SIRveNIB, a Major Primary Liver Cancer Study in the Asia-Pacific Region, Completes Enrolment
The results of Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC) Randomised Controlled Study Comparing Sorafenib and SIR-Spheres® Y-90 resin microspheres in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) are expected next year, in 2017.
The Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC), National Cancer Centre Singapore and the Singapore Clinical Research Institute (SCRI) have announced that the AHCC protocol 06 SIRveNIB randomised controlled study of SIR-Spheres Y-90 resin microspheres versus sorafenib in the treatment of unresectable primary liver cancer (hepatocellular carcinoma or HCC) has completed its target enrolment of at least 360 patients.
SIRveNIB was designed to compare the efficacy and safety of selective internal radiation therapy (SIRT) with yttrium-90 [Y-90] resin microspheres, a systemic treatment that is the current standard of care in advanced hepatocellular carcinoma. The patients in SIRveNIB were ineligible for potentially curative therapies, such as surgical resection, ablation or liver transplantation.
Professor Ricky Sharma commented:
"It is very important that patients with HCC are offered participation in clinical trials with meaningful endpoints. The SIRveNIB study investigators must be congratulated in achieving their target recruitment. Oncologists, hepatologists and all disciplines involved with caring for patients with HCC now await the overall survival results of this study, as well as the important secondary endpoints such as quality of life."
SIRT UK Network offers a CPD learning module for Selective Internal Radiation Therapy (SIRT) delivered with SIR Spheres.
Dr Jon Bell (pictured right), SUN member and Consultant Interventional Radiologist from The Christie Hospital in Manchester helped to set up the CPD website and create the courses.
Dr Bell completed sub-specialty training in Interventional Radiology in Manchester and was appointed as a Consultant Radiologist at The Christie in 2013. In 2015, he completed the European Board of Interventional Radiology. He is a member of the Faculty Board of Clinical Radiology at the Royal College of Radiologists and the Safety and Quality Committee of the British Society of Interventional Radiology.
Dr Bell works at a high volume SIRT centre and he has used this experience to produce accredited online learning material for the SIRT User Network. He has a strong interest in medical education and is an Associate Training Programme Director for Radiology at Health Education North West.
The CPD/CME site is a SIRT UK Network initiative to share learning around SIRT through a web based on line Continual Professional Development site.
By clicking the link in the logo (above) or visiting the learning page on the SIRT UK Network page, clinicians can register and view a number of educational videos of lectures about Selective Internal Radiation Therapy, answer a series of multiple choice questions and complete a personal reflection.
The learning module is based on lectures by Dr Bruno Sangro Director, Liver Unit, Clinica Universitaria de Navarra and Dr Andrew Kennedy, Physician in Chief, Radiation Oncology, Sarah Cannon, Tennessee, US.
The Royal College of Radiologists have accredited two modules and awarded 2 CPD points for each of the following two courses:
The National Institute for Health and Care Excellence (NICE) has published a Medtech Innovation Briefing (MIB) on the use of SIR-Spheres for treating patients with inoperable hepatocellular carcinoma (HCC).
The advice from NICE states that doctors can consider using SIR-Spheres as a new treatment alternative to existing therapies for patients with inoperable primary liver cancer (HCC).
The NICE advice has received a widespread welcome from clinicians and from patient groups.
The British Liver Trust, an official partner of SUN, commented yesterday on the publication by NICE and we have included their release in the media section of the SUN website:
CLICK HERE TO VIEW THE BRITISH LIVER TRUST RELEASE
Professor Daniel Palmer, Chair of Medical Oncology at the University of Liverpool and an Organising Committee member of SUN said:
"This NICE MIB is welcomed, as it opens the door for UK HCC patients to have access to SIR-Spheres Y-90 resin microspheres as a well-tolerated alternative to other standard therapies. This is good news for both HCC patients and their doctors, who over the years have had limited effective treatment options available to them.
Whilst exciting further research with this technology is already well along the way to completion, the new NICE MIB advice may be particularly important for those patients who can't tolerate TACE or sorafenib or are ineligible for these treatments."
