PARIS, Feb. 3, 2012 /CNW/ - 'SARAH' - a French national collaborative
randomized controlled trial of radioembolization with yttrium-90 resin
microspheres versus sorafenib in advanced hepatocellular carcinoma is
now open for recruitment.
The start of SARAH, a new randomized controlled trial to directly
compare the effectiveness of radioembolization with yttrium-90 resin
microspheres (SIR-Spheres® microspheres; Sirtex Medical Limited, Australia) versus sorafenib
(Nexavar®, Bayer HealthCare Pharmaceuticals, Germany), a systemic therapy that is
the current standard of care for patients with non-surgical advanced
hepatocellular carcinoma (HCC), was announced today by the principal
investigator, Professor Valérie Vilgrain MD, PhD, Department of
Radiology, Beaujon Hospital, Assistance Publique - Hôpitaux de Paris,
Clichy and Université Paris Diderot, Sorbonne Paris Cité, France.
SARAH (SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma)is a Phase III multi-centre prospective
randomized open-labelled trial, which aims to recruit 400 patients in
France with advanced HCC (Barcelona Clinic Liver Cancer stage C) with
or without portal vein thrombosis and no extrahepatic spread, who are
ineligible for surgical resection, liver transplantation or
radiofrequency ablation; or whose disease has progressed or recurred
after previous therapies.
The primary goal of the study will be to assess if radioembolization
with yttrium-90 resin microspheres provides an increased survival
benefit compared to sorafenib in patients with advanced HCC.
Professor Vilgrain said: "Around 20 specialist cancer centres throughout
France will be involved in this trial. SIR-Spheres microspheres were
selected for the test arm of this collaborative trial, which is being
promoted by the 'Assistance Publique - Hôpitaux de Paris'."
In patients with advanced HCC, sorafenib is now the standard treatment.
Its use is associated with an increased median overall survival (from
8 to 11 months in the SHARP trial) but 80% of patients also experience
treatment-related adverse events.
Selective Internal Radiation Therapy (SIRT), also known as
radioembolization, is a novel treatment for inoperable liver cancer
that delivers high doses of radiation directly to the site of tumours.
It is a minimally-invasive treatment, in which millions of radioactive
SIR-Spheres microspheres (diameter between 20-60 microns) are infused
via a catheter into the liver, where they selectively target liver
tumours with a dose of internal radiation up to 40 times higher than
conventional radiotherapy, while sparing healthy tissue. There is a
growing interest in radioembolization using yttrium-90 resin
microspheres in this patient population, based on a substantial number
of open-label single-group studies as well as a large multi-centre
European analysis of the long-term outcomes related to survival and safety of
radioembolization using SIR-Spheres microspheres in patients with
inoperable HCC. In 13 open-label single-group studies totalizing 400
patients with advanced HCC, the combined estimation of the median
overall survival after radioembolization with yttrium-90 microspheres
was of 15 months (min-max: 7 to 27 months).
SIR-Spheres microspheres are approved for use in Australia, the European
Union (CE Mark), New Zealand, Switzerland, Turkey and several other
countries including in Asia (e.g. India, Korean, Singapore and Hong
Kong) for the treatment of unresectable liver tumours. SIR-Spheres
microspheres are also indicated in the U.S. for the treatment of
non-resectable metastatic liver tumours from primary colorectal cancer
in combination with intra-hepatic artery chemotherapy using
Professor Vilgrain said that: "The SARAH trial is testing the hypothesis
that radioembolization using yttrium-90 resin microspheres can increase
the median overall survival with fewer side effects and/or a better
quality of life in comparison with sorafenib. We hope that the results
of this study will help improve the prognosis for these difficult to
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) occurs in people whose livers have become
severely damaged or cirrhotic, due to conditions such as hepatitis and
alcoholism. It is one of the ten most-common cancers in the world,
with nearly 750,000 cases diagnosed annually, and the third-leading
cause of cancer deaths. It occurs with greatest frequency in regions where viral hepatitis B
or C are most often diagnosed, such as in Asia Pacific and Southern
Hepatocellular cancer can be cured by surgery, either by resecting the
diseased parts of the liver, or by transplantation with a liver from a
healthy donor. These interventions, however, are inappropriate for the
great majority of patients, whose survival may range from a few months
to two or more years depending largely on the state of their liver at
the time of their diagnosis and the extent of tumour invasion.
SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma (SARAH): http://clinicaltrials.gov/ct2/show/NCT01482442.
Sangro B, Carpanese L, Cianni R et al on behalf of European Network on Radioembolization with yttrium-90
resin microspheres (ENRY). Survival after Y resin microsphere radioembolization of hepatocellular carcinoma across
BCLC stages: A European evaluation. Hepatology 2011; 54: 868-878.
GLOBOCAN. Liver Cancer Incidence and Mortality Worldwide in 2008. http://globocan.iarc.fr/factsheets/cancers/liver.asp accessed 28 June 2011.
SOURCE Sirtex Medical Limited
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