TY - JOUR
T1 - Sorafenib use for recurrent hepatocellular cancer after resection or transplantation
T2 - Observations from a US regional analysis of the GIDEON registry
AU - Martin, Robert C.G.
AU - Bruenderman, Elizabeth
AU - Cohn, Allen
AU - Piperdi, Bilal
AU - Miksad, Rebecca
AU - Geschwind, Jean Francois
AU - Goldenberg, Alec
AU - Sanyal, Arun
AU - Zigmont, Ellen
AU - Babajanyan, Svetlana
AU - Foreman, Pamela
AU - Mantry, Parvez
AU - McGuire, Brendan
AU - Gholam, Pierre
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2017/4/1
Y1 - 2017/4/1
N2 - 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%).
AB - 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%).
KW - Hepatocellular cancer
KW - Liver
KW - Recurrence
KW - Resection
KW - Sorafenib
KW - Transplantation
KW - Treatment of recurrent cancer
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U2 - 10.1016/j.amjsurg.2016.10.006
DO - 10.1016/j.amjsurg.2016.10.006
M3 - Article
C2 - 28318501
AN - SCOPUS:85015357332
SN - 0002-9610
VL - 213
SP - 688
EP - 695
JO - American Journal of Surgery
JF - American Journal of Surgery
IS - 4
ER -