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11th June 2024
Consultant radiologist Dr Gerald Lip took an early interest in the use of artificial intelligence in medicine. He tells Steve Titmarsh how his team’s work in Aberdeen is unveiling the technology’s potential to augment clinicians’ workflows in breast cancer screening, which they hope will improve patient outcomes and help colleagues manage an ever-increasing demand for their services.
It was a master’s degree in health informatics at Trinity College Dublin that ignited Dr Gerald Lip’s interest in artificial intelligence and its applications in medicine. And while his medical career began in surgery, after a short time he concluded that the world of radiology was better suited to him and so he commenced this training at Aberdeen Royal Infirmary.
Here, he was fortunate to be guided by an excellent academic team, including Professor Fiona Gilbert, now at Cambridge University, who led a number of national trials in breast screening and imaging, and was recently appointed the first clinical radiology AI lead advisor at the Royal College of Radiologists. It was this experience that brought Dr Lip to his speciality in breast screening, and after two years as a consultant he was appointed clinical director of the North East Scotland Breast Screening Programme.
In 2018, the agency Innovate UK wanted to establish five centres of excellence for AI, and one of these was based in Scotland, encompassing Aberdeen and Glasgow. Here, a five-year programme called iCAIRD – the Industrial Centre for Artificial Intelligence Research in Digital Diagnostics – was established and, for Dr Lip, the opportunity to determine the potential of AI in breast screening was a huge draw.
Dr Lip’s involvement in the iCAIRD radiology collaboration began with a retrospective study using a three-year dataset (1 April 2016 to 31 March 2019) from the Scottish Breast Screening Service.
Published in the journal Radiology: Artificial Intelligence in 2023, the results highlight the possible value of an AI tool to augment the work of human scan readers for breast screening.
This was only the beginning. Dr Lip and his team recently completed a prospective trial to evaluate the AI tool in a clinical setting, using it in addition to two human readers of breast scans in work funded by the NHS Health and Social Care Award.
The work was part of a project named GEMINI (Grampians Evaluation of Mia in an Innovative breast screening Initiative) – a collaboration led by the NHS Grampian Innovation Hub; Kheiron Medical Technologies, which developed the AI tool; and the University of Aberdeen.
The project uses AI to evaluate anonymised patient images in a secure and trusted environment for data processing. ‘We have a very strong information governance team in the hospital so what happens is screening images are stripped of identifiable patient information and given a pseudonymised number before being sent to the cloud. The AI does its analysis and then it comes back and within the NHS its rejoined [with the patient data],’ Dr Lip explains.
Some early initial results from GEMINI were presented at the European Congress of Radiology in March 2024. These revealed that by using AI as a ‘safety net’ image reader, 11 women were found to have cancer who would likely otherwise not have been detected until their next routine breast screening. As a result, they were detected at an earlier stage when their cancers were smaller.
This discovery has significant implications for breast screening, patient outcomes and health system resource. For example, ‘if a cancer smaller than 15mm in size is detected, generally the chance of survival is 95%’, Dr Lip says. ‘[A] key part of screening is we want to find small things before they become big things, and AI is one of the tools that can help us find these small things.’
In that way, this AI tool can act as a safety net, which can have positive implications for patients and reduce the need for more complex surgery, chemotherapy and radiotherapy.
Dr Lip’s team is currently working on a paper looking into the health economics of AI. ‘Similar work with chest X-rays by researchers in Glasgow shows that costs rise in the first two years of implementing AI due to greater detection rates,’ he explains. ‘But later, as the technology is scaled up, cost savings result from early detection and the reduced need for more expensive interventions for more advanced disease states.’
The next stage of this research will be to look at a larger dataset: Dr Lip’s team are co-applicants for an National Institute for Health and Care Research grant for a trial to evaluate AI in a UK-wide breast screening programme.
A key development in the evolution of breast cancer screening came in around 2015/16 in the switch from film to digital imaging. Traditional film imaging does not lend itself to the use of AI tools because the scanned film images are poor quality compared with digital counterparts. That development, coupled with the simultaneous rise of AI, led to their obvious pairing to enhance clinicians’ work.
The technology used in medical imaging, for example, is not the same as the much-discussed large language models such as ChatGPT. Instead, the AI used in the GEMINI project is very much a tool that can be fine-tuned to suit a specific use – and even a particular population – to produce the best results.
Another future benefit that Dr Lip hopes will result from employing AI is the automation of screening normal mammograms, reducing clinician workload. ‘Currently two radiologists look at each scan,’ he explains. ‘In future, if the AI records a mammogram as normal and a human screener agrees, there may be no need for a second human to verify the result.’
