Interventional chemoembolization with drug-eluting microspheres of domestic CalliSpheres for the treatment of primary hepatocellular carcinomas: preliminary results in 12 patients / 介入放射学杂志

ABSTRACT

Objective To evaluate the clinical safety and efficacy of CalliSpheres,a domestic drugeluting microspheres,in treating primary hepatocellular carcinoma (HCC).Methods A total of 12 HCC patients were enrolled in this study.Interventional chemoembolization with CalliSpheres was carried out in all patients.The preoperative and postoperative clinical data,laboratory results and imaging findings were retrospectively analyzed.Results The success rate of initial interventional chemoembolization in 12 patients was 100％,the median follow-up time was 7.5 months (6-9 months).One week after the treatment,both AST and ALT levels were obviously increased when compared with preoperative ones,the differences were statistically significant (P＜0.05),although their mean values did not exceed the normal upper limit of 40 U/L.No statistically significant differences in Child-Pugh grading,creatinine level,hemoglobin,white blood cell count and platelet count existed between preoperative data and postoperative ones (P＞0.05).At 3 months and 6 months after treatment,the disease remission rates (CR+PR) were 75.00％ and 66.67％ respectively,the disease control rates (CR+PR+SD) were 91.67％ and 83.33％ respectively.In 10 HCC patients whose preoperative AFP was ≥ 200 μg/L,the postoperative AFP levels showed a significant decrease.Three months after the treatment,the complete remission rate,disease remission rate and disease control rate in the CalliSpheres combined with Lipiodol sequential transarterial chemoembolization group were better than those in the simple CalliSpheres embolization group,but the differences were not statistically significant (P＞0.05).Postoperative complications were mainly abdominal pain and fever.During follow-up period,the complications included pleural effusion (n=2),liver abscess (n=l) and lung metastasis (n=l).Conclusion The use of domestic CalliSpheres,as a drug-eluting microspheres,for the treatment of primary HCC is safe and feasible with satisfactory short-term efficacy.Its long-term efficacy and the effect of combination use of CalliSpheres and Lipiodol need to be further clarified with multicenter and large sample researches.