Recommendations for head and neck cancer survivorship care issued by the EHNS

9th August 2022

Recommendations highlight the vital need for a multidisciplinary approach to care and more focus on psychosocial consequences of the disease and treatment

The recommendations, published in Oral Oncology, highlight the essential need for head and neck cancer survivorship care to follow a multidisciplinary approach, to include careful consideration of the psychosocial consequences of the disease, and to be individual to the survivor, reflecting its diverse consequences.

The publication is a revision of the American Cancer Society’s 2015 recommendations for Head and Neck Cancer Survivorship Care based on an extensive medical literature search and an expert panel review. 

The purpose of the revision was to update the ACS recommendations and adapt them for the European healthcare setting across five key areas of survivorship care: surveillance for cancer recurrence; screening for second primary cancers; assessment and management of long-term physical and psychosocial effects; health promotion, and care coordination and practice implications.

“Head and neck cancer is the 6th most common cancer in Europe, with 168,000 new cases diagnosed in 2020, and the disease can have devastating consequences for survivors and their loved ones,” said Professor René Leemans, co-author and chair of the Department of Otolaryngology Head and Neck Surgery at the Amsterdam University Medical Center. “These are the first survivorship care recommendations specific to the European healthcare setting and their publication has addressed an important need for up-to-date guidelines to reflect the current landscape and better support quality care for survivors.”

“Head and neck cancer survivors often require significant and ongoing treatment and support, but at present disparities in care exist,” said Professor Irma Verdonck-de Leeuw, co-author from theAmsterdam University Medical Center, Dept of Otolaryngology. “We hope these recommendations will help to bridge the gap in an effort to promote uniform and quality care for every survivor of head and neck cancer.”

The publication of the recommendations was completed by an expert author panel as part of the Make Sense campaign mandate. The Make Sense campaign, initiated in 2013 and run by the EHNS, aims to raise awareness of the disease, and ultimately improve outcomes for patients.

Consensus group calls for routine use of cancer biomarkers and molecular profiling to guide precision medicine 

8th August 2022

All patients’ cancers should be genetically profiled to improve care, say leading health experts

The NHS should offer all cancer patients genetic profiling of their cancers at diagnosis and during treatment to shape care and track how the disease evolves, a consensus group of leading experts has concluded.

Group members said action was needed to ensure use of cancer treatments was routinely guided by information about a patient’s individual cancer.

They called for barriers preventing patients from gaining access to ‘biomarker’ tests to be removed – so genetic information and other tests could routinely be used to select the most suitable precision medicine for each patient.

The consensus group was convened by The Institute of Cancer Research, London, and included nine leading institutions, charities, stakeholder groups and life-science companies, including Cancer Research UK, AbbVie, the Association of British HealthTech Industries, AstraZeneca, Bioclavis, Bristol Myers Squibb, Leukaemia UK and Precision Life and the Association of the British Pharmaceutical Industry.

Biomarker tests look for genetic, protein or imaging ‘markers’ to identify which patients are most likely to respond to treatment. 

It is crucial for clinicians to be able to assess biomarkers so they can select patients with particular weaknesses in their cancers and match treatment accordingly. But the consensus group warned that testing is not always done because regulatory processes and resources have not kept pace with the science.

The statements are calling for a series of changes in the way biomarker tests are developed, made available and routinely used in the UK:

• All people with cancer should have their cancers molecularly profiled as standard within the NHS to identify mutations and guide their treatment – helping them access more personalised and effective treatments, both as part of standard care and by taking part in clinical trials.
• The NHS should be using panel tests to assess many different biomarkers at once – not only at a patient’s diagnosis, but also at intervals afterwards so treatment can be adjusted in line with changes in the cancer.
• Biomarker tests should be routinely developed alongside new cancer drugs to ensure that the right patients are treated, and the cancers are targeted more effectively. Regulations should be reformed to make it much easier to assess biomarkers in trials and get them approved for use.
• The UK’s health technology assessment bodies, such as NICE, should take a more positive view of companion biomarker tests for new drugs – the UK could explore the possibility of offering incentives for companies that bring forward biomarker tests alongside new treatments. 
• The NHS should develop a broader and more transparent directory of biomarker tests, including all the non-genomic biomarker tests that the NHS will provide alongside gene tests.
• Patients and clinicians should be better informed and more aware of the biomarker tests available to them and their benefits. There is currently wide variation in access to biomarker tests in different parts of the UK.