Indeed, initial results from an evaluation of AI using data modelling predicted a 30% reduction in clinician workload. Dr Lip explains that in a real-world situation this could mean his centre, where they read 20,000 mammograms a year, would not need a second human to read around 5,000 mammograms. This would free up a significant amount of clinician time for other tasks such as biopsies or face-to-face time with patients, he says.
Given that the Royal College of Radiologists estimates a 29% shortage of radiologists, which will rise to 40% in five years without action, and with breast screening likely to be one of the most affected specialties due to rising breast cancer cases in women, the potential time saving afforded by using an AI tool could be significant.
What’s more, as breast screening in Scotland sits under a national Picture Archiving Communications System (PACS), Dr Lip says scaling the GEMINI project to cover the whole country could be achieved ‘quite easily’. This could also be the case for Northern Ireland, which runs a unified PACS programme, as well as in England’s emerging imaging networks.
For Dr Lip, a key message from his research so far is that AI should be seen as supplementary and not a replacement for clinicians’ expertise – an experienced human still needs to be in the loop.
Of course, another reason for human involvement is that the AI only analyses the data it is given so it would not automatically know about previous surgeries and biopsies, unless this data was inputted. It may also unnecessarily recommend call-backs based on lesions from previous surgery, for example, whereas a human investigator would have access to the patient history and be able to exclude such scans from being re-read.
Dr Lip says that another significant factor highlighted was the importance of effective monitoring. AI systems suffer from drift, which happens when the software, machine or population changes, and it means that the performance of the AI responses slowly degrade over time. Monitoring is therefore needed to ensure the performance remains as expected and required.
And then there’s bias, particularly in terms of different patient populations. It is important to ensure there is no bias for different ethnic groups, for example.
‘Bias is a hot word in the AI world to ensure that it’s not biased against one group,’ says Dr Lip. ‘If an AI is only trained on white women, are there are differences in the mammograms of white women compared to black women? We don’t have significant knowledge to that level and it’s a fast-moving space.’
Real-world data from a representative population that the AI tool is analysing needs to be used to try to reduce biased results.
Looking ahead, Dr Lip says ‘more than one AI tool may be used to assess breast scans’, and he is aware of this currently happening in other clinical areas. ‘For example, in stroke care, there is a tool trained on the black areas of scans and a second trained on the white parts, so using the two tools in conjunction could improve results,’ he explains.
Another area of research for Dr Lip is in so-called masking. If there is a lot of glandular tissue in a breast, it can mask tumours and AI seems to perform well in these cases, he says. Colleagues at the Karolinska Institute in Sweden have developed a masking tool and a density tool, which can be used along with the AI screening tool, and there is more work to be done in this area.
Genetics is also key to revolutionising breast cancer care. At the Aberdeen Centre for Health Data Science, in collaboration with Professor Lesley Anderson and her team, Dr Lip is undertaking multidisciplinary work in this field.
Using BioBank data in breast cancer, the aim is to advance treatment personalisation. In future, by combining scan data with genetic and biopsy information, for example, it may be possible to determine how often each woman should attend screenings to ensure cancers are detected as early as possible.
With all their published work and a host of novel projects in the pipeline, it’s clear that the work Dr Lip and his team in Aberdeen are doing with AI promises to help alleviate workforce pressures in the NHS, detect more cancers at an earlier stage and, ultimately, improve outcomes for patients.
3rd June 2024
While breast cancer mortality has reduced by as much as 40% over the past three decades, and five-year breast cancer survival rates exceed 90% in some countries, these figures mask global inequalities. Dr Carlos Barrios, director of the Latin American Clinical Oncology Research Group in Porto Alegre, Brazil, tells Katherine Price how The Lancet Breast Cancer Commission’s latest report provides a roadmap for change and how clinicians around the world can support it.
Breast cancer cases are increasing globally, and by 2040, it is predicted that there will be three million new diagnoses per year, with people living in low- and middle-income countries (LMICs) disproportionately affected.
‘We need to recognise that there has been unequal progress, and if we keep on doing what we have done so far, that’s not going to change,’ says Dr Carlos Barrios, director of the Latin American Clinical Oncology Research Group in Porto Alegre, Brazil.
To help to achieve this aim, Dr Barrios was invited to participate in The Lancet Breast Cancer Commission, an interdisciplinary group of commissioners and patient advocates from high-, middle- and low-income countries across the world seeking to address inequalities in healthcare access and education and counter the perception that this predicted upward trajectory in breast cancer cases is inevitable.
