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Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Research article

Efficacy and safety profile of drug-eluting beads transarterial chemoembolization by CalliSpheres® beads in Chinese hepatocellular carcinoma patients

Authors: Guan-Hui Zhou, Jun Han, Jun-Hui Sun, Yue-Lin Zhang, Tan-Yang Zhou, Chun-Hui Nie, Tong-Yin Zhu, Sheng-Qun Chen, Bao-Quan Wang, Zi-Niu Yu, Hong-Liang Wang, Li-Ming Chen, Wei-Lin Wang, Shu-Sen Zheng

Published in: BMC Cancer | Issue 1/2018

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Abstract

Background

This study aimed to investigate the efficacy and safety of drug eluting beads transarterial chemoembolization (DEB-TACE) treatment by CalliSpheres® in Chinese patients with hepatocellular carcinoma (HCC) as well as the predicting factors for response.

Methods

99 patients with HCC were consecutively enrolled in this study. All participants were treated by CalliSpheres® DEB-TACE. Clinical response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. Common Terminology Criteria for Adverse Events (CTCAE) was used to assess the adverse events and liver dysfunction during and after the operation.

Results

Post treatment, 16 patients (16.2%) achieved CR and 59 (59.6%) achieved PR, the ORR was 75.8%. Subgroup analysis showed that patients with higher BCLC stage were of worse CR and ORR rates, and the CR as well as ORR between patients with cTACE history and patients without cTACE history were similar. Univariate logistic regression analysis displayed that number of nodules > 3, higher BCLC stage and previous cTACE might be correlated with worse ORR but with no statistical significance. As to liver function, CTCAE grades of laboratory indexes for liver function were increased at 1 week compared to baseline and recovered to the baseline grades at 1–3 months post operation. Besides, most of the common adverse events were light and moderate in our study.

