国产CalliSpheres载药微球栓塞治疗不可切除肝癌17例分析
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摘要
目的:探讨国产CalliSpheres载药微球栓塞治疗不可切除肝癌的安全性及临床疗效。方法:回顾性分析2016年11月至2017年12月在本中心接受CalliSpheres载药微球栓塞治疗的17例不可切除肝癌患者临床资料,并依据国际通用的改良实体瘤疗效评价标准(mRECIST)评价治疗效果。结果:17例患者均成功完成手术,技术成功率100%。术后1周患者AST、ALT、肌酐、血红蛋白、白细胞及血小板数值与术前比较,差异无统计学意义(均P>0.05);17例患者随访6～12个月,中位随访时间为9个月。依据mRECIST标准,术后3、6个月时疾病缓解率(CR+PR)分别为76.5%、70.6%;疾病控制率(CR+PR+SD)分别为94.1%、82.4%。所有患者均未出现肝功能衰竭、胆囊炎、胆汁瘤及消化道出血等严重并发症。结论:国产CalliSpheres载药微球栓塞治疗不可切除肝癌是安全可行的,近期临床疗效较好,值得临床推广应用。
Objective:To investigate the safety and clinical effect of interventional chemoembolization with drug-eluting microspheres of domestic CalliSpheres for the treatment of unresectable hepatocellular carcinomas.Methods:The clinical data of 17 patients with unresectable hepatocellular carcinomas,admitted to our hospital from November 2016 to December 2017,were retrospectively analyzed.A total of 17 patients with unresectable hepatocellular carcinomas underwent transcatheter arterial chemoembolization with drug-eluting microspheres of domestic CalliSpheres,the results were evaluated with modified response evaluation criteria in solid tumors mRECIST.Results:The procedure was all successful in 17 patients,technical success rate was 100%.There was no significant difference in AST,ALT,creatinine,hemoglobin,white blood cell count and Platelet count existed between preoperative data and postoperative ones(P>0.05).All the 17 cases were followed up for 6 to 12 months,with a mean of 9 months.According to mRECIST,the disease remission rate(CR+PR) were 76.5% and 70.6% respectively,the disease control rate(CR+PR+SD) were 94.1% and 82.4% respectively.No serious complications,such as hepatic failure,cholecystitis,intrahepatic biloma and gastrointestinal bleeding,etc.occurred in all patients.Conclusion:The use of domestic CalliSpheres,as a drug-eluting microspheres for the treatment of unresectable hepatocellular carcinomas is safe and effective with short-term efficacy,which is worthy of clinical popularization and application.
Objective:To investigate the safety and clinical effect of interventional chemoembolization with drug-eluting microspheres of domestic CalliSpheres for the treatment of unresectable hepatocellular carcinomas.Methods:The clinical data of 17 patients with unresectable hepatocellular carcinomas,admitted to our hospital from November 2016 to December 2017,were retrospectively analyzed.A total of 17 patients with unresectable hepatocellular carcinomas underwent transcatheter arterial chemoembolization with drug-eluting microspheres of domestic CalliSpheres,the results were evaluated with modified response evaluation criteria in solid tumors mRECIST.Results:The procedure was all successful in 17 patients,technical success rate was 100%.There was no significant difference in AST,ALT,creatinine,hemoglobin,white blood cell count and Platelet count existed between preoperative data and postoperative ones(P>0.05).All the 17 cases were followed up for 6 to 12 months,with a mean of 9 months.According to mRECIST,the disease remission rate(CR+PR) were 76.5% and 70.6% respectively,the disease control rate(CR+PR+SD) were 94.1% and 82.4% respectively.No serious complications,such as hepatic failure,cholecystitis,intrahepatic biloma and gastrointestinal bleeding,etc.occurred in all patients.Conclusion:The use of domestic CalliSpheres,as a drug-eluting microspheres for the treatment of unresectable hepatocellular carcinomas is safe and effective with short-term efficacy,which is worthy of clinical popularization and application.
引文
[1] 周官辉,孙军辉,张岳林,等.HepaSphere载药微球栓塞治疗不可切除肝癌15例[J].介入放射学杂志,2015,24(10):869-872.
[2] Best J,Schotten C,Theysohn JM,et al.Novel implications in the treatment of hepatocellular carcinoma[J].Ann Gastroenterol,2017,30(1):23-32.
[3] Wu B,Zhou J,Ling G,et al.CalliSpheres drug-eluting beads versus lipiodol transarterial chemoembolization in the treatment of hepatocellular carcinoma:a short-term efficacy and safety study[J].World J Surg Oncol,2018,16(1):69.
