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Prospective Phase II trial of drug-eluting bead chemoembolization for liver transplant candidates with hepatocellular carcinoma and marginal hepatic reserve

Authors Fidelman N, Johanson C, Kohi MP, Kolli KP, Kohlbrenner RM, Lehrman ED, Taylor AG, Kelley RK, Yao FY, Roberts JP, Kerlan RK

Received 27 February 2019

Accepted for publication 7 May 2019

Published 17 June 2019 Volume 2019:6 Pages 93—103


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Ahmed Kaseb

Nicholas Fidelman,1 Curt Johanson,1 Maureen P Kohi,1 K Pallav Kolli,1 Ryan M Kohlbrenner,1 Evan D Lehrman,1 Andrew G Taylor,1 R Kate Kelley,2 Francis Y Yao,3 John P Roberts,4 Robert K Kerlan1

1Department of Radiology and Biomedical Imaging; 2Department of Medicine – Division of Gastrointestinal Oncology; 3Department of Medicine – Division of Hepatology; 4Department of Surgery – Division of Transplant Surgery, University of California San Francisco, San Francisco, CA, USA

Purpose: To determine whether chemoembolization using drug-eluting beads (DEB-TACE) is safe and effective for liver transplantation candidates with liver-limited hepatocellular carcinoma (HCC) without vascular invasion and baseline hepatic dysfunction.
Materials and methods: Seventeen adult liver transplantation candidates (median age 66 years, range 58–73 years; 13 men) with HCC were treated with DEB-TACE as a part of Stage 1 of a prospective single-institution Phase II trial. All patients had marginal hepatic reserve based on at least one of the following criteria: ascites (n=14), bilirubin between 3 and 6 mg/dL (n=5), AST 5–10 times upper normal limit (n=1), INR between 1.6 and 2.5 (n=4), portal vein thrombosis (n=2), and/or portosystemic shunt (n=2). Primary study objectives were safety and best observed radiographic response.
Results: Thirty-seven DEB-TACE procedures were performed. Objective response rate and disease control rate were 63% and 88%, respectively. HCC progression was observed in 12 patients. Median time to progression was 5.6 months (range 0.9–13.6 months). Within 1 month following DEB-TACE, 13 patients (76%) developed grade 3 or 4 AE attributable to the procedure. Four patients (all within Milan Criteria) were transplanted (2.7–6.9 months after DEB-TACE), and 12 patients died (1.8–32 months after DEB-TACE). All deaths were due to liver failure that was either unrelated to HCC (n=5), in the setting of metastatic HCC (n=5), or in the setting of locally advanced HCC (n=2). Mortality rate at 1 month was 0%.
Conclusions: DEB-TACE achieves tumor responses but carries a high risk of hepatotoxicity for liver transplant candidates with HCC and marginal hepatic reserve.

Keywords: hepatocellular carcinoma, chemoembolization, liver transplantation

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