Regulatory barriers to biomarker testing and development have a direct impact on patients – potentially denying them more personalised treatment.

Biomarker testing and development is expensive – currently, the costs of developing biomarker tests often outweigh the financial benefits of doing so, discouraging industry and academia from investing in biomarker research. 

But targeting therapies to those who are most likely to respond would be more cost-effective for the NHS. And clinical trials that use biomarkers to select patients are much more likely to succeed and result in marketing approval.

The ICR and the rest of the consensus group members hope that the calls to action in the new 13-point set of consensus statements will help speed up development of biomarker tests and widen access to them – so that the best treatments can reach the right patients as quickly as possible.

Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said: “We believe every cancer patient should have the opportunity for their cancer to be molecularly profiled to assess biomarkers that can give vital clues about how their disease should best be treated. Biomarker tests can direct treatment precisely to the patients who will most benefit, which can both improve the lives of patients and increase the cost-effectiveness of treatment for the NHS.

“It’s essential that the regulations that govern clinical trials and the approval of new tests and treatments keep pace with the rapidly moving science. At the moment, it can be hard to get new biomarker tests developed, approved and made available for patients. That can in turn act as a disincentive for companies and academics to develop new biomarkers to guide treatment in the future.”

Launch of the Hospital Healthcare Europe Mobile App

1st August 2022

Stay up to date with developments in the industry with the Hospital Healthcare Europe app – available on IOS and Android. 

Hospital Healthcare Europe is now available as an app on IOS and Android, offering you the latest clinical news, views and research analyses to your mobile or tablet. 

Through a combination of clinical zones, expert opinions, educational resources and timely reviews and research analyses via the website and weekly newsletters, Hospital Healthcare Europe is an indispensable resource for secondary care healthcare professionals across the UK and EU. 

Stay up to date with developments in the industry with the Hospital Healthcare Europe app – available on IOS and Android. 

Download the app on IOS or Android to be the first to read our latest content from your mobile or tablet.

CHMP recommends conditional marketing authorisation for multiple myeloma monotherapy

22nd July 2022

The Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorisation for Tecvayli® (teclistamab).

Teclistamab is an off-the-shelf, T-cell redirecting bispecific antibody. It targets both B-cell maturation antigen, a marker found on multiple myeloma cells, and CD3, on T-cells.

It is recommended as monotherapy for adult patients with relapsed and refractory multiple myeloma (RRMM), who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

In December 2021, the EMA granted accelerated assessment for teclistamab. Accelerated assessment reduces the timeframe for the CHMP to review a marketing authorisation application and is granted when a medicinal product is of major interest for public health and therapeutic innovation.

The CHMP recommendation is based on positive results from the multicohort, open-label, Phase I/II MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM.

The latest findings from the study were presented at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting and published in The New England Journal of Medicine.

Teclistamab resulted in deep and durable responses in patients with triple-class exposed multiple myeloma (n=165). With a median follow-up of approximately 14 months (14.1), the overall response rate was 63% (95% CI: 55.2–70.4), with 39.4% having a complete response (CR) or better. Almost half (46%) of patients who achieved a CR or better were minimal residual disease-negative.

Adverse events (AEs) were consistent with this patient population and toxicities consistent with T-cell redirection were mostly Grade 1/2. The most common AEs were cytokine release syndrome and neutropenia. Infections were frequent (76.4%; 44.8% Grade 3 or 4). The overall incidence of neurotoxic events was low and five patients had immune effector cell-associated neurotoxicity syndrome. There were five treatment-related deaths, and dose reductions and discontinuations due to AEs were infrequent.

World Obesity Day 2022: Study explores potential of bariatric surgery in preventing COVID-19 deaths in severe obesity

4th March 2022

Clinical evidence has revealed that bariatric surgery could prevent COVID-19 deaths in people living with obesity, a group that has been disproportionately affected during the pandemic. 

