Transplant Trial Watch

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

Kulik L, Vouche M, Koppe S, et al.

Journal of hepatology 2014; 61 (2): 309-317


Aims
To evaluate safety and adverse events of sorafenib plus radioembolization (Y90) compared to Y90 alone in patients awaiting liver transplantation.

Interventions
Participants received Y90 alone or 14 days of sorafenib therapy (+/- 3 days) prior to Y90. All patients were prescribed fluocinonide 0.05% cream.

Participants
23 hepatocellular carcinoma patients awaiting orthotopic liver transplantation.

Outcomes
Outcomes included follow-up blood counts, clinical adverse events, weekly blood pressure measurements, quantification of viable diseases and tumour staging biliary complications and acute cellular rejection.

Follow-up
>3 years.

CET Conclusions
This small, unblinded study investigates the addition of the angiogenesis inhibitor Sorafenib to radioembolization as a bridge to transplantation in patients with hepatocellular carcinoma. Twenty patients were analysed (10 per group), and there was no difference in the rate of transplantation between groups. There was, however, an increase in the risk of biliary complications and a trend towards increased acute rejection rates in the Sorafenib arm of the study. Sorafenib was also poorly tolerated, with all patients requiring a dose reduction and high rates of adverse events. Clearly, the size of this trial makes it very difficult to draw any firm conclusions, but the increase in the rate of biliary complications is worrying with no suggestion of benefit. The primary outcome from the study is unclear, making interpretation of the reported statistical power impossible. The use of Sorafenib in this way outside of the research setting cannot be recommended.

Jadad score
3

Data analysis
Modified intention-to-treat analysis

Allocation concealment
No

Trial registration
Not reported.

Funding source
Industry & non-industry funded