Conclusions

In conclusion, DEB-TACE by CalliSpheres® was efficient and well tolerated in Chinese HCC patients, and BCLC stage, number of nodules and cTACE history were possibly correlated with treatment response.
Literature
1.
2.
go back to reference Simard EP, Ward EM, Siegel R, Jemal A. Cancers with increasing incidence trends in the United States: 1999 through 2008. CA Cancer J Clin. 2012;62:118–28.CrossRefPubMed Simard EP, Ward EM, Siegel R, Jemal A. Cancers with increasing incidence trends in the United States: 1999 through 2008. CA Cancer J Clin. 2012;62:118–28.CrossRefPubMed
3.
go back to reference Granito A, Bolondi L. Non-transplant therapies for patients with hepatocellular carcinoma and child-Pugh-Turcotte class B cirrhosis. Lancet Oncol. 2017;18:e101–e12.CrossRefPubMed Granito A, Bolondi L. Non-transplant therapies for patients with hepatocellular carcinoma and child-Pugh-Turcotte class B cirrhosis. Lancet Oncol. 2017;18:e101–e12.CrossRefPubMed
4.
go back to reference Imai N, Ishigami M, Ishizu Y, Kuzuya T, Honda T, Hayashi K, et al. Transarterial chemoembolization for hepatocellular carcinoma: a review of techniques. World J Hepatol. 2014;6:844–50.CrossRefPubMedPubMedCentral Imai N, Ishigami M, Ishizu Y, Kuzuya T, Honda T, Hayashi K, et al. Transarterial chemoembolization for hepatocellular carcinoma: a review of techniques. World J Hepatol. 2014;6:844–50.CrossRefPubMedPubMedCentral
5.
go back to reference Varela M, Real MI, Burrel M, Forner A, Sala M, Brunet M, et al. Chemoembolization of hepatocellular carcinoma with drug eluting beads: efficacy and doxorubicin pharmacokinetics. J Hepatol. 2007;46:474–81.CrossRefPubMed Varela M, Real MI, Burrel M, Forner A, Sala M, Brunet M, et al. Chemoembolization of hepatocellular carcinoma with drug eluting beads: efficacy and doxorubicin pharmacokinetics. J Hepatol. 2007;46:474–81.CrossRefPubMed
6.
go back to reference Poon RT, Tso WK, Pang RW, Ng KK, Woo R, Tai KS, et al. A phase I/II trial of chemoembolization for hepatocellular carcinoma using a novel intra-arterial drug-eluting bead. Clin Gastroenterol Hepatol. 2007;5:1100–8.CrossRefPubMed Poon RT, Tso WK, Pang RW, Ng KK, Woo R, Tai KS, et al. A phase I/II trial of chemoembolization for hepatocellular carcinoma using a novel intra-arterial drug-eluting bead. Clin Gastroenterol Hepatol. 2007;5:1100–8.CrossRefPubMed
7.
go back to reference Baur J, Ritter CO, Germer CT, Klein I, Kickuth R, Steger U. Transarterial chemoembolization with drug-eluting beads versus conventional transarterial chemoembolization in locally advanced hepatocellular carcinoma. Hepat Med. 2016;8:69–74.CrossRefPubMedPubMedCentral Baur J, Ritter CO, Germer CT, Klein I, Kickuth R, Steger U. Transarterial chemoembolization with drug-eluting beads versus conventional transarterial chemoembolization in locally advanced hepatocellular carcinoma. Hepat Med. 2016;8:69–74.CrossRefPubMedPubMedCentral
8.
go back to reference Morimoto M, Kobayashi S, Moriya S, Ueno M, Tezuka S, Irie K, et al. Short-term efficacy of transarterial chemoembolization with epirubicin-loaded superabsorbent polymer microspheres for hepatocellular carcinoma: comparison with conventional transarterial chemoembolization. Abdominal radiology (New York). 2017;42:612–9.CrossRef Morimoto M, Kobayashi S, Moriya S, Ueno M, Tezuka S, Irie K, et al. Short-term efficacy of transarterial chemoembolization with epirubicin-loaded superabsorbent polymer microspheres for hepatocellular carcinoma: comparison with conventional transarterial chemoembolization. Abdominal radiology (New York). 2017;42:612–9.CrossRef
9.
go back to reference Kucukay F, Badem S, Karan A, Ozdemir M, Okten RS, Ozbulbul NI, et al. A single-center retrospective comparison of doxorubicin-loaded HepaSphere Transarterial chemoembolization with conventional Transarterial chemoembolization for patients with Unresectable hepatocellular carcinoma. J Vasc Interv Radiol. 2015;26:1622–9.CrossRefPubMed Kucukay F, Badem S, Karan A, Ozdemir M, Okten RS, Ozbulbul NI, et al. A single-center retrospective comparison of doxorubicin-loaded HepaSphere Transarterial chemoembolization with conventional Transarterial chemoembolization for patients with Unresectable hepatocellular carcinoma. J Vasc Interv Radiol. 2015;26:1622–9.CrossRefPubMed