The Commission published a report in April 2024, which Dr Barrios co-authored while also coordinating the working group looking at metastatic breast cancer (MBC). He says the report offers a roadmap for achieving more equal progress on breast cancer care worldwide.
‘The task that was given to us was to try to identify the discrepancies and be transformative – what do we need to do to change this situation?’ he says.
As well as improving representation of participants and research leads from LMICs in trials, many of The Lancet Breast Cancer Commission’s recommendations are for policy change, and Dr Barrios was keen that those responsible for making such changes were explicitly named.
‘Most of the recommendations require a very active and proactive position of policymakers and administrators,’ he explains.
For example, researchers estimate that up to a quarter of breast cancer cases in high-income countries (HICs) could be prevented by modifying risk factors such as alcohol, physical activity and obesity. In addition, identifying those at increased risk is essential for equitable access to personalised prevention strategies, including cheap and effective medications, and early detection programmes. The authors call for stage-shifting as a sustained decline in breast cancer mortality rates can be achieved by diagnosing at least 60% of invasive cancers at less than 2cm in size.
‘More than 50% of that improvement that we see in the mortality is actually driven by early diagnosis and adjuvant therapy,’ says Dr Barrios.
The findings highlight a lack of information in some areas, particularly MBC rates. Relapse is not typically recorded by most national cancer registries, even though 20-30% of patients with early breast cancer relapse.
‘If you don’t have a specific number, it’s very difficult to know the size of the problem and how to devote strategies to these patients,’ says Dr Barrios.
‘We need registry data that tells us actually how many patients we have with metastatic breast cancer, what treatment these patients received, and what the outcomes are of these patients in different places in the world.’
Within the past five years, median survival has reached five years for two of the three main MBC subtypes, which account for approximately 85% of patients with breast cancer, and some subgroups are starting to be considered as having a chronic disease. Dr Barrios and the report authors argue for eradicating social stigma around MBC as a rapidly fatal disease, and for patients to not be excluded from potentially life-extending treatments.
They make the case for at least 70% of registries worldwide to record MBC rates, and for initiatives to promote societal inclusion of people living with MBC, such as, changes to labour laws that empower more flexible working arrangements.
There is also a lack of information around the associated and hidden consequences of breast cancer – the physical, psychological, social and financial costs that are not routinely captured by global health metrics.
The Commission’s UK-based CASCARA pilot study found that a fifth of participants with early breast cancer and a quarter of those with MBC reported difficulty in covering the costs of travel for treatment, for example, and tools are needed to measure these costs and the benefits of addressing them to guide policymakers on interventions.
The report also argues that at least half of patients with MBC should be discussed at multidisciplinary meetings, as well as 80% of patients with a new breast cancer diagnosis. However, while a multidisciplinary approach from diagnosis onwards is essential, as is applying approaches that have worked well in HICs to settings with fewer resources. And this must be tailored to local contexts.
‘Most patients with breast cancer in the world are not going to be treated in institutions where you have the ability for multidisciplinary discussion,’ says Dr Barrios. ‘Most will be managed by physicians [who] work alone, that are outside the capitals, that are not in the tertiary centres.’
As such, telementoring and virtual multidisciplinary meetings are suggested by the Commission to help enable resource sharing between cancer centres and local community hospitals, even between HICs and LMICs, with a vision for technology-enabled data exchange between all stakeholders of the oncology healthcare system and always with a focus centred in the patients’ best interests.
Although many of the recommendations are actions and targets for policymakers, Dr Barrios stresses that clinicians can make a difference by identifying discrepancies around them. ‘See what you can do as a clinician in your everyday clinic to identify patients that may have problems with information or access to healthcare procedures or medications,’ he says.
Better patient communication, for example, is key in improving quality of life, decision-making, body image, and even adherence to therapy – with subsequent positive impacts on survival. The Commission’s report calls for all healthcare professionals to receive communication training and for patient involvement in all stages of breast cancer clinical research, and even provides a framework for patient-centred consultations.
It stresses that healthcare professionals are there to help patients make the decisions that are best for them, which requires the patient to understand the goals, logistics and side effects of treatment, and the clinician to understand the patient’s preferences, values and life goals.
While action from clinicians is crucial, enduring change sits firmly within the power of policymakers. It is hoped that widely sharing the The Lancet Breast Cancer Commission’s report, its findings and recommendations, for example at global oncology conferences, will pave the way to global government and policymaker attention and engagement.
‘The idea here is that we need to have a more significant impact on the national cancer care plans, because that’s where the action will reach the patients,’ says Dr Barrios.
