| Objective:The purpose of this study is to assess the security and feasibility of peripheral intravenous bolus of 131I-labeled-metuximab injection for the treatment of advanced hepatocellular carcinoma,and then explore the early curative effect and clinical application value.Method:(1)Before the treatment all patients were performed the detailed medical history collection,physical examination,laboratory and imageological examination,definite the TNM staging and Child-Pugh scores of liver function.According to the NCI toxicity grading standards after treatment,grading the nausea,vomiting,fever,pain and other adverse reactions that patient developed after treatment.10 days later,we evaluated the distribution of Licartin in the whole body by SPECT imaging.Blood routine,liver and kidney function,thyroid function were examined,at4 and 12 weeks after the treatment.(2)All the 54 patients were randomly divided into the group that injrcted Licartin through peripheral intravenous(the vein group)and the group that injrcted Licartin through hepatic artery associated TACE(the artery group).Blood routine examination,liver and kidney function and thyroid function between the two groups before treatment 1 week,after treatment 4 and 12 weeks were collected and compared.The emergence of adverse reaction rate and progression rate will be compared between the two groups Using chi-square test,in order to assess the security and feasibility of peripheral intravenous bolus of 131I-labeled-metuximab injection for the treatment of advanced hepatocellular carcinoma.(3)All the patients were Regular followed-up,and the physical status score(karpofsky,KPS)and liver cancer marker alpha-fetoprotein(AFP)changes after treatment 4 weeks were recorded,to assess effection on the patients quality of life.Based on the abdominal CT,MRI and other imaging examnation of patients before treatment,4 weeks after treatment,and then every 12 weeks,the objective efficacy were evaluated according to the WHO criteria.For patients who can evaluate AFP,AFP before treatment and after treatment to evaluate every 4 weeks.(4)Statistical methods:SPSS 19.0 software package was used for statistical analysis.P<0.05 was considered as statistical significance.Measurement data was expressed mean±standard deviation,Count data was expressed absolute value or percentage.For adverse events and the incidence of serious adverse events,list and describe the types and frequency of adverse events happened in the test.The method of CMH chi-square was used to assess the toxic effect changes before and poet-treatment.T-test was adopted in group measurement data,CMH chi-square test was used to compare count data between groups.Chi-square test was adopted to describe the incidence of adverse reactions in patients baseline normal and rate of adverse reaction progress in patients baseline abnormal between groups.Paired-t-test was used to compare the changes of KPS score and AFP before and after treatment.Results:(1)Positive rate when patients firstly received Licartin treatment is very low(2/38),HAMA response rate was 40.00%4 weeks after treatment,far higher than that reported when ? phase of clinical trials 3.90%(4/103).(2)Compared with the baseline level before treatment,the level of WBC,PLT count was a downward trend of two groups 4 weeks after treatment,the patient in artery group were more obviously,and the WBC and PLT count both almost returned to the baseline levels 12 weeks after treatment.(3)Compared with the baseline level before treatment,the liver toxicity of the treatment that peripheral intravenous bolus of Licartin injection were ALT,AST,STB,SDB rising,mostly ?/? inhibition,but only the STB levels increase was statistically significant(P<0.05)4 weeks after treatment,and when 12 weeks after the treatment it has basically recovered to the level that before treatment,characterized by a transient damage.(4)Compared to the baseline before treatment,BUN and Cr changes on 4 weeks,12 weeks after treatment,have no significant statistical significance(P>0.05).(5)The difference of incidence of adverse reactions between two groups in patients ALT normal baseline before treatment was statistically significant(P<0.05),while the difference of rate of adverse reaction progress in patients ALT abnormal baseline has no obvious difference(P>0.05).(6)The changes of Hb,WBC,N,PLT,AST,STB,SDB,BUN and Cr in patients between two groups ware no significant difference,P>0.05.(7)After treatment,the recent variety of adverse reactions of patients in the artery group was more than that in the vein group,and the incidence rate is higher,but there was no statistical difference between the two groups.(8)In the vein group,some patients'KPS score improved,AFP decrease rate was about 34.21%(13/38)4 weeks after treatment,but the changes above have no clear differences compared to the baseline before treatment.(9)In the vein group,the disease control rates(PR+SD)is about 78.79%,patients can benefit from this.Conclusion:(1)The treatment that peripheral intravenous bolus of Licartin injection for the treatment of advanced hepatocellular carcinoma can cause transiently myelosuppression and liver damage(mainly leucopenia and STB increased),mostly were I/II,III/IV level was rare,by 12 weeks after treatment almost returned to the baseline levels.(2)After treatment,the recent variety of adverse reactions of patients in the artery group was more than that in the vein group,and the incidence rate was higher,but there was no statistical difference between the two groups.(3)1t was beneficial to control the recent incidence of adverse reactions and blood toxicity that peripheral intravenous bolus of Licartin injection for the treatment of advanced hepatocellular carcinoma.(4)There was no obvious increase adverse reactions,even more secure in the vein group,the emergence of adverse reaction rate and progression rate between the two groups ware no significant difference.(5)The treatment that injected Licartin through peripheral intravenous can effectively simplify the treatment process,has a strong maneuverability,was conducive to the post-operative care of patients and medical personnel radiation protection.(6)Preliminary clinical observation confirmed that it can effectively improve the survival benefit for patients with advanced hepatocellular carcinoma,and show some advantage in the prevention of liver cancer recurrence and metastasis that injected Licartin through peripheral intravenous.The conclusion still depends on further confirmation in further clinical trials by amplifying samples. |
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