Clinical Efficacy Of TACE Combined With Sorafenib In The Treatment Of Advanced Primary Liver Cancer

ObjectivesBy studying the efficacy of transcatheter hepatic arterial chemoembolization（TACE）combined with Sorafenib in the treatment of intermediate and advanced primary liver cancer,to explore the effects of TACE combined with Sorafenib on hematological indexes and survival time of patients with intermediate and advanced primary liver cancer,and to screen the prognostic factors of patients with primary liver cancer.To provide reference for the treatment of patients with advanced primary liver cancer.MethodsThis study is divided into two parts.The first part is based on the inclusion and exclusion criteria.355 patients with primary liver cancer with complete case data admitted to the First Affiliated Hospital of Dali University from January 2018 to December 2021 are selected as subj ects.Including age,gender,always sick situation,personal history,family history,ECOG score,number of hospitalization,starting symptoms,tumor number（and size）,portal vein invasion,CNLC liver metastatic lesions,tumor staging,BCLC stage,liver function index,blood coagulation function,antiviral treatment,diagnosis methods,treatment methods and so on,The survival time of patients was regularly followed up to establish a database of primary liver cancer.SPSS26.0 statistical software was used for data analysis,kaplan-Meier method was used to draw survival curve,and Cox regression model was used to analyze related prognostic factors.In the second part,70 patients were divided into control group（n=44）and study group（n=26）according to whether TACE was combined with other treatments.The control group was treated with transhepatic arterial chemoembolization（TACE）alone,and the study group was treated with TACE combined with Sorafenib.Chi-square test or t test were used to compare the general information and related laboratories（AFP,liver function and coagulation function）before and after treatment between the two groups.The efficacy and safety were evaluated according to mRECIST of WHO and CTCAE5.0 of the us national cancer institute.Kaplan-meier method was used to analyze the survival time of patients in the two groups,and Cox risk regression model was used to analyze the factors influencing the prognosis of patients with intermediate and advanced primary liver cancer.Resuits1.355 patients with primary liver cancer were mostly male,and the incidence ratio of male to female was 4.6:1.The age of onset was 22-92 years,and most patients were 30-60 years old,accounting for 56.3%.71.8%of patients were infected with hepatitis B virus,2.8%had a clear family history of malignant tumor 7 patients（2%）had a history of schistosomiasis,116 patients（32.7%）had a history of alcohol consumption,and 99.7%had ECOG score 0-2.2.The most common initial clinical manifestations were abdominal pain,abdominal distension,poor appetite,nausea,vomiting,jaundice,fatigue,etc.Abdominal pain was the most common（69.0%）.At first visit,142（40%）patients had extrahepatic metastasis,including lung,lymph node,bone,adrenal gland,thoracolumbar spine,stomach,etc.Of which pulmonary metastasis was most common in 26 cases（7.3%）.66.5%of the patients had Child-Pugh grade A,and 64%of the patients had BCLC stage B or C.3.As of 31 December 2021,out of 355 patients,260 died and 95 survived.The overall survival was 0.7-104.7 months,and the mean survival time was（16.0±1.973）months.4.Univariate analysis showed that:The number of tumors>2 nodules,BCLC stage（B,C,D）,vascular invasion,distant metastasis,liver cirrhosis,AFP≥400ng/ml and supportive therapy alone were independent risk factors for survival and prognosis of patients.The survival of patients with AFP<400ng/ml was longer than that of patients with AFP≥400ng/ml.The median OS was（13.9±4.474）months,which was significantly longer than that of support therapy and single method therapy.Cox regression analysis showed that AFP≥400ng/ml and stage D of BCLC were independent risk factors affecting the survival and prognosis of PLC patients.The mortality risk of monotherapy and comprehensive supportive therapy could be reduced by 60.7%and 82.3%respectively.5.According to the treatment methods,70 patients were divided into control group（n=44）and study group（n=26）.There was no statistically significant difference in general data between the two groups before treatment.6.After treatment,AFP level in 2 groups was significantly decreased compared with before treatment.One month after treatment,AFP level in study group was significantly decreased compared with control group,with statistical significance（P<0.05）.Before treatment,there was no significant difference in ALT and TBIL between the two groups（P>0.05）;After treatment,ALT levels in the two groups were lower than before treatment,the difference was statistically significant（P<0.05）;After treatment,there was no significant difference in liver function between the two groups（P>0.05）.7.There were no significant differences in abdominal pain,fever,nausea and vomiting and myelosuppression between the two groups.Grade 1-2 adverse events were predominant in both groups,which were tolerable.In the TACE combined with Sorafenib group,1 patient was relieved after self-adjustment of Sorafenib dose due to fatigue,poor appetite and systemic rash,while the rest of the patients were controlled after treatment,and no death from adverse reactions occurred.8.Comparison of survival:median PFS of 70 patients was 3.9 months,3.4 months in the TACE group and 10.7 months in the TACE plus Sorafenib group,respectively.The median OS was 5.2 months and 12.7 months,respectively.The median PFS and OS in TACE combined with Sorafenib group were significantly longer than those in control group,and the difference was statistically significant（P<0.05）.9.Univariate analysis of 70 patients found that TACE times and whether TACE combined with Sorafenib were related to prognosis.TACE combined with Sorafenib reduced the risk of death by 55.4%compared with TACE alone,and multiple TACE treatments reduced the risk of death by 62.9%.The median overall survival time of multiple TACE treatments was 8.7 months,significantly longer than that of those who received only one TACE treatment,and the difference was statistically significant.The median OS of PES patients was significantly shortened,and the difference was notstatistically significant（P>0.05）.Multivariate Cox regression analysis showed that TACE treatment times and whether TACE combined with Sorafenib could significantly affect the survival status of patients.Conclutions1.The primary liver cancer patients in our hospital are mainly middle-aged and elderly men,most of whom are complicated with hepatitis and cirrhosis,most of them first started with pain in the liver area,and most of them were in middle or advanced stage at the time of presentation.2.Survival prognosis of PLC patients:Positive AFP and stage D BCLC increase the risk of death in PLC patients,and comprehensive supportive treatment can benefit patients’ survival.3.Compared with TACE alone,TACE combined with Sorafenib can prolong the PFS and OS of patients with advanced primary liver cancer.4.The adverse reactions of TACE combined with Sorafenib in the treatment of advanced primary liver cancer were tolerable and controllable.