He is optimistic about further improvements in breast cancer care on the horizon, particularly the development of new drugs in the treatment of hormone-receptor-positive disease and antibody-drug conjugates. He says these are ‘revolutionising’ MBC management and will eventually improve cure rates and help patients with early disease as well. He is also keeping a keen eye on research being led by fellow Commission participant Felicia Knaul at the University of Miami into measuring hidden costs and suffering, which he says would be ‘extremely significant’ and transformative for patients and for clinical practice.
Dr Barrios and his co-authors hope that application of the recommendations set out in The Lancet Breast Cancer Commission’s report will not only lead to improvements in breast cancer rates, treatment and outcomes in a more equal way, but have a positive impact across the cancer field, healthcare and society as a whole.
‘[These] solutions and strategies could be applicable to other diseases, and also empowering women in general,’ says Dr Barrios. ‘If we make women more participatory in the process, this will have much broader implications for women in society overall.’
23rd April 2024
Many people with breast cancer are not receiving the treatment they should, with inequalities in care leading to many groups being ‘systematically left behind, ignored and forgotten’, according to a new report.
This comes despite considerable advances in breast cancer research and treatment over the last three decades, which has led to a more than 40% reduction in breast cancer mortality in some high-income countries.
People living with metastatic breast cancer are particularly disadvantaged since rates of this type of cancer are unrecorded, and the needs of this population are unmet. The findings of The Lancet Breast Cancer Commission suggested that systematic recording of cancer rates must be established and call for increased prevention strategies and personalised treatment.
Current predictions suggest there will be three million new cases a year of breast cancer worldwide by 2040 and a million deaths, with people living in low- and middle-income countries disproportionately affected.
Tackling breast cancer gaps and inequities should be achieved through ‘global collaboration, and communication and empowerment’, the researchers said, stating that The Lancet Breast Cancer Commission is a ‘forward-looking and optimistic road map’ to address urgent challenges in breast cancer care and reduce breast cancer rates.
The findings highlighted a lack of information around rates of metastatic breast cancer, despite statistics showing that 20-30% of early breast cancers experience relapse.
Often, the physical, psychological, social and financial costs of breast cancer were found to be ‘immense but under-recognised’ since current global health metrics do not capture them.
Professor Charlotte Coles, professor of breast cancer clinical oncology and deputy head of department of oncology at the University of Cambridge, said: ‘Recent improvements in breast cancer survival represent a great success of modern medicine. However, we can’t ignore how many patients are being systematically left behind.’
She added: ‘We hope that, by highlighting these inequities and hidden costs and suffering in breast cancer, they can be better recognised and addressed by healthcare professionals and policymakers in partnership with patients and the public around the world.’
In response to the findings, the researchers established a UK-based pilot study that provides a snapshot of the economic burden and care needs of people affected by breast cancer. Nearly all of the 606 people living with breast cancer and carers surveyed experienced physical or wellbeing issues related to breast cancer, such as losing a job whilst undergoing treatment or experiencing sexual dysfunction.
Many cancer patients were also found to experience financial difficulty as a result of their illness, with 27% of patients with early breast cancer and 35% with metastatic breast cancer reporting money problems. A fifth of participants with early breast cancer and a quarter of those with metastatic breast cancer reported difficulty in covering the costs of travel for treatment.
Estimates of serious health-related suffering indicated the need for palliative care. In 2020, approximately 120 million days were spent with serious health-related suffering per year for people who died of their cancer. A further 520 million days were estimated for patients living with the disease.
Dr Carlos Barrios director of the the Oncology Research Center at Hospital São Lucas, Brazil, said: ‘Even in countries with well-developed healthcare systems, patients with breast cancer experience inadequate support and care. In countries lacking affordable health care facilities, patients experience these costs more commonly and intensely, too often leading to catastrophic spending and impoverishment.’
The Lancet Breast Cancer Commission advocates the development of new tools to estimate the hidden costs of breast cancer and better communication between healthcare workers and patients to improve the quality of life for patients and guide policymakers to invest in breast cancer prevention and interventions that relieve suffering, such as early detection, cost-effective therapy, optimal management and financial protection.
The researchers estimate that up to a quarter of breast cancer in high-income countries could be prevented by modifying risk factors for breast cancer. This involves education and awareness-raising efforts, as well as ‘bold policy changes’ that reduce the number of people exposed to these risk factors, such as alcohol consumption and being overweight.
In addition, systematic approaches that identify those at increased risk of the disease are essential to enable equitable access to personalised prevention strategies, including cheap and effective medications that can avert breast cancer for many women and early detection programmes.
