This website is intended for healthcare professionals only.
Take a look at a selection of our recent media coverage:
6th February 2025
Phage therapy presents a promising solution in the fight against antimicrobial resistance, particularly for infections caused by multidrug-resistant bacteria. As the need for, and interest in, phage therapy grows, hospital pharmacists and clinicians must understand guidance on patient selection, treatment administration and regulatory compliance. Here, Gerry Hughes explores the current landscape of phage therapy, including the role of healthcare professionals and optimising patient outcomes, with insights into two established phage services.
The phages discussed in this article refer to naturally occurring phages and phage cocktails and do not refer to genetically modified phages.
Bacteriophages, or phages, are naturally occurring viruses that specifically target and kill bacteria. Discovered in the early 20th century, phages were initially used as an alternative to antibiotics for treating bacterial infections. However, the widespread use of antibiotics led to a decline in their use in Western medicine.
In recent years, phages have regained attention due to the growing problem of antimicrobial resistance (AMR). This issue arises when bacteria develop resistance to multiple antibiotics, rendering traditional treatments less effective, especially for infections caused by multidrug-resistant (MDR) organisms such as Pseudomonas aeruginosa, Staphylococcus aureus and Escherichia coli.
Phage therapy has shown promise as a targeted, adaptive solution for these infections. As global demand for effective AMR treatments grows, phage therapy provides an alternative to combatting MDR infections.
Phage therapy is especially beneficial for treating infections caused by MDR bacteria when conventional antibiotics fail. A recent multicentre, retrospective study involving 100 patients treated with personalised phage therapy reported promising results. The study, conducted from 2008 to 2022, involved 35 hospitals across 12 countries and demonstrated clinical improvement in 77.2% of infections, with 61.3% of bacterial infections eradicated by the targeted bacteriophages.
The most commonly treated pathogens were Pseudomonas aeruginosa and Staphylococcus aureus, with phage preparations tailored to the specific bacterial strains isolated from each patient. When phage therapy was combined with antibiotics, bacterial eradication was more likely, highlighting the synergy between the two.
The process of guiding hospital pharmacists and clinicians on the safe and effective delivery of phage therapy is collaborative and involves multiple stages.
‘Once a request comes in, we get in touch with the treating doctor,’ explains Dr Maya Merabishvili, senior scientist at Queen Astrid Military Hospital (QAMH) in Belgium – a leading centre for phage therapy. ‘We then receive the medical file, assess whether the case is eligible for phage therapy, and if we have phages available for the pathogen.
‘The bacterial strain is sent to our lab, where we test our phage collection for compatibility. If no phages work, we inform the hospital that we have no solution. If several phages are effective, we test their compatibility to determine the best combination.’
The information on phage-antibiotic synergy is then provided to the clinicians involved in the patient’s care. ‘We prepare a phagogram detailing which phages showed activity,’ Dr Merabishvili continues. ‘We also check which antibiotics can be used with the phages and send the phages along with this information to the hospital pharmacy.’
In the UK, the National Clinical Phage Service, which was established in 2022, provides similar support. Dr Josh Jones, virologist and director of this service, explains that the service ‘operates a “bench to bedside” service for clinicians using phage therapy’, which begins with the clinician filling out a request form.
‘We’ll screen our phage library against the bacterial isolate we receive, and if we get a match, we’ll contact the manufacturer to get the phage produced, often within the EU, and then import it,’ he explains. ‘If we don’t get a match from our diagnostic panel, we go to international groups to source phages from there.’
Hospital pharmacists are essential brokers in sourcing safe, evidence-based phage therapy for patients with infections.
Phage therapy is particularly suitable for patients with chronic infections or those infected with MDR pathogens, and hospital pharmacists involved in antimicrobial stewardship or infectious disease management may assist in selecting appropriate candidates.
Once phage therapy is deemed suitable, hospital pharmacists with expertise in medicines management or aseptic compounding are typically involved in the safe procurement, storage, and administration of phages.
Dr Jones and a group of consultants from the UK have recently published guidance on assessing the suitability of patients for phage therapy, including considerations for special populations such as pregnant or breastfeeding patients, which can be used alongside support from the National Clinical Phage Service.
‘We offer clinical and scientific support to multidisciplinary teams and help with unlicensed medicines applications,’ Dr Jones says. ‘For pharmacists, we provide support in handling and storing phages safely. It’s about capacity building, education and awareness for NHS pharmacy departments so they can confidently handle phages in their own Trusts.’
Hospital pharmacists must ensure that phage preparations meet stringent safety standards and there are a range of quality assurance measures that should be taken into account, including dosing, stability and, as Dr Merabishvili explains, sterility.
‘The phages we send are sterile preparations, and we make sure the environment guarantees the sterility of the final product that will go to the patient. We work within biosafety cabinets to ensure the final product is sterile,’ she says.
In some cases, hospital pharmacists may need to perform further compounding of phage products and guidance on dilution of phages is also provided within Dr Merabishvili’s process.
‘Sometimes, the phage preparations we send are concentrated, and they need to be diluted by 100 or 1,000 times,’ she says. ‘This can be challenging for pharmacists [so] we provide a schema outlining the proper dilution steps.’
In contrast, phage therapy supplied by the UK’s National Clinical Phage Service comes in a ready-to-use format with no further manipulation required.
As phage therapy is still considered an unlicensed treatment, including in the EU and UK, hospital pharmacists must ensure that it is administered in compliance with regional regulations, and that informed consent is obtained from patients.
‘Phage therapy should be used in accordance with unlicensed medicines guidance, which pharmacists should be familiar with. Each local NHS Trust will also have its own unlicensed medicines policy,’ says Dr Jones.
How is phage therapy perceived by clinicians and patients? A recent survey of clinicians showed significant interest in phage therapy, especially given the rising threat of AMR. A majority of clinicians (71%) expressed willingness to consider phage therapy in appropriate cases, though just over half (59%) had previously heard of it.
Patient perceptions are similarly positive. In a study of diabetic foot infection patients, most were initially unfamiliar with phage therapy. However, when provided with clear information, over 89% said they would consider phage therapy if antibiotics failed. Patients viewed phage therapy as a hopeful alternative to invasive treatments like amputation.
Many patients also expressed interest in participating in clinical trials for phage therapy, indicating a strong desire for additional treatment options in the face of AMR.
Phage therapy holds significant potential in the fight against AMR, offering a promising solution for difficult-to-treat infections. The establishment of the UK’s National Clinical Phage Service marked a major step forward, and this, along with the work being done elsewhere in Europe, suggests there is considerable hope for the future.
As phage therapy develops, its integration into healthcare systems could revolutionise the treatment of infections, providing a sustainable, antibiotic-sparing approach. This innovation is poised to become a critical tool in addressing the global AMR crisis.
Switching from beta-blockers to digoxin as first line therapy for heart rate control in older patients with atrial fibrillation (AF) and symptoms of heart failure could produce a cost saving of over £100m a year for the NHS, a study has found.
