Efficacy of Quxie Capsule in Metastatic Colorectal Cancer: Long-Term Survival Update of A Double-Blind, Randomized, Placebo Controlled Trial.
10.1007/s11655-021-3281-1
- Author:
Tong ZHANG
1
;
Yun XU
1
;
Ling-Yun SUN
1
;
Bin HE
1
;
Jie HAO
1
;
Da ZHANG
1
;
Yu-Fei YANG
2
Author Information
1. Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
2. Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. yyf93@vip.sina.com.
- Publication Type:Journal Article
- Keywords:
Chinese medicine;
Quxie capsule;
metastatic colorectal cancer;
randomited controlles trial
- MeSH:
Humans;
Drugs, Chinese Herbal/therapeutic use*;
Colorectal Neoplasms/pathology*;
Colonic Neoplasms;
Progression-Free Survival;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
- From:
Chinese journal of integrative medicine
2022;28(11):971-974
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To verify the efficacy of Quxie Capsule in patients with metastatic colorectal cancer (mCRC).
METHODS:It was a block randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into 2 groups at a 1:1 ratio. The patients in the treatment group received conventional therapy including chemotherapy, radiotherapy, targeted therapy and supportive care, and Chinese herbal medicine combined with Quxie Capsule (each capsule of 0.4 g was orally administered at 50 mg/kg, twice daily, day 1-20, in a 30-day course) for 3 months. The patients in the control group received conventional therapy and Chinese herbal medicine combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Subgroup analysis was performed according to therapy lines, right or left-sided colon, targeted therapy and RAS gene status to determine the differences in PFS and OS between the two groups. Patients were followed up every 3 months until December 31st, 2018.
RESULTS:Median follow-up time was 19.4 months. The median OS was 23.9 months in the treatment group [95% confidence interval (CI) 15.9-28.5] vs. 14.3 months in the control group (95% CI 11.3-21.4, P<;0.05). Hazard ratio (95% CI) was 0.55 (0.31-0.95, P=0.040). There were no significant differences between the two groups in PFS (P>0.05). In the subgroups of ⩾second-line therapy, non-targeted therapy, RAS gene wild type and left-sided colon, the treatment group showed a significant survival benefit compared with the control group (P<;0.05 or P<;0.01), respectively.
CONCLUSION:Quxie Capsule can reduce the risk of death and prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733).