Professor Benjamin Anderson, professor of surgery and global health medicine at the University of Washington, concluded: ‘Access to evidence-based prevention and care that isn’t dependent on where an individual lives or their ability to pay would reap wide-ranging benefits for patients, families and healthcare systems striving to achieve universal health coverage.’
A version of this article was originally published by our sister publication Nursing in Practice.
9th November 2023
Women who live and work in areas with higher levels of fine particulate air pollution are at greater risk of developing breast cancer than women who live and work in less polluted places, finds research presented at the European Society of Medical Oncology (ESMO) Congress 2023.
In a matched case-control study, researchers compared home and workplace air pollution exposure in 2,419 French women diagnosed with breast cancer against the exposure of 2,984 women without the disease from 1990 to 2011.
They found a statistically significant linear increase in breast cancer risk related to mean fine particulate matter (PM2.5) exposure, with a 28% increase in risk with an increment of 10 µg/m3 of PM2.5.
Lead author Professor Béatrice Fervers, head of prevention, cancer environment department, Léon Bérard Comprehensive Cancer Centre, France, said: ‘This contrasts with previous research which looked only at fine particle exposure where women were living, and showed small or no effects on breast cancer risk.’
In a study abstract published in the Annals of Oncology, the research term explained cases were matched to randomly selected controls based on several variables including place of residence, age and menopausal status.
All participants were drawn from the prospective E3N cohort – the French element of the European EPIC Study, coordinated by the International Agency for Research on Cancer.
Researchers using a Land Use Regression model to estimate annual mean PM2.5, coarse particulate matter (PM10) and nitrogen dioxide (NO2) and assigned them to women based on geocoded home and workplace addresses.
Mean exposure was calculated for each woman from the time they were included in the E3N cohort to their index date – the date of diagnosis of cases.
For PM10 and NO2 exposure, researchers found a numerical, but statistically non-significant, increased risk with an incremental increase of 10 µg/m3.
Hormone receptor or menopausal status did not affect any of the results, they added.
Commenting on the findings, Professor Charles Swanton, clinician scientist at the Francis Crick Institute in London, UK, said fine particulate matter can penetrate deep into the lungs, entering the blood stream and then being absorbed into breast and other tissues.
Professor Swanton, who presented research at ESMO Congress 2022 suggesting how PM2.5 particles may trigger lung cancer in non-smokers, said there was already evidence that air pollutants can change breast architecture.
‘It will be important to test if pollutants allow cells in breast tissue with pre-existing mutations to expand and drive tumour promotion possibly through inflammatory processes, similar to our observations in non-smokers with lung cancer,’ he said.
‘There is an urgent need to set up laboratory studies to investigate the effects of these small air pollutant particles on the latency, grade, aggression and progression of breast tumours.’
The French research comes weeks after US National Institute of Health researchers published data in the Journal of the National Cancer Institute showing living in an area with high levels of fine particulate air pollution was significantly associated with an increased risk of breast cancer incidence.
Professor Jean-Yves Blay, ESMO director of public policy, said there was strong epidemiological and biological evidence for the link between PM2.5 particle exposure and cancer, with good clinical and economic reasons for reducing pollution to prevent cancers.
In September 2023, the European Parliament adopted in plenary session its report on the ongoing revision of the EU Ambient Air Quality Directives, reflecting ESMO’s recommendations to set the annual limit value for PM2.5 at 5 µg/m³.
This adoption opens interinstitutional negotiations between the co-legislators – European Parliament, European Commission and EU Council – to agree on the final text of the directive.
7th November 2023
The aromatase inhibitor anastrozole has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a preventative treatment for breast cancer in postmenopausal women at moderate or high risk of developing the disease.
Previously authorised for the treatment of breast cancer in postmenopausal women, the drug has been used off-label for prevention and is now approved for this indication.
Anastrozole, which is off patent, is taken as a 1mg tablet, once a day for five years. It works by blocking the aromatase enzyme and reducing the amount of oestrogen that a patient’s body makes.
The most common side effects are hot flushes, feeling weak, pain or stiffness in the joints, arthritis, skin rash, nausea, headache, osteoporosis and depression.
According to Cancer Research UK, the entire five-year course of treatment now costs just £78, or around 4p a day.
Anastrozole was first recommended as a preventive option by the National Institute for Health and Care Excellence (NICE) in 2017, however, with the treatment being unlicensed in this use, uptake has remained low.
