American Society of Clinical Oncology (ASCO) Publishes Abstract of SIRveNIB, an Investigator-led Asia Pacific Primary Liver Cancer Study to be Presented at ASCO Annual Meeting in Chicago, 4 June 2017

Singapore (ots/PRNewswire) -

The SIRveNIB abstract published on-line in the Journal of Clinical
Oncology states that treatment of locally advanced Hepatocellular
Carcinoma (HCC) with a single treatment of SIR-Spheres® Y-90 resin
microspheres results in Overall Survival not significantly different
from twice-daily oral sorafenib, but with significantly better tumour
response and fewer and less severe adverse events

The study was conducted by The Asia-Pacific Hepatocellular
Carcinoma Trials Group (AHCC) in collaboration with the National
Cancer Centre Singapore and Singapore Clinical Research Institute
(SCRI) and supported by the National Medical Council Singapore and
Sirtex Medical Limited

The lead author of the SIRveNIB abstract, Professor Pierce Chow,
Senior Consultant Surgeon at the National Cancer Centre Singapore and
the Singapore General Hospital, reported that: "Asia Pacific patients
with locally advanced primary liver cancer (HCC or hepatocellular
carcinoma) with no spread (metastases) outside the liver who are
treated with Y-90 resin microspheres have a significantly better
tumour response rate (TRR) compared to sorafenib, despite 28.6%
(n=52) of patients not receiving Y-90 therapy as planned (TRR - 16.5%
for Y-90 resin microspheres vs 1.7% for sorafenib, respectively; p <
0.001). Moreover, patients experienced fewer, less serious adverse
events when compared with those treated with sorafenib. There were no
statistically significant differences in the primary endpoint of
overall survival (OS) between the two treatments."

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Although the median OS in the intent-to-treat group[1] was 8.54
months for Y-90 resin microspheres vs. 10.58 months for sorafenib,
respectively (p=0.203), there was a trend in improvement in median OS
in the treated group[2] for Y-90 resin microspheres (11.27 vs. 10.41
months, p=0.273). While Y-90 resin microspheres were not superior to
sorafenib regarding OS, Professor Chow, who is also Professor and
Course Director at the Duke-NUS Medical School, indicated that "the
better tumour response and tolerability of Y-90 resin microspheres
offers a compelling treatment alternative for patients with advanced
hepatocellular carcinoma, for whom there are limited treatment
options available."

SIRveNIB was designed to compare the efficacy and safety of
selective internal radiation therapy (SIRT) with yttrium-90 [Y-90]
resin microspheres (SIR-Spheres; Sirtex Medical Limited, North
Sydney, Australia) versus sorafenib (Nexavar®; Bayer HealthCare
Pharmaceuticals, Berlin, Germany), a systemic treatment that is the
current standard of care in advanced hepatocellular carcinoma. The
patients in SIRveNIB were ineligible for potentially curative
therapies, such as surgical resection, ablation or liver
transplantation.

"Each year we are making good progress in treating liver cancer.
The deeper we go in our research the better we are able to understand
how the cancer behaves and we are able to widen the treatments
options for our patients. The results reinforced our belief that with
the right people on the research project, we can get the best
results. I am grateful to our partners for collaborating in this
study," added Professor Soo Khee Chee, Director of NCCS.

"Completion of the investigator-led SIRveNIB study represents a
significant milestone in Asia Pacific liver cancer research, and
underscores the strong private-public partnership that exists between
Sirtex Medical Limited, the National Cancer Centre Singapore and
Singapore Clinical Research Institute. We look forward to the
presentation of more complete results of SIRveNIB at the impending
ASCO Annual Meeting," said Associate Professor Teoh Yee Leong, CEO
Singapore Clinical Research Institute. "This is the first time we
have completed such a large-scale investigator-led clinical trial in
the Asia Pacific region, whose results will be beneficial to liver
cancer patients in our region."

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.[3] 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.[4] No new HCC treatment option has been tested
successfully in large studies for almost a decade.

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 programmes 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. 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. http://www.scri.edu.sg

Current Availability of SIR-Spheres Y-90 resin microspheres

SIR-Spheres Y-90 resin microspheres are approved for the treatment
of inoperable liver tumours in Australia, the European Union (CE
Mark), Argentina (ANMAT), Brazil, and several countries in Asia, such
as Turkey, India and Singapore. The product is also supplied for this
use in countries such as Hong Kong, Israel, Malaysia, New Zealand,
Taiwan and Thailand. SIR-Spheres Y-90 resin microspheres also have a
full Pre-Market Approval (PMA) by the FDA and are indicated in the
United States for the treatment of non-resectable metastatic liver
tumours from primary colorectal cancer in combination with
intra-hepatic artery chemotherapy using floxuridine.

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[1] Intent-to-treat group includes all patients who were enrolled
and randomly allocated to treatment and are analysed according to the
group to which they were randomized. The intent-to-treat-group
included n=182 (Y-90 resin microspheres) and n=178 (sorafenib).

[2] Treated group includes only those patients who completed the
treatment originally allocated. The treated group included n=130
(Y-90 resin microspheres) and n=162 (sorafenib).

[3] Ferlay J et al. Globocan 2012. v1.0, Cancer Incidence and
Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France:
International Agency for Research on Cancer; 2013. Available from:
http://globocan.iarc.fr , accessed on 18/May/2017.

[4] EASL-EORTC Clinical Practice Guidelines: Management of
hepatocellular carcinoma. J Hepatol 2012; 56: 908-43.

ots Originaltext: National Cancer Centre Singapore (NCCS) and Singapore Clinical Research Institute (SCRI)
Im Internet recherchierbar: http://www.presseportal.de

Contact:
National Cancer Centre Singapore
Ms Rachel Tan
Assistant Manager
Corporate Communications
Tel: +65 6236 9535
Hp: 9754 0842 Email: rachel.tan.c.h@nccs.com.sg
Ms Gillian Tan Senior Executive
Corporate Communications
Tel: +65 6236 9529 Hp: 8157 3671
Email: gillian.tan@nccs.com.sg

Original-Content von: National Cancer Centre Singapore (NCCS) and Singapore Clinical Research Institute (SCRI), übermittelt durch news aktuell