The study comes at a time when the NHS continues to be under severe pressure from COVID-19. The findings are part of a study, ‘Cost-effectiveness of bariatric and metabolic surgery, and implications of COVID-19 in the United Kingdom, co-authored by Dimitri Pournaras, a specialist in Upper Gastrointestinal, Bariatric, and Metabolic Surgery and funded by Johnson & Johnson Medical Devices Companies.

It explored the possible clinical and economic benefits of bariatric surgery compared with nonsurgical treatment options, considering the broader impact of COVID-19 on people living with obesity. The research team concluded that increased provision of bariatric surgery could reduce COVID-19-related morbidity and mortality, along with obesity-related comorbidities, ultimately reducing the clinical and economic burden of obesity. 

Among 1000 individuals with body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with obesity-related comorbidities, bariatric surgery would prevent 117 deaths due to COVID-19 alone. Looking at the impact on hospital usage in the same group and assuming that they would all get COVID-19, 124 people would not be admitted to the hospital and 161 would not be admitted to the intensive care unit.

Delaying bariatric surgery by five years further increased costs and had a negative impact on quality of life, compared with not delaying treatment.

Mr. Pournaras stated: “These striking figures are only focusing on outcomes associated with the pandemic. The benefits of bariatric surgery with sustained weight loss maintenance will have a persistent effect on improving survival, reducing the burden of obesity-associated disease and improving functional outcomes for the individuals who have received this type of treatment.

With the pandemic set to continue for the foreseeable future, the effective treatment of obesity should be a societal responsibility that we tackle together. Not just to ease the burden on the NHS, but to optimise outcomes for people living with obesity.” 

Sarah Le Brocq, obesity advocate and key stakeholder across several obesity groups – including sitting on the strategic council for the All-Party Parliamentary Group on Obesity – said: “People living with obesity are genuinely fearful of contracting COVID-19, amid a growing number of reports that they are at greater risk of dying. We clearly need to introduce measures that tackle this, both in terms of reducing the risk to patients and the probable impact of them in the long-term.”

Survey shows that cancer patients returning to work face a mental health crisis

4th February 2022

Research published on World Cancer Day 2022 reveals that the majority of working age cancer patients say that the mental health impact of their treatment is greater than the physical impact

The survey of 1241 working age people living with cancer highlights the importance of work for most cancer patients but also exposes the challenges many face in returning to, and thriving at, work. The research was conducted by Stephen Bevan of the Institute for Employment Studies (IES) and Barbara Wilson of Working With Cancer in the UK – who both live with cancer.

Other headlines from the survey include:

• Only 57% of cancer patients returning to work knew they were legally disabled under the 2010 Equality Act.
• Over half said that their medical teams or occupational health professionals did not discuss their return to work, and only 22% of HR departments told patients about their right to ask for reasonable adjustments and a phased return to work.
• A third of respondents did not make a phased return to work and a quarter had to take annual leave to receive vital cancer treatment.
• While most respondents had received positive support from their colleagues and line managers, a significant minority experienced bullying, being shunned at work and redundancy.
• Those living with advanced or metastatic cancer reported receiving lower levels of support and access to workplace adjustments, suggesting that many employers find it more difficult to know how to support patients with complex cancers and those with a terminal diagnosis.

Stephen Bevan, Head of HR Research Development at IES said, ‘Although cancer survival rates are increasing, which is good news, it is disappointing that so many people living with cancer face barriers to getting back to work after often distressing treatment. It is especially concerning that so few GPs and specialist cancer nurses are having conversations with patients about work.’

CEO of Working with Cancer Barbara Wilson commented, ‘We are worried that so many people living with cancer – and their employers – remain unaware that the Equality Act entitles cancer patients to workplace adjustments which can help them return to work and to adjust to a life with or after cancer. Our own work with people living with cancer shows that access to information about managing work and cancer, coaching support and flexible working can make an enormous difference to people’s lives.

