Innovations in Oncology - Q4 2021

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Q4 2021 | A promotional supplement distributed on behalf of Mediaplanet, which takes sole responsibility for its content

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Innovations in Oncology

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Proactive planning for the future of cancer care. ~ Christine Ridout, Associate Director of Research and Policy, The Health Policy Partnership

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Radioligand therapy - inequitable access to effective cancer treatment. ~ Dr John Buscombe, Past President, British Nuclear Medicine Society


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IN THIS ISSUE

“It is vital that the NHS is adaptable and ready for change.” Christine Ridout Associate Director of Research and Policy, The Health Policy Partnership

Cancer trials are a casualty of COVID-19

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Recruitment onto cancer trials has dropped by nearly 60% during the pandemic. But COVID-19 also offers clues to a recovery that can get new treatments to cancer patients more quickly. “Over the past few decades, the outcomes following liver transplantation (LT) have improved.” Dr Afsana Elanko and Professor Derek M Manas, British Association of Surgical Oncology, The Association for Cancer Surgery

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“Optimising clinical trials for greater inclusiveness in cancer care.” Luis Castelo-Branco Scientific and Medical Division Fellow, European Society for Medical Oncology (ESMO)

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he response to COVID-19 has proven that science can move in leaps and bounds when it’s properly funded and prioritised — transforming patients’ lives with new vaccines and drug treatments. But cancer trials — which provide hope to many patients facing a cancer diagnosis or progression — have become another casualty of the pandemic and recruitment onto trials has plummeted. The Government must urgently invest in COVID-19 recovery of cancer clinical trials and learn the lessons of the pandemic by streamlining the regulation of clinical research to promote innovation. Failing to do so would see the pipeline of new treatments stall and leave people with cancer — particularly those with advanced disease — without access to potentially life-saving medicines. Learning from COVID-19 The UK’s RECOVERY platform trial — which uncovered many of the treatments now benefiting COVID-19 patients worldwide — is a huge success story and an example of trial innovation. It received ethical and regulatory approval in just nine days and consisted of a flexible framework, allowing ineffective interventions to be dropped early, while permitting new, promising interventions to be swiftly added as new evidence emerged. The implementation of platform trials – which prepandemic was seen mostly in cancer research – has historically been slow. Even before COVID-19, cancer researchers faced many issues with setting up clinical trials – through lack of funding and excessive red tape. It has often taken months, sometimes years to secure funding for a new trial, followed by further delays before patients can be enrolled. Even when trials are funded, insufficient resource within the NHS often hinders their delivery.

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The implementation of platform trials – which pre-pandemic was seen mostly in cancer research – has historically been slow. Restoring cancer trials The pandemic has caused additional problems for cancer trials, causing a sharp reduction in patient recruitment. But COVID-19 trials like RECOVERY have also shown us what could be feasible with enough resource and commitment. We now need Government and funding and regulatory bodies to establish the infrastructure needed to make it easier to fund and deliver innovative trials. We must make up for lost time and test drugs in smarter, faster, more efficient trials to generate the required standard of evidence more quickly. By ensuring the regulation and delivery of trials keeps pace with advances in science, we can accelerate patients’ access to the next game-changing treatments.

WRITTEN BY

Professor Christina Yap Professor of Clinical Trials Biostatistics at The Institute of Cancer Research, London

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Secondary breast cancer: join us to tackle this incurable disease

disease, as well as accelerating drug development. In Spring 2022, we will open a call for research proposals and hope to fund more projects that help us tackle this devastating disease. Our commitment We are committed to the challenge of tackling secondary breast cancer. Our funded research will help us understand how breast cancer develops and spreads with a mission to find more effective treatments. We also provide specialist services for anyone affected by this incurable disease and campaign to ensure they receive the best possible treatment, care and support.

There is no time to waste in unravelling the complexities of secondary breast cancer to stop thousands of people dying from this devastating disease each year.

E WRITTEN BY Dr Simon Vincent Director of Research, Support and Influencing, Breast Cancer Now

ach month around 1,000 women and seven men die from incurable secondary (metastatic) breast cancer in the UK, and we’re concerned not enough progress is being made to tackle this disease in research and healthcare. Breast Cancer Now has a bold vision that by 2050 everyone diagnosed with breast cancer will live and be supported to live well. Paramount to achieving our vision is tackling secondary breast cancer, but many critical unanswered questions remain that must be urgently addressed. Research bringing hope for the future Funded by the Breast Cancer Now Catalyst Programme, which accelerates progress through innovation and

collaboration, Professor Janet Brown from University of Sheffield is trialling a combination of two drugs - avelumab with radium 223 dichloride - as a potential new treatment for breast cancer that has spread to the bones and other organs. Meanwhile, Professor Clare Isacke’s team from the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research, London, is working to better understand how cancer and non-cancer cells interact with each other. We hope this will lead to the next generation of treatments or even prevent secondary breast cancer. Through these projects, and others, we take a ‘bench to bedside’ approach, by supporting discovery research to increase our understanding of the

