Largest Multi-centre Evaluation of Radioembolisation Using SIR-Spheres for Patients With Inoperable Primary Liver Cancer Published in Hepatology
By Enry Trialists, PRNEWednesday, July 6, 2011
PAMPLONA, Spain, July 7, 2011 -
- ENRY Evaluation in 325 Patients Affirms Efficacy and
Safety of
Radioembolisation in Seriously-ill Patients and
Identifies Specific Populations who may Benefit
From Treatment
Results of the multi-centre European Network on
Radioembolisation with Yttrium-90 Resin Microspheres (ENRY)
analysis of the long-term outcomes related to survival and safety
of radioembolisation using SIR-Spheres in patients with inoperable
primary liver tumours were published on-line today in
Hepatology, the peer-reviewed journal of the American
Association of the Study of Liver
Diseases.[1]
Evaluation of 325 patients with inoperable primary liver cancer
(unresectable hepatocellular carcinoma), who were treated by teams
of liver specialists, oncologists, interventional radiologists and
nuclear medicine physicians at eight centres in Germany, Italy and
Spain, provided “robust evidence of the survival outcomes achieved
with radioembolisation, including patients with advanced disease
and few treatment options,” said Bruno Sangro, MD, PhD, Professor
of Hepatology in the Liver Unit of the Clinical University of
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.
Findings of the ENRY Evaluation
The majority of the patients (82.5%) evaluated by the ENRY group
had liver disease that was reasonably-well compensated (Child-Pugh
class A), with underlying cirrhosis (78.5%) and good ECOG
Performance status (ECOG 0-1: 87.7%). However, many of them had
multiple tumour nodes (75.9%), with disease present in both lobes
of the liver (53.1%) and/or occlusion of the portal vein (the
vessel that transports blood from the gastrointestinal tract to the
liver) in either a branch of the vein (13.5%) or the main vessel
(9.8%).
Over 40 per cent of the patients (41.5%) had progressed
following one or more other treatments prior to receiving
radioembolisation with SIR-Spheres (yttrium-90 resin microspheres;
Sirtex Medical Limited, Sydney, Australia), including surgery or
liver transplantation, percutaneous procedures such as ethanol
injection or radiofrequency ablation of individual liver tumours,
or vascular procedures such as transarterial embolisation (TAE) or
chemoembolisation (TACE) that block the liver arteries that feed
tumours.
Using Barcelona Clinic Liver Cancer (BCLC) staging criteria, the
vast majority of patients evaluated by the ENRY group had either
advanced (BCLC C: 56.3%) or intermediate (BCLC B: 26.8%)
disease.
The patients who received radioembolisation (also called
selective internal radiation therapy or SIRT) were administered a
median dose of 1.6 GBq of beta-radiating yttrium-90 resin
microspheres, predominately as a single procedure delivered
transarterially to the liver via a catheter through the femoral and
hepatic arteries. The median overall survival of the SIRT-treated
patients evaluated by the ENRY group was 12.8 months. Survival
varied significantly by disease stage: 24.4 months for patients in
BCLC A; 16.9 months in BCLC B; and 10.0 months in BCLC C.
“As ENRY was not a prospective study, our findings must be
interpreted conservatively,” Professor Sangro explained. “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.
“It is also clear from our analysis,” he added, “that
radioembolisation may be particularly helpful in four specific
patient populations. These include, firstly, patients who might
otherwise be considered for TACE but may benefit more from
SIR-Spheres; patients who are poor candidates for TACE due to the
high number of tumour nodules (>5) or spread to both lobes of
the liver; patients who have previously failed TACE; and, finally,
patients who are ineligible for TACE because of portal vein
occlusion. These patients have few other treatment options.”
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%).[3]
The ENRY collaboration found that radioembolisation was very
well-tolerated by these otherwise ill patients. More than half
(54.5%) experienced fatigue; around one third (32.0%) reported
nausea or vomiting; while slightly more than a quarter (27.1%)
reported abdominal pain and one in ten reported a mild fever. These
symptoms were transient in all cases.
A very small number of patients (3.7%) suffered from
gastrointestinal ulceration, which can occur when some microspheres
inadvertently pass into a gastric artery.
“Based on the ENRY evaluation,” Prof Sangro concluded, “we
believe that radioembolisation merits routine use in a number of
patients with primary liver cancer. Radioembolisation may also be a
synergistic option when combined with newer pharmaceutical
treatments, such as the tyrosine kinase inhibitor, sorafenib.”
Physicians and patients interested in participating in either of
two recently-initiated randomised controlled trials of
radioembolisation using SIR-Spheres may learn more at:
www.soramic.de - the
SORAMIC trial (
identifier NCT01126645) is being conducted in Europe on SIR-Spheres
combined with sorafenib compared to sorafenib alone in patients
with HCC;
www.sirvenib.com - the
SIRveNIB trial (
identifier NCT01135056) is being conducted in Asia Pacific and is
comparing SIR-Spheres to sorafenib in patients with HCC.
For Further Information:
SIR-Spheres are approved for use in Australia, the European
Union (CE Mark), New Zealand, Switzerland, Turkey and several other
countries for the treatment of unresectable liver tumours.
SIR-Spheres are also fully FDA-approved and are indicated in the
U.S. for the treatment of non-resectable metastatic liver tumours
from primary colorectal cancer in combination with intra-hepatic
artery chemotherapy using floxuridine.
Downloadable images, media background information, a mode of
action video and further supporting materials are available online
at
References:
1. 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; ePub doi:
10.1002/hep.24451.
2. GLOBOCAN. Liver Cancer Incidence and Mortality Worldwide in
2008.
accessed 28 June 2011.
3. 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.
For Further Information:
Sarah Hoffman
Aurora Communications
+44(0)20-7148-4170
.
Tags: Enry Trialists, July 7, Pamplona, Spain
