| [OBJECTIVE]To evaluate the efficacy and safety of transcatheter arterial chemoembolization(TACE)combined with apatinib versus TACE in the treatment of advanced hepatocellular carcinomas(HCCs).[METHODS]1、A prospective study of the treatment of advanced hepatocellular carcinomas at Navy General Hospital in the period between March 2015 and August 2015 was conducted.A total of 44 patients with advanced HCCs were enrolled(33 males and 11 females),the median age was 58.5(range,34-79)years.They were selected randomized into group A and group B,while TACE combining with apatinibn for group A and TACE monotherapy for group B.2、Twelve to eighteen months follow-up were conducted in all patients.The serum alpha fetoprotein(AFP)levels were compared between the two groups three months after treatment.The objective response rates(ORR)after treatment 3,6,9 and 12 months later were observed.The progression-free survival(PFS)and incidence of adverse reactions between the two groups were also compared.3、Statistical processing:The measurement data were expressed as the mean ±standard deviation(SD).Two paired samples t test were used for pretherapy and post-treatment statistical analyses in each group while two sample Student’s t-test were used for statistical analyses between two groups.The enumberation data were expressed as the frequency/percentages,statistical analyses by the chi-square test.Non-normal distribution data described with median(range),adoption of Wilcoxon’s signed rank test.Kaplan-Meier statistical analyses and Log-rank test were used for the median progression-free survival between the two groups.Survival curve were drawing at the same time.And p<0.05 was considered significant.[RESULTS]1.No significant difference of age,gender,Child-pugh classification,KPS scores and primary diseases between the two groups of patients were found(p>0.05).The diameters of the primary tumor in two groups were statistical analyzed,and no statistical significance was observed(p>0.05).Nineteen patients with increased serum AFP levels were confirmed in group A,while sixteen in group B.2.The serum AFP levels decreased apparently in two groups three months after treatment,and statistic differences were observed in each group pre and after treatment(Z=-2.289,-2.953,all p<0.05),while no statistic differences be tween the two groups were obtained after the treatment(Z=-0.126,p>0.05).Th e serum AFP levels of 5 cases dropped to normal in group A,while 6 in gro up B.3.The ORR at 3,6,9,12 months in group A were 36.36%,27.27%,13.64%,9.09%while 60%,50%,45%,35%in group B respectively.No statistic differ ences were found between the two groups 3 and 6 months after treatment(χ2=2.346;χ2=2.295,both p>0.05),while statistic differences were manifested aft er 9 and 12 months(χ2=5.050;χ2=4.177,both p<0.05).4.The medium PFS in group A was 6.0 months significantly lower than that 12.5months in group B(χ2=6.576,p=0.01).5.The postembolization syndrome adverse reactions,such as fever,abdomi nal pain,nausea and vomiting were observed.No statistically significant was ma nifested between the two groups(all p>0.05).Higher rates of apatinib-related a dverse reactions including hypertension,hand-foot syndrome and proteinuria we re observed in group B,and statistically significant were obtained(all p<0.05).All the adverse reactions in the two groups were relieved after symptomatic t reatment.[CONCLUSION]1.TACE combined with apatinib and TACE alone all reduce the serum AFP levels effectively in patients with advanced HCCs.The combined treatment group may improves the mid-long-term efficacy and prolong the PFS further.2.Most of the adverse reactions were slight,and could be released after symptomatic treatment.And the safety of TACE combine with apatinib was confirmed. |
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