Objective： To investigate the efficacy of integrated Chinese and Western medicine（IM） in the treatment of metastatic colorectal cancer（m CRC） in a cohort study.Methods： The survival outcome of patients receiving IM was compared with that of patients receiving Western medicine alone.The study design was adopted with ＂continuous administration of Chinese medicine for 3 months＂ as the exposure factor.Patients who met this exposure factor were assigned to the IM cohort（Group A,110 patients）.Patients who did not meet this exposure factor were assigned to the Western medicine cohort（Group B,225 patients）.The overall survival（OS）,progression-free survival（PFS）,and 1 st year,2 nd year,and 3 rd year survival in the two cohorts were compared.Results： The median OS in Group A and B were 18 months [95% confidence interval（CI） 15-21] and 16 months（95% CI 14-18）,respectively,and the median PFS in Group A and B were 6 months（95% CI 4-7） and 5 months（95% CI 4-6）,respectively.No statistically significant differences were observed between the groups（P=0.186,P=0.223）.Group A demonstrated significantly longer OS and PFS than Group B in the following subgroups： female patients,patients with lesions in the right half of the colon,and those who received first-line treatment（P〈0.05）.In the subgroup of elderly patients（age〉65 years）,the OS in Group A was longer than that in Group B（P〈0.05）.Conclusion： IM could prolong the survival of patients with m CRC.（Registry No.Chi CTR-IOR-17010497）
Objective：To verify the efficacy and safety of Quxie Capsule（祛邪胶囊） in patients with metastatic colorectal cancer（mC RC）.Methods：The present study was a randomized,double-blind,placebo-controlled trial.Sixty patients with mC RC 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 31 st 2016.Results：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 2 nd-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.Conclusions：Quxie Capsule showed good safety and efficacy,and could prolong the OS of patients with mC RC.
ZHANG TongYANG Yu-feiHE BinYI Dan-huiHAO JieZHANG Da