NHS England said around 289,000 women at moderate or high risk of breast cancer could be eligible for the drug. It estimated that if 25% of these women chose to take the drug, approximately 2,000 cases of breast cancer could potentially be prevented in England.
This would save around £15m in treatment costs, NHS England said.
NHS chief executive, Amanda Pritchard, said: ‘It’s fantastic that this vital risk-reducing option could now help thousands of women and their families avoid the distress of a breast cancer diagnosis.
‘Allowing more women to live healthier lives, free of breast cancer is truly remarkable, and we hope that licensing anastrozole for a new use today represents the first step to ensuring this risk-reducing option can be accessed by all who could benefit from it.’
The MHRA approval is based on the International Breast Cancer Intervention Study II (IBIS-II) study – an international, randomised double-blind, placebo-controlled trial.
The results showed a significant continuing reduction in breast cancer with anastrozole in the post-treatment follow-up period, and fewer women developed breast cancer in the anastrozole group compared to the placebo group.
After a median follow-up of 131 months (IQR 105–156), a 49% reduction in breast cancer was observed for anastrozole (85 vs 165 cases, hazard ratio 0.51, 95% CI 0.39–0.66, p<0.0001). The reduction was larger in the first five years (35 vs 89, 0.39, 0.27–0.58, p<0.0001), but still significant after five years.
Anastrozole is the first medicine to be repurposed through the new Medicines Repurposing Programme, which looks at using existing medicines in new ways to benefit patients and the NHS. It is hosted by NHS England and supported by the Department of Health and Social Care, the MHRA, NICE and the National Institute for Health and Care Research.
The licensing work was undertaken by Accord Healthcare on a not-for-profit basis, after Accord Healthcare was selected through an open competitive process. The Medicines Repurposing Programme will now work with the MHRA and the British Generic Manufacturers Association to ensure other companies that make anastrozole adopt the new licensed indication.
Dr David Crosby, head of prevention and early detection at Cancer Research UK, said: ‘Repurposing therapeutic drugs that have already been shown to be safe for prevention is an area with a lot of potential.
‘More research will be key to finding more opportunities like this, to better understand who is at a high risk of getting cancer, and to help lower that risk.’
11th September 2023
Greater ethnic diversity in pioneering breast cancer clinical trials is the primary objective of a recent collaborative pilot project between Barts Health NHS Trust, The Christie NHS Foundation Trust, Roche Products Ltd and Macmillan Cancer Support.
The evidence derived from randomised controlled trials constitutes the most rigorous test of efficacy, effectiveness and safety for healthcare interventions. Nevertheless, if participants enrolled in these trials do not fully reflect the wider population for which the intervention is designed, the generalisability of the findings are limited.
What’s more, a 2016 study published in the British Journal of Cancer shows that young black women with breast cancer have more aggressive tumour profiles, present with later stages of disease, have higher mortality rates and experience poorer cancer care, yet they are often under-represented in clinical trials.
In an effort to redress this imbalance, this pilot project, which will run until August 2024, aims to increase the representation of black, Asian and ethnic minority women in breast cancer trials by improving access and identifying new and better ways to disseminate information.
This will include creating more targeted and meaningful communications for the communities the project is aiming to reach; increasing data, comparative baselines and patient retention records for research purposes; and providing enhanced support to ensure breast cancer patients understand the disease, what clinical research is and navigating patients to suitable clinical trials.
Findings and recommendations from the project will be used to create a case study and framework for future clinical trials and improve representation.
Dr Peter Hall, a medical oncology consultant at Barts Health NHS Trust who is involved in the project, said: ‘It’s well known that we need to do more to improve the diversity of participants taking part in the clinical trials we run at Barts Health and indeed, across the NHS. That’s why I’m so excited about this project.
‘By taking a targeted approach to driving diversity in clinical trials for a specific disease, we can not only improve representation for this condition, but learn how we can do this for trials into other conditions too. Ultimately, it will help us be more confident that the treatments we’re providing really do work for everyone. It’s also great to see this project being run as a collaboration between the NHS, charity and the commercial sector.‘
Understanding why clinical trials have historically under-represented people of different ethnicities remains unclear. Some reasons include the need for a narrowly defined, homogenous population to reduce variance and hence sample size, together with the imposition of stringent inclusion and exclusion criteria.
A further possible reason is the lack of engagement with ethnic communities. According to Charles Kwaku-Odoi, chief executive of the Caribbean African Health Network, ‘across the black community there is an undoubted legacy of disengagement in research and most certainly clinical trials that stems back decades as a result of mistrust. This has not served us well because it leads to a lack of appropriate interventions that perpetuate the grave health inequalities in breast cancer care‘.