AF accounted for more than 1% of the annual NHS budget, predominantly from hospital admissions, researchers wrote in the journal Heart.
The RAte control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) study was a randomised, open-label trial embedded in the NHS that directly compared low-dose digoxin – usually used as second-line therapy – with the typical first-line approach of beta-blockers.
The trial initially randomised 160 older patients with permanent AF and symptoms of heart failure (mean age 76 years, 46% women).
Researchers previously reported no difference in the primary outcome of health-related quality of life in the physical activity domain between the groups at six months, however nearly all secondary outcomes favoured digoxin by 12 months, with better patient functional capacity and less evidence of cardiac strain.
There were lower rates of side effects, cardiovascular events and hospital admissions in those randomised to digoxin.
For this prespecified health economic analysis of the National Institute for Health and Care Research-funded trial, researchers assessed information from the 149 patients who had complete data and survived to 12 months follow-up.
The analysis found no significant effect on quality-adjusted life years (QALY) between groups, however treatment with digoxin was significantly less costly than therapy with beta-blockers, with a mean saving of £530.41 per patient per year.
‘This was principally due to substantially lower rates of adverse events, with less primary and secondary healthcare utilisation compared with beta-blocker therapy,’ the researchers reported.
Extrapolating the study findings to current prevalence and costs of AF in the NHS, suggested a potential cost saving of £102 million per year, which was equivalent to a 5.9% saving on the £1.7bn spent annually on AF, the study reported.
The researchers noted the cost of secondary care services, mainly inpatient care, was significantly lower in the digoxin arm, reflecting that these patients had substantially fewer serious adverse events (16 serious adverse events in 13 patients for digoxin vs 37 in 21 patients for beta-blockers) and fewer treatment-related adverse events (29 treatment-related adverse events in 20 patients for digoxin vs 142 in 51 patients for beta-blockers).
The mean total costs for secondary care were £8.88 per patient over 12 months in the digoxin group and £484.83 per patient in the beta-blocker group, with adjusted bootstrapped difference of –£518.04 per patient in favour of digoxin.
‘While likely applicable to similar healthcare settings outside the UK, further studies with formal economic evaluation are needed to address this key evidence gap and the implications for global management of patients with AF,’ the authors concluded.
Corresponding author Professor Sue Jowett, deputy head of the Health Economics Unit at the University of Birmingham, said the study highlighted the importance of health economic assessments and the role they could play in delivering appropriate treatments.
‘At the usual £20,000 per QALY threshold, the probability of digoxin being cost-effective compared to beta-blockers was 94%, which could lead to substantial savings if the trial results were adopted more broadly in this population,’ she said.
Trial chief investigator Professor Dipak Kotecha, professor of cardiology at the University of Birmingham, and a consultant cardiologist specialising in cardiac imaging at University Hospitals Birmingham NHS Trust, said cardiac conditions such as AF and heart failure were expected to double in prevalence over the next few decades.
‘Despite being one of the oldest drugs in use for heart disease, this study confirms an important role for digoxin in the management of these patients, providing safe and cost-effective treatment,’ he said.
Last year, the European Society of Cardiology released new guidelines at its congress in London, including one dedicated to the management of AF.
The novelties of this AF guideline included the recommendation of the new CHA2DS2-VA score to assess thromboembolic risk when making decisions on initiating oral anticoagulation, which no longer includes gender.
5th February 2025
Device-based remote monitoring decreases hospital service use by nearly three-quarters when used to monitor patients requiring ongoing care and 24/7 support, according to a new study.
The researchers conducted a systematic review of cluster randomised control trials (RCTs) examining device-based remote monitoring in Europe and the US, compared to usual care in patients of all ages and with any health condition.
They included studies where device-based remote monitoring used telecommunications to transmit patient-related physiological data to the hospital, using either a non-implantable, implantable or mobile device for clinical decision-making.
Frequently studied health conditions were heart failure (45%), COPD (14%), diabetes (6%), and arrhythmia (6%). Reported outcomes included hospitalisation or re-hospitalisation, the length of hospital stay, and the number of emergency or outpatient clinic visits.
The researchers identified 3,083 studies and included 118 analyses (from 116 unique RCTs). In nearly three-quarters of the studies (n=85/118, 72%), the device-based remote monitoring group showed a decrease in hospital service use compared to standard care. The reductions in hospital use for the device-based remote monitoring group were mostly condition-related hospitalisations (53%), followed by all-cause hospitalisations (35%).
The most commonly used devices were non-implantable devices such as wearables and scales, and these were associated with the smallest decrease in hospital service use (69%). Implanted or mobile devices were used less commonly but resulted in a greater reduction in hospital service use, at 89% and 76%, respectively.
Daily monitoring was the most common, with 69% of studies using daily measurements and 65% using daily data transmission. However, this resulted in a lower percentage reduction in hospital service use than continuous or less frequent monitoring. The frequency of data assessment by a healthcare worker also did not significantly affect the reduction in hospital service use.
In most studies, device-based remote monitoring involved doctors and nurses who were already participating in patient care. This scenario resulted in a smaller reduction in hospital service use (67%) than when healthcare providers outside the typical care team were involved (76%). An additional caregiver at home reduced hospital service use by 65%.
Finding that 72% of the included studies showed a decrease in at least some aspects of hospital service use indicates that device-based remote monitoring could play an essential role in healthcare.
The researchers concluded that with the addition of tailored support, automated processing and optimised care redesign, device-based remote monitoring has the potential to significantly improve hospital care at home.
Reference
Jansen, AJ et al. Device based monitoring in digital care and its impact on hospital service use. npj Digit. Med. 2025; Jan. 08: DOI: 10.1038/s41746-024-01427-8.
Paroxysmal nocturnal haemoglobinuria is an ultra-rare disease that imposes significant medical and psychological burdens on patients. Mainstay treatment with complement inhibitors has improved patient outcomes but unmet needs remain. Dr João Gonçalves PhD explains how the treatment landscape is evolving to encompass different therapeutic targets and modalities, including danicopan, to provide a personalised, person-centred approach to management.
Paroxysmal nocturnal haemoglobinuria (PNH) is a rare, life-threatening haematologic disorder characterised by complement-mediated haemolysis of red blood cells. The disease results from a somatic mutation in the phosphatidyl inositol glycan A (PIG-A) gene, leading to the absence of glycosylphosphatidylinositol-anchored proteins, particularly CD55 and CD59, on the surface of erythrocytes.