With 1 in 2 people in the UK likely to receive a cancer diagnosis, and half of those of working age, it essential that employers and healthcare professionals give a higher priority to good employment outcomes for cancer patients. Sadly, fewer than two-thirds of employees with cancer have returned to work or are still working a year after getting a diagnosis, often adding to the mental health and financial woes of many.

Dr Liz O’Riordan, consultant breast surgeon and breast cancer patient, said, ‘Sadly, I am not surprised by the results of this survey. As a doctor I had no idea that the Equality Act applied to every patient I operated on. When I got breast cancer myself, my own line manager didn’t know. It was only when a desperate internet search led me to ‘Working with Cancer’ that I realised I had rights and could ask for a longer phased return to work.’

The report highlights several areas where both healthcare professionals and employers can do more to ensure that more people living with cancer can return to work successfully and sustainably. These include:

• Healthcare professionals should prioritise return to work as a clinical outcome of their care.
• There should be improved training on having return to work conversations for cancer nurse specialists, GPs and occupational health professionals – with a specific recognition of the mental health challenges faced by many patients.
• Employers should update their return to work policies to recognise the provisions of the Equality Act as it related to people living with cancer.
• Employers should offer 1;1 coaching on return to work practices for both cancer patients and line managers.
• Employers should support & fund ‘buddy networks’ of employees who have had experience of cancer to help provide peer support and guidance for colleagues and their managers.

The Domino effect: COVID-19 and the implication on CRC screening

10th December 2021

Leading colorectal cancer (CRC) experts discuss the significant health impacts from the pandemic related to CRC screening delays and look towards a possible pathway forward to handle future health crises

Colorectal cancer (CRC) is the second most common cause of cancer death among both men and women in Europe.1 CRC accounts for 13% of all cancers and is the most common digestive cancer, with over 375,000 newly diagnosed cases annually.2 Colorectal cancer is easier to treat when detected at early stages; when diagnosed at stage I, the overall 5-year survival rate is around 90%.3

Since the rollout of screening programmes across Europe, a steady decline in CRC mortality rates has been observed.4 However, this success has been halted since the start of the pandemic due to screening delays.

A primary tool in FIT-positives used for the screening, early diagnosis, and treatment of digestive cancers is endoscopy. Following the pandemic and multiple lockdowns, endoscopy has been one of the most heavily affected procedures, leading to a dramatic decrease of screening and surveillance procedures.5 A new analysis of NHS England data led by UCL researchers concluded an estimated endoscopy screening backlog of 476,000 recorded in January 2021.6 This delay is particularly problematic as bar an expected increase in overall survival, early detection also allows for minimally invasive surgery. This type of surgery results in a faster recovery for the patient, and is consequently cheaper for the healthcare system, which is essential in times of crisis to help relieve economic burdens.6

The experts

Prof Luigi Riccardiello, Research Committee Chair, United European Gastroenterology
Impact of screening delays

“The majority of diagnostic and treatment pathways utilised in the management of CRC have been severely affected by COVID, most notably demonstrated by the delays for CRC screening tests. Delays in screening are particularly problematic for CRC as the best outcomes are attained in those whose tumours are diagnosed at an early stage.7 Screening delays beyond 4-6 months have been shown to significantly increase advanced CRC cases and impact mortality if lasting beyond 12 months.8

We need to focus on implementing an unbroken prevention pathway and reorganising our efforts against high-impact disease, such as CRC, to prepare for future waves of COVID-19 or other pandemics.8 Moving forward we need to make sure to address the backlog of screenings that has accumulated, to avoid the risk of significant increases in deaths from colorectal cancer over the next few years.”

Prof Thomas Seufferlein, Editor in Chief of the German Journal of Gastroenterology
Varying CRC screening rates across Europe

“The health impacts of the pandemic relating to CRC seem to be inconsistent across Europe, mostly dependent on the healthcare systems in place for each country. In Germany, where colonoscopy screening is largely done within private practice, there were fewer screening delays reported during the second and third COVID-19 waves once all protective measures were established.9,10

