TheraSphere Animation: Liver Cancer Therapy, Radioembolisation (International  Version)
Published on Aug 30, 2012 by nordion

TheraSphere is a radiation treatment used in cases of inoperable liver cancer. The radiation is targeted directly to the tumor,

Sept 2012

Nordion Provides Update on Europe-Focused Phase III Clinical Trial for TheraSphere® Yttrium-90 Liver Cancer Treatment

Principal Investigators and Contract Research Organization named for YES-P study
 
OTTAWA, Ontario — Nordion Inc. (TSX: NDN)
(NYSE: NDZ), a leading provider of products and services for the prevention, diagnosis and treatment of disease, today provided an update on its YES-P clinical trial for TheraSphere®, the company’s Yttrium-90 (Y-90) glass microsphere liver cancer  treatment, by naming the principal investigators (PI) and contract research organization (CRO) for the study.

The co-PIs are Professor Vincenzo Mazzaferro and Dr. Riad Salem. Professor  Mazzaferro is Director and Vice-Scientific Director, Gastro-Intestinal Surgery  and Liver Transplantation, Istituto Nazionale Tumori, Milan, one of the largest
comprehensive cancer centers in Europe. Dr. Salem is Professor of Radiology,  Medicine and Surgery; Chief, Section of Vascular and Interventional Radiology;  Director, Interventional Oncology; and Vice-Chairman, Image-Guided Therapy
Department of Radiology, Northwestern University. The trial will be conducted in  collaboration with Theorem Clinical Research, a global full-service CRO, which  is also conducting Nordion’s two other Phase III clinical trials – EPOCH and STOP-HCC.

YES-P is a randomized, multi-centre Phase III clinical trial to evaluate the  safety and efficacy of TheraSphere® vs. sorafenib in the treatment of patients with portal vein thrombosis (PVT)  associated with unresectable hepatocellular carcinoma (HCC), the most common form  of primary liver cancer.

“HCC patients with PVT have limited treatment options and, as a result, life expectancy remains unacceptably low,” said Mason Ross, MD, Nordion’s Vice President of Medical Affairs. “Nordion is pleased to be working with two world
renowned liver cancer experts and an internationally recognized CRO to assess whether TheraSphere® can extend the lives of these patients andto provide physicians with additional data to support their clinical decisions.”

The YES-P trial is targeting enrollment of 350 patients at approximately 24 sites in Europe, with additional sites to be identified globally. The study will follow a randomized two-armed design – in one arm, patients will undergo Y-90 radioembolization treatment with TheraSphere®, while patients in the other arm will receive sorafenib, the standard of care for advanced unresectable HCC.

About TheraSphere®
TheraSphere® is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter)
containing radioactive Y-90. The product is injected by physicians into the artery of the patient’s liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood flow.

TheraSphere® is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have
appropriately positioned arterial catheters.

In the US, TheraSphere® is used to treat patients with hepatocellular carcinoma (HCC) who can have appropriately
positioned hepatic arterial catheters, and can be used as a bridge to surgery or transplantation in these patients. It is also indicated for the treatment of HCC patients with partial or branch portal vein thrombosis or occlusion when clinical evaluation warrants the treatment. TheraSphere® is approved by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu.
Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to  the TheraSphere® package insert/instructions  for use at www.nordion.com/therasphere.

Read  more here:
http://www.heraldonline.com/2012/09/06/4240465/nordion-provides-update-on-europe.html#storylink=cpy  

Sept 1 2012

Yttrium90 radioembolization for intermediate-advanced hepatocarcinoma: A phase II study

Hepatology 

Abstract  
Background and Rationale:

yttrium-90 microspheres radioembolization (Y90RE) is a novel approach to
radiation therapy for hepatocellular carcinoma (HCC), never tested in phase II
studies. Fifty-two patients with intermediate (n.17) - advanced (n.35) HCC were
prospectively recruited to assess, as primary endpoint, efficacy of Y90RE on
time-to-progression (TTP). Secondary endpoints were tumor response, safety and
overall survival (OS). All patients were ECOG 0-1, Child-Pugh A-B7. Y90RE
treatments aimed at lobar delivery of 120 Gy. Retrospective dosimetric
correlations were conducted and related to response. 
 
Main Results: 
Fifty-eight treatments were performed on 52 patients. Median follow-up was 36
months. Median TTP was 11 months with no significant difference between portal
vein thrombosis (PVT) vs. no-PVT (7 vs. 13 mo). Median OS was 15 mo (95%CI:
12-18) with a non-significant trend in favor of non-PVT vs. PVT patients (18 vs.
13 mo). Five complete responses occurred (9.6%) and the 2yr-progression rate was
62%. Objective response was 40.4% whilst disease control rate (DCR: 78.8%)
significantly affected survival (responders vs. non-responders: 18.4% vs. 9.1%;
P = 0.009). Tumor response significantly correlated with absorbed dose
in target lesions (r=0.60, 95%CI: 0.41-0.74, P <0.001) and a
threshold of 500 Gy predicted response (AUC= 0.78). Mortality at 30-90 days was
0%-3.8%. Various grades of reduction in liver function occurred within 6 mo in
36.5% of patients with no differences among stages. At the multivariate analysis
tumor response was the sole variable affecting TTP (P <0.001) and
the second, after Child-Pugh stage, affecting survival. 
 