The NICE briefing states that SIR-Spheres could be used in patients with inoperable HCC as an alternative or adjunct to conventional transarterial chemoembolisation (TACE), drug-eluting bead TACE (DEB-TACE) or systemic drugs to control tumour size, extend life, reduce symptoms or to shrink tumours for resection or transplantation.
In view of this clear statement from NICE, the clinical decision of which treatment to use for an individual patient will depend on clinical factors such as the patient's general health and the extent/position of the tumour.
Importantly, the briefing points out that patients with inoperable HCC have poor outcomes and limited treatment options available, and that their review of the evidence suggests that SIR-Spheres Y-90 resin microspheres can be as effective as existing therapies such as TACE or sorafenib.
Medtech innovation briefings summarise the published evidence and information available for individual medical technologies. The briefings provide information to aid local decision-making by clinicians, managers and procurement professionals.
Medtech innovation briefings aim to present information and critically review the strengths and weaknesses of the relevant evidence, but contain no recommendations and are not formal NICE guidance.
The SIRFLOX study has now been published in the leading oncology journal, the Journal of Clinical Oncology (JCO). As you may remember, SIRFLOX was presented as an oral abstract at ASCO in May last year and we covered it extensively on the SUN website and in a SUN newsletter special.
The JCO has published the SIRFLOX study as a "Rapid Communication", defined as a commitment to freely disseminate ground-breaking and practice-changing information so that it may rapidly benefit all readers and patients.
Summary of SIRFLOX study outcomes:
The results of the SIRFLOX study with SIR-Spheres Y-90 resin microspheres have been published in the Journal of Clinical Oncology (JCO), a leading peer-reviewed cancer journal. Initial study findings were reported in an oral abstract presentation at the ASCO Annual Congress in Chicago, USA, in May 2015, and reported on the SUN Network last summer.
Lead author and the study's principal investigator, Professor Guy van Hazel from Perth, Australia, commented that “In the primary endpoint of the study, patients with non-resectable liver-dominant or liver-only colorectal cancer who received FOLFOX-based first-line chemotherapy alone had a median Progression-Free Survival (PFS) at any site of 10.2 versus 10.7 months in those that received chemotherapy plus SIR-Spheres, but this difference was not statistically significant.
The addition of SIR-Spheres Y-90 resin microspheres to chemotherapy significantly prolonged PFS in the liver, from a median of 12.6 months in the chemotherapy control arm compared to 20.5 months in the SIR-Spheres arm, which translated to a 31 percent reduction in the risk of tumour progression in the liver.
Long-term disease control is critical as liver metastases eventually cause the death of the majority of the hundreds of thousands of patients who get colorectal cancer that cannot be removed by surgery.
The primary endpoint of SIRFLOX was Progression Free Survival (PFS) at any site. Patients in the SIRFLOX control arm had a PFS at any site of 10.2 versus 10.7 months in the SIRT arm, but this difference was not statistically significant, with a hazard ratio (HR) of 0.93 (P = 0.43).
However, in respect to the study's key secondary endpoint of median PFS in the liver, which is the organ that SIR-Spheres Y-90 resin microspheres are used to target, liver-specific PFS was 12.6 versus 20.5 months in control versus SIRT by competing risk analysis. The Hazard Ratio (HR) was 0.69 (P = 0.002), representing a 31% gain with the addition of SIRT. In addition, while objective treatment response rate (ORR) at any site was similar (68.1% versus 76.4% in control versus SIRT; P = 0.113), ORR in the liver was improved with the addition of SIRT (68.8% versus 78.7% in control versus SIRT; P = 0.042), with complete responses in the liver increased over three-fold (1.9% versus 6.0% in control versus SIRT; P = 0.020).
Grade ≥3 adverse events (AEs) were reported in 73.4% and 85.4% patients in control versus SIRT (P = 0.516), including recognized SIRT-related effects. The safety profile of the combined therapy was noted by the investigators as being as expected and consistent with previous studies.