[4] Ling H,Xu QY,Chen LG,et al.A Meta-Analysis of Arsenic Trioxide Combined with Transcatheter Arterial Chemoembolization for Treatment of Primary Hepatic Carcinoma[J].Evid Based Complement Alternat Med,2016,26(5):1-10.
[5] Bruix J,Sherman M.Management of hepatocellular carcinoma[J].Hepatology,2005,42(5):1208-1236.
[6] 于海鹏,郭志,杨雪玲,等.经肝动脉放疗性栓塞治疗肝癌的研究进展[J].吉林大学学报(医学版),2016,42(3):626-629.
[7] Lencioni R,Llovet JM.Modified RECIST (mRECIST) assessment for hepatocellular carcinoma[J].Semin Liver Dis,2010,30(1):52-60.
[8] European Association for the Study of the liver,European Organisation For Research And Treatment Of Cancer.EASL-EORTC clinical practice guidelines:management of hepatocellular carcinoma[J].J Hepatol,2012,56(4):908-943.
[9] Kishore S,Friedman T,Madoff D C.Update on Embolization Therapies for Hepatocellular Carcinoma[J].Curr Oncol Rep,2017,19(6):40.
[10] 赵倩,颜志平.载药微球经导管动脉化疗栓塞治疗肝癌研究进展[J].介入放射学杂志,2017,26(11):1052-1056.
[11] 陈刚,张鼎,应亚草,等.国产载药微球经动脉化疗栓塞治疗不可切除原发性肝癌的临床研究[J].浙江大学学报(医学版),2017,46(2):44-51.
[12] 徐彦哲,丁佑铭,杨阳,等.微球联合碘化油栓塞化疗治疗肝细胞癌的Meta分析[J].中华肝胆外科杂志,2014,20(1):24-28.
[13] Facciorusso A,Di Maso M,Muscatiello N.Drug-eluting beads versus conventional chemoembolization for the treatment of unresectable hepatocellular carcinoma:A meta-analysis[J].Dig Liver Dis,2016,48(6):571-577.
[14] Malagari K,Pomoni M,Moschouris H,et al.Chemoembolization of hepatocellular carcinoma with HepaSphere 30-60μm.Safety and efficacy study[J].Cardiovascular & Interventional Radiology,2014,37(1):165-175.
[15] Megías Vericat J E,García M R,López B E,et al.Trans-arterial chemoembolization with doxorubicin-eluting particles versus conventional trans-arterial chemoembolization in unresectable hepatocellular carcinoma:A study of effectiveness,safety and costs[J].Radiología,2015,57(6):496-504.
[16] Malagari K,Pomoni M,Spyridopoulos T N,et al.Safety Profile of Sequential Transcatheter Chemoembolization with DC Bead:Results of 237 Hepatocellular Carcinoma (HCC) Patients[J].Cardiovasc Intervent Radiol,2011,34(4):774-785.
[17] Burrel M,Reig M,Forner A,et al.Survival of patients with hepatocellular carcinoma treated by transarterial chemoembolisation (TACE) using Drug Eluting Beads.Implications for clinical practice and trial design[J].J Hepatol,2012,56(6):1330-1335.
[18] 姜松,李桂杰,周祝谦,等.CalliSpheres 载药栓塞微球治疗中晚期肝癌临床效果评价[J].中华介入放射学电子杂志,2017,5(3):174-178.
[19] Sattler T,Bredt C,Surwald S,et al.Efficacy and Safety of Drug Eluting Bead TACE with Microspheres<150 μm for the Treatment of Hepatocellular Carcinoma[J].Anticancer Res,2018,38(2):1025.
[20] Padia SA,Shivaram G,Bastawrous S,et al.Safety and efficacy of drug-eluting bead chemoembolization for hepatocellular carcinoma:comparison of small-versus medium-size particles[J].J Vasc Interv Radiol,2013,24(3):301-306.
[21] Recchia F,Passalacqua G,Filauri P,et al.Chemoembolization of unresectable hepatocellular carcinoma:Decreased toxicity with slow-release doxorubicineluting beads compared with lipiodol[J].Oncol Rep,2012,27(5):1377-1383.
[22] Vogl TJ,Lammer J,Lencioni R,et al.Liver,gastrointestinal,and cardiac toxicity in intermediate hepatocellular carcinoma treated with PRECISION TACE with drug-eluting beads:results from the PRECISION V randomized trial[J].Am J Roentgenol,2011,197(4):562-570.
[2] Best J,Schotten C,Theysohn JM,et al.Novel implications in the treatment of hepatocellular carcinoma[J].Ann Gastroenterol,2017,30(1):23-32.
