Sirtex has announced that the SARAH (Sorafenib vs. radioembolisation in advanced hepatocellular carcinoma) randomised controlled study results will be presented at the upcoming European Association for the Study of the Liver (EASL), International Liver Congress (ILC) in Amsterdam, the Netherlands (19–23 April 2017).
The study will be presented on Saturday, 22 April 2017.
SARAH is a phase III multicentre prospective randomised open-label study for patients in France that directly compared the efficacy and safety of Sir-spheres Y-90 resin microspheres with the current standard-of-care systemic therapy, sorafenib (Bayer) in patients with advanced non-resectable primary liver cancer. Unless embargoed, the study abstract will be released on 5 April, a press release from the company states.
Patients with advanced hepatocellular carcinoma (Barcelona Clinic Liver Cancer [BCLC] stage C) with or without portal vein thrombosis and no extrahepatic spread, or patients with early/intermediate hepatocellular carcinoma (BCLC stage A or B) whose disease has progressed or recurred after previous therapies; and who are ineligible for surgical resection, ablation or liver transplantation were recruited to participate.
The primary endpoint of the SARAH study is overall survival. Secondary endpoints include safety, progression-free survival at six months, quality of life, and healthcare costs. The study completed enrolment of >460 patients in March 2015.
SARAH is the largest randomised study ever to compare selective internal radiation therapy using Sir-spheres microspheres against the standard-of-care systemic therapy in the treatment of hepatocellular carcinoma, the release adds.