10.
go back to reference Lammer J, Malagari K, Vogl T, Pilleul F, Denys A, Watkinson A, et al. Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol. 2010;33:41–52.CrossRefPubMed Lammer J, Malagari K, Vogl T, Pilleul F, Denys A, Watkinson A, et al. Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol. 2010;33:41–52.CrossRefPubMed
11.
go back to reference Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010;30:52–60.CrossRefPubMed Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010;30:52–60.CrossRefPubMed
12.
go back to reference Swarm R, Abernethy AP, Anghelescu DL, Benedetti C, Blinderman CD, Boston B, et al. Adult cancer pain. J Natl Compr Cancer Netw. 2010;8:1046–86.CrossRef Swarm R, Abernethy AP, Anghelescu DL, Benedetti C, Blinderman CD, Boston B, et al. Adult cancer pain. J Natl Compr Cancer Netw. 2010;8:1046–86.CrossRef
13.
go back to reference National Cancer Institute NIoH, U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Published May 28, 2009; Revised Version 4.03 June 14, 2010. (Vol Available from: http://evsncinihgov/ftp1/CTCAE/CTCAE_403_2010-06-14_QuickReference_5x7pdf. [Accessed May 20, 2013] [Ref list]. National Cancer Institute NIoH, U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Published May 28, 2009; Revised Version 4.03 June 14, 2010. (Vol Available from: http://​evsncinihgov/​ftp1/​CTCAE/​CTCAE_​403_​2010-06-14_​QuickReference_​5x7pdf.​ [Accessed May 20, 2013] [Ref list].
14.
go back to reference Zhang S, Huang C, Li Z, Yang Y, Bao T, Chen H, et al. Comparison of pharmacokinetics and drug release in tissues after transarterial chemoembolization with doxorubicin using diverse lipiodol emulsions and CalliSpheres beads in rabbit livers. Drug delivery. 2017;24:1011–7.CrossRefPubMed Zhang S, Huang C, Li Z, Yang Y, Bao T, Chen H, et al. Comparison of pharmacokinetics and drug release in tissues after transarterial chemoembolization with doxorubicin using diverse lipiodol emulsions and CalliSpheres beads in rabbit livers. Drug delivery. 2017;24:1011–7.CrossRefPubMed
15.
go back to reference Manini MA, Sangiovanni A, Martinetti L, Vigano D, La Mura V, Aghemo A, et al. Transarterial chemoembolization with drug-eluting beads is effective for the maintenance of the Milan-in status in patients with a small hepatocellular carcinoma. Liver Transpl. 2015;21:1259–69.CrossRefPubMed Manini MA, Sangiovanni A, Martinetti L, Vigano D, La Mura V, Aghemo A, et al. Transarterial chemoembolization with drug-eluting beads is effective for the maintenance of the Milan-in status in patients with a small hepatocellular carcinoma. Liver Transpl. 2015;21:1259–69.CrossRefPubMed
16.
go back to reference Rahman FA, Naidu J, Ngiu CS, Yaakob Y, Mohamed Z, Othman H, et al. Conventional versus doxorubicin-eluting beads Transarterial chemoembolization for Unresectable hepatocellular carcinoma: a tertiary medical Centre experience in Malaysia. Asian Pac J Cancer Prev. 2016;17:4037–41.PubMed Rahman FA, Naidu J, Ngiu CS, Yaakob Y, Mohamed Z, Othman H, et al. Conventional versus doxorubicin-eluting beads Transarterial chemoembolization for Unresectable hepatocellular carcinoma: a tertiary medical Centre experience in Malaysia. Asian Pac J Cancer Prev. 2016;17:4037–41.PubMed
17.
go back to reference Arabi M, BenMousa A, Bzeizi K, Garad F, Ahmed I, Al-Otaibi M. Doxorubicin-loaded drug-eluting beads versus conventional transarterial chemoembolization for nonresectable hepatocellular carcinoma. Saudi J Gastroenterol. 2015;21:175–80.CrossRefPubMedPubMedCentral Arabi M, BenMousa A, Bzeizi K, Garad F, Ahmed I, Al-Otaibi M. Doxorubicin-loaded drug-eluting beads versus conventional transarterial chemoembolization for nonresectable hepatocellular carcinoma. Saudi J Gastroenterol. 2015;21:175–80.CrossRefPubMedPubMedCentral
18.
