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Last updated on April 19, 2014 at 13:20 EDT

New Study of Primary Liver Cancer Seeks to Enroll 400 French Patients

February 3, 2012

PARIS, February 3, 2012 /PRNewswire/ –

‘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(R)
microspheres; Sirtex Medical Limited, Australia) versus sorafenib (Nexavar(R), 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 Valerie Vilgrain MD, PhD, Department of
Radiology, Beaujon Hospital, Assistance Publique – Hopitaux de Paris, Clichy and
Universite Paris Diderot, Sorbonne Paris Cite, 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.[1]

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 – Hopitaux 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[2] 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 floxuridine.

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 treat patients”.

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.[3] It occurs with greatest frequency in regions
where viral hepatitis B or C aremost often diagnosed, such as in Asia Pacific and Southern
Europe.

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.

References:

        1) SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma
          (SARAH): http://clinicaltrials.gov/ct2/show/NCT01482442.
        2) Sangro B, Carpanese L, Cianni R et al on behalf of European Network on
          Radioembolization with yttrium-90 resin microspheres (ENRY). Survival after [90]Y
          resin microsphere radioembolization of hepatocellular carcinoma across BCLC stages: A
          European evaluation. Hepatology 2011; 54: 868-878.
        3) 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


Source: PR Newswire