The loss of these regulatory proteins results in uncontrolled activation of the complement system, particularly the terminal pathway, which drives intravascular haemolysis and promotes a prothrombotic state.1–3
PNH presents with a characteristic triad of haemolytic anaemia, cytopaenia and thrombosis. Haemolysis leads to symptoms such as fatigue, haemoglobinuria and abdominal pain. Additionally, the haemolysis-related iron loss can exacerbate anaemia, further reducing patients’ quality of life. Cytopaenia in PNH patients is often due to associated bone marrow failure, which might coexist with aplastic anaemia or myelodysplastic syndromes.4,5
Thrombosis is a significant cause of morbidity and mortality in PNH, with patients exhibiting an increased risk of life-threatening thromboembolic events such as stroke, deep vein thrombosis and pulmonary embolism. The underlying mechanisms involve complement activation-induced platelet dysfunction, haemolysis-driven nitric oxide depletion and endothelial damage.6,7
The chronic nature of PNH significantly affects patients’ quality of life and health outcomes. Frequent medical interventions, including blood transfusions, anticoagulation therapy and hospitalisation for thromboembolic events, contribute to a substantial burden on healthcare systems.7,8
Additionally, the psychological impact of PNH, including increased anxiety and depression, complicates clinical management and highlights the need for effective, long-term therapeutic strategies.6
The advent of complement inhibitors, such as the monoclonal antibodies eculizumab and ravulizumab, has revolutionised PNH treatment by significantly reducing intravascular haemolysis and improving survival rates.
These drugs target C5 in the complement cascade, preventing the formation of the membrane attack complex and mitigating erythrocyte destruction.9,10 However, despite their efficacy, 11–27% of patients continue to experience breakthrough haemolysis, primarily attributed to extravascular haemolysis mediated by the alternative complement pathway.11–13
While C5 inhibitors have successfully addressed intravascular haemolysis, they do not entirely prevent C3-mediated extravascular haemolysis, which remains a significant challenge for some patients.
The persistence of anaemia in patients treated with ravulizumab or eculizumab underscores the need for targeting upstream mechanisms of complement activation. This has driven the development of next-generation therapies that address the alternative complement pathway, offering a more comprehensive treatment strategy.12,13
A promising addition to the PNH therapeutic landscape is danicopan, an oral complement factor D inhibitor that selectively targets the alternative complement pathway and is approved in the European Union as an add-on to ravulizumab or eculizumab for a subset of patients with PNH.
Unlike C5 inhibitors, danicopan acts upstream in the complement cascade, preventing C3-mediated extravascular haemolysis while preserving the efficacy of C5 blockade.14,15 This dual mechanism of action is particularly relevant for patients experiencing persistent anaemia or breakthrough haemolysis despite treatment with eculizumab or ravulizumab.13,14,16
Clinical studies have demonstrated that danicopan effectively reduces haemolysis and improves haemoglobin levels in patients with PNH inadequately controlled on C5 inhibitors.9,14 Oral administration provides a significant advantage over intravenous therapies, enhancing patient adherence and convenience.13,14
Given that frequent infusions pose a barrier to optimal management in PNH, oral administration could transform the treatment experience, reducing healthcare burden and improving patient satisfaction.7,8
The introduction of factor D inhibitors signals a shift towards personalised, multi-targeted complement inhibition strategies. Future research may explore combination therapies that further refine complement regulation, addressing both intravascular and extravascular haemolysis more effectively.
Additionally, gene therapies and haematopoietic stem cell transplantation remain areas of interest, particularly for patients with severe bone marrow failure syndromes.9
PNH is a complex and debilitating disorder that imposes significant clinical and psychological burdens on patients. Although C5 inhibitors have dramatically improved outcomes, breakthrough haemolysis and extravascular haemolysis remain challenges for some individuals.
The introduction of danicopan as an add-on therapy, targeting an alternative complement pathway to provide a more comprehensive therapeutic approach, represents a significant advance in treating PNH.
With its oral formulation, danicopan has the potential to enhance patient adherence, reduce treatment burden and improve overall quality of life. Future innovations in complement inhibition and emerging gene therapies will refine PNH management, offering new hope for patients suffering from this rare and potentially life-threatening disease.
João Gonçalves PharmD PhD
Faculty of Pharmacy, University of Lisbon, Portugal
1 Graf M, Gallicchio V. History, etiology, and treatment of paroxysmal nocturnal hemoglobinuria. Trends Int Med 2022;2(1):1–8.
2 Graciaa S et al. Risk of disseminated gonococcal infections with terminal complement blockade. J Pediatr Hematol Oncol 2021;44(2):e493–e495.
3 Bravo-Perez C. Paroxysmal nocturnal hemoglobinuria: biology and treatment. Medicina 2023;59(9):1612.
4 Ahsan M, Ishtiaq R, Ishtiaq D. Ischemic stroke presenting as the first symptom in a setting of paroxysmal nocturnal hemoglobinuria. Cureus 2017;9(7):e1439.
5 Di Matteo S et al. Cost-utility analysis comparing pegcetacoplan to anti-c5 monoclonal antibodies in the treatment of paroxysmal nocturnal hemoglobinuria. ClinicoEconomics and Outcomes Res 2024;16:225–32.
6 Panse J et al. The burden of illness of patients with paroxysmal nocturnal haemoglobinuria receiving c5 inhibitors in France, Germany and the United Kingdom: patient‐reported insights on symptoms and quality of life. Eur J Haematol 2022;109(4):351–63.
7 Dingli D et al. The burden of illness in patients with paroxysmal nocturnal hemoglobinuria receiving treatment with the c5-inhibitors eculizumab or ravulizumab: results from a us patient survey. Ann Hematol 2022;101(2):251–63.
8 Griffin M, Kelly R, Pike A. A review of the treatment landscape in paroxysmal nocturnal haemoglobinuria: where are we now and where are we going? Ther Adv Rare Dis 2020;Oct 22.
9 Brodsky RA et al. Characterization of breakthrough hemolysis events observed in the phase 3 randomized studies of ravulizumab versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria. Haematologica 2020;106(1):230–7.
10 Kelly R et al. Long-term treatment with eculizumab in paroxysmal nocturnal hemoglobinuria: sustained efficacy and improved survival. Blood 2011;117(25):6786–92.
11 Latyshev V. Hematological response in patients with paroxysmal nocturnal hemoglobinuria treated with c5-inhibitor. Oncohematology 2024;19(1):83–91.
12 Versino F, Fattizzo B. Complement inhibition in paroxysmal nocturnal hemoglobinuria: from biology to therapy. Int J Lab Hematol 2024;46(S1):43–54.
13 Risitano A, Perna F, Selleri C. Achievements and limitations of complement inhibition by eculizumab in paroxysmal nocturnal hemoglobinuria: the role of complement component 3. Mini Rev Med Chem 2011;11(6):528–35.
14 Risitano A et al. Danicopan: an oral complement factor D inhibitor for paroxysmal nocturnal hemoglobinuria. Haematologica 2020;106(12):3188–97.
15 Yuan X et al. Small-molecule factor d inhibitors selectively block the alternative pathway of complement in paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Haematologica 2016;102(3):466–75.
16 Kulasekararaj A et al. Phase 2 study of danicopan in patients with paroxysmal nocturnal hemoglobinuria with an inadequate response to eculizumab. Blood 2021;138(20):1928–38.
