Efficacy and Safety of Quxie Capsule (祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial
- 41 Downloads
To verify the efficacy and safety of Quxie Capsule (祛邪胶囊) in patients with metastatic colorectal cancer (mCRC).
The present study was a randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into two groups at a 1:1 ratio by sealed envelope. The treatment group received conventional therapy combined with Quxie Capsule for 3 months. The control group was treated with conventional therapy combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Subgroup analysis was performed according to age, right or left-sided disease, and second-line therapy to determine the differences in PFS and OS between the two groups. Patients were followed up every 3 months until Dec 31st 2016.
The median OS was 23 months in the treatment group [95% confidence interval (CI): 15–not calculated] vs. 14 months in the control group (95% CI: 11–22, P=0.060). The OS of the treatment group tended to be longer than that of the control group (P>0.05). In the subgroups of patients <65 years old, left-sided colon, and 2nd-line therapy, the treatment group showed a significant survival benefit compared with the control group (P=0.006, 0.038, 0.013, respectively). There were no significant differences between the two groups in PFS (P>0.05). Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.
Quxie Capsule showed good safety and efficacy, and could prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733)
KeywordsChinese medicine Quxie Capsule metastatic colorectal cancer randomized controlled trial
Unable to display preview. Download preview PDF.
- 5.Yang YF, Xu Y, Wu Y, Wang LP, Li Z, Zhang LZ, et al. Randomized controlled clinical study of Quxie Capsule in reducing postoperative relapse and metastasis of colorectal cancer. Chin J Integr Tradit Chin West Med (Chin) 2007;27:879–882.Google Scholar
- 6.Yang YF, Chen ZX, Xu Y, Wu Y, Wu XW, Zhu YW, et al. Randomized controlled study of Quxie Capsule in improving survival and quality of life of advanced colorectal cancer patients. Chin J Integr Tradit Chin West Med (Chin) 2008;28:111–113.Google Scholar
- 9.Tejpar S, Stintzing S, Ciardiello F, Tabernero J, Van Cutsem E, Beier F, et al. Prognostic and predictive relevance of primary tumor location in patients with RAS wild-type metastatic colorectal cancer: retrospective analyses of the CRYSTAL and FIRE-3 trials. JAMA Oncol 2016;2016:3797.Google Scholar
- 10.Thuong PT, Khoi NM, Ohta S, Shiota S, Kanta H, Takeuchi K. Ent-kaurane diterpenoids from Croton tonkinensis induce apoptosis in colorectal cancer cells through the phosphorylation of JNK mediated by reactive oxygen species and dual-specificity JNK kinase MKK4. Anticancer Agents Med Chem J 2014;14:1051–1061.CrossRefGoogle Scholar
- 12.Li JL, Han SL, Fan X, Wang X, Zhang C, Liang HP, et al. Effects of evodiamine on autophagy of human colon cancer cells. Chin J Gener Surg (Chin) 2011;26:41–44.Google Scholar
- 13.Wang YH, Zhou ZH. The regulation effect of evodiamine on the malignant biological behavior of human colon cancer cell line HT29 and Wnt/ß-catenin signaling pathway. J Hainan Med Univ (Chin) 2016;8:729–731.Google Scholar
- 14.Ding N, Yang YF, Liu YN, Xu Y, He B. Study on the inhibitory effects and mechanism of Qingxue Granules and Quxie Capsule on proliferation of human colorectal cancer HCT-116 cell. China J Basic Med Tradit Chin Med (Chin) 2013;19: 38–40.Google Scholar