| Purpose:Hepatocellular carcinoma(HCC)is one of the most common malignant tumors in China.Most patients are already in advanced stage when they receive treatment.Lenvatinib is a first-line targeted drug for the treatment of advanced HCC.Studies have confirmed that lenvatinib monotherapy is safe and effective.Programmed cell death protein 1(PD-1)antibodies can be used to treat malignant tumors.Transcatheter arterial chemoembolization(TACE)is the main treatment for unresectable HCC.This study intends to explore the efficacy and safety of lenvatinib monotherapy,lenvatinib plus PD-1,and lenvatinib plus TACE in the treatment of advanced HCC.Methods:This study retrospectively analyzed 59 patients with advanced HCC who were admitted to Tianjin Medical University Cancer Institute & Hospital from December01,2018 to May 31,2019.Among them,20 patients received lenvatinib monotherapy group,20 patients received lenvatinib plus PD-1 therapy,and 19 patients received lenvatinib plus TACE therapy.We collected the imaging features,demographic and clinical data of the patients at baseline and four follow-ups.According to the modified response evaluation criteria in solid tumors(m RECIST),we measured the length of target lesions and recorded the presence or absence of non-target lesions.We recorded the occurrence of Adverse events(AEs)in patients with grade 3 and above was recorded,calculated Albumin-bilirubin(ALBI)score,and compared complete response(CR)and partial response(PR),stable disease(SD)and progression disease(PD)cases,progression-free survival(PFS),Objective response rate(ORR),disease control rate(DCR),time of effctive and tumor inhibition time of the patients in the three groups.Results:(1)The ORR of all therapies was evaluated according to the m RECIST.It was45.00% in lenvatinib monotherapy group,60.00% in lenvatinib plus PD-1 treatment group,and was 52.63% in lenvatinib plus TACE treatment group.(2)The DCR of alltherapies was also evaluated according to the m RECIST.It was 95.00% in lenvatinib monotherapy group,90.00% in lenvatinib plus PD-1 group,and 89.47% in lenvatinib plus TACE treatment group.(3)The ORR for lenvatinib plus TACE treatment group was significantly better than that for lenvatinib monotherapy group at the 1st follow-up(P = 0.008),while there were no statistically significant difference between other groups.(4)The changes of the total tumor length of the target lesions at baseline and four follow-ups were compared.At the 3rd follow-up,the total length of the target lesions of lenvatinib plus TACE treatment group decreased by an average of 59.6%,which was significantly better than that of lenvatinib monotherapy group(32.2%,P = 0.017)and lenvatinib plus PD-1 treatment group(31.2%,P = 0.042).(5)A total of 30 cases(38.46%)of grade 3 and above AEs occurred during the treatment period,of which 9 cases(33.33%)occurred in the lenvatinib monotherapy group,12cases(46.15%)occurred in the lenvatinib plus PD-1 treatment group and 9 cases occurred in the lenvatinib plus TACE treatment group(36.00%).The most common AEs were hypertension(21 cases,26.92%),liver disfunction(5 cases,6.41%)and proteinuria(4 cases,5.13%).All patients did not have severe AEs.The ALBI scores of the three groups at the baseline and 4th follow-up were compared.The ALBI score of lenvatinib plus TACE treatment group was-2.30 ± 0.23,which was significantly higher than that of lenvatinib monotherapy group(-2.73 ± 0.26,P = 0.001).(6)The level of AFP in patients with objective response was significantly higher than that in patients with stable disease and disease progression(P = 0.028).(7)There was no statistically significant difference in PFS(P = 0.498)among lenvatinib monotherapy group,lenvatin plus PD-1 treatment group and lenvatinib plus TACE treatment group,of which the median PFS were 207.9,264.0,and 226.8 days,respecitively.(8)There was no significant difference in tumor inhibition time among lenvatinib monotherapy group,lenvatinib plus PD-1 treatment group,lenvatinib plus TACE treatment group(P = 0.218).There was no median tumor inhibition time for lenvatinib plus PD-1treatment group.The median tumor inhibition time of the lenvatinib monotherapy group and lenvatinib plus TACE treatment group was 167.0 and 193.0 days,respectively.Conclusions:(1)Lenvatinib combination therapy is safe and effective for advanced HCC treatment.(2)Lenvatinib plus PD-1 therapy shows more durable objective response rate than lenvatinib monotherapy and lenvatinib plus TACE therapy.Patients received lenvatinib plus PD-1 treatment have better live reserve function than those received other treatments.(3)Lenvatinib plus TACE therapy shows better short-term therapeutic effect for patients with advanced HCC than lenvatinib monotherapy,while also lead to a certain degree of decline in liver reserve function.(4)Patients with higher AFP levels benefit more from lenvatinib treatment.(5)Lenvatinib combination therapy group showed longer PFS than lenvatinib monotherapy group,which provide the possibility to extend the patients’ overall survival. |
