Prevention of Recurrence and Metastasis of Stage III Colorectal Cancer by Compound Cantharis Capsule: A Multicenter Clinical Study
ZHENG Jia-bin,WANG Ying-tian,GUAN Liang
Abstract:
Objective To investigate the efficacy and safety of Compound Cantharis Capsule (CCC) on disease free survival (DFS) in curatively resected stage III colorectal cancer (CRC) patients. Methods Totally 141 curatively resected stage III CRC patients who completed adjuvant chemotherapy for more than 4 cycles were divided into observation group (68 cases) and control group (73 cases). The patients in observation group were orally given CCC, and the patients in control group were given placebo. After 6 months of intervention, the recurrence and metastasis, clinical symptoms, quality of life (QOL) and safety of the two groups were evaluated. Results After a median follow-up of 36.5 months, 8 patients (11.8%) in observation group and 15 cases (20.6%) in control group had relapse and metastasis events. The 2-year DFS was signi.cantly improved in the observation group (95%) compared with the control group (82%) (HR=0.24, 95%CI 0.07-0.85, P=0.02). Compared to the control group, patients in the observation group reported significantly greater improvement in global health status (P<0.0001), fatigue (P=0.002), pain (P=0.0003), and shortness of breath (P=0.005) as assessed by the European Organization for Research and Treatment of Cancer QOL questionnaire. There is no statistical difference in adverse events (AEs) between two groups, and no severe AEs (grade>=3) were observed in either group(P>0.05). Conclusions This study showed preliminary evidence of ef.cacy and safety that CCC could improve 2-year DFS and QOL for curatively resected stage III CRC patients who have completed 4 or more cycles of adjuvant chemotherapy. Further study should be conducted to con.rm the ef.cacy and safety on long term intervention and overall survival.