There is an urgent need for new pancreatic cancer treatments

INTERVIEW WITH

Harpreet S Wasan Consultant & Reader in (Medical) Oncology Lead for Medical Oncology & Clinical Divisional Lead for Cancer for N.W London Research Network Department of Cancer Medicine Hammersmith Hospital, Imperial College Healthcare NHS Trust

References 1. https://www.cancerresearchuk.org/ health-professional/cancer-statistics/ statistics-by-cancer-type/pancreatic-cancer [last accessed Nov 21]

ypically seen in later life, common symptoms include jaundice, weight loss or severe pain – often mimicking back pain. Early diagnosis is important according to Harpreet S Wasan, Consultant and Reader in Oncology at Hammersmith Hospital, London. “Only about 10% of patients diagnosed with pancreatic cancer can be operated on, even with early diagnosis surgery may not be an option as tumours quickly start attaching to major surrounding blood vessels.” This bleak outlook has persisted for some time, but a recent clinical trial offers oncologists a potential new addition to their therapeutic toolkit. A pilot study investigated the safety of the OncoSil™ device which allows for the implantation of radioactive microparticles, delivering a high dose of radiotherapy directly into pancreatic tumours. Other advantages of the interventional procedure include speed, efficiency and less risk to organs surrounding the pancreas. Although the UK has well-organised cancer networks and specialist pancreatic cancer centres, there is currently no approval of, or funding for, the procedure to be used in the NHS despite its potential and its approval as a device by the BSI (British Standards Institution).

More must be done to stop people dying from secondary breast cancer and to help those diagnosed to live well, but we can’t do this alone. Join us More must be done to stop people dying from secondary breast cancer and to help those diagnosed to live well, but we can’t do this alone. That’s why we’re calling on other organisations to help us accelerate progress in secondary breast cancer through innovation and collaboration so that together, we can make the progress so urgently needed.

Find out more at breastcancer now.org/research

Nuclear medicine is offering innovative therapies for pancreatic cancer

There were 10,000 pancreatic cancer cases in the UK annually (2018) and increasing in incidence and remains difficult to diagnose, so usually presents late with limited treatment options.1

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Paid for by Breast Cancer Now

Research and investment into nuclear medicine has been gathering pace over the last decade and is developing some promising options for pancreatic cancer patients.

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n alignment of science, research, funding and innovation has resulted in an acceleration of radionuclide therapy for both diagnosis and treatment of cancer, says Zarni Win, Consultant Radiologist at the London Clinic. The potential of harnessing radioactive substances to treat cancer has taken off in the last five years. Pancreatic cancer patients will benefit from these new developments, says Dr Win. “People tend to present too late once the cancer has spread and options for surgery are limited. Chemotherapy and radiotherapy are not targeted in the same way as therapies such as Oncosil ™ which deliver the treatment directly, in a single sitting, without the side effects of conventional treatments.” The desired outcome is that patients become eligible to undergo surgery. A recent clinical trial showed that 33% of participants became candidates for surgery compared to 10% with conventional treatment. The London Clinic was the first site in the UK to offer the Oncosil ™ procedure and Dr Win is optimistic that this ‘game changing’ therapy will soon be available on the NHS.

INTERVIEW WITH Dr Zarni Win Consultant Radiologist and Nuclear Medicine Physician, Head of Service Nuclear Medicine, Imperial College Healthcare Trust

WRITTEN BY Judith Ozkan

Paid for by OncoSil Medical oncosil.com

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Enabling a greater choice for patients in clinical trial design Digital technology is leading to broader diversity in recruitment for clinical trials and enabling patients to have a stronger voice in design of modern medical studies.

W INTERVIEW WITH

Clare Campbell Senior Director Digital Strategy & Solutions, Labcorp Drug Development

INTERVIEW WITH

Melissa Harris Director Patient Recruitment & Engagement, Labcorp Drug Development SPREAD WRITTEN BY

