Prospective Phase II trial of drug-eluting bead chemoembolization for liver transplant candidates with hepatocellular carcinoma and marginal hepatic reserve
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-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 2
Editor who approved publication: Dr Ahmed O. 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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