[3] Wu B,Zhou J,Ling G,et al.CalliSpheres drug-eluting beads versus lipiodol transarterial chemoembolization in the treatment of hepatocellular carcinoma:a short-term efficacy and safety study[J].World J Surg Oncol,2018,16(1):69.
[4] Ling H,Xu QY,Chen LG,et al.A Meta-Analysis of Arsenic Trioxide Combined with Transcatheter Arterial Chemoembolization for Treatment of Primary Hepatic Carcinoma[J].Evid Based Complement Alternat Med,2016,26(5):1-10.
[5] Bruix J,Sherman M.Management of hepatocellular carcinoma[J].Hepatology,2005,42(5):1208-1236.
[6] 于海鹏,郭志,杨雪玲,等.经肝动脉放疗性栓塞治疗肝癌的研究进展[J].吉林大学学报(医学版),2016,42(3):626-629.
[7] Lencioni R,Llovet JM.Modified RECIST (mRECIST) assessment for hepatocellular carcinoma[J].Semin Liver Dis,2010,30(1):52-60.
[8] European Association for the Study of the liver,European Organisation For Research And Treatment Of Cancer.EASL-EORTC clinical practice guidelines:management of hepatocellular carcinoma[J].J Hepatol,2012,56(4):908-943.
[9] Kishore S,Friedman T,Madoff D C.Update on Embolization Therapies for Hepatocellular Carcinoma[J].Curr Oncol Rep,2017,19(6):40.
[10] 赵倩,颜志平.载药微球经导管动脉化疗栓塞治疗肝癌研究进展[J].介入放射学杂志,2017,26(11):1052-1056.
[11] 陈刚,张鼎,应亚草,等.国产载药微球经动脉化疗栓塞治疗不可切除原发性肝癌的临床研究[J].浙江大学学报(医学版),2017,46(2):44-51.
[12] 徐彦哲,丁佑铭,杨阳,等.微球联合碘化油栓塞化疗治疗肝细胞癌的Meta分析[J].中华肝胆外科杂志,2014,20(1):24-28.
[13] Facciorusso A,Di Maso M,Muscatiello N.Drug-eluting beads versus conventional chemoembolization for the treatment of unresectable hepatocellular carcinoma:A meta-analysis[J].Dig Liver Dis,2016,48(6):571-577.
[14] Malagari K,Pomoni M,Moschouris H,et al.Chemoembolization of hepatocellular carcinoma with HepaSphere 30-60μm.Safety and efficacy study[J].Cardiovascular & Interventional Radiology,2014,37(1):165-175.
[15] Megías Vericat J E,García M R,López B E,et al.Trans-arterial chemoembolization with doxorubicin-eluting particles versus conventional trans-arterial chemoembolization in unresectable hepatocellular carcinoma:A study of effectiveness,safety and costs[J].Radiología,2015,57(6):496-504.
[16] Malagari K,Pomoni M,Spyridopoulos T N,et al.Safety Profile of Sequential Transcatheter Chemoembolization with DC Bead:Results of 237 Hepatocellular Carcinoma (HCC) Patients[J].Cardiovasc Intervent Radiol,2011,34(4):774-785.
[17] Burrel M,Reig M,Forner A,et al.Survival of patients with hepatocellular carcinoma treated by transarterial chemoembolisation (TACE) using Drug Eluting Beads.Implications for clinical practice and trial design[J].J Hepatol,2012,56(6):1330-1335.
[18] 姜松,李桂杰,周祝谦,等.CalliSpheres 载药栓塞微球治疗中晚期肝癌临床效果评价[J].中华介入放射学电子杂志,2017,5(3):174-178.
[19] Sattler T,Bredt C,Surwald S,et al.Efficacy and Safety of Drug Eluting Bead TACE with Microspheres<150 μm for the Treatment of Hepatocellular Carcinoma[J].Anticancer Res,2018,38(2):1025.
[20] Padia SA,Shivaram G,Bastawrous S,et al.Safety and efficacy of drug-eluting bead chemoembolization for hepatocellular carcinoma:comparison of small-versus medium-size particles[J].J Vasc Interv Radiol,2013,24(3):301-306.
[21] Recchia F,Passalacqua G,Filauri P,et al.Chemoembolization of unresectable hepatocellular carcinoma:Decreased toxicity with slow-release doxorubicineluting beads compared with lipiodol[J].Oncol Rep,2012,27(5):1377-1383.
[22] Vogl TJ,Lammer J,Lencioni R,et al.Liver,gastrointestinal,and cardiac toxicity in intermediate hepatocellular carcinoma treated with PRECISION TACE with drug-eluting beads:results from the PRECISION V randomized trial[J].Am J Roentgenol,2011,197(4):562-570.