3rd February 2025
Using procalcitonin (PCT) levels to guide intravenous antibiotic use in children hospitalised with bacterial infections does not shorten the duration of therapy compared with usual care, a large UK study finds.
Previous research had suggested that PCT – a rapid response biomarker for bacterial infection – could guide antibiotic discontinuation, but the test was not routinely used in the NHS, the study authors wrote in The Lancet Child & Adolescent Health.
In a multicentre trial at 15 hospitals in England and Wales, researchers assessed whether a PCT-guided algorithm would safely reduce the duration of antibiotic therapy in children hospitalised with confirmed or suspected bacterial infections compared with usual care, which commonly used C-reactive protein as a biomarker.
Children aged 72 hours to 18 years who were hospitalised and being treated with intravenous antibiotics for more than 48 hours were eligible for the trial.
Between 11 June 2018 and 12 October 2022, a total of 15,282 children were screened for eligibility, with 1,949 randomly assigned (1:1) to receive either current clinical management alone (usual care group) or clinical management with the addition of a PCT-guided algorithm (PCT group).
In the PCT group, plasma PCT levels were tested at baseline and every one to three days during intravenous antibiotic treatment.
Assay results were fed into an algorithm which provided guidance on antibiotic management; however, clinicians could decide to over-rule the algorithm.
The study found the addition of a PCT-guided algorithm was non-inferior in terms of safety but did not reduce the duration of intravenous antibiotic use compared with usual care.
In addition, a cost-effectiveness analysis showed that PCT-guided antibiotic management was more costly than usual care.
The median intravenous antibiotic duration was 96 hours in the PCT group and 99.7 hours in the usual care group (hazard ratio 0.96 [95% CI 0.87–1.05]), data showed.
Of the 917 participants in the PCT group, 78 (9%) had at least one event covered by the composite safety outcome measure compared with 85 (9%) of 904 participants in the usual care group (estimated adjusted risk difference –0.81% [95% CI upper bound 1.11]).
Among the study limitations, the researchers noted low adherence to the PTC-guided algorithm (36% at first clinical review and 54% at any clinical review).
In addition, the four hospitals who recruited the most participants had already implemented antimicrobial stewardship programmes.
Concluding, the authors recommended PCT-guided algorithms should be tested in subgroups of paediatric patients to establish whether they can reduce the duration of intravenous antibiotic treatment among patients with specific clinical characteristics.
Study chief investigator Professor Enitan Carrol, professor of paediatric infection at the University of Liverpool, UK, noted the study was a pragmatic trial in which clinicians did not have to adhere to the diagnostic algorithms.
‘Adherence to the algorithm was low in our study, and there were challenges in integrating the test into routine clinical workflows,’ he said.
‘The study highlights the importance of including behaviour change and implementation frameworks into pragmatic trial designs.’
The research, known as the ‘Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection’ (BATCH) trial, was led by the University of Liverpool and conducted in collaboration with Cardiff University’s Centre of Clinical Trials Research, with funding from the National Institute for Health and Care Research (NIHR).
It followed a National Institute for Health and Care Excellence recommendation for further studies to assess the effectiveness of adding PCT algorithms to guide antibiotic treatment in hospitalised adults and children with suspected or confirmed serious bacterial infections.
Late last year, a large NIHR-funded and commissioned trial in adults found PCT-monitoring could significantly reduce antibiotic overuse in sepsis.
Professor Martin Röcken talks to Helen Quinn about the current challenges and opportunities in dermatology treatments, particularly when it comes to immunotherapy for skin cancers, the importance of multidisciplinary working to optimise patient care, and his hopes for the future of the field.
Professor Martin Röcken is established as the chairman of a large dermatology department at the University Hospital Tübingen in Germany and head of the Röcken Laboratory at the same University. He has worked in this department for the past 22 years, overseeing some of the most dramatic developments in dermatology and playing a pivotal role in establishing immune-based therapies in inflammatory skin diseases and oncology.
Having recently concluded his tenure as president of the European Academy of Dermatology and Venereology and as clinical chair, Professor Röcken is committed to advancing knowledge, translating research into treatment advances and improving patient care.
‘There’s a large spectrum of very exciting areas in dermatology. My goal was and is to jointly advance both clinics and research,’ he explains.
Nowhere is this translational research more apparent than in the pioneering oncology work undertaken in the field of dermatology by the Röcken laboratory, especially in developing immune-based cancer therapies.
Professor Röcken explains: ‘The development of cancer immune therapies has mainly come from dermatology. Dermatology has a very strong oncology group that started with the first treatment trials. We pushed it, really, from the beginning.’
The idea of immunotherapy – driving the immune system to be stronger against cancers – evolved around 30 years ago, but there were no sustainable results from studies at the time. The breakthrough occurred when researchers realised that working to get a stronger, more sustained immune response would not work against cancer because the cancer was silencing the body’s immune response to protect itself.
The trials that followed around a decade ago, showed that if, instead of boosting immunity, the immune response was silenced, then a sustained autoimmunity could develop against melanoma metastases, which until then was a tumour resistant to almost all therapies.
‘If melanomas respond to therapy, you may have a relatively quick response; you see what’s happening. As there was no therapy for metastatic melanomas, and as melanomas responded to the first immunotherapy trials, melanomas were originally used to establish immune therapies,’ he explains. ‘Both specific drug inhibiting cancer proliferation and immunotherapy were developed in dermatology over the past 15 years.’
Following the successful trials, immunotherapy was approved for use in melanoma in 2017 and shortly after for other cancer types, including lung, kidney and some types of gastrointestinal cancers.
Despite notable milestones that have transformed patient treatment, Professor Röcken says many unsolved issues remain. He describes how limitations in immunotherapy emerged earlier than expected, prompting his lab to investigate how the therapy can be used more efficiently and how best to treat patients.
Previously, when a patient had metastatic disease, clinicians would undertake surgery first and then give immunotherapy to prevent the relapse. ‘But what dermatologists realised is that it’s better to first do immunotherapy and then surgery later,’ says Professor Röcken.
For this neoadjuvant therapy approach, dermatology again took the lead, and the concept is now being tested in lung and other cancers.
Finding new ways to treat ‘very difficult cancers’ is also high on Professor Röcken’s radar. For patients who undergo transplant surgery and develop lymphomas of the skin, treatment options can often be limited since the cancer cannot be controlled by treatments which target their immune system.
Alongside the innovations in oncology, the field of dermatology has made significant advances in the treatment of inflammatory and autoimmune diseases. This includes monoclonal antibodies and novel small molecules.
A new generation of drugs that can suppress the immune system – especially antibodies that are highly specific to certain pathways or diseases – are now available to patients.
‘When I started 30 years ago, it was much less satisfactory to treat patients than today. Often when we had patients with joint psoriasis, and we couldn’t treat them sufficiently, and they were desperate. Now they come in, and we can really help them,’ states Professor Röcken.