Conclusions: 
Y90RE is an effective treatment in intermediate-advanced HCC, particularly in
case of PVT. Further prospective evaluations comparing Y90RE with conventional
treatments are warranted.
(ClinicalTrials.gov NCT00910572) (HEPATOLOGY 2012.)

Funding Information   
 
Funded by

• The Italian Association for Cancer Research (AIRC)
• Institutional grants (Hepato-Oncology Project, 5×1000)
• The Italian National Ministry of Health within the Oncology Project
• The device used (Therasphere®) was granted by the producing
  Company

June 2011

Radioembolization Data Highlight Safety of Treatment for Liver Tumors
ISSUE: JUNE 2011 | VOLUME: 62:06
by David WildBerlin and Chicago—Radioembolization of liver tumors using Yttrium 90 (Y90)-emitting resin and glass microspheres is well tolerated and may improve survival in patients with unresectable liver tumors and additional portal vein occlusion (PVO), according to findings from two open-label, prospective studies....

2010

New European Study Shows TheraSphere® Prolongs Liver Cancer Survival Rates

MDS Nordion, a leading provider of products and services to the global health science market, today announced that the first large European study using Yttrium-90 (Y-90) glass microspheres has been published on the use of TheraSphere®, an innovative radioembolisation therapy for the localised treatment of patients with advanced hepatocellular carcinoma (HCC) or primary liver cancer.

The publication, which currently can be viewed online/(*see abstract below) and is expected to appear in the November 2010 edition of Hepatology, concludes that radioembolisation with TheraSphere® is both safe and effective, and states that the overall survival rate is similar to that found in another recently published large study analysing Y-90 glass microspheres for the treatment of HCC. .n Conducted at MDS Nordion’s European Centre of Excellence in Essen, Germany, the study involved 108 patients, none of whom were eligible for conventional locoregional therapies. Patients achieved a median overall survival of 16.4 months with minimal damage to the surrounding healthy tissue, even in patients with advanced liver cirrhosis or portal vein thrombosis.

No lung or visceral toxicity was observed. The most frequently observed adverse event was a transient fatigue-syndrome.Philip Hilgard, MD, hepatologist and lead author of the paper says, “The outcomes of this study were not unexpected, but it was extremely important for us to be able to substantiate and verify the treatment here in Europe. We feel confident that the publication of our study will help towards giving more patients access to this advanced therapy.
 Full Article. ,

 About TheraSphere ,

 TheraSphere is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90. The product is injected by physicians into the main artery of the patient’s liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood vessels. TheraSphere treatment can generally be administered on an outpatient basis and does not usually require an overnight hospital stay. MDS Nordion is approved (CE Mark) in Europe to distribute TheraSphere for treatment of hepatic neoplasia.
MDS Nordion established a European TheraSphere Centre of Excellence in Essen, Germany to train and educate oncology professionals on the use of this innovative cancer treatment.In addition, there are multiple treatment centres across Europe, including the BCLC Group Hospital Clinic in Barcelona, Spain; Centre Eugene Marquis in Rennes, France; and Istituto Tumori in Milan, Italy. f

TheraSphere treatment has some common side effects, including mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the common flu. Some patients will experience some loss of appetite and temporary changes in several blood tests.

For details on the rarer side effects, please refer to the Instructions for Use on our website at
 http://www.mdsnordion.com/ n

TheraSphere
The Data n

Radioembolization with Yttrium-90 glass microspheres in hepatocellular carcinoma: European experience on safety and long term survival n

Philip Hilgard1,2,*,‡, Monia Hamami3, Amr El Fouly1, André Scherag4,
Stefan Müller3, Judith Ertle1, Till Heusner6, Andreas Paul5, Andreas Bockisch3,
Guido Gerken1, Gerald Antoch6DOI: 10.1002/hep.23944 http://onlinelibrary.wiley.com/doi/10.1002/hep.23944/abstract (HEPATOLOGY 2010.) n

Abstract

Radioembolization has been demonstrated to allow locoregional therapy of patients with hepatocellular carcinoma not eligible for transarterial chemoembolization or other local therapies. The aim of this study was to validate evidence of the safety and efficacy of this treatment in a European sample of patients with advanced HCC. m Therefore, 108 consecutive patients with advanced HCC and liver cirrhosis were included. Y-90 microspheres were administered in a lobar fashion over the right or left branch of the hepatic artery. The response to treatment was evaluated by CT imaging applying RECIST and WHO criteria with recent EASL/NCI amendments. Time to progression and overall survival were estimated by the Kaplan-Meier method. 159 treatment sessions were performed ranging between 1 to 3 treatments per patient. The mean radiation dose per treatment was 120 (±18) Gy. According to EASL criteria, complete responses were determined in 3% of patients, partial responses in 37%, stable disease 53% and primary progression in 6% of patients. Time to progression was 10.0 months whereas the median overall survival was 16.4 months . No lung or visceral toxicity was observed. The most frequently observed adverse events was a transient fatigue-syndrome.
 
Conclusions:

Radioembolization with Yttrium-90 glass microspheres for patients with advanced HCC is a safe and effective treatment which can be utilized even in patients with compromised liver function. Since TTP and survival appear to be comparable to systemic therapy in selected patients with advanced HCC, randomized controlled trials in combination with systemic therapy are warranted. (HEPATOLOGY 2010.)