Randomized trial of hepatic artery embolization for hepatocellular carcinoma using doxorubicin-eluting microspheres compared with embolization with microspheres alone Journal Article

Authors: Brown, K. T.; Do, R. K.; Gonen, M.; Covey, A. M.; Getrajdman, G. I.; Sofocleous, C. T.; Jarnagin, W. R.; D'Angelica, M. I.; Allen, P. J.; Erinjeri, J. P.; Brody, L. A.; O'Neill, G. P.; Johnson, K. N.; Garcia, A. R.; Beattie, C.; Zhao, B. S.; Solomon, S. B.; Schwartz, L. H.; DeMatteo, R.; Abou-Alfa, G. K.
Article Title: Randomized trial of hepatic artery embolization for hepatocellular carcinoma using doxorubicin-eluting microspheres compared with embolization with microspheres alone
Abstract: Purpose Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres. Materials and Methods At a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual. Results Between December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, -0.1%; 95% CI, -9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively. Conclusion There was no apparent difference between the treatment arms. These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC. (C) 2016 by American Society of Clinical Oncology
Keywords: cisplatin; malignancy; guidelines; therapy; model; tissue; transarterial chemoembolization; beads; tace
Journal Title: Journal of Clinical Oncology
Volume: 34
Issue: 17
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2016-06-10
Start Page: 2046
End Page: 2053
Language: English
ACCESSION: WOS:000377378400013
DOI: 10.1200/jco.2015.64.0821
PUBMED: 26834067
PMCID: PMC4966514
Notes: Article -- Presented in part at the 10th Annual American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco, CA that took place January 24-26, 2013, and at the 39th Annual Meeting of the Society of Interventional Radiology in San Diego, CA that took place March 22-27, 2014 -- Source: Wos
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MSK Authors
  1. Ronald P Dematteo
    591 Dematteo
  2. Mithat Gonen
    692 Gonen
  3. Anne Covey
    115 Covey
  4. Ghassan Abou-Alfa
    210 Abou-Alfa
  5. Peter Allen
    433 Allen
  6. William R Jarnagin
    576 Jarnagin
  7. Kinh Gian Do
    110 Do
  8. Lynn Brody
    90 Brody
  9. Karen T Brown
    158 Brown
  10. Stephen Solomon
    255 Solomon
  11. Alessandra   Garcia
    5 Garcia