Comparative Study Of Irinotecan Drug-Loaded Microspheres With Hepatic Artery Embolization And Systemic Chemotherapy For Unresectable Liver Metastases From Colorectal Cancer

Purpose:Colorectal cancer is one of the common malignant tumors in China.More than50% of patients will have liver metastasis throughout the course of the disease,which is one of the main causes of death in patients with colorectal cancer.Radical surgical resection is the most effective treatment for prolonging the survival of patients with colorectal liver metastases(CRLM),but most patients have lost their chance of surgery at the time of diagnosis.Chemotherapy is the primary treatment for patients with inoperable CRLM.Although chemotherapy can improve the survival of these patients,but the effect is limited.In recent years,patients with CRLM treated with DEBIRI-TACE have been reported frequently.This retrospective study is to explore the efficacy and safety of Intra-arterial infusion of irinotecan-loaded drug-eluting beads(DEBIRI)and intravenous therapy(FOLFIRI)for hepatic metastases from colorectal cancer.Materials and Methods:We have retrospectively analyzed the clinical and follow-up data of 50 patients with unresectable Colorectal Liver Metastases(CRLM)from the second affiliated hospital of nanchang university from January 2016 to December 2017,of which 25 patients were treated with DEBIRI as one group and another 25 patients were treated with FOLFIRI as another group.Analyzing and recording the laboratory data,imaging examination and adverse reaction before and after treatment for these patients,and then comparing the Time-To-Progress(TTP),adverse reaction,2 months,4 months,6 months of objective response rate(ORR)and disease control rates(DCR)of this two groups.The follow-up time was 6-12 months.We used the modified response evaluation criteria in solid tumors(mRECIST)to evaluate the efficacy.The SPSS24.0 statistical software was used for data analysis.Kaplan-meier method was used to draw the survival curve of TTP and calculate the survival time.The categorical variables were tested by chi-square test,and the number of cases or percentage was used to describe the counting data.And p<0.05 indicated that thedifference was statistically significant.Results:There were 50 patients in this two groups,including 25 patients in every groups.There were no statistical differences between the two groups in gender,age,whether the primary lesion had been removed,liver metastasis,treatment before enrollment,liver function,ECOG score and tumor indicators(p > 0.05).According the mRECIST standard,the efficacy evaluation of the DEBIRI group and the FOLFIRI group after treatment was as follows: ORR at 2 months was 72% and 32%(P=0.005);ORR at 4months was 76% and 40%(P=0.01);ORR at 6 months was 52% and 24%,(P=0.041)and DCR was 92% and 60% at 2 months(P= 0.008),92% and 52% at 4 months(P=0.002),and 72% and 44% at 6 months(P= 0.045),respectively.The short-term efficacy of the DEBIRI group was significantly higher than that of the FOLFIRI group,and the difference was statistically significant(P <0.05).And in the DEBIRI group,1 patient developed complete remission(CR)of liver metastases for 4 months,while the FOLFIRI group no one did so.By the time of December 2018,50 patients enrolled had undergone TTP analysis,and the mTTP of the two groups were 6.8months in the DEBIRI group(95%ci: 4.4-8.0 months)and 4.8 months in the FOLFIRI group(95%ci: 3.1-6.9),with statistically significant difference(P = 0.023).During the whole follow-up,a total of 5 patients reached the surgical standard during the treatment period due to the shrinkage of liver metastasis and received concurrent surgical treatment,including 3 patients in the DEBIRI group(12%)and 1 patient in the FOLFIRI group(4%).Although the difference between the two groups was not statistically significant(P >0.05),the tumor downstaging rate in the DEBIRI group was higher than that in the FOLFIRI group.Patients in both groups did not show grade IV or above intolerable toxic side effects.Bone marrow suppression,nausea and vomiting,fatigue and diarrhea were common adverse reactions in the two groups,but the reaction in the DEBIRI group was less severe than that in the FOLFIRI group.Post Embolization Syndrome(such as fever and abdominal pain)only appeared in patients in the DEBIRI group,but all patients recovered within about 1 week,and no severe complications such as bleeding at the puncture site and liver and kidney failure occurred in all patients postoperatively.Conclusions:1.For inoperable CRLM patients,DEBIRI treatment can improve short-term efficacy and prolong TTP compared with traditional FOLFIRI treatment.2.DEBIRI is safe and feasible for the treatment of patients with CRLM.