Document Type

Article

Original Publication Date

2017

Journal/Book/Conference Title

AMERICAN JOURNAL OF SURGERY

Volume

213

Issue

4

First Page

688

Last Page

695

DOI of Original Publication

10.1016/j.amjsurg.2016.10.006

Comments

Originally published at http://doi.org/10.1016/j.amjsurg.2016.10.006

Date of Submission

July 2017

Abstract

Treatment of unresectable recurrent hepatocellular carcinoma (HCC) in patients who recur after resection or orthotopic liver transplantation (OLT) remains a clinical challenge. One option is sorafenib, although little is known about its safety and tolerance in this unique patient population; therefore, we analyzed patients who underwent prior surgical resection and/or OLT and were treated with sorafenib in US cohort of GIDEON registry. In US, 645 patients were enrolled; 553 for intent to treat and 563 for safety. Data were analyzed in the safety population of 479 patients no surgery and 56 for resection or OLT. Forty-one patients underwent resection prior to the initiation of sorafenib, 15 patients had previously received an OLT, and 6 patients had both resection and OLT. Initial low starting doses (400 mg/day) were observed for more patients with prior OLT (71%) than prior resection (36%), resection and OLT (50%), concomitant OLT (25%), and no surgery (36%). Most AEs occurred in the first 4 weeks of treatment. Drug-related AEs were higher in patients with prior resection (87%), prior OLT (100%), or both (100%) than in patients with concomitant OLT (63%) or no surgery (70%). However, incidence of AEs resulting in permanent discontinuation were similar in all groups (19-38%).

Rights

(C) 2016 Elsevier Inc. All rights reserved.

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VCU Surgery Publications

Included in

Surgery Commons

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