Mark Nicholls

ith a growing recognition that patients have a pivotal role to play in the design and development of clinical trials, specialists who recruit to trials also point to the value of digital technology in helping create a diverse, relevant and representative patient group that is able to actively participate. Increasingly, that participation is conducted remotely - reducing the need for participants to attend hospitals, clinics or trial centres - with data captured and transmitted from a home environment in real-time to the study team or by conducting televisits with the hospital staff. The ripple effect With disparities in ethnicity, low socioeconomic background, age, geographical location, cognitive impairment, and with patients who are transient or have religious or educational needs, assembling the right patient group is critical. “All of these have to be taken into account when we design a protocol that works for the patient population,” explains Melissa Harris, who recruits patients for trials for the pharmaceutical industry. “But there is also a significant ripple effect. If there is a lack of evidence to support that these trials have been done in the right populations, doctors might be reluctant to prescribe. That means we would let down an entire community of patients for generations to come. “We have to know how these new drugs work in different patient groups, so it is critical that we get the right patients into the trial.” Patient voice Patients are recruited to clinical trials via electronic health records, from referring hospitals and specialist centres, social media and traditional advertising and patient advocacy groups. Harris is Director in the Patient Recruitment and Engagement Team at Labcorp Drug Development, a clinical research organisation, which runs studies for pharmaceutical companies. Her focus is on ensuring that patients on clinical trials receive the education and support that they need to take part. “We do that through our Voice of the Patient programme; listening to our diverse sets of patients in order that we can truly drive inclusive trial designs,” she explains. So, why is it important that the patient voice is heard? “If you do not include the ‘voice of the patient’, you end up with a trial design that is not liveable - it needs to be a trial that patients want to and can take part in. We have to make

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We have to know how these new drugs work in different patient groups, so it is critical that we get the right patients into the trial. sure that we are listening to the patient population who live with that condition to meet their needs.” Diverse populations Clare Campbell, a Senior Director for Digital Strategy and Solutions at Labcorp, says patients are increasingly more informed in their understanding and knowledge of clinical trials, but fewer patients are joining them. “It is our job to reach out to diverse patient populations to help them understand that clinical trials might be a powerful option for their care,” she says. This is assisted by technologies that can allow patients from different backgrounds to access oncology trials, whilst reducing the burden of trial participation on them and their caregivers. Increasing inclusivity Technology gained wider acceptance among patients during the COVID-19 pandemic, but it has also catalysed increased inclusivity and broadened the diversity of patients, as well as helping researchers provide greater equity of access to trials. Campbell says digital solutions also help to increase data quality – for example wearable devices that can record and transmit biometric measurements such as heart rate - which allows the site trial team to review in near real time. Technology can empower people to have greater involvement in their care, lessen the burden of participating in a trial as well as deliver high quality, meaningful patient endpoint data so all stakeholders benefit.

Find out more at drugdevelopment. labcorp.com

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Advancing cancer care through clinical trials Dr Saini, a practicing locum medical oncologist at the NHS, and Executive Medical Director at Labcorp, which operates one of the largest clinical trial services and clinical laboratory networks in the world. “Doctors, researchers, planners, regulators and industry are seeking to address that gap. But one of the biggest challenges for cancer researchers today is how to fully realise the potential of precision medicine which involves getting the right treatment to the right cancer patient at the right time.”

Image provided by Labcorp

Cancer patients are accessing unique opportunities for individualised care through participation in ground-breaking clinical trials.

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aking part in clinical trials is increasingly being seen as a critical step in offering greater individualisation of care for cancer patients. With one in two people in the UK likely to have cancer at some point in their lives, the latest NHS Long Term Plan aims to deliver dramatic improvements in ways to diagnose and treat cancer. While this includes screening programmes, earlier diagnosis, investing in cutting edge treatments and technologies and highlypersonalised therapies for patients, clinical research as a care option will be a critical element in evolving cancer care and introduction of innovative diagnostic and therapeutic options which will provide opportunity for earlier cancer diagnosis, and more personalised therapies that manage the individual patients’ cancer. Providing care through clinical trials Even though the proportion of cancer patients participating in clinical trials

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is higher in the UK than in most other countries, there is significant scope for further improvement. This can be achieved by increasing the availability of suitable cancer trials in the UK, improved patient access in rural areas and lower socioeconomic groups, and creating awareness among patient advocacy groups and healthcare providers within the NHS. Medical oncologist Dr Kamal Saini says treatments have moved away from a one-size-fits-all approach to greater precision and individualised treatments, but there are opportunities to advance that further. “We’re progressing beyond treating patients in broad groups towards delivering more precise and personalised therapies. Such individualisation is accelerating, especially with the development of cell and gene therapies for cancer. But there is a gap between what is possible for selected patients with cutting edge science and what can be delivered at scale through our existing clinical infrastructure,” says