The new drugs mean there are now more opportunities to treat diseases that were once difficult to treat.
‘We [as clinicians] are now more happy than the patients because they don’t realise anymore what the reality would be without the drug. It’s a nice position to be in, I’m happy, and they consider this normal,’ he adds.
However, Professor Röcken cautions that although these new drugs offer advantages over traditional treatment options, concerns remain about their high cost and widespread use for long-term conditions.
‘The main challenge for the future will be to have a balanced view between the classical drugs and the new drugs to see how long to use them and to know more about their [long-term] safety. Then we can go towards a really bright future for the patients,’ he says.
‘Importantly, we also have to value previous medications such as methotrexate. Some of these drugs are highly effective in terms of treatment outcomes, have very few long-term safety concerns and are not costly at all. They can really help many patients worldwide and should be the first choice to think of.”
Researchers investigating treatments for inflammatory disease found that symptoms could be reduced through the use of antibodies. These therapies were originally established in dermatology and rheumatology based on the understanding that they ‘could be used to target distinct pathways, such as the tumour necrosis factor pathway, the interferon pathway, the interleukin-23/17 pathway and the immunoglobulin E pathway’, Professor Röcken explains.
‘These pathways could be blocked with antibodies, which allowed for the treatment of a large spectrum of very different skin diseases. Now, antibodies are used not only for joints and psoriasis but also for a series of other diseases affecting internal organs, like bowel diseases or lung diseases.’
Professor Röcken hopes that new treatments will become more manageable for his patients, and novel ideas are currently being developed. For example, the antibodies currently injected into patients to treat conditions such as atopic dermatitis and asthma will eventually be developed into pills, which will be much more convenient.
Trials are ongoing, alongside the development of other solutions, such as medications that can block not only the soluble mediators that cause the disease but also the signalling. This will give patients new drugs that are as efficient as the antibodies.
One of the ‘hottest’ new treatment advances for dermatology patients, according to Professor Röcken, lie in the exploration of gene therapies. This area is beginning to offer hope for dermatological patients with rare but severe genetic conditions.
Topical gene therapy is being trialled as an effective treatment for a rare disease in which patients lack the molecule that anchors the upper skin to the lower skin.
‘A cream which contains missing genes goes into the wounded skin and starts to educate it to make the correct molecules. It’s very early, but this shows that you can make gene replacement. One can think of topical gene therapy as replacing genes missing in the skin,’ Professor Röcken explains.
‘It’s fantastic – that’s one of the hottest newest advances. It’s not yet where we want to be, but it shows it works.’
The transformative developments in dermatology over recent years would not be possible without input from other areas of medicine. Professor Röcken stresses the importance of multidisciplinary working across all strands of dermatology. ‘We have six to eight hundred new melanoma patients each year, so we have weekly interdisciplinary meetings with colleagues from radiology, internal medicine and surgery,’ he says.
In addition, his hospital department is very closely linked to paediatrics, internal medicine and neurology, facilitating better patient outcomes and exchanging information on the latest developments in order to treat more complex patients through a combined approach.
This collaboration will continue to be required as Professor Röcken focuses his future research on immunogenetics, particularly how genetic factors influence responses to immune-based cancer treatments.
‘What I’m doing now is going beyond to see why some cancers fail despite the best treatment. What are the reasons? Is it the cancer? Is it the patient’s response? So, we go into basic questions to understand where the problems are coming from. And it’s quite promising,’ he says.
There is undoubtedly much more to come from the Röcken laboratory.
Public health officials in the UK have updated the list of which antibiotics can be prescribed and when, as part of efforts to tackle antimicrobial resistance.
It has meant some shuffling of antibiotic choices between the ‘Access, Watch, Reserve’ – or AWaRe – categories set out by the World Health Organization (WHO).
All first-generation cephalosporins are now classed as Access instead of Watch antibiotics, the UK Health Security Agency (UKHSA) said, which means they should be used to treat the most common infections.
The move, which covers cefadroxil, cefalexin, cefazolin and cefradine, does not ‘mandate increased use of cephalosporins’, the guidelines stated, and all other cephalosporins remain in the Watch or Reserve categories.
But it means that patients with certain allergies, such as penicillin allergy, can be prescribed a wider range of antibiotics ‘that currently show less potential to develop resistance to bacteria than others’, UKHSA added.
However, officials have made a decision to keep amoxicillin/clavulanic acid in the watch category in the UK, despite WHO guidance moving it to the least restrictive Access list.
This is because in the UK setting specifically, experts judged that ‘its use is more likely to develop resistance in bacteria compared to other antibiotics’, UKHSA added.
The guidance, which is included in an NHS antimicrobial stewardship tool will apply across the four devolved nations and follows advice from WHO which updated its categories in 2023.
Use of antibiotics in the Watch or Reserve categories is carefully monitored as part of antibiotic stewardship programmes.
By 2029, the UK is aiming to achieve 70% of total use of antibiotics from the Access category to preserve the usefulness in the future, which, according to the latest figures from 2023, is 64.1% for England.
Dr Colin Brown, deputy director at UKHSA said: ‘The AWaRe classification has played an important role in antibiotic stewardship in the UK and continues to do so.
‘This review for the UK will help healthcare professionals choose the best treatment options for their patients, while preserving the effectiveness of antibiotics for future use.’
He added: ‘It will also support the development of guidelines for antibiotic prescribing and our UK targets to tackle antibiotic resistance set out in the National Action Plan.
‘Appropriate use of antibiotics is essential in our fight against resistant bacteria.’
A version of this article was originally published by our sister publication Pulse.
31st January 2025
Speaking at Hospital Healthcare Europe’s Clinical Excellence in Cardiovascular Care event, Dr Rebecca Dobson discussed the acute need to assess cardiovascular risk in cancer care, understanding cardiotoxicity and the importance of multidisciplinary team coordination in cardio-oncology.
Following on from her previous Clinical Excellence session in which she discussed the need and demand for cardio-oncology services, Dr Rebecca Dobson, consultant cardiologist specialising in imaging and cardio-oncology at Liverpool Heart and Chest Hospital, turned her attention to considerations such as baseline assessment, cardiovascular risk factors and the impact of systemic anti-cancer therapy on the cardiovascular system – even years down the line.
Dr Dobson also championed collaborative care between cardiology, oncology, radiology and other fields to ensure patients can continue their cancer therapy alongside cardio-protective therapies to optimise their short- and long-term outcomes.
Trends change, and cancer is becoming more common, but happily cancer survival has also doubled in the UK in the last 40-50 years. It’s really important that we, as cardiologists and cardiology teams, don’t shy away from this group of patients, because there’s a lot we can do from a cardiovascular perspective to help them live long, healthy lives after they’ve had cancer.
The authors of a recent paper in the European Heart Journal looked at all patients with cancer and stratified them according to cancer mortality rate and cardiovascular disease mortality rate.
