| Background and Purpose:The clinical efficacy and safety of bgb-a317 and sorafenib were compared in patients with advanced hepatocellular carcinoma who had not previously received systemic therapy.Methods:This study will be selected in May 2018 to May 2019,Harbin medical university affiliated tumor hospital of surgical treatment of HCC,and have not received systemic treatment(do not rule out always have received topical treatments)of the patients,the Child-Pugh,grade A,ECOG 0 or 1 patients were randomly assigned to the following treatment groups: group A: BGB-200 mg,A317 every 3weeks(q3w),30 minutes intravenous drug delivery.Group B: 400 mg sorafenib,twice daily(bid),swallowed in warm water.Imaging methods were used to evaluate the tumor status every 9 weeks in the first year and every 12 weeks from the second year.RECIST(ver.1.1)and nci-ctc AE 4.0 were used to observe and evaluate the efficacy and adverse reactions.The primary objective was to compare the total survival(OS)of bgb-a317 and sorafenib as first-line therapy in subjects with unreactable HCC,and the secondary objective was progression-free survival(PFS)and objective response rate(ORR)as well as adverse reactions.OS is defined as the time from the date of randomization to the date of death of various causes;PFS is defined as the time of tumor progression or death as assessed by the BRIC in accordance with RECIST(ver.1.1)from randomization to the first objective record,whichever is the first.SPSS24.0 software was used to analyze clinical data,kaplan-meier method was used to calculate patients’ OS and PFS,and log-rank test was used for inter-group comparison.P <0.05 was considered to be statistically significant.Results : A total of 42 eligible subjects with advanced liver cancer were enrolled,including 21 in the bgb-a317 group and 21 in the sorafenib group.By the end of the follow-up date,11 of the 21 patients in the sorafenib group died and 5continued to take the drug.Of the 21 patients in the bgb-a317 group,11 died,5continued to take the drug,and the remaining patients were followed up for survival after disease progression.The median survival time of sorafenib group was15.13 months(4.10～22.90).Median survival time of bgb-a317 group was 16.57months(3.10～24.10).The survival curves of the two groups were compared,and the results showed that the OS of patients in the bgb-a317 group was better than that in the sorafenib group,and the difference was statistically significant(P=0.0011).The median progression-free survival time of sorafenib group was 4.40months(1.10～22.90).The median progression-free survival time of bgb-a317 was4.13(1.46～24.10)months.The PFS curves of the two groups were compared,and the results showed that the PFS of the bgb-a317 group was close to that of the sorafenib group,and the difference was statistically significant(P<0.01).The ORR of sorafenib group and bgb-a317 group were 4.8% and 21.7% respectively at 12 months.Among the 21 subjects in the bgb-a317 group,14 patients developed AE during the medication,with the level of 1-2.After symptomatic treatment,it is generally well controlled and does not affect the continuation of medication.No AE occurred in 7 patients.In the sorafenib group,a total of 21 subjects developed grade3 AE during the medication period,indicating abnormal liver function and delayed medication.The remaining adverse reactions included decreased white blood cell count and decreased platelet count.There were no fatal adverse reactions in the two groups,and no patients were discontinued due to adverse drug reactions.Conclusions: First-line use of bgb-a317 monotherapy may benefit patients with advanced hepatocellular carcinoma(HCC)that is not suitable for radical surgery and/or regional therapy,and is clinically safe. |
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