Finding appropriate UK clinical trials Dr Ken Morrison, Global Head for Operational Strategy and Planning at Labcorp, says: “What we are seeing is an evolution in cancer trial design that is moving from broad categorisation e.g. “breast cancer” – to a very precise profiling of an individual patient’s breast cancer based on the individual cancer disease genetic mutations and protein expression, informing treatment options that data shows to be most effective. “We provide both the diagnostic assessment and characterisation of an individual patient’s cancer and then access to suitable clinical trials options in partnership with the cancer patient’s healthcare professional.” Technological advances - such as artificial intelligence, big data, and digital biomarkers – are being embraced by academic centres across the UK, to offer detailed individualised reports about a patient’s cancer, and how they are responding or likely to respond to treatments. Rapid improvement The science is advancing. Immunooncology drugs have become the ‘backbone of treatment for cancer’ but newer mechanisms, like mRNAbased vaccines for individual patients and CAR-T and cell and gene therapy solutions are also being developed. “We are at the cusp of great cceleration in adoption of novel therapies” says Dr Saini. “There will be rapid improvement in outcomes for cancer patients and clinical trials are needed to develop and implement the next generation of cancer therapies.” While clinical trials are increasingly attractive as a treatment option, assessing patients for their suitability, recruiting them to participate, partnering with specialist cancer centres across the UK and focusing on patients’ needs through clinical trials at the point of care remain critical in establishing the infrastructure for adoption of these innovative therapies in the NHS.

INTERVIEW WITH Kamal Saini, MBBS, MD, MRCP (UK), DM (Med Onc) Executive Medical Director, Labcorp Oncology

INTERVIEW WITH Ken Morrison PhD PMP Executive Director, Global Head Operational Strategy & Planning Oncology, Labcorp Oncology

Spread paid for by Labcorp

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Readiness and resilience are essential requirements of building systems that are prepared for whatever the future brings.

Proactive planning for the future of cancer care The NHS must focus on readiness and data-driven planning across the entire system to prepare cancer services for new treatment approaches.

R WRITTEN BY Christine Ridout Associate Director of Research and Policy, The Health Policy Partnership

eadiness and resilience take on particular significance in the context of cancer care, as they help ensure continuity of care and adaptability of services despite external forces and change. The COVID-19 pandemic has brought to light pre-existing deficits in cancer care, often resulting in unacceptable delays to diagnosis, treatment and ongoing care. We are now faced with a unique opportunity to reinforce and improve our cancer services. We need to expand and update our infrastructure, improve data collection, support our workforce and ensure the entire health system better reflects the needs of people with cancer. Readiness and resilience are essential requirements of building systems that are prepared for whatever the future brings. Why do we need readiness for innovation in cancer care? With new and improved screening, diagnostics and treatments emerging all the time, cancer services should be flexible enough to quickly integrate these innovations. We know that this is not always the case across the NHS. There is a ‘postcode lottery’ in access to care for almost every type of cancer and uptake of innovation can be extremely slow. NHS leaders at every level must proactively plan how to integrate new approaches into daily practice, to ensure that they are available to all who need them.

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There is a ‘postcode lottery’ in access to care for almost every type of cancer and uptake of innovation can be extremely slow. Proactive planning for innovation As new approaches to treating cancer become increasingly multidisciplinary and collaborative, it is essential that planning takes place across the whole system. When a new treatment emerges, we need to quickly improve awareness and update training for healthcare professionals and ensure patient-facing materials are fit for purpose. We must consider how health facilities can deliver the treatment sustainably and review data collection to ensure it informs practice. Ultimately, we need to consider all factors that influence how, when and why an intervention will be used. It is vital that the NHS is adaptable and ready for change. With a concerted focus on forward planning for readiness across all its policies, the NHS can become a health system that is ready for the future of cancer care.

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Help improve access to personalised therapies for cancer patients Advances in technology have the potential to lead to greater democratisation of personalised medicine as biomarker targeted therapies become more widely available.

D INTERVIEW WITH Jose Luis Costa EMEA Director Medical Affairs, Thermo Fisher Scientific WRITTEN BY Mark Nicholls

elivering personalised therapy to cancer patients can involve complex medical and scientific processes. Advances are now enabling innovative techniques to be made more widely available in what the scientific community regards as greater democratisation of healthcare. Doctor Jose Luis Costa, Director Medical Affairs based in the EU from Thermo Fisher Scientific says: “We know that every cancer patient, and every tumour, is different. By providing solutions to better stratify and test tissues samples obtained from cancer patients, we can help to identify the needs for each individual.” Genetic characteristics This involves molecular testing of the specific genetic characteristics of tumours to target them. As a company in the oncology space providing also diagnostic solutions, Thermo Fisher Scientific provides tests which enable the identification of genetic alterations so oncologists can better understand the needs for particular patients. Using the power of NGS (next generation sequencing), it is possible to provide a fast analysis of cancer samples, leading to a better understanding of the genetic make-up of tumours. To target different tumour types, the company provides an entire dedicated NGS research solution.

