Treatment of Primary Liver Cancer: Sarah Study Now Available for All Eligible Patients throughout France

PARIS, June 24, 2013 /PRNewswire/ --

Launched by the Assistance Publique - Hôpitaux de Paris (AP-HP) in December 2011, SARAH, a French national collaborative randomized controlled trial of radioembolization with yttrium-90 resin microspheres versus sorafenib in advanced hepatocellular carcinoma seeks to enroll 400 patients

To date, more than 150 patients have taken part in this study

PARIS (June 20, 2013) In patients with advanced HCC, sorafenib (Nexavar(R) , Bayer HealthCare Pharmaceuticals, Germany), with which radioembolization is being compared, is now the standard treatment. Its use is associated with an increased median overall survival (from 8 to 11 months in the SHARP trial) but 80% of patients also experience treatment-related adverse events. The SARAH trial is testing the hypothesis that radioembolization using yttrium-90 resin microspheres (SIR-Spheres(R) microspheres; Sirtex Medical Limited, Australia) can increase the median overall survival with fewer side effects and/or a better quality of life in comparison with sorafenib.

Coordinated at the national level by Professor Valérie Vilgrain MD, PhD (Department of Radiology, Beaujon Hospital, AP-HP) - Principal Investigator of this large study, 19 specialist cancer centres throughout France (Angers, Bondy, Bordeaux, Caen, Clichy, Créteil, Dijon, Grenoble, Marseille, Montpellier, Nancy, Nantes, Nice, Paris, Poitiers, Saint Etienne, Strasbourg, Villejuif; cf. http://clinicaltrials.gov/ct2/show/NCT01482442) are currently accruing patients. The aim is to recruit 400 patients in France with the following inclusion criteria:([) (1) (]) -- Patients with advanced HCC with or without portal vein thrombosis or whose disease has progressed after chemoembolization or recurrence of HCC; -- No extrahepatic spread; -- Ineligible for: -- surgical resection; -- liver transplantation; -- radiofrequency ablation.

There is a growing medical interest in radioembolization using yttrium-90 resin microspheres in this patient population, based on a substantial number of open-label single-group studies as well as a large multi-centre European analysis([) (2) (]) of the long-term outcomes related to survival and safety of radioembolization using SIR-Spheres microspheres in patients with inoperable HCC.

SIR-Spheres microspheres are approved for use in Australia, the European Union (CE Mark), New Zealand, Switzerland, Turkey and several other countries including in Asia (e.g. India, Korean, Singapore and Hong Kong) for the treatment of unresectable liver tumours. SIR-Spheres microspheres are indicated in the U.S. for the treatment of unresectable metastatic liver tumors from primary colorectal cancer together with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).

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.([) (3) (]) It occurs with greatest frequency in regions where viral hepatitis B or C are most often diagnosed, such as in Asia Pacific and Southern Europe.

Hepatocellular cancer can be cured 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.

About Selective Internal Radiation Therapy (SIRT)

SIRT, also known as radioembolization, is a novel treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumours. It is a minimally-invasive treatment, in which millions of radioactive SIR-Spheres microspheres (diameter between 20-60 microns) are infused via a catheter into the liver, where they selectively target liver tumours with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.

References: 1. SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma (SARAH): http://clinicaltrials.gov/ct2/show/NCT01482442. 2. 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. 3. GLOBOCAN. Liver Cancer Incidence and Mortality Worldwide in 2008. http://globocan.iarc.fr/factsheets/cancers/liver.asp accessed 28 June 2011.

SOURCE SARAH trialists

/CONTACT: Contact: MHC Communication, Marie-Hélène Coste, 38 avenue Jean Jaurès - 94110 Arcueil, Tél. : +33-(0)1-49-12-03-40 - Fax : +33-(0)1-49-12-92-19 - email : mhc@mhccom.eu; Nathalie Amoury, Sirtex, info@sirtex-europe.com

Liver Cancer: Video Understanding SIR-Spheres microspheres - Whats Being Discussed ?

Understanding SIR-Spheres microspheres - Whats Being Discussed ?

.

SIR-Spheres microspheres are used to treat "secondary liver cancer where the cancer originates in the bowel (colon) and then spreads to the liver". This type of cancer is called metastatic colorectal cancer. SIR-Spheres microspheres is generally not regarded as a cure, but has been shown to shrink the tumors more than chemotherapy alone.

