A Comparison Of The Efficacy Of Donafenib Versus Lenvatinib (Combined Interventional Therapy) In Conversion Therapy For HCC Patients

Objective : To investigate the Hepatocellular carcinoma patients have received transformation therapy in the Hospital Information System(HIS)of the First Afliated Hospital of Kunming Medical University,and to compare the discrepant early efficacy between Donafenib treatment group and Lenvatinib treatment group by analysing the Objective Response Rate(ORR),Progression Free Survival(PFS),Overall Survival(OS)and Adverse Events(AEs)of two groups in a retrospective cohort study.Meanwhile,to confirm the feasibility,effectiveness and safety of targeted drugs in HCC transformation therapy further.Methods: A retrospective cohort study on analyzing 47 cases of HCC patients receiving interventional therapy from May 2022 to December 2022 in our hospital through transcatheter arterialchemoembolization,conventional(TACE)and Hepaticartery infusion chemotherapy(HAIC).According to different targeted drugs,the patients were divided into Donafenil group and Lenvatinib group.Medical statistics were used to compare the basic clinical data of patients in two groups before intervention combined with targeted drug therapy,and whether there were statistical differences in outcomes,survival time and adverse reactions after treatment,so as to draw conclusions.Results: 47 patients who were diagnosed with HCC before the operation of "TACE+HAIC" voluntarily refer to targeted drug therapy after the surgery(Donafenil group,n=22;Lenvatinib,n=25),which shows 11 objective responses in the Donafenib group and 12 objective responses in the Lenvatinib group(11 VS.12,x~2=0.019,P=0.891),12 and 8 disease progression respectively(12 VS.8,x~2=2.433,P=0.119),and 6 deaths in both groups(6 VS.6,x~2=0.066,P=0.797).There was no statistical difference(50% VS.48%,x~2=0.019,P=0.891)in ORR at 1 month after combination therapy in the Donafenib group compared with the Lenvatinib group,and treatment measure(OR=1.603,95%CI 0.391-6.577,P=0.513)did not affect the early(>1 month)treatment outcome of m RECIST,and extrahepatic metastasis of tumor(OR=0.16195%CI 0.037-0.691,P=0.014)was the only factor affecting the treatment outcome.Progression-free survival(45.5% VS.68.0%,x~2=1.434,P=0.231))observed in both groups showed no statistically significant difference,in which the tumor had extrahepatic metastasis(HR=4.182,95%CI 1.428-12.244,P=0.009)was the only factor affecting progression-free survival in HCC patients during follow-up,while treatment measure(HR= 0.448,95%CI 0.168-1.191,P=0.107)was not statistically significant.There was no statistically significant difference in survival rate between the two groups(73.7% VS.76.0%,x~2=0.110,P=0.740),while aspartate aminotransferase(HR=1.007;95%CI 1.001-1.013,P=0.033),extrahepatic metastasis(HR=8.618,95%CI 1.831-40.557,P=0.006)were important factors affecting the survival rate of patients during follow-up,for which treatment regimen(HR=0.934,95%CI 0.176-4.969,P=0.936)was not statistically significant.AEs resulted in reduction or discontinuation in 31.82%(7/22)of patients receiving donafenib versus64%(16/25)in the Lenvatinib group,with a statistically significant difference between the two groups(31.82% VS.64.00%,x~2=4.850,P=0.028).Conclusions: 1.There was no significant difference in the early(>1 month) outcome(objective remission)of m RECIST in the "TACE+HAIC+ Donafenib/Lunvatinib "treatment between the Donafenib group and the Lenvatinib group,but the extrahepatic metastasis of tumors before treatment may hinder the remission of the disease;2.There is no significant difference between Donafenib and Lenvatinib in prolonging PFS and OS in patients with longer-term conversion therapy,and HCC patients with extrahepatic metastasis before treatment may have poor prognosis in both aspects.The increase of pre-Aspartate aminotransferase(AST)in middle-late HCC patients before treatment may increase the risk of death after treatment,and AST may be negatively correlated with OS.3.Ronavatinib may be superior to Donafenib in delaying disease progression,and patients may tolerate Donafenib better than Ronavatinib,and patients may obtain safer,stable efficacy from oral donafenib.