He added: ‘This partnership approach to build solutions to improve engagement in clinical trials in breast cancer treatment and care is very much welcomed. We are looking forward to working in a collaborative way to build trust, improve awareness and ensure that barriers surrounding access to clinical trials are addressed.‘
In 2020, the INCLUDE group set out a multicomponent work stream project to improve representation of under-served groups in clinical trials. Under-representation of patients from different ethnicities is a recognised problem. For instance, research has revealed a lack of ethnic diversity within lipid lowering drug trials.
30th August 2023
Women receiving breast cancer therapy across six clinical centres in Europe will be enrolled in a study to determine whether behavioural and psychological interventions can reduce the cardiac damage from anti-cancer therapies.
The innovative CARDIOCARE project, which was launched in 2021 by a consortium of European partners including the European Society of Cardiology (ESC), aims to radically change the management of older women with breast cancer by harnessing the expertise of a multidisciplinary team to improve the monitoring, treatment and care these patients receive.
It is already known that breast cancer survivors have an estimated 32% higher risk of cardiovascular disease.
Now, a clinical trial evaluating the impact of behavioural and psychological interventions on quality of life, physical and mental wellbeing, and the cardiotoxic effects of breast cancer treatment will be conducted in 750 patients with breast cancer.
As part of the trial, all patients will receive the CARDIOCARE mobile app, which includes psychological and behavioural elements called ePsycHeart and eHealtHeart. Participants will be randomly allocated to receive both ePsycHeart and eHealtHeart – the intervention group – or to receive ePsycHeart only.
ePsycHeart monitors quality of life, mobility and mental health using a wearable chest band heart rate sensor, smartwatch and questionnaires. eHealtHeart encourages patients to adopt behaviours such as physical activity, healthy diet, games to improve memory and changing the home environment to reduce the risk of falls.
A further aim of the trial is the early identification of women with breast cancer who are at the greatest risk of cardiac damage from anti-cancer treatments. The trial will utilise cutting-edge technologies, such as next generation sequencing, to pinpoint changes in gut microbe species that signal damage of the heart and blood vessels before symptoms occur. In addition, artificial intelligence will be used to analyse images of the heart to predict the likelihood of heart damage.
Professor Dimitrios Fotiadis, project coordinator and professor of biomedical engineering at the University of Ioannina in Greece, said: ‘Cardiovascular disease is a devastating complication of anti-cancer treatment that affects physical and mental health. CARDIOCARE will provide women over the age of 65 with breast cancer the tools to improve their physical health and to psychologically adapt to the disease.
‘CARDIOCARE is on track to improve the physical and mental health of older women with breast cancer by detecting the cardiovascular side effects of anti-cancer treatment early and providing digital tools to help patients improve their mental and physical wellbeing.‘
9th August 2023
Using an AI-supported mammography screening tool results in a similar breast cancer detection rate compared with standard double reading but with a substantially lower screen-reading workload, according to the interim safety findings of a new randomised controlled trial.
Making use of AI-supported software, researchers from Lund University in Sweden, have shown that a screening mammography avoids the need for double reading of all mammograms, without increasing false positives and almost halving radiologists‘ screen-reading workload.
Although previous retrospective analyses have indicated that combining AI with a radiologist improves the accuracy of breast cancer detection and reduces radiologist workload, there have been no randomised trials evaluating this approach until now.
Commenting on the findings, lead author Dr Kristina Lång said: ‘These promising interim safety results should be used to inform new trials and programme-based evaluations to address the pronounced radiologist shortage in many countries. But they are not enough on their own to confirm that AI is ready to be implemented in mammography screening.
‘We still need to understand the implications on patients’ outcomes, especially whether combining radiologists’ expertise with AI can help detect interval cancers that are often missed by traditional screening, as well as the cost-effectiveness of the technology’.
Published in The Lancet Oncology, the Mammography Screening with Artificial Intelligence (MASAI) trial enrolled 80,033 Swedish women aged 40-80 years who were eligible for mammography screening. Participants were randomly allocated 1:1 to either AI-supported screening (the intervention group, n = 40,003) or standard double reading without AI (the control group, n = 40,030).
The primary outcome measure of the MASAI trial was the interval cancer rate. Secondary outcomes examined included early screening performance (cancer detection rate, recall rate, false positive rate) and screen-reading workload (number of screen readings and consensus meetings).
The AI-supported system provided an examination-based malignancy risk score on a continuous scale ranging from 1 to 10. These examination were then categorised as either low risk (risk score 1 to 7), intermediate risk (risk scores 8 and 9) or high risk (risk score 10). In the intervention group, examinations with risk scores of 1 to 9 underwent single reading, whereas examinations with risk scores of 10 underwent double reading.