Democratisation of care Improved access to molecular characterisation and personalised treatment democratises cancer care, which may become possible when large scale, easy access is created in addition to existing large academic centres with high concentrations of equipment and expertise. Jose Luis Costa, also says: “We aim to develop state-of-theart technologies and strategies to enable and empower local and regional hospitals to have the capacity to provide these solutions to their local patient population.” That is a combination of creating more cost-effective solutions that are accessible to a broader level of expertise and are also simpler to use. “By making everything as simple as possible and accessible to laboratories, any patient will be able to benefit from the technology being available in their hospital,” he adds. Supporting improved patient outcomes Thermo Fisher’s technology provides the oncologist with answers on the tumour in as little as a couple of days which reduces waiting time. Delays in diagnosis and treatment can lead to further deterioration in a patient’s condition as well as seeing treatment options narrow. Additionally, an evolving field is in liquid biopsies, where blood can be analysed to assess the genetic make-up of a tumour in the future. While this is less invasive than standard surgical biopsies, it remains a specialist and developing area.

New one-day next generation sequencing technology transforms lung cancer care Next-generation sequencing (NGS) technology is being implemented across the country thanks to massive investment by the NHS in cancer care and rare diseases.

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he roll out of a new hub and spoke model of genetics laboratories across England has gone hand in hand with significant investment in precision medicine, boosting the speed and accuracy of a comprehensive diagnosis, including genetics changes in the tumour needed to guide therapy following biopsy.

Page paid for by Thermo Fisher

Treating patients faster For Dr Yvonne Wallis, consultant clinical scientist at Birmingham Women’s and Children’s NHS Foundation Trust, this is a great step forward, particularly for lung cancer care. She says: “The sooner you get an accurate result, the better. We can help

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oncologists to start getting patients on to the right treatment as fast as possible.” In the new NHS National Genomic Medicine Service, care is spearheaded by seven new genomic laboratory hubs (GLH). According to Dr Wallis, the advent of ever more targeted therapies for specific cancer types, as well as a growing emphasis on the need to identify multiple cancer ‘biomarkers’ simultaneously at the earliest possible stage, have driven demand for rapid, highly accurate and more sensitive analysis. It is very important that the scientists across the GLH network have access to the most up to date genomic technologies to enable the speedy delivery of these time sensitive services.

More accurate, faster diagnosis “The initial strategy, followed also by other GLH labs, was to implement comprehensive NGS solutions that subsequently we realised were not considering tissue limitations that some tumours, like lung, are associated with. For these cancers, we developed a salvage pathway choosing among the NGS technologies the solution offering one-day NGS – a technology which can extract crucial diagnostic information more accurately, faster and with more sensitivity from a single small tissue biopsy.” A key benefit for lung cancer patients and clinicians is to increase the number of patients accessing targeted treatment more quickly and from a smaller biopsy sample. The impact has been so positive that now one-day NGS has become first line testing for lung tumours. Dr Emily Shaw from University Hospital Southampton NHS Foundation Trust says NGS is delivering unquestionable benefits for patients. She says: “One by one, these technological developments are helping to resolve the challenges that we face with getting maximum information out of small lung cancer samples.”

INTERVIEW WITH Dr Yvonne Wallis Consultant Clinical Scientist, Birmingham Women’s & Children’s NHS Foundation Trust

INTERVIEW WITH Dr Emily Shaw Consultant Cellular Pathologist, University Hospital Southampton NHS Foundation Trust WRITTEN BY: Ailsa Colquhoun

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Radioligand therapy - inequitable access to effective cancer treatment Radioligand therapy is a rapidly developing field of cancer treatment which combines a tumour killing radio-nuclide with a ligand which targets the cancer cell. However, there are concerns over equitable access to these treatments in the UK.

WRITTEN BY Dr John Buscombe Past President, British Nuclear Medicine Society

Patient based treatment To ensure this kind of treatment can work, the same ligand is attached to a radioactive element which can be converted into an image by a gamma camera or PET machine. If there is uptake in the cancer seen on the scan, there is a significant chance that the radioligand will work. An example of this has been the use of Ga-68 DOTATOC and Lu-177 DOTATATE* in treating metastatic neuroendocrine cancer. In a large international clinical trial, it was shown that by using this combination the chance of the cancer growing is reduced by 82%. Funded but not available The results of this trial were so good that Lu-177 DOTATATE was approved

by NICE and funded by NHS England. Therefore, all patients with this cancer type who fit the criteria for treatment should receive it. The British Nuclear Medicine Society received reports this was not the case and conducted a survey which was presented at their recent scientific meeting. The survey flagged that the chance of receiving this treatment is dependent on where the patient lives, with good provision in the South and North but poor provision throughout the Midlands.

The image on the left shows the liver and pancreas where the red represents uptake of a diagnostic radioligand Ga-68 DOTATOC in a metastatic neuroendocrine cancer and the image on the right shows matched uptake of the therapy radioligand Lu-177 DOTATATE

Liver transplantation: A new treatment for unresectable liver metastases Liver transplantation is providing further options for patients with unresectable liver metastases.

