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:
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.
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.
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:
The SIRT UK Network would like to thank Dr Jon Bell, Consultant Interventional Radiologist from The Christie Hospital in Manchester for being instrumental in writing the questions and facilitating Royal College of Radiologists' Approval for the course.
Please note that there are further lectures and information on the non-CME section of the site.
The SIRT UK Network intends to add further CME courses in the future.
Click on the e-learning logo (above) to register.
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:
Reference: Kennedy AS, Ball DS, Cohen SJ et al. Safety and efficacy of radioembolization in elderly (≥ 70 years) and younger patients with unresectable liver-dominant colorectal cancer. Clinical Colorectal Cancer 2015 Nov 2; ePub doi: 10.1016/j.clcc.2015.09.001
The study was a retrospective analysis of 160 elderly (≥ 70 years) and 446 younger (< 70 years) consecutive patients from 11 US centers who received RE using ytrrium-90 (90Y) resin microspheres (90Y radioembolization [90Y-RE]) between July 2002 and December 2011. A further analysis was conducted in 98 very elderly patients (≥ 75 years).
Mean ages (± standard deviation) in the younger (< 70 years), elderly (≥ 70 years), and very elderly (≥ 75 years) cohorts were 55.9 ± 9.4 years, 77.2 ± 4.8 years, and 80.2 ± 3.8 years, respectively. Overall survival was similar between elderly and younger patients: 9.3 months (95% confidence interval [CI], 8.0-12.1) and 9.7 months (95% CI, 9.0-11.4) (P = .335). There were no differences between cohorts for any grade adverse events (P = .433) or grade 3+ events (P = .482). Analysis of patients ≥ 75 years and < 75 years confirmed similar overall survival (median, 9.3 months vs. 9.6 months, respectively; P = .987) and grade 3+ events (P = .398) or any adverse event (P = .158) within 90 days of RE.
The SIRT Users' Network (SUN) welcomes a new partnership with the British Nuclear Medicine Society (BNMS). The BNMS is a registered charity that was originally established in 1966 as the Nuclear Medicine Society. It is the only independent forum devoted to all aspects of nuclear medicine, clinical practice, education, research and development of nuclear medicine within the UK.
Commenting on the partnership, Professor Ricky Sharma, Chair of SUN, said:
"The BNMS is an important organisation for so many of the health professionals involved in planning and delivering SIRT treatment safely and effectively. We are delighted that they have agreed to be an official partner to SUN. Many of the SUN members are also members of the BNMS. In recent months, we have been extending our communications and cooperation with several professional and membership organisations connected with SIRT. This closer relationship with BNMS is an ideal addition to our growing partnership base."
"We look forward to a close relationship with the BNMS which will help SUN members get even more out of the SIRT Users' network." Further details on the work of the BNMS and their members can be found here:
Adding SIR-Spheres® Y-90 resin microspheres to first-line chemotherapy for patients with unresectable metastatic colorectal cancer in the liver (mCRC) further extends Progression-Free Survival in that organ.
New data from the SIRFLOX study presented at the European Society for Medical Oncology (ESMO) 17th World Congress of Gastrointestinal Cancer (WCGIC) has shown that patients with unresectable metastatic colorectal cancer (mCRC) that has spread only to the liver experienced the greatest improvement in Progression-Free Survival (PFS) in the liver from the addition of SIR-Spheres Y-90 resin microspheres to a current first-line chemotherapy regimen.
New findings were also disclosed regarding the impact of bevacizumab in the chemotherapy regimen used in the SIRFLOX study.
In both groups – the 292 patients who had an intention to treat using bevacizumab in addition to first-line mFOLFOX6 chemotherapy, and the 238 who did not – the addition of Y-90 resin microspheres resulted in a statistically significant 8.3 month delay and 31% reduction in the risk of disease progression in the liver (hazard ratio 0.69).
