free survival was negatively correlated with worse emotional function [ 8 ].…”