Orlando, Florida (23 March 2012) ‒ Findings from the largest comparative multi-centre study performed to date using radioembolisation report a significantly prolonged survival benefit following SIR-Spheres microspheres in patients with treatment-refractory liver tumours from colorectal and other cancers. The results of the study were presented today at the 65th Annual Cancer Symposium of the Society of Surgical Oncology, by Associate Professor Lourens Bester, Director of Radiology at St Vincent’s Hospital, Sydney.1
Radioembolisation, which is also called Selective Internal Radiation Therapy or SIRT, is a novel approach to treating liver tumours using microspheres labelled with radioactive yttrium-90 (90Y). The microspheres are implanted by interventional radiologists to selectively target the tumours with radiation while sparing the remaining healthy liver tissue.
Prof. Bester and his colleagues evaluated 463 patients with chemotherapy refractory liver- dominant tumours and found that “radioembolisation is associated with a significantly improved and clinically meaningful survival benefit. Whilst confounding factors may play a role, offering this treatment may confer the best prognosis for these patients,” he said.
Among the 251 patients with colorectal liver metastases, median survival in the 220 patients treated with SIR-Spheres microspheres was 11.6 months, compared to only 6.6 months for the 31 patients who received standard or best supportive care (p=0.021). In 212 patients with liver tumours from other cancers, including cholangiocarcinoma (41), neuroendocrine (40), hepatocellular carcinoma (27), pancreatic (13) breast (11), gastric (9) and other cancers (71), median survival was 9.5 months in the 180 patients treated with SIR-Spheres microspheres versus 2.6 months in 32 patients who received standard or best supportive care (p=0.013).
“The significant improvement in overall survival in this study confirm the benefits demonstrated in two previous but smaller comparative studies that were performed in patients with treatment- refractory colorectal liver metastases, notably the multi-centre phase III randomised controlled trial conducted by Hendlisz and colleagues in Belgium, and the matched-pair analysis by Seidensticker and colleagues from Magdeburg, Germany, that reported median survivals of 10.0 and 8.3 months, respectively,” Prof. Bester added.2,3
Two large international randomised controlled trials are currently underway to evaluate the effectiveness of adding radioembolisation using SIR-Spheres microspheres to first-line chemotherapy in order to assess whether this treatment should be used as an early intervention in the treatment of patients with colorectal cancer liver metastases. In addition, three large randomised controlled trials are evaluating radioembolisation using SIR-Spheres microspheres in hepatocellular carcinoma.
About the study
The aim of the study conducted at St Vincent’s Hospital was to compare the outcomes of patients with liver tumours treated using radioembolisation with patients receiving standard or best supportive care alone in the setting of treatment-refractory disease.
All patients had chemotherapy refractory liver-dominant tumours with radiologically confirmed progression, and were no longer qualified for other treatment modalities such as resection, ablation or chemoembolisation.
The study excluded any patient with extensive extrahepatic metastases, symptoms that confined them to bed for more than 50% of the waking hours (ECOG performance status >2), excessive liver tumour burden (>75% of liver replaced by tumour) and/or compromised residual liver function.
Of the 463 patients who underwent initial evaluation for radioembolisation, 63 patients were considered unsuitable, due either to (a) hepatic arterial anatomy that could not be corrected and which could otherwise have led to complications, (b) extensive hepatopulmonary shunting between the liver and lungs, which raised the potential for excess radiation exposure to the lungs (>30 Gy), or (c) reasons relating to patient consent, such as a preference for another treatment option.
“The patients who were unsuitable for radioembolisation were referred back to their treating physician for conservative treatment or continued supportive care,” explained Prof Bester. “This group was unlikely to represent patients with more advanced disease and was consequently used as a standard-care comparison cohort.”
About Colorectal Cancer
In 2008, 153,000 people in the United States of America and 333,000 in the European Union were diagnosed with colorectal cancer.4 Around half of these patients will develop metastases that have spread from the original site of the disease, predominately to the liver. Up to 90% of these patients ultimately die from liver failure due to the spread of the disease.
For further information:
Contact: David Faktor
St Vincent’s Hospital
Tel: +61 2 8382 2866
Tel: +44 (0)20 7148 4176
Tel: +1 919 457 0749
You are about to leave the Sirtex Web site. This link is provided to you as a service and will take you to a site maintained by a third party who is solely responsible for the content.
Please be aware that Sirtex takes no responsibility for content of these external sites, nor do we endorse, warrant or guarantee the products, services or information described or offered on other internet sites.
Click 'Continue' to proceed to the third-party Web site.
You are about to leave the Sirtex Website. This link is provided to you as a service and will take you to the Sirtex Virtual Booth.
Sirtex is responsible for the content of the Virtual Booth, which is hosted on a website maintained by a third-party. Except for Sirtex’s Virtual Booth experience, please be aware that Sirtex takes no responsibility for the other content of these external sites, nor do we endorse, warrant, or guarantee the products, services or information described or offered on other internet sites.
The Sirtex site you are linking to is intended only for healthcare practitioners and patients outside your current region.
Any products discussed herein may have different approved product labeling; therefore, any information provided may not be appropriate for use in your region.
Click 'Continue' to proceed to the other Sirtex region Web site.