The clinical benefit of adding Y-90 resin microspheres to first-line chemotherapy appears to be independent of the use of bevacizumab.
The clinical benefit observed was accompanied by an acceptable level of adverse events resulting from the addition of Y-90 resin microspheres to first-line chemotherapy in mCRC.
This matters because:
Summarizing the impact of the new SIRFLOX findings, Prof. van Hazel commented that, “Even in the absence of a statistically significant improvement in Progression-Free Survival at all sites, as was the case in SIRFLOX, and even as we await overall survival data from the combined 1100-patient SIRFLOX, FOXFIRE and FOXFIRE Global studies in 2017, these new pre-planned sub-group findings for PFS in the liver should lead oncologists to consider adding SIR-Spheres Y-90 resin microspheres to first-line chemotherapy.
The liver remains the organ to which colorectal cancer spreads first, and for those patients who are ineligible for potentially curative liver-resection, liver failure due to the growth of liver metastases will unfortunately be the ultimate cause of their death, which makes our findings especially relevant for mCRC patients diagnosed with liver metastases.”
Professor Ricky Sharma for SUN commented:
“By increasing PFS in the liver, we would anticipate that this will translate to increased overall survival. SIRT is a liver-directed therapy, and the SIRFLOX data confirm the magnitude of the effect within the liver. The difference between the chemotherapy-alone arm and the chemotherapy plus SIRT arm is striking. The SIRFLOX data should encourage clinicians to refer patients as early as possible for consideration of SIRT.”
The American Society for Clinical Oncology (ASCO) has published the SIRFLOX Study Abstract as part of the 2015 Annual Meeting Abstracts which revealed a statistically significant improvement in median Progression-Free Survival (PFS) in the liver when combining FOLFOX chemotherapy (± bev) with SIRT using yttrium-90 (Y-90) resin microspheres as first-line treatment of patients with liver metastases from mCRC.
Key highlights of SIRFLOX study abstract:
In first-line treatment of patients with non-resectable CRC liver metastases, the addition of SIRT to standard chemotherapy failed to improve overall PFS.
The SIRFLOX study results revealed a statistically significant improvement in median Progression-Free Survival (PFS) in the liver. Reported median PFS in the liver was 20.5 months in the SIR-Spheres microspheres + mFOLFOX6 chemotherapy+/- biologic agent bevacizumab arm versus 12.6 months in the mFOLFOX6 +/- bevacizumab arm, with a P value p=0.002 and a Hazard Ratio of HR=0.69.
This means that there was less than a 0.2% chance the result in the liver was due to chance alone and that there was a 31% reduction in the risk of tumour progression in the liver for patients whose treatment included SIR-Spheres microspheres while on study.
The Complete Response Rate in the liver was 6.0% in the SIR-Spheres microspheres + mFOLFOX6 +/- bevacizumab arm versus 1.9% in the mFOLFOX6 +/- bevacizumab arm, with a P value of p=0.02. This result indicates that patients who received SIR-Spheres microspheres as part of their treatment experienced approximately a threefold higher rate of complete disappearance of tumours in their liver, compared to patients who did not receive SIR-Spheres microspheres.
The Overall Survival (OS) data from the SIRFLOX study will be combined with the FOXFIRE and FOXFIRE Global studies to provide sufficient statistical power in over 1,000 patients globally to detect a clinical significant difference in OS between the SIR-Spheres microspheres and control arms. Analysis of OS from the SIRFLOX study cannot be progressed at this time for reasons of (a) bias and (b) statistical power for these studies. Overall OS data is anticipated in 2017.
The ASCO Annual Meeting in Chicago brings together 30,000 oncology professionals from around the world. Educational sessions feature world-renowned faculty discussing state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field. Science sessions present the latest round-breaking research in oral and poster format.
The SIRFLOX data will be presented at ASCO by Dr Peter Gibbs in the oral presentation session starting at 3 pm on Saturday 30th May 2015.
