| Backgrounds and aims:Hepatocellular carcinoma(HCC)is a kind of cancer with high degree of malignancy and mortality.Most patients are diagnosed at a middle and advanced stage as its onset is occult,who are unsuitable to undergo surgical resection and local-regional therapies.Current guidelines recommend molecular targeted therapies for these patients.These oral agents can not only restrain revascularization of tumors,but also can suppress the development of cancer.Effective molecular targeted therapies can improve tumor-related symptoms,boost the quality of life,raise the survival time.After patients accepting molecular targeted therapies,it is necessary to evaluate the changes of lesions by means of medical imaging methods to determine whether the therapeutic regimen is effective and whether needs to be changed.The Response Evaluation Criteria in Solid Tumors version 1.1(RECIST1.1)and modified RECIST(mRECIST)are commonly used to assess tumor response,which one is better to evaluate efficacy for patients with HCC after molecular targeted therapies is still controversial.This meta-analysis intended to compare the value of RECIST1.1 and mRECIST criteria in the efficacy evaluation of molecular targeted therapies in patients with hepatocellular carcinoma,to select better criteria to guide the formulation of the next therapeutic plan.Material and methods:Literature about the evaluation of efficacy in patients with hepatocellular carcinoma after molecular targeted therapies were collected by searching commonly used foreign databases such as EMBASE,PubMed,Web of Science and Cochrane Library according to different literature search strategy,and relevant literature were screened according to the strict inclusion and exclusion criteria,and then data were extracted.The Newcastle-Ottawa scale(NOS)was used to assess the quality of the studies.Data analysis were pooled using the statistical software SPSS,and inter-method concordance between similar categorical items of the two criteria was measured using the k coefficient.Hazard ratio(HR)for overall survival were used for meta-analysis,considering responders versus non-responders according to RECIST1.1 and mRECSIT criteria by Cochrane Collaboration’s Review Manager 5.4.Statistical heterogeneity among the studies was assessed using chi-square tests with the significance set at p<0.05,heterogeneity was quantified using the I2 statistic,funnel plots and Egger’s test were used to grossly exclude publication bias.Results:A total of 19 studies including 1,432 patients were included.724 patients treated with sorafenib,30 patients treated with axitinib,289 patients treated with lenvatinib,379 patients treated with regorafenib and 10 patients treated with ramucirumab.The percentage of responders according to RECIST1.1 and mRECIST criteria was 10.40%and 22.93%,respectively(p<0.001).The disease control rate according to RECIST1.1 and mRECIST criteria was 66.94%and 68.36%,respectively(p=0.5).A total of 7 studies,including 361 patients with hepatocellular carcinoma,were used to compare consistency of the RECIST1.1 and mRECIST criteria.For objective response,the agreement of tumor response between the two criteria was moderate(k=0.469,95%CI 0.328-0.576).For disease control,the agreement of tumor response between the two criteria was almost perfect(k=0.900,95%CI 0.851-0.944).Survival analysis was performed in 7 studies,the results showed that the objective response rate according to mRECIST was 18.73%,mRECIST criteria could distinguish the prognosis of the responders and the non-responders,the survival time of responders was significantly longer than non-responders(HR=0.56,95%Cl 0.41-0.78,p=0.0004);The objective response rate according to RECIST1.1 was 8.5%,however this criteria did not distinguish the prognosis of the responders and the non-responders(HR=0.68,95%CI 0.44-1.05,p=0.08).These results indicated that there were significant differences between RECIST1.1 and mRECIST criteria in evaluating the efficacy of molecular targeted therapy in patients with hepatocellular carcinoma.The objective response rate assessed by mRECIST criteria was significantly higher than RECIST1.1 criteria,and the tumor response assessed by mRECIST criteria had a high correlation with survival.Conclusion:The mRECIST criteria appears more accurate than RECIST1.1 to evaluate the efficacy of molecular targeted therapies in patients with hepatocellular carcinoma.It is recommended that the mRECIST criteria can be used to evaluate the efficacy of molecular targeted therapis in patients with hepatocellular carcinoma to guide clinical practice and predict prognosis. |
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