go back to reference Liu YS, Ou MC, Tsai YS, Lin XZ, Wang CK, Tsai HM, et al. Transarterial chemoembolization using gelatin sponges or microspheres plus lipiodol-doxorubicin versus doxorubicin-loaded beads for the treatment of hepatocellular carcinoma. Korean J Radiol. 2015;16:125–32.CrossRefPubMedPubMedCentral Liu YS, Ou MC, Tsai YS, Lin XZ, Wang CK, Tsai HM, et al. Transarterial chemoembolization using gelatin sponges or microspheres plus lipiodol-doxorubicin versus doxorubicin-loaded beads for the treatment of hepatocellular carcinoma. Korean J Radiol. 2015;16:125–32.CrossRefPubMedPubMedCentral
19.
go back to reference Aliberti C, Carandina R, Lonardi S, Dadduzio V, Vitale A, Gringeri E, et al. Transarterial chemoembolization with small drug-eluting beads in patients with hepatocellular carcinoma: experience from a cohort of 421 patients at an Italian center. J Vasc Interv Radiol. 2017;28:1495–502.CrossRefPubMed Aliberti C, Carandina R, Lonardi S, Dadduzio V, Vitale A, Gringeri E, et al. Transarterial chemoembolization with small drug-eluting beads in patients with hepatocellular carcinoma: experience from a cohort of 421 patients at an Italian center. J Vasc Interv Radiol. 2017;28:1495–502.CrossRefPubMed
20.
go back to reference Burrel M, Reig M, Forner A, Barrufet M, de Lope CR, Tremosini S, 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 Hepatol. 2012;56:1330–5.CrossRefPubMed Burrel M, Reig M, Forner A, Barrufet M, de Lope CR, Tremosini S, 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 Hepatol. 2012;56:1330–5.CrossRefPubMed
21.
go back to reference Syha R, Gatidis S, Grozinger G, Grosse U, Maurer M, Zender L, et al. C-arm computed tomography and volume perfusion computed tomography (VPCT)-based assessment of blood volume changes in hepatocellular carcinoma in prediction of midterm tumor response to transarterial chemoembolization: a single center retrospective trial. Cancer Imaging. 2016;16:30.CrossRefPubMedPubMedCentral Syha R, Gatidis S, Grozinger G, Grosse U, Maurer M, Zender L, et al. C-arm computed tomography and volume perfusion computed tomography (VPCT)-based assessment of blood volume changes in hepatocellular carcinoma in prediction of midterm tumor response to transarterial chemoembolization: a single center retrospective trial. Cancer Imaging. 2016;16:30.CrossRefPubMedPubMedCentral
22.
go back to reference Reis SP, Sutphin PD, Singal AG, Grzybowski R, Fisher S, Ball C, et al. Tumor enhancement and heterogeneity are associated with treatment response to drug-eluting bead chemoembolization for hepatocellular carcinoma. J Comput Assist Tomogr. 2017;41:289–93.CrossRefPubMed Reis SP, Sutphin PD, Singal AG, Grzybowski R, Fisher S, Ball C, et al. Tumor enhancement and heterogeneity are associated with treatment response to drug-eluting bead chemoembolization for hepatocellular carcinoma. J Comput Assist Tomogr. 2017;41:289–93.CrossRefPubMed
23.
go back to reference Kokabi N, Ludwig JM, Camacho JC, Xing M, Mittal PK, Kim HS. Baseline and early MR apparent diffusion coefficient quantification as a predictor of response of Unresectable hepatocellular carcinoma to doxorubicin drug-eluting bead chemoembolization. J Vasc Interv Radiol. 2015;26:1777–86.CrossRefPubMed Kokabi N, Ludwig JM, Camacho JC, Xing M, Mittal PK, Kim HS. Baseline and early MR apparent diffusion coefficient quantification as a predictor of response of Unresectable hepatocellular carcinoma to doxorubicin drug-eluting bead chemoembolization. J Vasc Interv Radiol. 2015;26:1777–86.CrossRefPubMed
24.
go back to reference Llovet JM, Bru C, Bruix J. Prognosis of hepatocellular carcinoma: the BCLC staging classification. Semin Liver Dis. 1999;19:329–38.CrossRefPubMed Llovet JM, Bru C, Bruix J. Prognosis of hepatocellular carcinoma: the BCLC staging classification. Semin Liver Dis. 1999;19:329–38.CrossRefPubMed
25.
go back to reference Kao WY, Chao Y, Chang CC, Li CP, Su CW, Huo TI, et al. Prognosis of early-stage hepatocellular carcinoma: the clinical implications of substages of Barcelona clinic liver Cancer system based on a cohort of 1265 patients. Medicine (Baltimore). 2015;94:e1929.CrossRef Kao WY, Chao Y, Chang CC, Li CP, Su CW, Huo TI, et al. Prognosis of early-stage hepatocellular carcinoma: the clinical implications of substages of Barcelona clinic liver Cancer system based on a cohort of 1265 patients. Medicine (Baltimore). 2015;94:e1929.CrossRef
