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

Laura Kulik, Michael Vouche, Sean Koppe, Robert J. Lewandowski, Mary F. Mulcahy, Daniel Ganger, Ali Habib, Jennifer Karp, Patrice Al-Saden, Mario Lacouture, Jonathan Cotliar, Michael Abecassis, Talia Baker, Riad Salem*

*Corresponding author for this work

Research output: Contribution to journalArticle

39 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)309-317
Number of pages9
JournalJournal of Hepatology
Volume61
Issue number2
DOIs
StatePublished - Jan 1 2014

Fingerprint

Hepatocellular Carcinoma
Transplantation
Transplants
Liver Transplantation
sorafenib
Survival Rate
Safety

Keywords

  • Hepatocellular carcinoma
  • Radioembolization
  • Sorafenib
  • Transplantation

ASJC Scopus subject areas

  • Hepatology

Cite this

Kulik, Laura ; Vouche, Michael ; Koppe, Sean ; Lewandowski, Robert J. ; Mulcahy, Mary F. ; Ganger, Daniel ; Habib, Ali ; Karp, Jennifer ; Al-Saden, Patrice ; Lacouture, Mario ; Cotliar, Jonathan ; Abecassis, Michael ; Baker, Talia ; Salem, Riad. / Prospective randomized pilot study of Y90 +/- sorafenib as bridge to transplantation in hepatocellular carcinoma. In: Journal of Hepatology. 2014 ; Vol. 61, No. 2. pp. 309-317.
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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.",
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author = "Laura Kulik and Michael Vouche and Sean Koppe and Lewandowski, {Robert J.} and Mulcahy, {Mary F.} and Daniel Ganger and Ali Habib and Jennifer Karp and Patrice Al-Saden and Mario Lacouture and Jonathan Cotliar and Michael Abecassis and Talia Baker and Riad Salem",
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Prospective randomized pilot study of Y90 +/- sorafenib as bridge to transplantation in hepatocellular carcinoma. / Kulik, Laura; Vouche, Michael; Koppe, Sean; Lewandowski, Robert J.; Mulcahy, Mary F.; Ganger, Daniel; Habib, Ali; Karp, Jennifer; Al-Saden, Patrice; Lacouture, Mario; Cotliar, Jonathan; Abecassis, Michael; Baker, Talia; Salem, Riad.

In: Journal of Hepatology, Vol. 61, No. 2, 01.01.2014, p. 309-317.

Research output: Contribution to journalArticle

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T1 - Prospective randomized pilot study of Y90 +/- sorafenib as bridge to transplantation in hepatocellular carcinoma

AU - Kulik, Laura

AU - Vouche, Michael

AU - Koppe, Sean

AU - Lewandowski, Robert J.

AU - Mulcahy, Mary F.

AU - Ganger, Daniel

AU - Habib, Ali

AU - Karp, Jennifer

AU - Al-Saden, Patrice

AU - Lacouture, Mario

AU - Cotliar, Jonathan

AU - Abecassis, Michael

AU - Baker, Talia

AU - Salem, Riad

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N2 - 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.

AB - 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.

KW - Hepatocellular carcinoma

KW - Radioembolization

KW - Sorafenib

KW - Transplantation

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