| Purpose:The metastasis of gastric cancer includes direct spread,lymph node metastasis,hematogenous metastasis and abdominal implantation,while liver is the most important target organ for hematogenous metastasis of gastric cancer.3%-14% of gastric cancer patients have liver metastasis,liver metastasis is a major cause of death in patients with advanced gastric cancer,and only 11%-21% of gastric cancer patients with liver metastasis are suitable for radical surgery.The main treatment method for the majority of patients with unresectable liver metastasis of gastric cancer is chemotherapy,but there is no standard treatment plan for second-line treatment after refractory chemotherapy.Transcatheter arterial chemoembolization(TACE)is considered to be an effective treatment for unresectable liver metastasis of gastric cancer,but there are still some limitations.Drug-eluting bead transarterial chemoembolization(DEBIRI-TACE)as a new alternative therapy,Irinotecan DrugEluting Beads(DEBIRI)is a new type of embolization material,which can maintain high concentration of irinotecan in tumor and slow release of drug,prolong the action time with tumor cells,and has good efficacy and safety.In this study,we retrospectively analyzed the therapeutic efficacy and adverse effects Between Irinotecan drug-eluting beads with transarterial chemoembolization(DEBIRI-TACE)plus systemic chemotherapy and systemic Chemotherapy alone in unresectable gastric cancer with liver metastas Methods:Retrospective collection Clinical and follow-up data of 45 patients at our hospital from March 2016 to November 2018 for second-line treatment of progress after chemotherapy for unresectable gastric cancer liver metastasis,of which 15 patients received Irinotecan drug-eluting beads with transarterial chemoembolization plus S-1(combination group),another 30 accepted the stand for Irinotecan(CPT-11)+ S-1 therapy(chemotherapy alone group).Clinical data of the two groups of patients were recorded,including gender and age of patients,tumor location,degree ofdifferentiation and liver metastasis,tumor markers(CA19-9,CEA),Imaging examinations and so on for statistical analysis.in the combination group and the chemotherapy alone group were evaluated short-term efficacy according to RECIST1.1 criteria,progression-free survival(PFS)was analyzed for both groups patient,and the side effects were evaluated according to CTCAE4.0 criteria.All data were statistically analyzed by SPSS 24.0.Mean standard deviation or median was used to represent continuous variables,T test was used for normality,non-parametric rank sum test was used for non-normality,to analyze the short-term efficacy and toxic and side effects of combination group and chemotherapy alone group was used ?2test.Kaplan-meier method was used to calculate the survival rate of patients in the combination group and the chemotherapy group alone,and the survival curve was drawn.p< 0.05 means the difference is statistically significant.Results:1.Among the 45 patients,the median age was 50 years old(27-70 years old);15patients in the combination group: a total of 24 times of DEBIRI-TACE were performed,with an average of 2±1 times;There were 12 males and 3 females;5patients aged ?65 years old and 10 patients aged < 65 years old;Tumor location: 2cases from cardia,2 cases from gastric bottom,1 case from gastric body and 10 cases from gastric antrum;degree of differentiation: 6 cases of low differentiation,5 cases of low-medium differentiation and 4 cases of medium differentiation;ECOG PS score :0-1 for 14 cases and 2 for 1 case;liver metastasis degree: 4 cases in H1,7 cases in H2,and 4 cases in H3;Child grading: 13 cases of grade A and 2 cases of grade B;8cases with CEA ?15(ng/ml)and 7 cases with CEA < 15(ng/ml);8 cases of CA-199?80(ng/ml)and 7 cases of < 80(ng/ml)?30 patients in the chemotherapy alone group:There were 23 males and 7 females;8 patients aged ?65 years old and 22 patients aged < 65 years old;Tumor location:2 cases from cardia,5 cases from gastric bottom,3 case from gastric body and 10 cases from gastric antrum;degree of differentiation:10 cases of low differentiation,8 cases of low-medium differentiation and 12 cases of medium differentiation;ECOG PS score :0-1 for 28 cases and 2 for 1 case;liver metastasis degree: 6 cases in H1,12 cases in H2,and 12 cases in H3;Child grading: 25 cases of grade A and 5 cases of grade B;25 cases with CEA ?15(ng/ml)and 5 caseswith CEA < 15(ng/ml);18 cases of CA-199? 80(ng/ml)and 12 cases of < 80(ng/ml).There was no statistically significant difference in general data between the two groups(p > 0.05).2.Short-term efficacy evaluation results showed that in the combination group,there were 0 cases of CR,9 cases of PR(60%),5 cases of SD(26.7%),2 cases of PD(13.3%),60% of ORR(9/15),and 86.7% of DCR(13/15).In the chemotherapy alone group,there were 0 cases of CR,8 cases of PR(26.7%),10 cases of SD(33.3%),12 cases of PD(40%),26.7% of ORR(8/30),and 60% of DCR(18/30).ORR of combined treatment was significantly higher than that of chemotherapy alone,and the difference was statistically significant(p = 0.010,),while DCR was not statistically significant in combined treatment and chemotherapy alone(p = 0.139).3.Long-term efficacy evaluation results showed that the mPFS of patients in the combination group was 4.5 months(95% CI: 3.46-5.736 months),and that of the chemotherapy alone group was 3.1 months(95%CI: 2.44-3.75 months),with statistically significant difference(p = 0.010).4.In terms of adverse reaction,two groups of patients were not ? magnitude adverse reaction;?-? level in the combination group of adverse reaction to pain(66.7%),nausea(46.7%),fatigue(46.7%),vomiting(40%),abnormal liver function(33.3%),leukopenia(33.3%),anemia(26.7%),decreased platelet(20%),diarrhea(20%).In the chemotherapy alone group,fatigue(66.7%),leukopenia(63.3%),nausea(56.7%),vomiting(46.7%),abnormal liver function(40%),anemia(33.3%),thrombocytopenia(26.7%),and pain(16.7%)were the main causes.?-?level is the common side effects,?-? level of pain analysis and comparison of difference was statistically significant(p = 0.001).? level side reaction in the combination group:leukopenia occurred in 1 case,severe pain occurred in 1 case,fatigue occurred in 1case;1 cases of abnormal liver function;In the chemotherapy alone group :there were3 cases of leukopenia,2 cases of thrombocytopenia,2 cases of delayed diarrhea;fatigue occurred in 1 case and 3 cases of liver dysfunction.? level difference of adverse reaction has no statistical significance(p > 0.05).Both the dose reduction and the toxic and side effects after symptomatic support treatment could be alleviated,and no death occurred due to chemotherapy drugs and DEBIRI-TACE in both groups.Conclusions:1.Compared with systemic chemotherapy alone,DEBIRI-TACE plus systemic chemotherapy can improve ORR and DCR in patients with unresectable gastric cancer with liver metastasis.2.Compared with systemic chemotherapy alone,DEBIRI-TACE plus systemic chemotherapy prolong the PFS of patients with unresectable gastric cancer with liver metastasis.3.DEBIRI-TACE plus systemic chemotherapy is safe and feasible,with tolerable toxic and side effects.It can be used as an optional second-line or above treatment for the progression of liver metastasis of unresectable gastric cancer after chemotherapy,which is worthy of further clinical research and promotion. |
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