In one group, the patients sadly have very high cancer mortality rates (70-90%) and, as a cardiologist, there’s very little I can do with that cohort of patients to change the natural trajectory of that disease. The impact from a cardio-oncologist perspective is relatively low.
The second group of patients have a slightly lower cancer mortality rate (40-60%) and an increasing cardiovascular disease mortality rate (10-20%), and there’s more we can do in terms of trying to reduce long-term effects of systemic anti-cancer therapies and reducing the risk of cardiotoxicity to avoid cardiovascular complications.
In the third group, these patients are as likely to die from cardiovascular disease as they are from their cancer – both at 20-30%. It’s really important that we don’t cure these patients’ cancer and then leave them alone. We really need to optimise the cardiac care of these patients to consider them as a whole, not just as a cancer patient.
As a consequence of increasing cancer rates and survival, more patients are being exposed to potentially cardiotoxic therapies, and more people with pre-existing cardiovascular disease – who 30 years ago would have died of their cancer – are now surviving. That’s where the subspecialty of cardio-oncology has come from.
We specifically see three different groups of patients. Firstly, we see patients at the beginning of their cancer journey to risk-stratify them. That could be a patient with any cardiovascular disease who then receives a cancer diagnosis and needs to be risk-stratified and optimised from a cardiovascular perspective. Importantly, there needs to be a discussion with the oncology team about that patient’s cancer therapy to ensure it won’t destabilise their existing cardiovascular disease.
As patients go through their cancer journey, we screen and monitor them to detect cardiovascular injury at earliest possible stage so we can get them on appropriate cardio-protective therapies and reduce the interruptions to systemic anti-cancer therapy.
This has been a big change over the last 10 or 20 years. Historically, if you had cancer and then you developed potential cardiotoxicity, it was a binary decision. Sadly, for these patients, cancer therapies were generally discontinued, whereas now we try to continue cancer therapy wherever possible.
The last group of patients we see within the cardio-oncology service is screening and monitoring patients who are cured of their cancer but are at risk of significant long-term cardiovascular late effects.
Classically, this would be patients who had a haematological malignancy or a bone cancer as children or young adults and received significant amounts of anthracycline chemotherapy. We know that puts them at risk of late-effects even 30 years later.
We don’t want these patients to be discharged and forgotten about but then present in adulthood in heart failure. So, we’ve set up a service, certainly in Liverpool, whereby every patient who has had a significant dose of anthracyclines gets put into a late effects clinic. We see them every three to five years, so they don’t fall off that cliff.
Baseline assessment is a little bit contentious from an oncology point of view, and oncology teams have a lot to do with their patients when they first get their cancer diagnosis. To then ask them to also risk-stratify patients from cardiovascular perspective is challenging.
As a cardio-oncologist, I see my role as facilitating this baseline assessment and I work with the region’s oncology teams to do this.
It helps us consider what changes may be required to systemic anti-cancer therapy and enables us to potentially detect undiagnosed cardiovascular problems at baseline.
We are performing increasingly more investigations on patients receiving chemotherapy and radiotherapy. It can be difficult to interpret these investigations without a baseline for comparison otherwise we won’t know if cancer therapy has caused an issue or whether there was pre-existing disease. It also enables us to reduce the risk of cardiotoxicity as patients move through treatment.
I recommend that you download the European Society of Cardiology’s guidelines on cardio-oncology because it gives a helpful overview. It’s a large document but there’s lots of useful information in there.
When I talk to oncologists, they’ll often ask, ‘how do we assess cardiovascular risk, what is it we need to do?’ The first thing to say is that not every patient needs every test. I’m a real believer in that there’s no point doing a test unless you know what you’ll do with an abnormal result. That’s particularly challenging for oncology teams who aren’t used to dealing with echoes, troponins, NT-proBNPs, cardiac MRI scans or sometimes even ECGs.
It’s really important to tailor the approach to the patient depending on their comorbidities and what systemic anti-cancer therapy is proposed. Things like age, sex, demographics, past medical history, lifestyle factors like smoking or being overweight, a family history – if alarm bells are ringing as the history is being taken and the examination is happening, then you might think that the patient needs to go on to have further complementary tests.
It’s really important when we’re setting up these services that cardiology teams work collaboratively with oncology teams to make sure pathways are in place to help us work out what we’re going to do with the abnormalities.
There’s an easy way of quantifying risk now. If you download the free ESC app, you can access risk calculators. It’s easy to fill out the yes or no questions and it gives you a risk at the end: low, medium, high and very high.
The four outcomes are very arbitrary, but the ESC cardio-oncology guidelines stipulate that this is the approximate risk we should be discussing with patients – high-risk conversations will be very different to low-risk ones.
If you’re low risk, you’ve got a less than 2% chance of developing cardiotoxicity, although note that it’s not zero – I always tell patients we can never say they won’t develop a cardiovascular problem. Low-risk patients should have standard monitoring, and, hopefully, as cardiologists or cardio-oncologists, we don’t need to get involved with them.
Medium-risk patients should have closer monitoring, which will differ depending on your region’s resources. We don’t see medium-risk patients here, but we often speak with oncology teams and suggest closer echo or blood pressure monitoring, whatever the issue might be.
High-risk and very high-risk patients have a substantially increased risk of cardiotoxicity. A cardio-oncologist or a cardiologist with an interest in oncology should be involved to optimise them from a cardiovascular perspective. It’s about having an open discussion with the oncologist about their proposal and the additional risk and then feeding that back to the patient.
I tell patients this is a balancing act and we’re trying to ensure the benefit of cancer treatment outweighs cardiovascular risk. There are only few circumstances where it doesn’t and the risk of killing them with chemotherapy is higher than the risk of curing them.
People have different levels of acceptable risk and different priorities, so involving them in decisions is really important. My role is to facilitate safe cancer therapy.
Whenever we thought about cancer and the heart, we used to think about Herceptin and heart failure. Certainly, we do see left ventricular systolic dysfunction associated with Herceptin, but nowhere near as frequently as we used to because of all the cardio-oncology measures that are in place.
Occasionally we see patients with dramatic cardiotoxicity that develops as they’re receiving their cancer therapy. Classically, for example, someone who is receiving paclitaxel and acutely decompensates. They might get chest pain or go into heart failure, but, actually, these patients tend to do well and it’s reversible so they recover as quickly as they deteriorated.
We see patients who have early cardiotoxicity in the days and weeks following systemic anti-cancer therapy, or we can see it months or years later. There’s a challenge there to unpick the timeline and work out what’s causing what. Certain drugs are good at causing late effects and other drugs cause acute cardiotoxicity.
I learn all the time, as cancer therapies develop, about new cardiovascular toxicities or new presentations of cardiotoxicity. It’s really important to keep an open mind when looking after patients who have cardiac issues and have received, or are receiving, systemic anti-cancer therapies and think could these two things be related.