It has been reported that only 14% of EU citizens aged between 50-74 years old have the opportunity to participate in formal population-based screening programme for CRC.4 Therefore, having a screening programme alone is not sufficient, it must also meet quality criteria in terms of invitations for every inhabitant and equal opportunities for all, awareness creation, repeat messages, and sensitivity to tone and style that will enhance citizen participation.4,8 EU member governments should look to urgently address both the implementation and reorganisation of screening programmes available, in a bid to improve both the coverage and overall quality of screenings.2”

Prof Evelien Dekker, Gastrointestinal Oncology
The role of pre-existing barriers

“Pre-existing barriers to screenings were still present throughout the pandemic and if anything were exacerbated.11 This includes patient barriers such as fear, where individuals who may have already been apprehensive to participate in for a screening were even more conscious throughout the pandemic, and thus the fear of getting COVID only compounded the issue of people not going for their screening. Therefore, moving forward we must focus on reassuring a patient with a positive FIT result that colonoscopy centers are safe and COVID-free areas. This will help foster individual compliance for screenings and prevent later stage diagnosis of CRC.

Additionally, there are health care provider and health system barriers, such as a lack of follow-up and screening costs, which would have been a larger cause for concern throughout the pandemic.11 Due to the overload on resources, its likely many providers were late in following up with individuals to get them in for screenings, which would have added to screening delays. Systems were also stretched in terms of budgets to keep up with the demands of COVID-19, and thus the screening costs may have acted as a barrier to ensuring prompt and speedy screenings for patients.

Lastly, but possibly most importantly, the significance of screening by FIT cannot be understated. According to the European guideline, this is the preferred screening test, triaging those that need colonoscopy and thus sparing the limited capacity for those who need it.

FIT-programmes are not only beneficial in reducing morbidity but also cost-effective and making best use of colonoscopy capacity, which is always essential, but especially during pandemic. It results in performing colonoscopy in those who need it most, and saving money needed for treating advanced stage cancers which can be reallocated for necessary COVID-care.”

References

1. World Health Organization. Colorectal Cancer. 2021/2. www.euro.who.int/en/health-topics/noncommunicable diseases/cancer/news/news/2012/2/early-detection-of-common-cancers/colorectal-cancer (accessed December 2021).
2. Open Access Government. Reducing the burden of colorectal cancer across Europe. 2020. [online] www.openaccessgovernment.org/reducing-the-burden-of-colorectal-cancer-across-europe/83896/ (accessed December 2021).
3. Iarc.who.int. 2021. Colorectal Cancer Awareness Month 2021 – IARC. [online] www.iarc.who.int/news-events/colorectal-cancer-awareness-month-2021/> (accessed December 2021).
4. Maringe C et al. The impact of the COVID-19 pandemic on cancer deaths due to delays in diagnosis in England, UK: a national, population-based, modelling study. Lancet Oncol 2020;21(8):1023–34.
5. Peck‐Radosavljevic M et al. COVID‐19 and digestive health: Implications for prevention, care and the use of COVID‐19 vaccines in vulnerable patients. United Eur Gastroenterol J 2021;9(9):1091–5.
6. UCL. COVID-19: Backlog of half a million endoscopies and rising. 2021. [online] www.ucl.ac.uk/news/2021/mar/covid-19-backlog-half-million-endoscopies-and-rising (accessed December 2021).
7. Ricciardiello L et al. 2021. Impact of SARS-CoV-2 Pandemic on Colorectal Cancer Screening Delay: Effect on Stage Shift and Increased Mortality. Clin Gastroenterol Hepatol 2021;9(7):1410–17.e9.
8. Iarc.who.int. 2021. Launch of online learning programme on “Improving the Quality of Cancer Screening” – IARC. [online] www.iarc.who.int/news-events/launch-of-online-learning-programme-on-improving-the-quality-of-cancer-screening/> (accessed December 2021).
9. Mangiapane S et al. Veränderung der vertragsärztlichen Leistungsinanspruchnahme während der COVID-Krise. Hrsg.: Zentralinstitut für die kassenärztliche Versorgung in der Bundesrepublik Deutschland (2020).
10. Schmidt C. Auswirkungen der COVID-19-Pandemie. Z Gastroenterol 2020;58:1–4.
11. Unger-Saldaña K et al. Barriers and facilitators for colorectal cancer screening in a low-income urban community in Mexico City. Implement Sci Commun 2020;1:64.