The SIRFLOX study was an international, multi-centre, randomised controlled study that enrolled over 500 patients with mCRC whose disease was non-resectable and had spread to either the liver alone or the liver plus a limited number of sites outside the liver, including lymph nodes and the lungs.
The SIRFLOX study recruited 530 patients who had been diagnosed with unresectable mCRC at 87 medical centres in Australia, Europe, Israel, New Zealand, and USA, between October 2006 and April 2013. Of these 530 patients, 263 control patients were randomized to be treated with the mFOLFOX6 regimen of 5FU, leucovorin and oxaliplatin, with the biological agent bevacizumab allowed at local investigator's discretion.
The other 267 patients received selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres in addition to the mFOLFOX6 chemotherapy regimen (± bevacizumab).
The study was conducted in more than 100 hospitals across Australia, Europe, Israel, New Zealand and the United States.
Elderly patients with metastatic colorectal cancer are often considered ineligible for certain clinical studies or certain standard treatments by their oncologists. There is a considerable knowledge gap in how to offer optimal care for them.
This month we have included the outcomes of a retrospective review on over 600 patients treated with SIRT to investigate the effects of the treatment on patients of different ages. The MORE data were published recently in the journal Clinical Colorectal Cancer.
The study concluded that:
Criteria for selecting patients should not include age for exclusion
A new analysis of the MORE dataset on 606 mCRC patients treated with SIR-Spheres Y-90 resin microspheres, published recently in the journal Clinical Colorectal Cancer, confirms that patient age is not a barrier to appropriate treatment with SIRT.
The report concluded that for patients with unresectable liver-dominant mCRC, who meet eligibility criteria for Radioembolisation (RE), SIR-Spheres Y-90 resin microspheres appear to be effective and well-tolerated, regardless of age.
The study concludes that the selection of patients for RE should not exclude the elderly.
Principal study author, Andrew S. Kennedy, MD, Director, Radiation Oncology Research, Sarah Cannon Research Institute said that "the analysis of the data from the MORE study confirmed that age alone should not exclude patients from being considered for, or receiving, SIR-Spheres® Y-90 resin microspheres treatment."
Overall, the study found that 90Y-RE was equally well tolerated in eligible elderly (≥ 70 years) and very elderly (≥ 75 years) and younger patients, without evidence of an increased risk of Radioembolization-induced liver disease or hepatic dysfunction in the elderly who were assessed up to 90 days after the procedure.
Overall, the incidence of grade 3+ events after 90Y-RE was low. Mild to moderate fatigue was slightly more prominent in the elderly than in the younger patients, although between-group differences were not statistically significant.
Clinical Practice Points from the study:
SIRT UK Network has announced a CPD learning module for Selective Internal Radiation Therapy (SIRT) delivered with SIR Spheres.
The CPD/CME site is a SIRT UK Network initiative to share learning around SIRT through a web based on line Continual Professional Development site.
By clicking the link in the logo:
or visiting the learning page on the SIRT UK Network page, clinicians can register and view a number of educational videos of lectures about Selective Internal Radiation Therapy, answer a series of multiple choice questions and complete a personal reflection.
The learning module is based on lectures by Dr Bruno Sangro Director, Liver Unit, Clinica Universitaria de Navarra and Dr Andrew Kennedy, Physician in Chief, Radiation Oncology, Sarah Cannon, Tennessee, US.
The Royal College of Radiologists have accredited two modules and awarded 2 CPD points for each of the following two courses:
Click on the links below to view / download earlier PDF versions of the SUN enewsletters:
SUN newsletter – October 2015SUN produces two newsletters per year for its members. Please contact us if you would prefer not to receive our newsletters.
Il existe un forum réservé aux cliniciens participant à la procédure SIRT afin de les aider à partager leurs pratiques et leurs expériences.
Cliquez ici pour vous inscrire ou vous identifier
Il existe un site dédié aux patients SIRT du Royaume-Uni, à leur famille et à leur personnel soignant qui s'appelle My SIRT Story.
Cliquez ici pour en savoir plus