Not only do we see a spectrum in terms of the timeline, we see a spectrum with the cardiotoxicity and the clinical presentation.
Hypertension is hugely under-recognised and under-treated in cancer patients. We know there’s a lot of overlap between risk factors for cancer and for cardiovascular disease, so it’s not surprising that many cancer patients have hypertension. If you add in that they’ve been diagnosed with cancer; they’re likely to be undergoing challenging, difficult-to-tolerate treatments; and they’re anxious, frightened, in pain, anaemic and tired – all these will raise their blood pressure.
Then you’re giving them cancer drugs, many of which can cause hypertension. We can see why 40% of patients with cancer have hypertension. But we undertreat it and we excuse it, but we should be managing it like we would with any other patient with hypertension. We should be monitoring them appropriately and getting them on antihypertensive medications.
Vascular toxicity tends to be more of an issue with the treatments we use for gastrointestinal cancers. We see destabilisation of coronary artery plaques, patients presenting with myocardial infarction, patients with coronary artery spasm. This may just be a bit of indigestion-type chest pain, and the patient may not even present to a healthcare professional but, at the other end of that spectrum, we’ve seen patients with coronary artery spasm who’ve presented with a cardiac arrest. It’s really important that these patients are taken seriously when they say they’ve got chest pain and that everyone is aware that it is a recognised vascular toxicity of the these chemotherapeutic agents.
Myocarditis is an increasing worry with patients who receive checkpoint inhibitors or immunotherapy. When I started in cardio-oncology, we only used immunotherapy for patients with melanoma or renal cell carcinoma. Now, around 75% of cancer patients are eligible for treatment with immunotherapy and that’s not just in a palliative setting, but in a neoadjuvant and adjuvant setting.
Checkpoint inhibitors have a 2% risk of causing myocarditis, and if we miss this and don’t treat it, the patient will die from the myocarditis. So, it’s really important that we consider this in patients who have received immunotherapy because they may present innocuously with fatigue, ankle swelling, breathlessness. You can see there’s a challenge there because what cancer patient doesn’t have those symptoms? But keep it in mind for these patients because the sooner you recognise it, the better the outcome for the patient.
But it’s not all about cardiac function. We need to consider blood pressure, QT interval, myocarditis and, thinking about later effects, things like ischemic heart disease.
Patients who had radiotherapy, particularly mediastinal or left-sided radiotherapy, many years ago can present years down the line with quite significant proximal coronary artery stenoses. And it never fails to amaze me how many patients forget to tell you they’ve had cancer when you’re taking their history. I think a lot of patients block it from their memory. So, particularly if a younger patient is presenting with angina-type symptoms and you think it’s a bit unusual, always ask about their cancer history specifically.
I always say to the oncology teams regionally that cardiotoxicity is a bit of a jigsaw. Certainly, understanding the patient’s clinical presentation is key, and then using that with complementary biochemical and other cardiac investigations to fit everything together.
Within cardiology teams, we’re all familiar with troponin and NTproBNP, but remember, the oncology teams are not. It’s important we help them interpret these and have pathways in place so they know what to do with abnormalities.
Imaging, obviously, is our backbone of decision making within cardio-oncology. It’s really a complimentary modality to help us put into context the clinical signs and symptoms and the biochemistry. Where possible, we should be measuring global longitudinal strain (GLS) and ejection fraction using 3D volumes in all our oncology patients.
We know 3D volumes are more reproducible and have less temporal variability. We don’t want to stop someone’s chemotherapy because we think they’ve dropped the ejection fraction when, actually, it’s just because the pictures were a bit rubbish and the 2D ejection fraction was way off. We need to make sure we’ve got accurate, reproducible echo data to help guide our decision-making.
There’s been a real shift over the last decade in trying to continue chemotherapies and radiotherapies and permitting a certain degree of cardiotoxicity. It comes back to the question of at what point does the risk outweigh the benefit?
It’s about changing your mindset from ‘should this therapy be discontinued’ to ‘how can this therapy be continued’. Because we know that if we interrupt anti-cancer therapy, it’s an independent prognostic marker for worse disease-free survival and overall survival.
For the patients with asymptomatic cardiotoxicity or mild-to-moderate cardiotoxicity, the challenge is trying to work out what to do to safely continue their cancer therapies. And that’s where the cardio-oncology service comes in with increased screening, monitoring, optimising of cardio-protective therapies.
It’s important that if we stop therapies, we consider rechallenging them. In the past, nobody would be rechallenged, but many patients will have a successful rechallenge once they’ve been optimised from a cardiovascular perspective.
That brings us back to the multidisciplinary team (MDT) and the importance of that two-way discussion with cardiology and oncology in terms of making sure that we’ve thought about everything to enable treatment to continue or be restarted.
When you’ve got a cardiologist making unilateral decisions, you’re going to run into difficulties. A pivotal part of our service is that we see patients quickly. There’s no point a patient being referred with their chemotherapy discontinued and me saying I’ll see them in six months, which is probably what a lot of cardiology outpatient waiting times are. We’ve set our service up to see patients within two weeks. If we can’t see them within that timeframe then we offer advice on cardiovascular risk to ensure treatment interruptions are minimised.
Efficient communication throughout is important. I work at Liverpool Heart and Chest Hospital, four miles from Clatterbridge Cancer Centre. That’s a different Trust with a different electronic patient record. We can’t see each other’s echocardiograms, so it’s challenging, but we’ve worked hard to improve communications between the teams.
We’re becoming more aware that it’s not just thinking about a patient’s heart or cancer but thinking holistically because these patients are complex and we want to get the decisions right.
In terms of the MDT, people dip in and out, depending on the patient and the clinical need. We have cardiologists, a cardio-oncology specialist nurse, specialised cardiac physiologists, medical and clinical oncologists, palliative care specialist nurses, pharmacists, radiologists, surgeons, anaesthetists, a dietitian.
When I started the cardio-oncology service in 2019, we ran a fortnightly clinic, but now we run three per week. We have a weekly ward round at Clatterbridge Hospital, four weekly oncology echo lists and a weekly virtual MDT where we ensure we have oncology, cardiology and radiology representation as a minimum.
Everyone’s perspective is different, and it’s really important that we all understand these to ensure that patients have the right decisions made.
Momentum is increasing, and certainly people are more aware of it now than they were 10 years ago. There are not many fully fledged cardio-oncology services, but I think more and more cardiologists and oncologists are aware of cardiotoxicity and are seeing patients within their clinics and realising they need to funnel them in a slightly different way.
We’re all aware that the NHS has no money, so trying to develop business cases and set up new services is incredibly challenging, but one of the things that I feel really strongly about is if we set up those services and risk stratify patients to optimise them at baseline, we’re hugely reducing the risk of cardiotoxicity and saving money. The drugs that we use to treat cardiotoxicity cost tens of thousands of pounds per patient, and if we can reduce the risk of that happening in the first place, prevention is definitely better than cure. I think the service will pay for itself over time, but that is very challenging.