The SIRFLOX study is 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 study was conducted in more than 100 hospitals across Australia, Europe, Israel, New Zealand and the United States. SIRFLOX is the first, large randomised controlled study that has examined the use of Selective Internal Radiation Therapy (SIRT, also known as radioembolisation) in the treatment of colorectal liver metastases. For more information, please visit www.sirflox.com
Click here to view the ASCO abstract
BSIR logoThe SIRT Users' Network (SUN) welcomes the BSIR as an official partner. The BSIR is a charitable foundation which promotes and develops the practice of Interventional Radiology. As SIRT is delivered by skilled interventional radiologists, many of the members of SUN are also members of the BSIR.
Commenting on the collaboration, Professor Ricky Sharma, Chair of SUN, said:
"We are pursuing ways in which we can increase our communication with professional organisations involved with all aspects of this important new treatment. BSIR are a natural partner and we are delighted that they have accepted our invitation to partner with SUN.
We look forward to a close working relationship with BSIR to improve SIRT treatment for patients with cancer. Our members and their patients can only benefit from this new alliance."
The BSIR maintains the online SIRT Registry which is actively collecting data on SIRT for primary and secondary liver tumours. The Registry also enables the NHS to assess and evaluate SIRT patient outcomes as part of the Commissioning through Evaluation programme.
Dr Raman Uberoi, Vice President of BSIR, welcomed the new partnership:
"BSIR is delighted to collaborate with the SIRT Users' Network to support patients and clinicians in improving the quality of patient care."
The following release was issued by SUN yesterday following the annoucement by NHS Wales that SIRT will now be available through Commissioning through Evaluation in Wales for the first time.
7th October 2014. NHS Wales has announced today that life-extending Selective Internal Radiation Therapy (SIRT) will be made available to eligible patients in Wales with liver cancer that has spread from the bowel or for patients with bile duct cancer. NHS Wales has confirmed that Wales will join the Commissioning Through Evaluation (CtE) process to enable access for patients to SIRT and provide central funding to support this.
SIRT is the first treatment to be funded in Wales through the new NHS 'Commissioning through Evaluation' policy that is hoped will improve the availability of cutting-edge cancer treatments. Access to SIRT in Wales was previously only available if it was paid for privately or if an application was made for its use under exceptional circumstances, a process that could take many months and was unacceptable at a time when patients may only have a short time left to benefit from treatment.
Following a widespread review by NHS Wales, SIRT will now be available for the first time on the NHS for eligible patients. Patients in South Wales will be treated at the University Hospital Wales in Cardiff and arrangements have been made for patients in North Wales to be treated at the Christie Hospital in Manchester.
Mark Drakeford AM, Minister for Health and Social Services, confirmed the adoption of CtE in Wales and said, "I am delighted to announce the extension of CTE to Wales for SIRT for patients with liver tumours. In February, I agreed that the NHS in Wales would join the Commissioning Through Evaluation process to enable access for a small number of patients to SIRT and provided central funding to support this.
"Positive clinical discussions have recently taken place regarding the implementation of the programme. It has now been confirmed by the NHS England CtE Programme that University Hospital Wales in Cardiff meets the standards and requirements for selection as a provider of SIRT
Agreement has been reached for NHS Wales to participate in the programme and patient assessment for SIRT will commence this month.
The Christie Hospital in Manchester is the selected SIRT centre meeting the commissioning though evaluation criteria for North West England and North Wales."
The decision has been widely welcomed by clinicians and patient groups.
Professor Ricky Sharma, Consultant Clinical Oncologist and Chair of the SIRT Users' Network (SUN), commented: "We are delighted that patients in Wales will now have equal access to this important treatment. As an Oncologist, I have been referred several patients from Wales over the past year who have been denied funding for this treatment because they live on the other side of the border. It has been an emotional time for those patients and their loved ones, as well as for the medical teams trying to access the best treatments for them.