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ver the past few decades, the outcomes following liver transplantation (LT) have improved. Fiveyear patient survival rates in the UK are greater than 80% for adult first-time transplants from deceased donors; hence, indications for transplantation are expanding. New hope for patients Since 1996, unresectable hepatocellular cancer (HCC), on the background of liver cirrhosis, has been an indication for LT. Since then, many centres have successfully extended the boundaries for transplanting HCC. As a result, there is renewed interest in liver transplantation as a treatment option for other primary and secondary unresectable liver malignancies. Improved results from Europe and the US published over the past 15 years, coupled with the poor survival rates seen with current standard therapeutic options, have spearheaded the formation of the UK Transplant Oncology Group. This resulted in the NHS Blood and Transplant (NHSBT) Liver Advisory Group reviewing current practice. In January 2021, they recommended that unresectable liver metastases from neuroendocrine tumours (NET), hilar cholangiocarcinoma (h-CCA) in patients with primary sclerosing cholangitis (PSC), colorectal cancer (CRC) and small (less than 2cm)

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Does this matter? It could be argued that neuroendocrine cancers are rare and that the number of patients affected is small, but a range of new radioligands are about to arrive in the UK which will treat common cancers. Next year may see the approval of a new radioligand therapy for metastatic prostate cancer patients which fail radiotherapy. If the present inequitable access to radioligand therapy continues, thousands of patients across the UK will miss out.

Images provided by Dr Navilkissoor, Royal Free London NHS Foundation Trust

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ver the past decade a new form of anti-cancer treatment has been developed which combines the best of chemotherapy, radiotherapy and immunotherapy. This technique uses a targeting molecule called a ligand, which is designed to latch onto a particular target on the cancer cell. The ligand is also attached to a radioactive element which can then destroy the cancer cell.

intra-hepatic cholangiocarcinoma (i-CCA) should be included in the UK national LT program. Evidence based implementation Based on published literature, we have a ‘road-map’ to follow which will help to facilitate the safe implementation of this transplant oncology program. Following the recommendations from several expert fixed time working groups, the Liver Advisory Group have approved transplantation for: • Hilar CCA in patients with PSC: Strict patient selection and adherence to the ‘Mayo protocol’ is the recommendation. • Intra-hepatic CCA: Recent data has demonstrated that survival figures for the subgroup of cirrhotic patients with unifocal tumours less than 2cm are comparable to similar patients with HCC currently being offered LT, thus allowing these patients to be considered. • Neuroendocrine liver metastases (NETLM): R0 surgical resection is potentially the only means of achieving a cure. Around 10-20% of patients with NETLM are eligible for curative resection. • Colorectal liver metastases (CRLM): Based on the Norwegian (SECA-1) pilot study, patients with unresectable CRLM following resection of the colorectal primary tumour, who have completed at least six weeks of chemotherapy, have no extrahepatic disease by a staging CT scan and diagnostic laparoscopy with hilar node sampling may be considered. Challenges and hope There are many challenges to overcome, not least the timely ability to allocate an organ to a patient who is eligible and has completed the required neo-adjuvant treatment. With the recent research and development in the area, liver transplantation for unresectable liver metastases may provide new hope for cancer patients.

WRITTEN BY Dr Afsana Elanko Director of Education, British Association of Surgical Oncology The Association for Cancer Surgery

WRITTEN BY Professor Derek M Manas Consultant Hepatobiliary and Transplant Surgeon, Clinical Director, Newcastle’s Institute of Transplantation, Associate Medical Director: Governance for NHS Blood and Transplant Trustee BASO - The Association for Cancer Surgery

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Image provided by Rutherford Health

New ways of delivering radiotherapy treatment could improve patient wellbeing

When it comes to treating cancer, we know that approximately 50% of cancer patients will undergo radiotherapy treatment. However, the method in which they receive this, in terms of type, time and dose, is constantly changing.

WRITTEN BY Professor Karol Sikora Chief Medical Officer, Rutherford Health plc

WRITTEN BY John Pettingell Chief Physicist and Head of Radiotherapy, Rutherford Cancer Centres

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very day, we, as clinicians and healthcare professionals, innovate. Whether that be something big or small, like developing a completely new drug or technology or perhaps it is simply altering tried and tested methods in treatment planning, we are always looking for ways to improve our capacity to treat and ultimately cure. Targeted proton beam therapy In recent years, the demand for proton beam therapy – a specialised form of radiotherapy – has surged, positioning the UK as a key provider of this advanced treatment. In contrast to conventional radiotherapy using X-ray beams, proton beam therapy delivers beams of protons which are more targeted to reduce damage to peripheral tissue and organs. In its simplest form, its high precision and ability to stop the beam at a defined point means that it can dramatically reduce long-term side effects in some cases. Capacity to treat patients with

