Laura Kulik1, Michael Vouche2, Sean Koppe1, Robert J Lewandowski3, Mary F Mulcahy4, Daniel Ganger1, Ali Habib2, Jennifer Karp2, Patrice Al-Saden1, Mario Lacouture5, Jonathan Cotliar6, Michael Abecassis7, Talia Baker7, Riad Salem8. 1. Department of Medicine, Division of Hepatology, Northwestern University, Chicago, IL, USA. 2. Department of Radiology, Section of Interventional Radiology, Northwestern University, Chicago, IL, USA. 3. Department of Radiology, Section of Interventional Radiology, Northwestern University, Chicago, IL, USA; Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA. 4. Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA. 5. Department of Medicine, Division of Dermatology, Memorial Sloan Kettering, New York, NY, USA. 6. Department of Dermatology, Northwestern University, Chicago, IL, USA. 7. Department of Surgery, Division of Transplant Surgery, Northwestern University, Chicago, IL, USA. 8. Department of Radiology, Section of Interventional Radiology, Northwestern University, Chicago, IL, USA; Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA; Department of Surgery, Division of Transplant Surgery, Northwestern University, Chicago, IL, USA. Electronic address: r-salem@northwestern.edu.
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.
RCT Entities:
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.
Authors: Giuseppe Maria Ettorre; Giovanni Battista Levi Sandri; Andrea Laurenzi; Marco Colasanti; Roberto Luca Meniconi; Raffaella Lionetti; Roberto Santoro; Pasquale Lepiane; Rosa Sciuto; Giuseppe Pizzi; Roberto Cianni; Rita Golfieri; Gianpiero D'Offizi; Adriano M Pellicelli; Mario Antonini; Giovanni Vennarecci Journal: World J Surg Date: 2017-01 Impact factor: 3.352