.

***Note

Primary liver cancer (or hepatocellular cancer), intrahepatic bile duct cancer (cholangiocarcinoma), are diseases that occur when the tumor originates in the liver and did not spread from another organ.
..

Recommended Reading....... All About Liver Cancer

..

Also See Press Release Nov 30th

SIR-Spheres microspheres Option For Inoperable Liver Cancer/Update Nov 30 2010

.

.

SIR-Spheres microspheres are an innovative means of treating liver cancer. In cases where it is not possible to surgically remove the liver tumors, SIR-Spheres microspheres can be used to deliver targeted, internal radiation therapy directly to the tumor.

Liver tumor being treated with SIR-Spheres

This new therapy is called Selective Internal Radiation Therapy also known as SIRT.

This technique uses millions of tiny polymer beads or microspheres which contain a radioactive element called yttrium-90. SIR-Spheres microspheres are very small, approximately 32 microns in size, and are about one-third the diameter of a strand of hair.

SIRT is usually administered as an outpatient procedure by a specially trained physician known as an interventional radiologist. A small catheter is guided into the liver and the SIR-Spheres microspheres are infused through the catheter. The microspheres with the radioactive yttrium-90 are carried by the bloodstream directly to the tumors in the liver where they preferentially lodge in the small vessels feeding the tumor and deliver their dose of radiation. Unlike conventional external beam radiation, which can only be applied to limited areas of the body, SIR-Spheres microspheres selectively irradiate the tumors and therefore have the ability to deliver more potent doses of radiation directly to the cancer cells over a longer period of time.
SIR-Spheres microspheres were developed in the 1980's in Perth, Western Australia. Since then, the product and the procedure has been refined and many hundreds of patients have been treated. SIR-Spheres microspheres received PMA approval by the Food and Drug Administration (FDA) in 2002.

,

SIR-Spheres microspheres At Work

Radiation is an effective agent for destroying tumors and is widely used in cancer treatment. However, organs in the body are sensitive to radiation and high doses can seriously affect or injure a patient. SIR-Spheres microspheres and the SIRT technique enables specific targeting and destruction of the tumors within the liver, while sparing the normal healthy tissue. Scientists and doctors at Sirtex understood that liver tumors are hypervascular and derive most of their blood supply from the hepatic artery while healthy liver tissue is fed predominantly by the portal vein. By administering the SIR-Spheres microspheres into the hepatic artery they are carried preferentially to the tumor thereby sparing the normal liver. Once infused into the hepatic artery, SIR-Spheres microspheres travel in the bloodstream to the tumors, where they become lodged around the tumors. The dose of radiation from the SIR-Spheres microspheres in conjunction with their proximity to the tumor, destroys the tumor and preserves the healthy liver tissue. The SIRT procedure allows a more pin-pointed delivery of radiation to liver tumors than other radiotherapy techniques, making it more effective in killing the cancer.

How Are They Administered?

SIR-Spheres microspheres are administered by a specially trained interventional radiologist. Your individual treatment plan will be reviewed by other specialists experienced in the treatment of liver tumors. The procedure is usually performed as an outpatient procedure under local sedation in the radiology suite. A small incision will be made in the patient's groin and a flexible catheter will be guided into the liver under x-ray vision. The catheter is moved through the hepatic artery and positioned by the interventional radiologist to allow for targeted infusion of the SIR-Spheres microspheres to the liver tumors. SIR-Spheres microspheres take about 15 minutes to be infused and the whole procedure takes about one hour from beginning to end.
After the procedure is completed you may be sent to have a special scan to check the level of radioactivity of the SIR-Spheres microspheres in your liver. You will be monitored for a few hours after the procedure and most patients are discharged within 24 hours. There are few precautions you and your family need to keep in mind the first week after treatment, with SIR-Spheres microspheres; there should be no close physical contact with others for longer than 2 hours, the patient should sleep in bed alone, there should be no contact with pregnant family members and children and pets should not sit on the patients lap. After a week the patient will be able to resume normal contact with family members.

.

See Flash There is no audio component in this video presentation.

