Copenhagen, Denmark, Friday 24 April: Radioembolisation with Yttrium-90 (Y-90) glass microspheres is a safe and effective treatment for patients with advanced HCC +/- portal vein thrombosis, according to new research presented today at EASL 2009, the Annual Meeting of the European Association for the Study of the Liver in Copenhagen, Denmark.
According to the researchers, these findings create the foundation for a trial comparing and combining radioembolisation with multi-targeted kinase inhibitor, sorafenib. This would represent a new treatment option for sufferers of advanced HCC who currently have limited therapeutic choices.
HCC is a primary malignancy of the liver cells, generally leading to death within 6-20 months. It is currently one of the most common worldwide causes of cancer death. Locoregional treatment of HCC is considered the most effective palliative therapeutic approach. However, advanced tumour stages including portal vein thrombosis, diffuse multifocal liver infiltration and large tumour burden are obstacles for conventional local treatments. Due to the possibility of unselective application, radioembolisation with Yttrium-90 glass microspheres may allow effective local ablative therapy even in patients with intra-hepatic advanced HCC.
The aim of this open-label phase II study was to evaluate the safety and efficacy of radioembolisation in a European cohort of patients with locally advanced HCC and to assess the response rate according to different approved response criteria (WHO, RECIST and EASL).
Professor Guido Gerken, Head of Department of Hepatology and Gastroenterology, Essen University Hospital, Germany, who led the study, said: “In terms of a global strategy, we hope to achieve a major impact on the incidence of HCC through current vaccination strategies for HBV virus infection, screening and treatment for HCV infections, and from the reduction of alcoholic liver disease. However, because the latency period from hepatic damage to HCC development is very long, it may be many years until the incidence of HCC decreases as a result of these interventions. Previous therapeutic options have been limited to transplant or selective locoregional treatment but this exciting advance means new hope for HCC sufferers in the form of a novel treatment.”
From November 2006 to August 2008, researchers in this study assessed 71 patients with advanced unresectable HCC +/- portal vein thrombosis for inclusion in this prospective study. Y-90 microsphere radiotherapy was performed in a lobar fashion via the right or left hepatic artery. In bilobar disease, right and left liver lobes were treated with 4-6 weeks intervals in between. The mean radiation dose was 115 (+/-23) Gy per treatment. Response rate was assessed according to (WHO, RECIST and EASL) criteria with sequential computed tomography scans till the last clinical visit or death. The safety of this technique was evaluated according to CTC toxicity criteria.
51/71 patients had a follow-up of at least six months. 52/71 patients had liver cirrhosis. 7.30% of the patients had portal vein thrombosis before therapy. Partial response rate was detected in 52%. With consideration of necrosis (EASL criteria) partial response was 80%. During the limited follow up, 2/70 patients died within the first month after therapy. 11/70 patients died within at least 6 months after therapy. Time to progression (TTP) was 6 months. One year survival rate was 72%. TTP and overall survival seem comparable to systemic therapy. The main adverse events were a transient fatigue-syndrome and lymphopenia. Five patients developed bilirubin elevation after therapy.