Cancer clinical trial recruitment dropped by 60% during COVID

9th December 2021

Calls for urgent investment in COVID-19 recovery for cancer clinical trials, as well as streamlined regulation and redesigned treatment pathways 

Cancer experts set out a series of findings on 9 December 2021 on the barriers to carrying out clinical trials in the UK, and proposals for boosting participation by enhancing information, changing treatment pathways and streamlining regulations.

The Institute of Cancer Research (ICR), London, is publishing a report collating data on cancer trials, and the views of patients and clinicians on how barriers to making trials more widely available can be overcome. It is warning that without urgent action to open up clinical trials to patients more widely and earlier in treatment, huge opportunities could be missed to drive improvements in outcomes.

Figures obtained from the National Institute for Health Research show that the number of patients recruited onto clinical trials for cancer in England fell to 27,734 in 2020/21, down from an average of 67,057 over the three years previously. The number of patients recruited onto trials fell for almost every type of cancer analysed.

The ICR also published findings showing that issues with making clinical trials available to patients are longstanding and go far beyond the COVID-19 pandemic.

An interview-based study of 12 leading clinical trial researchers from across the UK commissioned from health charity Picker found strong agreement that more needed to be done to widen access to clinical trials for cancer patients. The study, carried out from April to July 2020 during the early part of the pandemic, identified the following issues:

• There is an excessive administrative burden in setting up clinical trials, especially for innovative trial designs such as biomarker-driven studies for precision medicine.
• The NHS does not have systems in place for rapid genetic testing of patients to select them for precision medicine trials.
• Patients face a postcode lottery in access to the latest trials. Funding for doctors to carry out clinical research varies between hospitals – meaning some patients miss out on the latest treatments.
• Information about clinical trials for patients and doctors is inadequate – existing information is spread across multiple platforms, not kept up to date and often in a format that is difficult for patients to understand.

The ICR also commissioned a YouGov survey of 500 people who had been treated for cancer, which was carried out in March 2020. It found that 95% of respondents thought it was important that cancer patients were offered access to treatment in clinical trials. But only 37% had had a conversation about clinical trials during their own treatment, and just 11% participated in a trial. There was also a difference in ability to access trials in different parts of the country, with some patients in rural areas reporting travelling more than 100 miles for treatment on a clinical trial. In light of the barriers identified, the ICR is calling for the following:

• Urgent investment in cancer clinical trial recovery post pandemic – to build patient recruitment back up and ensure new trials can enter the pipeline.
• Learning from COVID-19 to streamline regulations – making it easier and faster to set up innovative study designs including biomarker-driven trials for precision medicine, and virtually monitoring patients.
• Making trials available earlier in treatment – by having conversations about trials and offering genetic testing shortly after diagnosis, and ensuring trials are no longer seen as a last resort, but a viable alternative to some existing treatments.
• Making trial information accessible – through funding to ensure information is up to date, understandable for patients and doctors, and accessible through a single point of
• Addressing the postcode lottery in access – ensuring hospitals across the UK have trained staff in specialisms such as R&D, pathology and radiology, and that oncologists are properly supported to devote time to research.
• Tackling barriers to reaching underserved communities – since there is evidence that poorer patients and those from ethnic minorities are less likely to gain access to trials.

Professor Udai Banerji, Deputy Director of the Drug Development Unit at The Institute of Cancer Research, London said: “Cancer medicine has changed hugely over the last two decades, with patients increasingly treated with precision drugs targeted against particular genetic faults within tumours. It’s essential that our clinical trial systems keep pace with the science.

“We need streamlined and accelerated approval of promising drugs using novel trial designs. Clinical trials of drugs should be embedded into all aspects of cancer medicine from prevention, curative or non-curative therapy to palliative care. The pandemic has caused us to pause and identify areas we can do better. It’s time to make up for lost time.” 

Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said: “Clinical trials have huge benefits for patients, both by providing access to the latest drugs and technologies, and by demonstrating the effectiveness of the next generation of treatments for use on the NHS. We would like to see a clinical trial being made available for every cancer patient who would like to participate in one. That requires both investment in recovery of clinical research post Covid-19, to get us back to where we were before the pandemic, and broader measures to widen access to trials by reshaping funding, regulation, information and treatment pathways.”

