PATIENTS THROUGHOUT FRANCE

PR Newswire

PARIS, June 24, 2013

PARIS, June 24, 2013 /PRNewswire/ --

Launched by theAssistance Publique - Hôpitaux de Paris(AP-HP) in December
2011, SARAH, a French national collaborative randomized controlled trial of
radioembolization with yttrium-90 resin microspheres versus sorafenib in
advanced hepatocellular carcinoma seeks to enroll 400 patients

To date, more than 150 patients have taken part in this study

PARIS (June 20, 2013) In patients with advanced HCC, sorafenib (Nexavar^®,
Bayer HealthCare Pharmaceuticals, Germany), with which radioembolization is
being compared, 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. The SARAH
trial is testing the hypothesis that radioembolization using yttrium-90 resin
microspheres (SIR-Spheres^® microspheres; Sirtex Medical Limited, Australia)
can increase the median overall survival with fewer side effects and/or a
better quality of life in comparison with sorafenib.

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Coordinated at the national level by Professor Valérie Vilgrain MD, PhD
(Department of Radiology, Beaujon Hospital, AP-HP) - Principal Investigator of
this large study, 19 specialist cancer centres throughout France (Angers,
Bondy, Bordeaux, Caen, Clichy, Créteil, Dijon, Grenoble, Marseille,
Montpellier, Nancy, Nantes, Nice, Paris, Poitiers, Saint Etienne, Strasbourg,
Villejuif; cf. are currently
accruing patients. The aim is to recruit 400 patients in France with the
following inclusion criteria:^[^1^]

  oPatients with advanced HCC with or without portal vein thrombosis or whose
    disease has progressed after chemoembolization or recurrence of HCC;
  oNo extrahepatic spread;
  oIneligible for:

       osurgical resection;
       oliver transplantation;
       oradiofrequency ablation.

There is a growing medical 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

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
indicated in the U.S. for the treatment of unresectable metastatic liver
tumors from primary colorectal cancer together with adjuvant intra-hepatic
artery chemotherapy (IHAC) of FUDR (Floxuridine).

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 are most 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.

About Selective Internal Radiation Therapy (SIRT)

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. 


1.SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma
2.Sangro B, Carpanese L, Cianni R et al on behalf of European Network on
    Radioembolization with yttrium-90 resin microspheres (ENRY). Survival
    after ^90Y 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. accessed 28 June

SOURCE SARAH trialists

Contact: Contact: MHC Communication, Marie-Hélène Coste, 38 avenue Jean Jaurès
- 94110 Arcueil, Tél. : +33-(0)1-49-12-03-40 - Fax : +33-(0)1-49-12-92-19 -
email :; Nathalie Amoury, Sirtex,
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