Prospective randomized pilot study of Y90 +/- sorafenib as bridge to transplantation in hepatocellular carcinoma Journal Article


Authors: Kulik, L.; Vouche, M.; Koppe, S.; Lewandowski, R. J.; Mulcahy, M. F.; Ganger, D.; Habib, A.; Karp, J.; Al-Saden, P.; Lacouture, M.; Cotliar, J.; Abecassis, M.; Baker, T.; Salem, R.
Article Title: Prospective randomized pilot study of Y90 +/- sorafenib as bridge to transplantation in hepatocellular carcinoma
Abstract: Background & Aims: To investigate the safety and adverse event profile of sorafenib plus radioembolization (Y90) compared to Y90 alone in patients awaiting liver transplantation. Methods: 20 patients with HCC were randomized to Y90 alone (Group A) or Y90 + sorafenib (Group B). Adverse events, dose reductions, and peri-transplant complications were assessed. Results: All patients in the sorafenib group necessitated dose reductions. Seventeen of 20 patients underwent liver transplantation; median time-to-transplant was 7.8 months (range: 4.2-20.3) and similar between groups (p = 0.35). In the sorafenib group, there were 4/8 peri-transplant (<30 days) biliary complications (p = 0.029) and 3/8 acute rejections (p = 0.082); there were none in the Y90-only group. Survival rates were 70% (Group A) and 72% (Group B) at 3 years (p = 0.57). Conclusions: The addition of sorafenib to Y90 necessitated dose reductions in all patients awaiting transplantation. Preliminary data suggest that the combination was associated with more peri-transplant biliary complications and potentially trended towards more acute rejections. Caution should be exercised when considering sorafenib in the transplant setting. Further investigation is warranted.
Keywords: adult; clinical article; controlled study; aged; survival rate; hepatocellular carcinoma; sorafenib; artificial embolism; drug dose reduction; drug safety; hepatic encephalopathy; liver cell carcinoma; liver transplantation; prospective study; transplantation; psoriasis; acute kidney failure; add on therapy; pilot study; liver resection; living donor; hospital admission; yttrium 90; radioembolization; acute graft rejection; erythroderma; human; male; female; priority journal; article
Journal Title: Journal of Hepatology
Volume: 61
Issue: 2
ISSN: 0168-8278
Publisher: Elsevier Science, Inc.  
Date Published: 2014-08-01
Start Page: 309
End Page: 317
Language: English
DOI: 10.1016/j.jhep.2014.03.023
PROVIDER: scopus
PUBMED: 24681342
DOI/URL:
Notes: Cited By (since 1996):2 -- Export Date: 2 September 2014 -- CODEN: JOHEE -- Source: Scopus
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  1. Mario E Lacouture
    457 Lacouture