SIRT: Treatment Options

SIR-Spheres microspheres therapy is regarded as a regional treatment; that is, the anti-cancer effect is concentrated in the liver and there is no effect on the cancer at other sites. SIR-Spheres microspheres are used to treat secondary liver cancer where the cancer originates in the bowel (colon) and then spreads to the liver. This type of cancer is called metastatic colorectal cancer. SIR-Spheres microspheres is generally not regarded as a cure, but has been shown to shrink the tumors more than chemotherapy alone. Quality of life can improve, and life expectancy may increase. For a small number of patients, treatment with SIR-Spheres microspheres can cause marked shrinkage of the liver tumor allowing for surgical removal at a later date.

Continue Reading ..............

.

SIRFLOX study
The SIRFLOX study is an international research study designed to evaluate a new treatment option for patients with colorectal cancer that has undergone metastatic spread to the liver. The study is designed to evaluate whether FOLFOX chemotherapy in combination with Selective Internal Radiation Therapy is more effective than chemotherapy alone. This study represents the first time that these treatments have been assessed together as part of a randomised controlled study and as a first-line therapy (i.e. in patients who have not previously received chemotherapy for their liver metastases).

About the SIRFLOX study
The SIRFLOX study is an international research study designed to evaluate a new treatment option for patients with colorectal cancer that has undergone metastatic spread to the liver.
Read more

.

.

About your liver

About SIR-Spheres microspheres

Treatment Comparisons

Clinical Assessment

Procedure I

Procedure II

Procedure III

Recovery I

Recovery II

,

Click here (pdf, 1.168 kB) for additional information regarding the use of SIR-Spheres microspheres for the treatment of liver tumours. (Versions in German (pdf, 1.250 kB), French (pdf, 1.050 kB), Spanish (pdf, 1.260 kB))

,

US Treatment Centers United States of America Europe Asia Pacific Corporate Australia / NZ

.

SIR-Spheres microspheres Option For Inoperable Liver Cancer/Update Nov 30 2010

What Is SIR-Spheres Microspheres ? Liver Cancer: Video Understanding SIR-Spheres microspheres - Whats Being Discussed ?

.

Press Release

.

Studies Reconfirm Significant Benefits Regarding the Use of SIR-Spheres® Microspheres for the Treatment of Inoperable Liver Tumors

http://www.sirtex.com/

Sirtex Announces Latest Clinical Findings and Provides Updates on Research Initiatives

WILMINGTON, Mass.--(EON: Enhanced Online News)--Sirtex, a leading developer of targeted and innovative liver cancer therapies, provided an update on clinical initiatives regarding SIR-Spheres® microspheres.

Highlights include the results of two independent studies in Belgium and Italy published recently in the Journal of Clinical Oncology and the British Journal of Cancer, respectively. The studies reconfirmed evidence from earlier research that established “significant clinical benefits from the use of targeted radioactive SIR-Spheres microspheres as an effective option for patients with inoperable liver cancer.”

“These two independent studies provide further evidence that SIR-Spheres microspheres can improve clinical outcomes in a patient population with limited treatment options”
In addition to the two completed studies, Sirtex also released updates regarding a larger, independent global study currently enrolling patients at 40 sites including several in the United States. The SIRFLOX study, with a primary endpoint of Progression Free Survival, is a prospective randomized study looking at SIR-Spheres microspheres in combination with chemotherapy for first line treatment of patients with unresectable liver metastases from colorectal cancer.

Belgian Study Yields Positive Results for Patients with Metastatic Colon Cancer
Results of a randomized controlled 46-patient Belgian trial published in the Journal of Clinical Oncology revealed that in patients with liver metastases from colorectal cancer who had failed all available standard-of-care chemotherapy, SIR-Spheres microspheres more than doubled the time to progression in the liver (the primary endpoint of the study) from a median of 2.1 months in patients receiving chemotherapy alone to 5.5 months in patients receiving SIR-Spheres microspheres plus chemotherapy (p=0.003).1,2

SIR-Spheres microspheres also significantly extended the time to progression of disease anywhere in the body, from 2.1 months in the chemotherapy control arm to 4.5 months in patients in the combination arm (p=0.03), as well as significantly increasing disease control, from 35 percent to 85 percent, respectively (p=0.001).
For ethical reasons, the trial included a cross-over design for patients in the control arm following failure of chemotherapy alone. All patients in the control arm were reassessed for suitability for SIR-Spheres microspheres, with 43 percent of patients receiving Selective Internal Radiation Therapy (SIRT).

