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Comparison of the Adverse Event Profile of TheraSphere® with SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma: A Systematic Review

  • Clinical Investigation
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Abstract

To compare the safety profiles of TheraSphere® (glass) and SIR-Spheres® (resin) Y90 microspheres for the treatment of hepatocellular carcinoma. A systematic review was conducted using the databases MEDLINE, Embase, and Cochrane Trials Register to identify all relevant studies. Baseline characteristics and adverse events of all grades related to gastrointestinal, hepatobiliary, and respiratory systems were collected along with commonly reported outcomes related to post-embolization syndrome. For all outcomes, data from each study were tabulated for each intervention. Adverse events and patients were summed across studies on TheraSphere® and SIR-Spheres®, respectively, and the resulting proportion of patients experiencing an outcome for both interventions was calculated. Thirty-one observational studies were included in the review. In the adverse events of all grades, more patients treated with resin microspheres reported gastric ulcers, hepatic encephalopathy, cholecystitis, hepatic failure, and pleural effusion. Patients treated with resin microspheres also had more hepatobiliary adverse events of grade 3 or higher. In the events related to post-embolization syndrome, glass microspheres exhibited a similar safety profile compared to resin microspheres. Ascites and nausea grade 3 or higher were recorded more frequently with glass microsphere treatment. Based on this review of the published literature, glass microspheres exhibit a safety profile with fewer gastrointestinal and pulmonary adverse events compared to resin microspheres in the treatment of hepatocellular carcinoma.

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Abbreviations

AE:

Adverse event

AFP:

Alpha-fetoprotein

BCLC:

Barcelona Clinic Liver Cancer

C–P:

Child–Pugh

CI:

95% confidence interval

CT:

Computed tomography

ECOG:

Eastern Cooperative Oncology Group

HCC:

Hepatocellular carcinoma

MAA:

Macroaggregated albumin

MRI:

Magnetic resonance imaging

NASH:

Non-alcoholic steatohepatitis

PVT:

Portal vein thrombosis

Y90:

Yttrium-90

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Acknowledgements

We would like to acknowledge the efforts of Philip Sinclair and Jennifer Bull, both employees of BTG. BTG provided funding for the systematic review.

Funding

The data analysis supporting this manuscript was developed by Redwood Outcomes Inc. and was supported by funding from BTG International Inc.

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Authors and Affiliations

  1. Section of Interventional Radiology, Department of Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, 676 N. St. Clair, Suite 800, Chicago, IL, 60611, USA

    Joseph Ralph Kallini, Ahmed Gabr, Robert J. Lewandowski & Riad Salem

  2. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada

    Kristian Thorlund & Shanil Ebrahim

  3. Redwood Outcomes Inc, Vancouver, BC, Canada

    Kristian Thorlund, Chakrapani Balijepalli, Dieter Ayres, Steve Kanters, Shanil Ebrahim & Edward Mills

  4. Department of Health Sciences, Simon Fraser University, Vancouver, BC, Canada

    Chakrapani Balijepalli

  5. Stanford Prevention Research Center, Stanford School of Medicine, Stanford University, Stanford, CA, USA

    Edward Mills

  6. Division of Hematology and Oncology, Department of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA

    Robert J. Lewandowski & Riad Salem

Authors
  1. Joseph Ralph Kallini
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  2. Ahmed Gabr
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  4. Chakrapani Balijepalli
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  9. Robert J. Lewandowski
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Correspondence to Riad Salem.

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Conflict of interest

Robert Lewandowski and Riad Salem are advisors to BTG international. Kristian Thorlund, Chakrapani Balijepalli, Dieter Ayres, Steve Kanters, and Edward Mills are employees of Redwood Outcomes, a health economics and outcomes research firm that provides services to the healthcare industry. The Redwood employees provided the systematic review, data extraction, statistical analyses, “Methods” section, and data output. None of the other authors report a conflict of interest. Joseph Kallini, Ahmed Gabr, Robert Lewandowski, and Riad Salem drafted the first version of the manuscript.

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Kallini, J.R., Gabr, A., Thorlund, K. et al. Comparison of the Adverse Event Profile of TheraSphere® with SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma: A Systematic Review. Cardiovasc Intervent Radiol 40, 1033–1043 (2017). https://doi.org/10.1007/s00270-017-1594-4

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