| The study abstract involved two parts:efficacy and safety of Quxie capsule in metastatic colorectal cancer:a double-blind,randomized,placebo controlled trial,and cohort study on the prognosis of patients with metastatic colorectal cancer treated with Integrated Traditional Chinese and Western Medicine.So abstract have two research summary statements.1.Efficacy and safety of Quxie capsule in metastatic colorectal cancer:a double-blind,randomized,placebo controlled trial.Background:In a previous study,we found that Quxie capsule reduces the risk of stage Ⅱ-Ⅲ colorectal cancer postoperative recurrence and metastasis and prolongs the survival of patients with metastatic colorectal cancer(mCRC).The present clinical trial was designed to verify the efficacy and safety of Quxie capsule in patients with mCRC.Methods: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.The treatment group received conventional therapy combined with Quxie capsule.The control group was treated with conventional therapy combined with placebo.Main outcome measures were overall survival(OS)and progression-free survival(PFS).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)(Kaplan-Meier,Log-rank p = 0.060).The OS of the treatment group tended to be longer than that of the control group,although the difference was not significant.This may have been related to the small sample size.In the subgroups of patients<65 years old,left-sided colon,and>second-line therapy,the treatment group showed a significant survival benefit compared with the control group(p = 0.006,0.038,0.013).There were no significant differences between the two groups in PFS.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 can prolong the OS of patients with mCRC.2.Cohort study on the prognosis of patients with metastatic colorectal cancer treated with Integrated Traditional Chinese and Western MedicineBackground:Integrated traditional Chinese and Western medicine is an important feature and advantage of malignant tumor treatment in China.However,it is limited by the differences in theoretical system and the clinical characteristics of"individualized therapy".The effectiveness of integrated traditional Chinese and western in treating malignant tumors such as colorectal cancer still lacks high quality clinical trials and sufficient evidence-based medical evidence.The previous study conducted within our department shows:traditional Chinese medicine treatment can reduce the recurrence and metastasis rate of stage Ⅱ-Ⅲ colorectal cancer,and extend the survival of patients with advanced colorectal cancer.In this study,we investigated the efficacy of integrated traditional Chinese and Western medicine in the treatment of advanced colorectal cancer by comparing the survival outcome of patients receiving integrated traditional Chinese and Western medicine treatment and patients receiving Western medicine treatment alone by cohort study of patients with metastatic colorectal cancer.Methods:Cohort study design was adopted with "continuous administration of traditional Chinese medicine treatment for≥3 months" as the exposure factor.Patients who met this exposure factor were assigned to the integrated traditional Chinese and Western medicine cohort(110 patients).Patients who did not meet this exposure factor were assigned to the western medicine cohort(225 patients).The overall survival(OS),progression-free survival(PFS),and first year,.second year,and third year.survival of the two cohorts were compared.Results:The mOS of integrated traditional Chinese and Western medicine cohort was 18 months(95%CI 15-21),the mOS of the Western medicine cohort was 16 months,the mPFS of the integrated traditional Chinese and western medicine cohort was 6 months(95%CI 4-7),and the mPFS of Western medicine cohort was 5 months(95%CI 4-6),with no statistically significant difference detected(p = 0.186,0.223).The integrated traditional Chinese and Western medicine cohort demonstrated significantly longer OS and PFS than Western medicine cohort in subgroup of female patients,patients with lesion at the right half of the colon,and those received first-line treatment.In the subgroup of elderly patients(age>65),the OS of integrated traditional Chinese and Western medicine cohort was longer than that of the Western medicine cohort.Conclusions:Integrated Traditional and Western Medicine treatment can prolong the survival of patients with metastatic colorectal cancer.3.Multivariate analysis of the characteristics of Chinese Medicine in the treatment of metastatic colorectal cancerBackground:Clinically,we found that not all patients with mCRC can benefit from the treatment of Chinese Medicine.How to further improve the clinical efficacy of colorectal cancer,to find the benefit of