PR65985

Liver Cancer Researchers from AP-HP and Singapore Collaborate on a Prospective Meta-Analysis of Two Studies of Y-90 resin microspheres versus Sorafenib in Patients with Unresectable Hepatocellular Carcinoma (HCC)

PARIS and SINGAPORE, Oct. 6, 2016 / PRNewswire=KYODO JBN /--

      Cancer researchers from Assistance Publique - Hopitaux de Paris (AP-HP)

and The Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC), National

Cancer Centre Singapore (NCCS) and Singapore Clinical Research Institute (SCRI)

announced that they will collaborate on a prospective meta-analysis that will

combine the impending results of two large, randomized controlled studies of

Y-90 resin microspheres versus sorafenib. The two studies, which have completed

patient recruitment, enrolled approximately 800 patients with advanced primary

liver cancer (hepatocellular carcinoma or HCC).

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    The French HCC study, called SARAH, sponsored by AP-HP with the financial

support of the company Sirtex, and the Singapore HCC study, called SIRveNIB

(AHCC protocol 06), which also received financial support from Sirtex, use

similar research designs to compare the efficacy, safety profiles and quality

of life (QoL) of selective internal radiation therapy (SIRT) with

liver-directed Y-90 resin microspheres and sorafenib, a systemic chemotherapy

treatment that is the current standard of care in advanced hepatocellular

carcinoma. HCC patients enrolled in SARAH and SIRveNIB were ineligible for

potentially curative therapies, such as surgical resection, ablation or liver

transplantation and had either failed or were unsuitable for treatment with

Trans-Arterial Chemo-Embolisation (TACE).

    Professor Pierce Chow, Principal Investigator of the SIRveNIB study, and

Senior Consultant Surgeon at the National Cancer Centre Singapore and the

Singapore General Hospital, explained that, "As we stated when we first

announced completion of enrolment in SIRveNIB, the search for more effective

and better tolerated treatments of HCC is important because so few proven

treatment options currently exist. Our study enrolled more than 360 patients

from 27 specialist centres in 10 Asia-Pacific countries. While our data will be

reported independently, the opportunity to combine these data in a prospective

meta-analysis with the results of the French SARAH study presents a compelling

scientific undertaking across a much larger patient population that will

significantly increase the data available for various pre-planned statistical

analyses, including overall survival. This should provide physicians who treat

HCC with even greater certainty of the applicability of our results in the

treatment of this increasingly common and deadly cancer."

    Professor Valerie Vilgrain MD, PhD, Principal Investigator of the SARAH

study, Head of Department of Radiology, Beaujon Hospital AP-HP, and Professor

at the Universite Paris Diderot, Sorbonne Paris Cite, France, said that "The

SARAH study was conducted in more than 25 specialist centres throughout France

and is expected to report results in the first half of 2017. While we will also

report the results of SARAH independently, we believe a prospective

meta-analysis of our findings combined with those of the SIRveNIB study may be

very compelling. HCC in France and most of Europe is found in patients whose

livers have become cirrhotic primarily from the Hepatitis C virus and alcohol

misuse, while the majority of HCC cases in Asia are triggered initially by the

Hepatitis B virus. Thus, our prospective meta-analysis will provide safety and

efficacy data on patients who presented with a full range of the major HCC

aetiologies, potentially increasing the clinical applicability of the study

results."

    Results of the prospective meta-analysis are expected to be available in

2017. In the interim, further details regarding the methodological and

statistical approach to the meta-analysis are to be published in a

peer-reviewed journal.

    About Hepatocellular Carcinoma

    Hepatocellular carcinoma (HCC) is the most common form of primary liver

cancer - cancer that starts in the liver - which is the sixth most-common

cancer in the world and the second most-common cause of cancer-related death.

It affects mainly patients with cirrhosis from any cause, including viral

hepatitis and alcohol abuse. HCC occurs with greatest frequency in regions

where hepatitis is most often diagnosed, such as in the Asia Pacific region and

Southern Europe. When diagnosed in its early stages, HCC can be treated by

surgical resection, ablation or liver transplantation with expectation of

improved long-term survival. However, these options are not available to the

great majority of patients. For patients with unresectable HCC, the outlook is

bleak, with survival ranging from a few months to about two years depending

largely on the extent of their tumours and state of their liver at the time of

diagnosis. No new HCC treatment option has been tested successfully in large

studies for almost a decade.

    About AP-HP, Greater Paris University Hospitals

    Beaujon Hospital, the principle centre of the SARAH study is part of the

Public Hospital System of the City of Paris, AP-HP. The AP-HP is affiliated

with a university and has a European dimension that is recognised worldwide.

Its 39 hospitals admit 8 million sick persons every year for consultation,

emergency treatment, for scheduled hospitalization or hospital at home. It

assures public health service for everyone, 24/7; this is its pride and

purpose. The AP-HP is the largest employer of the Ile de-France: 95,000 people

- physicians, researchers, paramedics, administrative personnel and workers -

are employed there. Its teams also pursue an important clinical research

activities. In 2015 its teams conducted more than 3,400 research projects, and

published more than 9100 scientific publications, accounting for 40% of all

French medical research publications. The AP-HP holds a portfolio of 825 active

international patents. For more information, visit the AP-HP website at

http://www.aphp.fr/international

    About Asia-Pacific Hepatocellular Carcinoma Trials Group

    The Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group is a

collaborative group formed in 1997 by clinicians treating hepatocellular

carcinoma in major medical centres in the Asia-Pacific region. The aims of the

trials group are to conduct preventive and therapeutic trials in hepatocellular

carcinoma, to carry out basic and translational research in this field and to

develop training and educational programs pertaining to HCC. For more

information, visit the AHCC website at

http://www.scri.edu.sg/crn/asia-pacific-hepatocellular-carcinoma-ahcc-trials-group/about-ahcc

    About National Cancer Centre Singapore

    National Cancer Centre Singapore (NCCS) provides a holistic and

multi-disciplinary approach to cancer treatment and patient care. We treat

almost 70 per cent of the public sector oncology cases, and they are benefiting

from the sub-specialisation of our clinical oncologists. NCCS is also

accredited by the US-based Joint Commission International for its quality

patient care and safety. To deliver among the best in cancer treatment and

care, our clinicians work closely with our scientists who conduct robust

cutting-edge clinical and translational research programs which are

internationally recognised. NCCS strives to be a global leading cancer centre,

and shares its expertise and knowledge by offering training to local and

overseas medical professionals. For more information, visit the NCCS website at

http://www.nccs.com.sg

    About Singapore Clinical Research Institute

    Singapore Clinical Research Institute (SCRI) is a National Academic

Research Organisation dedicated to enhance the standards of human clinical

research. Its mission is to spearhead and develop core capabilities,

infrastructure and scientific leadership for clinical research in Singapore.

SCRI is a national clinical trials coordination centre that works with National

Medical Research Council (NMRC) to assist the Ministry of Health in

implementing clinical trials policy and strategic initiatives to support and

develop clinical research competencies locally.

    In driving towards its vision, SCRI collaborates with clinicians to enhance

Singapore's clinical research and strengthen its expertise in executing

multi-site, multi-national studies and the development of regional clinical

research networks. SCRI is a wholly-owned subsidiary of MOH Holdings.

    For more information, visit the SCRI website at http://www.scri.edu.sg

    SOURCE: Greater Paris University Hospitals (AP-HP), Asia-Pacific

Hepatocellular Carcinoma Trials Group (AHCC), National Cancer Centre Singapore

(NCCS), and Singapore Clinical Research Institute (SCRI)