Button battery ingestion in children: A growing problem

2nd December 2021

Button battery ingestion (BBI) in children can be devastating, potentially leading to severe morbidity and even death.

Despite being the most harmful type of battery when swallowed by children,1 and an increasing number of cases being reported worldwide,2,3 due to the wide abundance of button batteries in consumer electronics, BBI remains an issue too few people understand or are aware of.

BBs are used to power many household items including toys, gadgets, watches, medical devices (hearing aids, thermometers, glucometers), small appliances (key fobs, remote controls) and many other electronic devices. The Child Accident Prevent Trust (CAPT) have provided useful guidance on where button batteries can be found. BB are accessible throughout their lifecycle; including when purchased new, from appliances, and at the end of life. A study has shown that in around 60% of cases, batteries are directly taken from an electrical device by the child itself, while around 30% of the children ingest loose batteries. In approximately 10% of cases, the batteries were obtained from the packaging.4 Currently in Europe, only toys are required to have durable, secure battery compartments.

According to recent data there has been a seven-fold increase in the relative risk of severe morbidity due to BBI in the last two decades.5 Of all children worldwide presenting with foreign body ingestion, the percentage of children with battery ingestion is estimated to be as high as 7–25% (approximately).6–9 Most BBI cases occur in children below 6 years of age, with a peak at 1 year of age, which is also when the highest risk of complications occurs.2,10 Worryingly, research from Great Ormond Street Hospital revealed that BBI in children rose significantly during the lockdown period in the UK.11

Dangers and impact
The tragic case of Harper-Lee Fanthorpe, who died from BBI at the age of just 2 in May 2021 has served as a reminder of the devastating impact BBI can have. The small, shiny surface and round shape of BBs make them both appealing and easy to swallow, particularly for young children. Once consumed, BBs can trigger a chemical reaction that results in a penetrating burn. Importantly, problems caused by BBs are not usually due to chemicals leaking from the battery but driven by the battery itself reacting with bodily fluids, such as mucus or saliva. This creates a circuit that releases a strong alkali that can burn through the throat or stomach and potentially cause further damage to other internal organs.

BBs are particularly dangerous when stuck in the oesophagus, and studies have shown that 12.6% of children who ingested a 20-mm BB suffered severe or fatal injuries.12 This danger is compounded by the fact that BBI diagnosis is particularly challenging, as many ingestions go unwitnessed by parents or carers, and children (depending on age) may not be able to say what has happened. Furthermore, in contrast to the devastating burn occurring inside, the symptoms of ingestion are variable and non-specific, mimic other common childhood illnesses and evolve over the period that the battery is located in the oesophagus. These factors can often lead to delayed diagnosis. Subsequently including battery ingestion in the diagnosis of unexplained symptoms is paramount to avoid unnecessary delay and increasing the risk of severe complications and death.

To effectively treat and manage BBI, early recognition is critical due to the extremely narrow 2-hour time window for removal of batteries impacted in the oesophagus. ESPGHAN has recently published a clinical paper on BBI, developed by its Button Battery Task Force, which includes a medical algorithm providing clinicians with a step-by-step guide on the treatment pathways for BBI.13

Solutions and action
Perhaps the most pressing BBI matter to address is prevention and the urgent need for solutions and action. There are four core elements on this which are set out here: improving public awareness, increasing HCP understanding, BB product design and innovation, and driving policy.

Public awareness
Improving awareness of BBI among parents, carers and the general public, and educating them on how to mitigate the risks of it happening is a key step forward. This will help increase cautiousness when it comes to products containing button batteries or properly disposing of old batteries, but above all it will help push them towards seeking early medical attention when they suspect an ingestion may have taken place. Increasing public awareness will be challenging, not least because it will require the involvement of industry, media, schools, and the Government in addition to medical professionals. However, ESPGHAN is already helping lead the way with this process, developing a short guide for parents, and there are plans for additional resources to be published next year. The European Portable Battery Association (EPBA) has also produced a helpful video for parents regarding safe use of button batteries.

