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

PR68624

SINGAPORE, May 19, 2017 /PRNewswire=KYODO JBN/ --

    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(R) 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(R); 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.

SOURCE: National Cancer Centre Singapore (NCCS) and Singapore Clinical Research

Institute (SCRI)