26.
go back to reference Soydal C, Arslan MF, Kucuk ON, Idilman R, Bilgic S. Comparison of survival, safety, and efficacy after transarterial chemoembolization and radioembolization of Barcelona clinic liver Cancer stage B-C hepatocellular cancer patients. Nucl Med Commun. 2016;37:646–9.CrossRefPubMed Soydal C, Arslan MF, Kucuk ON, Idilman R, Bilgic S. Comparison of survival, safety, and efficacy after transarterial chemoembolization and radioembolization of Barcelona clinic liver Cancer stage B-C hepatocellular cancer patients. Nucl Med Commun. 2016;37:646–9.CrossRefPubMed
27.
28.
go back to reference Feo F, Pascale RM. Multifocal hepatocellular carcinoma: intrahepatic metastasis or multicentric carcinogenesis? Ann Transl Med. 2015;3:4.PubMedPubMedCentral Feo F, Pascale RM. Multifocal hepatocellular carcinoma: intrahepatic metastasis or multicentric carcinogenesis? Ann Transl Med. 2015;3:4.PubMedPubMedCentral
29.
go back to reference Goh BK, Chow PK, Teo JY, Wong JS, Chan CY, Cheow PC, et al. Number of nodules, child-Pugh status, margin positivity, and microvascular invasion, but not tumor size, are prognostic factors of survival after liver resection for multifocal hepatocellular carcinoma. J Gastrointest Surg. 2014;18:1477–85.CrossRefPubMed Goh BK, Chow PK, Teo JY, Wong JS, Chan CY, Cheow PC, et al. Number of nodules, child-Pugh status, margin positivity, and microvascular invasion, but not tumor size, are prognostic factors of survival after liver resection for multifocal hepatocellular carcinoma. J Gastrointest Surg. 2014;18:1477–85.CrossRefPubMed
30.
go back to reference Monier A, Guiu B, Duran R, Aho S, Bize P, Deltenre P, et al. Liver and biliary damages following transarterial chemoembolization of hepatocellular carcinoma: comparison between drug-eluting beads and lipiodol emulsion. Eur Radiol. 2017;27:1431–9.CrossRefPubMed Monier A, Guiu B, Duran R, Aho S, Bize P, Deltenre P, et al. Liver and biliary damages following transarterial chemoembolization of hepatocellular carcinoma: comparison between drug-eluting beads and lipiodol emulsion. Eur Radiol. 2017;27:1431–9.CrossRefPubMed
31.
go back to reference Lee S, Kim KM, Lee SJ, Lee KH, Lee DY, Kim MD, et al. Hepatic arterial damage after transarterial chemoembolization for the treatment of hepatocellular carcinoma: comparison of drug-eluting bead and conventional chemoembolization in a retrospective controlled study. Acta Radiol. 2017;58:131–9.CrossRefPubMed Lee S, Kim KM, Lee SJ, Lee KH, Lee DY, Kim MD, et al. Hepatic arterial damage after transarterial chemoembolization for the treatment of hepatocellular carcinoma: comparison of drug-eluting bead and conventional chemoembolization in a retrospective controlled study. Acta Radiol. 2017;58:131–9.CrossRefPubMed
32.
go back to reference Kalva SP, Pectasides M, Liu R, Rachamreddy N, Surakanti S, Yeddula K, et al. Safety and effectiveness of chemoembolization with drug-eluting beads for advanced-stage hepatocellular carcinoma. Cardiovasc Intervent Radiol. 2014;37:381–7.CrossRefPubMed Kalva SP, Pectasides M, Liu R, Rachamreddy N, Surakanti S, Yeddula K, et al. Safety and effectiveness of chemoembolization with drug-eluting beads for advanced-stage hepatocellular carcinoma. Cardiovasc Intervent Radiol. 2014;37:381–7.CrossRefPubMed
33.
go back to reference Nam HC, Jang B, Song MJ. Transarterial chemoembolization with drug-eluting beads in hepatocellular carcinoma. World J Gastroenterol. 2016;22:8853–61.CrossRefPubMedPubMedCentral Nam HC, Jang B, Song MJ. Transarterial chemoembolization with drug-eluting beads in hepatocellular carcinoma. World J Gastroenterol. 2016;22:8853–61.CrossRefPubMedPubMedCentral
Metadata
Title
Efficacy and safety profile of drug-eluting beads transarterial chemoembolization by CalliSpheres® beads in Chinese hepatocellular carcinoma patients
Authors
Guan-Hui Zhou
Jun Han
Jun-Hui Sun
Yue-Lin Zhang
Tan-Yang Zhou
Chun-Hui Nie
Tong-Yin Zhu
Sheng-Qun Chen
Bao-Quan Wang
Zi-Niu Yu
Hong-Liang Wang
Li-Ming Chen
Wei-Lin Wang
Shu-Sen Zheng
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4566-4

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