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high-energy proton beam therapy in the UK has gone from zero just three years ago to being capable of treating thousands of patients, with the Rutherford Cancer Centres now the biggest provider in the country, and a European leader. The NHS has one centre open in Manchester and another opening next year at UCLH in London. We got to that point through innovation. Proton beam therapy is by no means a panacea for all cancers, but it is an excellent treatment for many patients. Hypofractionation technique More recently within this space, the UK has been leading the international community in how we deliver proton beam therapy. Based on new clinical evidence for the treatment of prostate and breast cancers, Rutherford has introduced a technique known as hypofractionation – the process of delivering higher doses of radiation per fraction and using fewer daily fractions – which means we are able to vastly reduce the overall duration of treatment for patients. As a result, we can gain the benefits of proton beam therapy whilst

making the whole experience easier for patients, mentally and physically. The technique itself is not new. Hypofractionation is commonly used for conventional radiotherapy under the NHS and in cancer centres around the world. In fact, the NHS has been a world leader in the use of hypofractionation for conventional radiotherapy in the treatment of breast and prostate cancer. By combining this method with proton beam therapy, and taking advantage of the improvements made in imaging, in some prostate cancers we have been able to successfully cut down a treatment plan which would traditionally have consisted of 37 sessions over seven and a half weeks to just seven sessions over two and a half weeks. In a breakthrough in the treatment of some breast cancers by using hypofractionation we can potentially cut the standard treatment plan of 25 fractions over five weeks to just five fractions over a week.

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In contrast to conventional radiotherapy using X-ray beams, proton beam therapy delivers beams of protons which are more targeted to reduce damage to peripheral tissue and organs. Making the UK an innovation leader for cancer care Currently, we are the only network of centres in the world to use that regime for proton beam therapy. In recent years, proton beam therapy has radically changed how we treat cancer. By increasing our capacity and developing new delivery methods, we can push and position the UK as a leader in the innovation in cancer care. The Rutherford Cancer Centres are at the forefront of particle therapy and precision radiotherapy research and development, working with some of the world’s top academic institutions and advanced medical technology providers. By working collaboratively with public and independent healthcare providers, we can make advanced cancer therapies such as proton beam therapy more accessible to those who need them.

Find out more at therutherford.com

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Optimising clinical trials for greater inclusiveness in cancer care Clinical trials are our best tool to improve cancer care for patients through testing the clinical value of a new treatment or intervention. However, eligibility criteria are overly restrictive.

O WRITTEN BY Luis Castelo-Branco Scientific and Medical Division Fellow, European Society for Medical Oncology (ESMO)

ne year ago, the approval of the first COVID-19 vaccine was fuelling debate in the oncology community about whether it was safe or efficacious to immunise patients with cancer. Patients under immunosuppressive anticancer treatment were excluded from vaccine trials despite their increased risk of severe infection or death from COVID-19. Whereas further research confirmed the safety and efficacy profile of vaccines also for people with cancer, questions were raised about overly restrictive eligibility criteria in clinical research. In a recent editorial on ESMO Open, the European Society for Medical Oncology (ESMO) launched a discussion on how to innovate clinical research to facilitate equitable access to clinical trials of real-world populations in a pragmatic, simplified and methodologically robust way for the benefit of all our patients. Diversifying patient involvement in clinical trials Engagement of patient populations in research is essential to tackle the diversity of cancer as a complex disease and inform a patient-centered approach in cancer care. Before the pandemic, the restrictive eligibility criteria and under-representation of the real-world population were already considered potential deficits in cancer research. For instance, some immunotherapy trials historically excluded elderly patients, those with auto-immune diseases, patients with HIV, or those treated with corticosteroids, despite these groups representing a significant proportion of people with cancer.

Engagement of patient populations in research is essential to tackle the diversity of cancer as a complex disease and inform a patient-centered approach in cancer care.

Ensuring oncologist training keeps up with innovative practice WRITTEN BY Dr Rachel Cooper Medical Director for Clinical Oncology Education and Training, The Royal College of Radiologists

As treatment innovations transform cancer care, innovations in curriculum design are transforming the training of oncologists.