The cancer detection rate (per 1,000 screened women) was broadly similar, with a rate of 6.1% for the AI group and 5.1% in the control group. Similarly, recall rates were also not significantly different (2.2% vs 2.0%) and neither were the false positive rates (1.5% in both arms).
The number of screen readings was considerably lower for the AI-supported group (46,345 vs 83,231), representing a 44.3% workload decrease for reading screening mammograms.
27th July 2023
Women who are both diagnosed and treated for breast cancer appear to undergo accelerated biological ageing compared to those who remain free of the cancer, according to a recent study.
Biological aging is accelerated following a breast cancer diagnosis and treatment according to the findings of a new study led by a team from the National Institute of Environmental Health Sciences (NIEHS). Their research,
Published in the Journal of the National Cancer Institute, the researchers from the National Institute of Environmental Health Sciences examined paired blood samples through DNA methylation profiling collected from women enrolled in the prospective Sister Study cohort at the initial and follow-up visits, which were an average of 7.7 years apart.
Researchers also included patients who remained free of breast cancer for comparative purposes and used linear regression models to assess differences in several biological aging metrics at the second sample collection or follow-up by breast cancer status.
A total of 417 women, of whom 190 were diagnosed and treated for breast cancer between blood sampling, were included in the study.
Among women who developed breast cancer, diagnoses occurred an average of 3.5 years after the initial blood draw and four years before the second sample. After adjusting regression models for covariates and biological aging metrics measured at baseline, it was found that women diagnosed and treated for breast cancer had higher biological aging metrics at the follow-up.
In analyses assessing the associations with different breast cancer therapies, radiation had strong positive associations with biological aging. In contrast, surgery had little association with the biological aging metrics.
Commenting on the study, co-author Dale Sandler said ‘Radiation is a valuable treatment option for breast cancer, and we don’t yet know why it was most strongly associated with biological age.’ He added that ‘This finding supports efforts to minimise radiation exposures when possible and to find ways to mitigate adverse health effects among the approximately four million breast cancer survivors living in the United States.’
9th June 2023
The combination of ribociclib and standard endocrine therapy improves invasive disease-free survival rates more than endocrine therapy alone in patients with early stage, hormone receptor–positive, HER2-negative (HR+/HER2-) breast cancer, according to recent data presented at ASCO 2023.
The standard treatment for HR+/HER2- advanced or metastatic breast cancer involves the use of endocrine therapies such as aromatase inhibitors, selective oestrogen receptor (ER) modulators, and selective ER down-regulators. However, a problem with this approach is the development of treatment resistance, which therefore requires additional therapeutic strategies.
Ribociclib is a cyclin-dependent kinase 4/6 inhibitor, approved in combination with endocrine therapy for treatment of HR+/HER2- advanced or metastatic breast cancer in both pre- and post-menopausal women.
In a 2019 study, use of ribociclib and endocrine therapy significantly improved progression-free survival and had manageable toxicity in both pre- or peri-menopausal and postmenopausal women with HR+/HER2- metastatic or advanced breast cancer. However, whether this combination would benefit women with early stage breast cancer remains unclear.
The current NATALEE trial – a phase 3 multi-centre, randomised, open-label trial – is designed to evaluate the efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer.
In an abstract presented at the American Society of Clinical Oncology 2023, women with early stage breast cancer given ribociclib were found to have a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS) compared to standard endocrine therapy alone.
For the trial, both pre- and post-menopausal women were randomised 1:1 to ribociclib (RIB) and endocrine therapy (ET) or ET alone for up to three years. RIB was given at a dose of 40 mg daily (three weeks on and one week off) and ET comprised letrozole 2.5 mg daily or anastrozole 1 mg day for longer than five years.
In total, 5,101 participants were randomised to either RIB and ET (2,549) or ET alone and followed for a median of 34 months. The combination of RIB and ET showed a significantly longer iDFS than ET alone (Hazard ratio, HR = 0.75, 95% CI 0.62 – 0.91, p = 0.014). In addition, the three-year iDFS rates were rates were 90.4% vs 87.1% respectively.
The abstract also reported how this iDFS benefit was generally consistent across stratification factors and other subgroups. Moreover, while not reported, the authors indicated that the secondary endpoints of overall survival, recurrence-free survival and distant disease–free survival consistently favoured RIB. In addition, at the dosage used (400 mg), RIB had a favourable safety profile with no new signals.
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