The challenge is getting enough people interested. Everyone is busy and when you go along to a TAVI operator or a cardiothoracic surgeon and say, ‘I want to get you interested in cardio-oncology’, people run the other way. But the service does speak for itself: the more patients we see, the more we assess cardiovascular risk, the less interruptions to systemic anti-cancer therapy are happening. The oncology team certainly values the service, and they are desperate for help with this group of patients.
So, in terms of tips for setting it up, get an interested oncologist on board and start your discussions there to build a joint business case.
In terms of funding, it took me four years to get funding for a cardio-oncology specialist nurse. The only way I managed in the end was getting our local Cancer Alliance to fund a year’s salary and a private donor contributing as well. We’re all facing challenges in the current climate and it’s about looking at alternative funding sources. So, could your local hospital charity do a funding campaign for you to help with these services?
With capacity, the way we’ve set the service up means these patients are all going through dedicated cardio-oncology clinics. We make sure we save urgent slots every week, but we drowned in patients after a couple of years and I suspect that as demand goes up again, we’ll struggle. But for now, we’ve just doubled the number of clinics that we offer, and having a cardio-oncology nurse specialist has further allowed us to increase our capacity.
30th January 2025
An ultrasensitive blood test which detects even low levels of circulating tumour DNA (ctDNA) could help to improve disease stratification in early-stage lung adenocarcinoma (LUAD), a UK study suggests.
It was known that ctDNA detection could predict clinical risk in early-stage tumours, the UK research team wrote in the journal Nature Medicine. However, it was challenging to detect preoperative ctDNA in early-stage LUADs due to low levels of ctDNA in plasma – frequently below 100 ppm.
In the Cancer Research UK-funded study, scientists from University College London (UCL), the Francis Crick Institute, University College London Hospitals NHS Foundation Trust (UCLH), and the biotechnology firm Personalis, collaborated to test the company’s NeXT Personal platform.
Described as an ultrasensitive, tumour-informed liquid-biopsy platform, the researchers said NeXT Personal had been analytically validated for ultrasensitive ctDNA detection at 1-3 ppm of ctDNA with 99.9% specificity.
They used the platform to analyse preoperative ctDNA in 171 adults with early-stage lung cancer from Cancer Research UK’s TRACERx study.
It detected ctDNA preoperatively in 81% of the patients with LUAD, including 57% of those with pathological tumour-node-metastasis (pTNM) stage 1 disease.
Analysis showed people with a low level of ctDNA before surgery were less likely to relapse and also had improved overall survival rates compared with people with a high level of ctDNA.
The researchers were also able to show that patients with <80 ppm preoperative ctDNA levels had reduced overall survival compared with ctDNA-negative patients with LUAD.
‘Although prospective studies are needed to confirm the clinical utility of the assay, these data show that our approach has the potential to improve disease stratification in early-stage LUADs,’ the study authors concluded.
The data from TRACERx was analysed retrospectively, the researchers acknowledged, with future data from prospective cohorts needed to evaluate the clinical utility of the assay.
‘Although NeXT Personal is already in use as a clinical diagnostic test, it, like other tumour-informed ctDNA detection assays, is of higher complexity and requires a longer turnaround period to develop the panel and obtain a clinically actionable result, compared with non-tumour-informed approached,’ they wrote.
Study first author Dr James Black, a postdoctoral clinical fellow at the Francis Crick Institute and the Cancer Research UK Lung Cancer Centre of Excellence at UCL, said the study had shown the presence or absence of tumour DNA in the blood was strongly predictive of prognosis.
‘ctDNA testing, especially using ultrasensitive platforms, could help clinicians make more informed decisions about treatment and give patients a more accurate idea of how their disease might progress,’ he said, adding that ‘more research to validate these tests will help to get them on the agenda for regular clinical use.’
Study senior author Professor Charles Swanton, who holds positions at the UCL Cancer Institute, the Francis Crick Institute and UCLH and is chief investigator of the TRACERx study, noted that lung cancer is one of the most common types of cancer in the UK and has a high relapse rate.
‘It’s vital to understand who would benefit from more aggressive treatment, especially for patients with stage 1 disease who are often diagnosed during CT screening for those at a higher risk,’ he said.
‘Using sensitive ctDNA tests is one way to do this, which we hope will maximise clinical benefit and minimise unnecessary treatment for individual patients.’
Speaking at Hospital Healthcare Europe’s recent Clinical Excellence in Respiratory Care event, Dr Zaheer Mangera,the lung cancer lead at North Middlesex University Hospital NHS Trust in London, said ctDNA tests were among the innovations to watch in lung cancer care, with the Trust involved in a ctDNA pilot in recent months.
Digital health technologies offer opportunities to improve healthcare if integrated appropriately into healthcare systems. A recent study in Germany examining the use of digital health technologies in rheumatology care found that their use and acceptance among patients are increasing. The research highlights the need for ongoing, standardised tracking of digital technologies’ integration into patient care.
The researchers surveyed 337 rheumatology patients from three different clinics in Germany, exploring current acceptance, use and preferences regarding digital health technologies. They also considered the impact of the Covid-19 pandemic on these factors. They analysed the results using descriptive statistics and correlation analysis.
Patients widely accepted digital health technologies as valuable tools in rheumatology care, and the accessibility and flexibility of each one drove their choice of which to use.
Over half of the participants (53%, n=179) reported using digital health technologies, including wearables (21%), mHealth apps (21%), digital therapeutics (9%), electronic prescriptions (9%), video consultations (4%) and at-home blood self-sampling (1%). Users were more likely to have a university education than non-users, with 63.7% of users having a degree versus 27.8% amongst non-users.
Patients identified the main benefits of digital health technologies as being able to access the devices anywhere (72%) and at any time (64%). The main barriers included insufficient user knowledge (49%) and limited information on digital health services (40%).
The researchers highlighted the ‘multidisciplinary digital transformation’ taking place in healthcare, particularly the ‘notable surge in digital technologies’ in rheumatology care. They attributed this to the increasing numbers of patients with rheumatic and musculoskeletal disease and the static and, in some cases decreasing, availability of healthcare professionals in this field.
The study showed that digital health technologies are increasingly accepted and used among rheumatology patients in Germany. Highlighting the opportunities and understanding the obstacles to integrating these technologies into patients’ care will aid the digital transformation in rheumatology care, the researchers said. However, they concluded that a standardised monitoring system needs to be developed to maximise their potential.
Reference
May, S et al. Digital Transformation of Rheumatology Care in Germany: Cross-Sectional National Survey. J Med Internet Res 2025; Sept. 09: DOI: 10.2196/52601.
IMPORTANT LINKS
MORE FROM COGORA
© Cogora 2025
Cogora Limited. 1 Giltspur Street, London EC1A 9DD
Registered in the United Kingdom. Reg. No. 2147432