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linical and medical oncologists focus on different aspects of cancer care, with clinical oncologists being the sole providers of radiotherapy. The Royal College of Radiologists’ new curriculum for clinical oncology (CO), introduced earlier this year, ensures the next generation of cancer doctors are at the forefront of innovation. The new curricula for these consultant specialties now include a common year to strengthen clinical overlaps and ensure broad understanding of shared techniques. This is essential as treatment plans using chemotherapy and radiotherapy together are being used more and use of combined therapies requires new ways of working. The curricula also focus on generalist skills and holistic management, to ensure new consultants can meet the complex needs of our changing, aging patient population. Managing side effects from novel therapies New treatments bring hope for better outcomes, but they can also bring new side effects. Patients presenting with complications from novel treatments need early oncology input and stretched A&E services need support managing patients on unfamiliar treatments. Acute oncology services are becoming an essential route to ensuring cancer patients have expert care in an emergency and the new CO curriculum clearly defines the skills trainees need to run, lead and expand acute oncology provision.

New treatments bring hope for better outcomes, but they can also bring new side effects. Future-proofing training The rate of advancement in cancer care makes it difficult to predict what practice may look like when our latest CO intake qualifies. Artificial intelligence has the potential to transform treatment planning and genomics is making truly personalised cancer care a possibility. We cannot know exactly how these technologies may be used in the future, but we can ensure trainees have the skills to evaluate and implement new technologies and awareness of new research and tech are key requirements. The pandemic emphasised the need for flexibility in training and this is built into the new CO curriculum. Instead of being restricted by the granular tick box approaches of the past, the curriculum focuses on highlevel abilities and allows trainees to evidence progress in a variety of ways outside of prescriptive assessments – tomorrow’s COs even have innovation and relevance embedded into their assessment cycle.

Changing eligibility criteria Oncologists need to find innovative ways to be more inclusive without affecting the quality of research. Instead of exclusions due to age or the presence of certain comorbidities, clinically relevant and valid tools with predefined but not very restrictive thresholds assessing frailty or disease severity should be used more to identify patients who can be included on a case-by-case basis. “In the midst of every crisis, lies great opportunity,” said Albert Einstein. The COVID-19 pandemic is a dramatic and negative experience. However, lessons learnt could be taken further to increase access to clinical trials for the benefit of all our patients. 10

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Helping cut the cancer backlog with new upright approach Smaller and more mobile upright radiation therapy equipment could prove to be an important factor in helping reduce backlogs of cancer care created by the COVID-19 pandemic.

D INTERVIEW WITH Stephen Towe CEO, Leo Cancer Care

WRITTEN BY Mark Nicholls

elivering radiation therapy to patients in an upright position could increase the potential for mobile treatment and speed up access to cancer care. With thousands facing treatment delays, the upright approach is being advocated as an efficient solution with benefits for patients, health systems and care delivery. These include a better patient experience, feeling comfortable and more in control because of the seated position rather than laying down. In addition, an upright radiotherapy system occupies less space, needs less shielding and has advantages in terms of installation, maintenance and running costs.

We are moving away from the idea of rotating a large radiation generation source around a patient to keeping the radiation source fixed and slowly rotating the patient instead. Accurate radiation delivery Physicist Stephen Towe, who describes it as a “more human way to deliver radiation therapy,” also points to research from major centres highlighting how positioning a patient upright results in less organ movement during treatment, leading to more accurate radiation delivery. As CEO of Leo Cancer Care, a start-up company developing a system for upright radiation therapy, he believes that by making equipment that is a quarter the size of conventional

X-ray radiotherapy machines, cheaper and simpler to use, will improve global access to radiation therapy and help reduce the cancer treatment backlog. “We are moving away from the idea of rotating a large radiation generation source around a patient to keeping the radiation source fixed and slowly rotating the patient instead,” he explains. “That brings the cost of equipment and construction down by about 50%.” Mobile solution The COVID-19 pandemic saw radiation oncology appointments fall by 20% with patients unable to get to hospitals, staff redeployed and restrictions in place. But delaying treatment impacts recovery, with some 40,000 patients caught in radiation therapy treatment backlogs, there are concerns that delays have resulted in deaths. With NHS radiotherapy units already working at capacity, a benefit of Leo Cancer Care’s upright radiation equipment is that it is smaller and has the possibility to go mobile. Workflow benefits The centralised nature of healthcare and bringing radiation therapy patients in to one centre rather than taking care to the patient, has not helped with the backlog, he adds. The upright system also has workflow benefits with patients positioned in less time and easier equipment sanitisation afterward. The Leo Cancer Care technology is still in development but has been installed in a French hospital for research and will go through the regulatory phase in 2022.

Paid for by Leo Cancer Care

Find out more at leocancercare.com

With the recent research and development in the area, liver transplantation for unresectable liver metastases may provide new hope for cancer patients. ~Dr Afsana Elanko and

Professor Derek M Manas, British Association of Surgical Oncology, The Association for Cancer Surgery

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With new and improved screening, diagnostics and treatments emerging all the time, cancer services should be flexible enough to quickly integrate these innovations. ~Christine Ridout, Associate Director of Research and Policy, The Health Policy Partnership

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