This announcement is a very big deal for Welsh patients with bowel cancer or bile duct cancer and their families."
Dr Richard Adams, Consultant Clinical Oncologist in Cardiff said, "This is a very welcome announcement and patients in Wales with bowel cancer that has spread to the liver will now be offered this innovative treatment for the first time at a stage when few other treatment options are available to them. I am delighted that patients in South Wales will be treated in Wales".
"This is tremendous news for cancer patients and their families in Wales", said Andrew Langford, Chief Executive from the charity The British Liver Trust. "We are delighted that NHS Wales has extended CtE to Wales to enable eligible patients to benefit".
Treatment with SIRT will be available to eligible patients in Wales by referral from their local specialist consultants. SIRT will only be funded for patients where all other routine approaches, such as surgery and chemotherapy, have been tried or have been poorly tolerated.
The SIRT procedure is a form of radiotherapy in which millions of tiny radioactive beads are injected into the arteries that supply the cancer. SIRT using SIR-Spheres® microspheres (yttrium-90 resin microspheres) has been shown to significantly improve survival in patients with bowel cancer that has spread to the liver when the cancer has progressed through prior chemotherapy.[i],[ii]
[i] Seidensticker R et al. Matched-pair comparison of radioembolization plus best supportive care versus best supportive care alone for chemotherapy refractory liver-dominant colorectal metastases. Cardiovasc Intervent Radiol 2012; 35; 1066-1073.
[ii] Bester L et al. Radioembolization versus standard care of hepatic metastases: comparative retrospective cohort study of survival outcomes and adverse events in salvage patients. J Vasc Interven Radiol 2012; 23: 96-105.
Newly published European Society for Medical Oncology (ESMO) clinical guidelines for the treatment of metastatic colorectal cancer (mCRC) endorse radioembolisation, specifically with Yttrium-90 resin microspheres, as a clinically proven technology to 'prolong time to liver tumour progression' in mCRC patients who have failed to respond to available chemotherapy options.
The new guidelines, authored on behalf of the ESMO Guidelines Working Group by Professors Eric Van Cutsem (Leuven, Belgium), Andres Cervantes (Valencia, Spain), Bernard Nordlinger (Paris, France) and Dirk Arnold (Freiberg, Germany) were published online in a 4 September 2014 supplement to the Annals of Oncology.
As clinical evidence for the new ESMO recommendation, the authors cited a multi-centre randomised controlled study conducted by Professor Alain Hendlisz (Brussels, Belgium) and colleagues. The Hendlisz study was a 'Phase III trial comparing intravenous fluorouracil infusion with yttrium-90 resin microspheres for liver-limited metastatic colorectal cancer refractory to standard chemotherapy.'
ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up of Metastatic colorectal cancer states that:
"In patients with liver-limited metastases failing the available chemotherapeutic options, radioembolisation with yttrium-90 resin microspheres can also prolong the time to tumour progression"
Published in 2014 - Ann Oncol (2014) 25 (suppl 3): iii1-iii9.
Authors: E. Van Cutsem, A. Cervantes, B. Nordlinger and D. Arnold
The SIRT Users' Network is being launched today by the University of Oxford, in association with its partners, Sirtex Medical, the British Liver Trust, Beating Bowel Cancer and the NIHR Oxford Biomedical Research Centre.
The network has been established in response to SIRT (Selective Internal Radiotherapy) becoming available for the first time for national commissioning on the NHS. SIRT is the first therapy available in the UK through NHS England's 'Commissioning through Evaluation' process (CtE), which allows clinicians to provide SIRT to eligible patients on the NHS.
SIRT is available through CtE in England and Scotland in 11 specialist cancer centres, which is an important advance in the delivery of specialist services currently available in the UK.
The SIRT Users' Network is a web-based network open to all clinicians and scientists involved with delivering this treatment to patients. Members of the network work in a variety of clinical disciplines (oncology, interventional radiology, imaging, nuclear medicine, medical physics, pathology and surgery). For the first time, these diverse specialists can come together in an online forum to share best practice, clinical experiences, patient information and to organise SIRT masterclasses and workshops.
