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)
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Zhang T, Xu Y, He B and Yang YF conceived the design of the study. Zhang T wrote the manuscript. Sun LY performed the sample size calculation. Zhang T, Sun LY, Hao J and Zhang D contributed to study design, coordination and data acquisition. All authors have critically revised the manuscript and have read and approved the final manuscript for publication.
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Conflict of Interest
We declare that there has no financial and personal relationships with other people or organizations that can inappropriately influence this work. There is no professional or other personal interest of any nature or kind in any product, service and/or company that could be construed as influencing the position presented in the manuscript.
Supported by National Natural Science Foundation of China (No. 81573958)
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Zhang, T., Xu, Y., Sun, Ly. et al. Efficacy of Quxie Capsule in Metastatic Colorectal Cancer: Long-Term Survival Update of A Double-Blind, Randomized, Placebo Controlled Trial. Chin. J. Integr. Med. 28, 971–974 (2022). https://doi.org/10.1007/s11655-021-3281-1
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DOI: https://doi.org/10.1007/s11655-021-3281-1