Median survival increased from 7.3 months in the chemotherapy control arm to 10 months in the SIR-Spheres microspheres plus chemotherapy arm.
Investigators noted that SIR-Spheres microspheres should be considered as a valid therapeutic option for patients with chemotherapy-refractory liver-limited metastatic colorectal cancer (mCRC).

Italian Multi-Center Study Produces Significant Response in Patients
At the same time, the results of a 50-patient, independent, multi-center Italian study published in the British Journal of Cancer showed SIR-Spheres microspheres produced a significant and meaningful response in patients with advanced inoperable liver tumors who had failed all available chemotherapy treatments.3,4 The study, conducted by the Italian Society of Locoregional Therapies in Oncology (SITILO), was the first single-arm, prospective clinical trial of SIR-Spheres microspheres in the salvage therapy of patients with mCRC who had been heavily pre-treated with chemotherapy.
The results revealed an overall response rate of 24 percent, which met the trial’s pre-determined criteria for significance, plus stable disease reported in a further 24 percent of patients.

In two patients, the tumors shrank sufficiently to permit surgeons to plan potentially curative surgery. The median overall survival for the trial was 12.6 months. Patients that responded to SIR-Spheres microspheres, or who had stable disease, experienced a significantly longer median survival compared to non-responders (16 months versus 8 months; p=0.0006), with 40 percent of the responders remaining alive at two years compared to none of the non-responders.
The investigators concluded that patients with liver-only or liver-dominant colorectal cancer metastases who had failed chemotherapy and who remained fit should be considered for radioembolization, which highlights the potential for SIR-Spheres microspheres to be used to provide meaningful clinical benefits in a greater number of patients than at present.
SIRFLOX Study Currently Enrolling

SIRFLOX is the first prospective randomized study looking at SIR-Spheres microspheres in combination with standard therapy for first line treatment, FOLFOX6 with or without bevacizumab, in patients with unresectable liver metastases from colorectal cancer. The primary endpoint of the study is Progression Free Survival.
The SIRFLOX study is open and enrolling at more than 40 sites worldwide. To date, 180 patients have enrolled with enrollment of 450 patients anticipated complete by the end of 2011. An independent data safety monitoring committee (IDSMC) recently finalized a safety analysis on the first 80 patients and found the study has no major safety issues that would preclude continuing as scheduled.

The aim of SIRFLOX is to determine if SIR-Spheres microspheres in combination with FOLFOX6 with or without bevacizumab can be considered a valid first line option for patients with liver-limited metastatic colorectal cancer.
A sister study, FOXFIRE, is underway in the United Kingdom. The study is identical in design except that the primary endpoint is Overall Survival. It is anticipated that data on over 800 patients from the two trials can be combined to determine an Overall Survival endpoint across both studies.

“These two independent studies provide further evidence that SIR-Spheres microspheres can improve clinical outcomes in a patient population with limited treatment options,” said Michael Mangano, President, Sirtex Medical Inc. “We are excited that the SIRFLOX trial is well underway in the United States. We believe that this study, along with FOXFIRE, will confirm that SIR-Spheres microspheres should be added to modern first-line chemotherapy for patients with metastatic colorectal cancer, to extend survival, in line with the clinical benefits seen in the two European studies in patients who have failed all available treatment options.”
SIR-Spheres microspheres therapy is available to patients throughout the United States and a full list of treating sites can be found at www.sirflox.com/home.

About Selective Internal Radiation Therapy (SIRT)

About Selective Internal Radiation Therapy (SIRT) using SIR-Spheres microspheres Selective Internal Radiation Therapy (SIRT), also known as radioembolization, is a novel treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumors. In a minimally-invasive treatment, millions of radioactive SIR-Spheres microspheres are infused via a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.

Clinical trials have confirmed that liver cancer patients treated with SIR-Spheres microspheres have response rates higher than with other forms of treatment, resulting in increased life expectancy, greater periods without tumor activity, and improved quality of life. SIRT has been found to shrink liver tumors more than chemotherapy alone.