Chinese medicine treatment is the key to improve the efficacy of colorectal cancer.However,what are the characteristics of the benefit groups of TCM treatment that we are not known yet.It is of great strategic significance for the individual treatment of cancer and health economics to explore the degree of benefit of the treatment of patients with malignant tumor,and to select the beneficial and non beneficial groups.At present,there is no report on screening characteristics of benefit groups with mCRC in Chinese medicine treatment.The basic characteristics of screening and induction therapy of traditional Chinese medicine benefit groups,TCM treatment measures corresponding to the realization of"Chinese medicine for colorectal cancer is the accurate treatment",improve the clinical efficacy of a breakthrough,provides a new perspective for the study of traditional Chinese medicine in the treatment of advanced malignant tumor.In the first part of the additional Quxie Capsule RCT was verified by our clinical hypotheses:Chinese Medicine treatment(including Quxie Capsule)on male,radiotherapy and RAS/BRAF mutation in mCRC was positively related.However,limited by the sample size,we can analyze the less clinical characteristics,and the test efficiency is not high.Therefore,we designed second parts of the cohort study to expand the sample size,in the second part of the study compared the efficacy of traditional Chinese and Western medicine treatment queue and simple western medicine treatment cohort.The third part is the research content in the second part of the research on the basis of further attempts to find and answer what factors are the dominant factors,traditional Chinese medicine treatment of advanced colorectal cancer or that with what factors were the population benefit from treatment of TCM.Methods:We review all patients with stage IV colorectal cancer in Xiyuan Hospital,Department of Gastroenterology,Beijing Cancer Hospital,from August 1,2013 to December 31,2015.According to the "continuous accepted more than 3 months of treatment of traditional Chinese medicine" as the exposure factors were divided into two groups:Western medicine treatment group and Western medicine treatment group,patients were followed up until death.The patients were followed up until November 30,2016.According to the patients’ overall survival is more than 18 months into"benefit people" and "non benefit people’.Traditional Chinese medicine and Western medicine treatment group collected 15 clinical data such as age,sex,left and right,logistic regression analysis.Western medicine treatment group collected 12 clinical data for logistic regression analysis.Screening for the benefit of combination therapy of traditional Chinese medicine and Western medicine in the treatment of advanced colorectal cancerResults:Sex,left and right half,targeting and metastasis(low vs high),the degree of differentiation(high vs low),asthenia(deficiency of lung and kidney,liver and kidney deficiency,spleen and kidney deficiency VS of liver stagnation and spleen deficiency)the difference was statistically significant.Among other factors,women were 3.5 times more likely to have good effect(p = 0.029).Right-sided colon cancer was 4.4 times higher than that the left-sided colon cancer(p = 0.049).Patients who did not receive targeted therapy were 5.2 times more likely to be treated(p = 0.016).The probability of good curative effect in patients with bone,lymph node and other metastasis was 38.2 times that of liver,pleura,peritoneum,brain metastasis,lung,spleen,abdominal wall and anastomotic stoma(p = 0.001).The probability of high differentiation was 13.2 times that of low differentiation(p = 0.012).Lung and kidney deficiency,deficiency of liver and kidney deficiency,spleen and kidney deficiency probability effect is 4.7 times of liver depression and spleen deficiency(p = 0.028).Conclusions:(1)The characteristics of benefit groups are:female,right-sided colon,targeted therapy,bone metastasis,lymph node metastasis and high differentiation,syndrome of lung and kidney deficiency syndrome,liver and kidney deficiency syndrome,spleen and kidney deficiency syndrome.(2)It is consensus that the prognosis of right colon cancer is significantly worse than that of left colon cancer.In this study,we selected the "right colon" and "female" in Chinese medicine treatment group,however,it is consistent with the adverse prognostic factors.Survival subgroup analysis and multivariate analysis showed that the combination of traditional Chinese medicine and Western medicine significantly prolonged the survival time of patients with right colon,female and non target therapy.For patients with RAS mutations,there is a tendency to prolong survival. |
PDF Full Text Request