| Objectives This study was designed to investigate the difference in the efficacy of sequential Xeloda for 2 months after 4-month CAPOX regimen and 6-month CAPOX regimen for high-risk stage ?(T4/N2)colon cancer,further to explore the best course of adjuvant therapy of oxaliplatin,and to observe the adverse reactions between the two groups,as well as the differences of pharmacoeconomic indicators between the two groups,so as to provide more effective,safe and economical post-operative adjuvant chemotherapy for patients.Methods The enrolled cases were from two hospital during the period from September 1,2016 to March 1,2017,and 49 patients who underwent radical resection of colon cancer.The pathological stage after operation was confirmed to be high-risk stage ?(T4/N2).The patients were randomly divided into experimental group(CAPOX 4 months sequential capecitabine 2 months),25 cases and control group(CAPOX 6 months),a total of 24 cases.The experimental group: oxaliplatin 130 mg/?,intravenous drip,Day1,Xeloda 1000 mg/? from the first day to the 14 th day,oral,bid(morning and evening),rest 7 days,every 3weeks for a cycle,lasting 4 months;sequential single drug Xeloda 1250 mg/? from the first day to the 14 th day,oral,bid(morning and evening),rest 7 days,every 3 weeks for a cycle,lasting 2 months;the control group: oxaliplatin 130 mg/?,intravenous drip,Day1,Xeloda 1000mg/? from the first day to the 14 th day,oral,bid(morning and evening),rest for 7 days,every 3 weeks for a period of 6 months.Adverse reactions and related pharmacoeconomic indicators were evaluated in each chemotherapy cycle.Every 2~3cycles of chemotherapy were followed by a comprehensive examination,including CEA series of tumors,liver color Doppler ultrasound,upper abdomen + lower abdomen + pelvic CT.Evaluate every 3 months after the end of chemotherapy to find out whether the patient has any progress after operation,including local recurrence and distant metastasis.Results 1 Evaluation of curative effect: The 2-year disease-free survival rate(DFS)of the experimental group and the control group were 84.0%(21/25)and 79.2%(19/24),(HR0.75;95% CI 0.20~2.78;P=0.671).There was no significant difference between the two groups.The 2-year overall survival rate(OS)of the experimental group and the control group were 96.0%(24/25)and 91.7%(22/24),(HR 0.44;95% CI 0.05~4.25;P=0.548),without significant statistical difference.2 The 6-month completion rate of adjuvant chemotherapy in the experimental group and the control group was 72.0%(18/25)and41.7%(10/24)(P=0.032),respectively,with significant difference.There was a significant difference in the completion rate of adjuvant chemotherapy 6 months after operation between the two groups.The experimental group showed better treatment compliance.3Adverse reactions: most of the adverse reactions occurred in the course of chemotherapy were grade 1/2,and the adverse reactions of grade 3/4 were less.The incidence of oxaliplatin-induced peripheral neurotoxicity was higher,but the incidence of oxaliplatininduced peripheral neurotoxicity in the experimental group was significantly lower than that in the control group(P=0.046).There was no significant difference in the incidence of hand-foot syndrome caused by Xeloda between the experimental group and the control group(P=0.680).Bone marrow depression occurred in both groups,leukopenia rate,neutropenia rate and thrombocytopenia rate in the experimental group were significantly lower than those in the control group(P=0.032;P=0.015;P=0.024).There was no significant difference in the incidence of gastrointestinal adverse reactions such as anorexia,nausea,vomiting and diarrhea between the two groups(P>0.05).4 The quality of life score of the two groups decreased significantly after treatment(P<0.05),and the quality of life scores of the two groups were significantly correlated before and after treatment.5 Drug cost-benefit analysis: Xeloda 40 yuan/tablet,oxaliplatin 500 yuan/branch,according to body surface area 1.5 ?.The total cost of chemotherapeutic drugs(excluding other bed fees,diagnosis and treatment fees,etc.)for 6 months was 30,400 yuan in the experimental group.The total cost of drugs was 32160 yuan in the control group.The cost of drugs in the experimental group was significantly lower than that in the control group.Cost-benefit analysis showed that the experimental group increased DFS by 0.27% and OS by 0.24% at a cost of less than 100 yuan.Conclusions 1.The efficacy of four-months of CAPOX sequential two-month singledrug Xeloda treatment model and the six-month CAPOX treatment model is similar.The four-months of CAPOX sequential two-month single-drug Xeloda treatment model also reduced adverse reactions,improved patients' treatment compliance and quality of life,and gained better pharmacoeconomic value.2.Sequential single-drug Xeloda 2-month treatment mode after four-month CAPOX regimen can be considered as an alternative treatment mode for 6-month CAPOX regimen after operation.3 According to the results of the study,four-months of adjuvant chemotherapy after operation may be the best course of treatment for oxaliplatin.Figure3;Table4;Reference 125... |
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