SIR-Spheres microspheres are approved for use in Australia, the United States of America (FDA approval), and the European Union (CE Mark) and additionally supplied in countries such as Hong Kong, Malaysia, Singapore, Thailand, Taiwan, India, Israel and Turkey with approximately 13,500 treatments worldwide.

Manufactured by Sirtex, SIR-Spheres microspheres are the only FDA-approved microsphere radiation therapy for the treatment of colorectal liver metastases. Sirtex Medical Inc.’s SIR-Spheres microspheres are indicated for the treatment of non-resectable metastatic colorectal cancer in combination with intra-arterial FUDR chemotherapy. Information regarding other disease states or agents in combination with this device, that is presented in peer-reviewed literature or medical meetings may differ from the approved USA indications as per the labeling for the product.

1. Hendlisz A, Van den Eynde M, Peeters M et al. Phase III trial comparing protracted intravenous fluorouracil infusion alone or with yttrium-90 resin microspheres radioembolization for liver-limited metastatic colorectal cancer refractory to standard chemotherapy. Journal of Clinical Oncology 2010; 28: 3687–3694.
2. The clinical trial was conducted at the following university hospitals:
Institut Jules Bordet, Brussels, Belgium
Universitair Ziekenhuis Gent, Gent, Belgium
University Hospital Gasthuisberg, Leuven, Belgium
3. Cosimelli M, Golfieri R, Cagol PP et al. Multi-centre phase II clinical trial of yttrium-90 resin microspheres alone in unresectable, chemotherapy refractory colorectal liver metastases. British Journal of Cancer 2010; 103: 324–331.
4. The SITILO clinical trial was conducted at the following hospitals:
Regina Elena Cancer Institute, Rome, Italy
University of Bologna, Bologna, Italy
University of Udine, Udine, Italy
Fondazione Pascale Cancer Institute, Naples, Italy
® SIR-Spheres is a Registered Trademark of Sirtex SIR-Spheres Pty Ltd
Contacts
of Fleishman-Hillard on Behalf of SirtexAndrea Moody, 919-457-0743

andrea.moody@fleishman.com
Permalink: http://eon.businesswire.com/news/eon/20101130006286/en/Sirtex/SIR-Spheres/radioembolization

,

Additional News /Liver Cancer and Treatment

Nov 30 th

Cutting edge liver cancer treatment comes to Toledo

Dr. Banker previously performed the procedure when he worked at the University of Mississippi. He's excited to bring the technology to Toledo. "The procedure requires getting into the hepatic artery in the liver and injecting small particles with high levels of radiation directly into the tumors and destroying the tumors from the inside out," he explained....

continue reading

,

Jim Belushi Chicago Abc Yes Liver Cancer Symposium

November News Liver Cancer and Treatments

,

Apricus, FDA agree on liver cancer drug study

Apricus Biosciences Inc. said Monday it reached an agreement with the Food and Drug Administration on the design of a trial for a potential liver cancer drug, making approval more likely if the study is successful.

,

Hepatitis C News: FDA Approves Merit Phase 3 clinical trial protocol to treat primary liver cancer

SOUTH JORDAN, Utah, Nov. 29, 2010 (GLOBE NEWSWIRE) --
The Food and Drug Administration (FDA) has approved Merit Medical Systems, phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere(TM) Microspheres (hqTACE) for delivery of doxorubicin. The clinical trial will involve U.S. and international interventional radiologists who treat patients with localized, unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer. The FDA action will result in the first phase 3 study in the U.S. comparing drug-eluting microspheres to conventional chemoembolization (cTACE) in the treatment of hepatocellular carcinoma. Currently in the U.S. there is no FDA-approved embolic for the treatment of liver cancer.

,

Liver Treatments:Body Radiation Therapy (SBRT)

,

EDDA Technology Introduces IQQA®-Liver Suite To Provide Dedicated Total Solutions For Liver Cancer Diagnosis And Treatment Management

,

Combination therapy improves survival time for patients with advanced liver cancer

,

Combination Therapy Improves Survival Time For Patients With Advanced Liver Cancer

,

Celsion Receives COMP Recommendation For Orphan Drug Designation In Europe For ThermoDox® To Treat Primary Liver Cancer

,

Mayo Researchers Find Mortality Rates From Liver Diseases