Speaking at the launch today, Professor Ricky Sharma, Honorary Consultant in Clinical Oncology at the Oxford University Hospitals NHS Trust said:
"This is a very exciting time for all clinicians involved in offering SIRT to patients with cancer. There are a number of clinical disciplines that have to work together harmoniously to deliver the best SIRT service to patients. This new network represents the first opportunity to bring all these clinicians together to share knowledge, best practice and outcomes across all the centres involved in SIRT in the whole of the UK.
The key aim of the network is to benefit patients. We hope the network will help us all to work together, clinicians and patients, to improve outcomes."
Commenting on the SIRT Users' Network, Nigel Lange, Chief Executive of Sirtex's European Division said,
"This network is a great testament to the skills, expertise and dedication of a wonderfully talented group of clinicians who have worked for years with SIRT patients and who have strived to make SIRT more widely available to UK patients a reality in the NHS. I pay full tribute to their success.
Sirtex is dedicated to improving patient outcomes and the launch of the SIRT UK Network is an enormous and important step in that direction. We are proud and privileged to be a partner in this important initiative."
SIRT, also called 'Radioembolisation', is a method of treating malignant liver tumours, whether those tumours originate from the liver itself, or have spread to the liver from elsewhere in the body (e.g. bowel cancer).
Millions of little resin or glass 'beads' are injected into the arteries inside the liver. The microspheres are tiny and too small to see with the naked eye. Each microsphere is much smaller than the width of a human hair.
These microspheres contain a radioactive isotope which emits radiation that travels only a very short distance within the liver. Once injected, the microspheres lodge in the vessels that supply the tumour and emit radiation, which kills the tumour cells.
The microspheres also help to cut off the blood supply to the tumours, thus starving them of oxygen and essential nutrients. Although the radiation lasts for a period of days, the treatment effect on the tumour can last much longer.
SUN has an academic focus, and is independent of commissioning and service considerations. The SUN website has a secure "members' only" discussion forum to allow clinicians to hold private and secure exchanges of views on all aspects of the SIRT procedure and clinical issues. The site also provides freely available resources for clinicians and patients.
All the members of The SUN Users' Network are involved in the treatment of cancer patients with SIRT. The remit of the Network is to:
NHS England has announced the list of provider hospitals chosen to take part in a new £4.8 million initiative, aimed at increasing access to specialist radiotherapy services.
The 10 centres will provide Selective Internal Radiotherapy (SIRT) to around 220 patients a year as part of a time-limited programme called 'Commissioning through Evaluation'.
The successful centres are:
Commissioning through Evaluation will enable SIRT to be funded within defined parameters, in a relatively small number of centres, and within an explicit evaluation programme. It is anticipated that the programme will be funded for between 1-3 years.
This approach provides an opportunity for patients, who are deemed clinically suitable, to access SIRT - a treatment which shows significant promise in terms of improving quality of life - but is not accessible through a formal research trial.
Dr Adrian Crellin, Chair of NHS England's SIRT Commissioning through Evaluation Steering Group, said:
"This is a very exciting development for those patients who can potentially benefit from treatment with SIRT, and for those clinicians who wish to contribute to the growing evidence base supporting this treatment.
NHS England is committed to expanding access to all forms of specialist radiotherapy, and we await the outcome of this innovative commissioning programme with some anticipation, as is it will help us determine how best to deliver these important, and life-saving, services to patients in the future".
There is a restricted access forum for all clinicians involved in the SIRT procedure to help share best practice and experiences. If you have or you would like to share your experiences or you want to find out more about the procedure and the latest clinical developments, please join our community.
Click here to join or sign-in
There is a designated site for SIRT patients, their families and carers called My SIRT Story.
Click here to find out more