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OLDER LIVER CANCER PATIENTS RESPOND TO RADIOEMBOLISATION USING SIR-SPHERES EQUALLY AS WELL AS YOUNGER PATIENTS, NEW STUDY IN JOURNAL OF HEPATOLOGY SAYS

June 20, 2013

BOLOGNA, Italy, June 20, 2013 /PRNewswire/ –

Based on New Data from Multi-Centre ENRY Evaluation of 325 Patients, Authors

Suggest that Radioembolisation May Be a Well-Tolerated and Effective Option for an

Increasing Population of Older Patients

Results of a new analysis by members of the multi-centre European Network on
Radioembolisation with Yttrium-90 Resin Microspheres (ENRY), published on-line in the
Journal of Hepatology, the peer-reviewed official journal of the European Association for
the Study of the Liver[1], may have important implications for older patients with
inoperable primary liver cancer (hepatocellular carcinoma, or HCC).

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The analysis found essentially identical long-term treatment outcomes following
radioembolisation using SIR-Spheres in 128 elderly (age 70 years or older) compared to 197
younger (less than 70 years of age) patients with otherwise similar demographics. “Our
findings suggest that age alone should not be a discriminating factor for the management
of HCC patients. This is important because there is a trend towards increased age in
patients diagnosed with HCC, particularly in developed countries,” said the article’s lead
author, Rita Golfieri, MD, Professor of Radiology in the Department of Digestive Diseases
and Internal Medicine of The University of Bologna.

Prof. Golfieri also stated that “While age should not be a barrier to the management
of older patients with HCC, physicians should definitely take age and frailty into account
when deciding which treatments to use.

“For example, the relative mildness of procedure-related events after
radioembolisation with SIR-Spheres compared with transarterial chemoembolisation, or TACE,
suggests that an effective single radioembolisation procedure may be more acceptable to
elderly patients than the multiple courses of treatment required with TACE.

“In addition, while the tyrosine kinase inhibitor, sorafenib, represents a good
treatment option for many elderly patients with HCC, the increased frequency of adverse
events associated with its use in patients over 75 years old may require dose-modification
,” Prof. Golfieri said.

The new study is the most recent report based on an extensive evaluation of 325 HCC
patients treated by teams of liver specialists, oncologists, interventional radiologists
and nuclear medicine physicians at eight centres in Germany, Italy and Spain, and
coordinated by Bruno Sangro, MD, PhD, Director of the Liver Unit at Clinica Universidad de
Navarra, Pamplona, Spain, and chair of the ENRY group.

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.[2] It occurs with greatest frequency in regions
where hepatitis is most often diagnosed, such as in Asia Pacific and Southern Europe.

Hepatocellular cancer can be cured only 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.

Key Findings of the Age-based ENRY Evaluation

The new analysis compared HCC treatment outcomes among 128 patients age 70 or older
(mean age 74) with those for 197 younger patients (median age 58). The authors also
performed an additional sub-analysis of 49 very elderly patients ranging from 75-87 years
(median age 78).

The elderly and younger age groups had similar baseline characteristics, with many
having multi-nodular, advanced-stage HCC which was present in both lobes of the liver and
had reasonably-well compensated (Child-Pugh class A) underlying cirrhosis. Elderly
patients had a significantly lower tumour burden, smaller liver volume – both overall and
the amount targeted by radioembolisation – and were less likely to have had hepatitis B
viral infection.

Overall survival of patients in the study was not statistically significant between
elderly (median 14.5 months) and younger (12.8 months) patients. There was also no
significant difference in survival between very elderly patients (75 years or older) and
those under that age (median 14.9 vs. 12.8 months).

Radioembolisation with SIR-Spheres was equally well-tolerated in both age groups.
Common procedure-related events, such as fatigue, nausea and/or vomiting, abdominal pain,
fever and raised bilirubin, were predominantly mild-to-moderate in severity and short in
duration. Almost none of these events were rated at grade 3 or above, the exceptions being
one reported case of grade 3 fatigue and two grade 4 elevations in bilirubin.
Gastrointestinal (GI) ulceration (caused by the inadvertent deposition of microspheres in
the GI tract) was similarly infrequent and of mild-to-moderate intensity in the two age
groups. Severe GI ulcers (grade 3 and above) were actually almost three times less common
among older patients (0.8% vs. 2.7%).

When the consolidated ENRY data were first published in 2011,[3] Professor Sangro
noted that: “As ENRY was not a prospective study, our findings must be interpreted
conservatively. What we can say, based on our evaluation of a broad range of patients with
HCC treated in routine clinical practice, is that radioembolisation using SIR-Spheres
directly targets tumours and spares viable liver tissue, which enables us to reduce the
burden of disease and potentially increase both the patient’s survival and quality of
life. The greatest survival benefit can be expected in those patients with better
performance status, fewer tumour nodules and no occlusion of the portal vein.

“What we can now also say based on Prof. Golfieri’s analyses, is that the benefits we
observed apply as much to older patients as to younger ones, with some potential added
value for radioembolisation based on its relatively mild side-effect profile compared to
other treatments for this very serious disease. These patients have few other treatment
options,” Prof. Sangro explained.

Other treatment options that have been demonstrated to extend survival for patients
with inoperable HCC include TACE, which requires repeated interventional procedures and
hospitalisation due to the resulting post-embolisation syndrome; and sorafenib, an oral
medication taken twice daily which can give side effects leading to discontinuation of the
drug in more than a third of patients (38%).[4]

“Radioembolisation may also be a synergistic option when combined with newer
pharmaceutical treatments, such as sorafenib,” Prof. Sangro said.

Physicians and patients interested in participating in one of three on-going
randomised controlled trials of radioembolisation using SIR-Spheres may learn more at:

        - the SORAMIC trial is being conducted in Europe on SIR-Spheres combined
          with sorafenib compared to sorafenib alone in patients with HCC (
          http://www.soramic.de and http://clinicaltrials.gov/ct2/show/NCT01126645);
        - the SIRveNIB trial is being conducted in Asia Pacific and is comparing
          SIR-Spheres to sorafenib in patients with HCC (http://www.sirvenib.com and

http://clinicaltrials.gov/ct2/show/NCT01135056);

        - the SARAH trial is being conducted in France and is comparing SIR-Spheres to
          sorafenib in patients with HCC (http://clinicaltrials.gov/ct2/show/NCT01482442).

References:

        1) Golfieri R, Bilbao JI, Carpanese L, et al on behalf of European Network
          on Radioembolization with Yttrium-90 resin microspheres (ENRY). Comparison of the
          survival and tolerability of radioembolization in elderly versus younger patients with
          unresectable hepatocellular carcinoma. Journal of Hepatology 2013; ePub doi:
          http//dx.doi.org/10.1016/j.jhep.2013.05.025.
        2) GLOBOCAN. Liver Cancer Incidence and Mortality Worldwide in 2008.
          http://globocan.iarc.fr/factsheets/cancers/liver.asp accessed 28 June 2011.
        3) 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.
        4) Llovet J, Ricci S, Mazzaferro V et al for the SHARP Investigators Study
          Group. Sorafenib in advanced hepatocellular carcinoma. New England Journal of Medicine
          2008;359:378-390.

708-EUA-0613


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SOURCE ENRY Trialists


Source: PR Newswire