HCP understanding
Currently, clinical understanding and process is not geared towards early diagnosis of BBI in children, as many in the medical community are not well informed. It is vitally important that medical professionals are able to identify a button battery impacted within the oesophagus and are aware of the diagnostic and management approach when a child presents with a battery ingestion. This includes considering BBI as a potential diagnosis, particularly for unexplained symptoms, and ensuring all healthcare professionals are equipped with the knowledge and guidance to address BBI appropriately. This could be achieved by giving more attention to this subject in medical school, post-graduate paediatric, emergency and family medicine training. Furthermore, resources need to be developed by experts and distributed to the medical community. ESPGHAN has recently finalised a short, visual and easy-to-use clinical advice guide on BBI. Collaboration amongst clinical networks is also required to develop and promote strategies for recognising unwitnessed cases, expediting care and managing complications in centres with specific expertise in button battery injury.

BB product innovation
Mitigating the risk of BBI injury also needs to be driven by battery and product design and innovation. One study has calculated that almost 70% of the ingestions can be prevented with screw-secured compartments and individual blisters for batteries.14 Another solution that has been explored is making the battery less attractive for children and while there is currently limited data of its impact on BBI, bitter coatings have been created and are being developed.15

Collaborating with industry on this issue is critical, and ESPGHAN has been working alongside a coalition of other organisations, including the EPBA, to ensure a clear understanding of the hazards that come with poorly secured products and how we effectively tackle those hazards. Earlier this year, the group joined forces to publish a joint statement that committed to preventing button battery ingestion in children. Additionally, ESPGHAN and its Public Affairs Committee has now formed a task force that regularly meets to review the progress of awareness, prevention and management initiatives.

Policy
Lastly, there is an important overarching role for regulatory agencies and policymakers to play on this issue, through evaluating current legislation and implementing national strategies on improving awareness and the safety of button batteries. Recent legislative developments in Australia16 and in the UK17 have hinted towards kickstarting this process. The Australian regulation, due to come into effect in June 2022, replicates existing requirements in international toy standards and includes the requirement for child resistant button battery packaging alongside durable and secure battery compartments for products powered by button batteries. However, these isolated examples can only go so far, and the situation demands widespread action in Europe and across the Globe.

Conclusion
Ultimately, urgent action on BBI is essential and it is required now. The sudden, devastating and potentially fatal impact BBI can have on children simply cannot be ignored and it is imperative on us all to ensure we protect future generations from this completely unnecessary burden. The reality is that we are at the beginning phase of resolving this problem, however, encouragingly we have the knowledge and tools to help significantly reduce BBI cases. We now need the concerted will to implement these properly at the public, medical, industry and policy level.

References

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Regdanvimab recommended as a treatment for COVID-19 by the CHMP

12th November 2021

The CHMP has issued a positive scientific opinion recommending marketing authorisation for regdanvimab (CT-P59), a monoclonal antibody treatment for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

The CHMP positive opinion for regdanvimab marks the first time a monoclonal antibody treatment for COVID-19 has received a recommendation for marketing authorisation from the European Medicines Agency (EMA). 

The positive CHMP opinion was supported by data from the global Phase III clinical trial in which Celltrion enrolled more than 1315 people to evaluate the efficacy and safety of regdanvimab in 13 countries including the US, Spain, and Romania. Data showed regdanvimab significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19.

Rolling review of regdanvimab had been initiated by the EMA in February 2021 and the announcement of the CHMP positive opinion for regdanvimab follows the submission of a marketing authorisation application to the EMA seeking approval of regdanvimab in October 2021.

“The primary benefits of monoclonal antibodies are their high specificity and safety – they are highly specific for a single target, so these monoclonal antibodies rarely cause undesirable side effects,” said Oana Sandulescu, MD, PhD, Associate Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy in Romania. “An infusion of an hour of monoclonal antibodies like regdanvimab can ease COVID-19 symptoms and reduce complications in recently diagnosed, non-hospitalised people at high risk, and thus plays an important role in preventing further spread of the virus.”