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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.
Domiciliary transcutaneous electrical stimulation of the hypoglossal nerve could be used to reduce the severity of symptoms experienced by patients with obstructive sleep apnoea (OSA), according to the findings of recent study.
Patients treated with transcutaneous electrical stimulation showed improvements in nocturnal breathing and a significant reduction of daytime exhaustion.
The TESLA open-label phase 3 trial, which was published in eClinical Medicine and led by researchers from King’s College London and Guy’s & St Thomas’ NHS Foundation Trust, examined whether domiciliary transcutaneous electrical stimulation would control OSA and provide health benefits. Traditionally used for arthritis and during child labour, this study marked the first time the device has been used for OSA.
Participants with an apnoea-hypopnoea-index (AHI) of 5 to 35 (i.e. mild-to-severe disease) and a body mass index of 18.5 to 32, together with a documented lack of adherence to continuous positive airway pressure (CPAP) therapy, were included. Individuals were then randomised 1:1 to receive domiciliary transcutaneous electrical stimulation or usual care with ongoing CPAP therapy.
The primary outcome of the trial was the change in AHI at three months. Secondary outcomes included sleepiness – based on the Epworth Sleepiness Scale (ESS) – and the 4% oxygen desaturation index (ODI).
A total of 56 participants were enrolled and randomly assigned to domiciliary transcutaneous electrical stimulation (29 participants, of which 27 completed the trial) or usual care (27 participants) and followed for a median of three months. The two groups were similar in terms of age, gender and body mass index.
At follow-up, the AHI had improved in the transcutaneous group (p = 0.006) compared to baseline, but not in the usual care group (p = 0.69). The unadjusted group difference in the AHI was −11.5, which was statistically significant (p = 0.016). However, when adjusted for the baseline value, this difference was no longer significant (p = 0.12).
Despite this, the mean group difference in the ESS at the end of the trial was significant after adjustment for the baseline value (p = 0.020), favouring the intervention. Similarly, adjusted mean difference in ODI was also significant (p = 0.036).
Minor adverse events were found in one of the participants who developed mild headaches related to the intervention.
The authors concluded that domiciliary transcutaneous electrical stimulation for patients with OSA without significant comorbidities is feasible, safe and reduces disease severity.
Professor Joerg Steier, consultant in respiratory and sleep medicine at Guy’s & St Thomas’ and professor of respiratory and sleep medicine at King’s College London’s School of Basic and Medical Biosciences, said: ‘A TENS machine is non-invasive, has little side effects and is cheap. The TESLA trial shows us the potential of a new therapeutic option, transcutaneous electrical stimulation, and it will be interesting to see how the method can be used in clinical practice.‘
OSA is a common condition affecting up to one billion people worldwide. It is diagnosed based on several symptoms including excessive daytime sleepiness, snoring, fatigue and witnessed breathing pauses (apnoeas), gasping, or choking while sleeping. Last year, evidence emerged that OSA may be diagnosed using machine learning diffusion tensor imaging models.
8th August 2023
Irregular sleep patterns, caused by ‘social jetlag’ – the shift in a person’s internal body clock when sleeping patterns change between workdays and free days – are associated with harmful gut bacteria and adverse health outcomes, according to a new study.
Undertaken by King’s College London (KCL) and published in the European Journal of Nutrition, the study was designed to explore the relationship between social jetlag and gut microbial composition, diet and cardiometabolic health.
It found that social jetlag is associated with unfavourable diet quality, including a higher intake of potatoes and sugar-sweetened beverages and lower intakes of fruits and nuts, together with slightly higher markers of inflammation, compared to those without social jetlag.
The researchers used information from the ZOE PREDICT 1 study, which includes data from 1,002 monozygotic, dizygotic and non-twin healthy UK individuals aged 18-65 years.
The team assessed demographic, diet, cardiometabolic, stool metagenomics and postprandial metabolic measures. Sleep patterns were self-reported and used to calculate social jetlag. This was deemed to be a 90-minute difference in the timing of the midpoint of sleep – the halfway point between when a person goes to sleep and when they wake up – on weekdays versus weekend days.
The team also collected blood samples following the consumption of a standardised meal consisting of two high-fat muffins and a milkshake.
A total of 934 individuals were included in the analysis and 145 were defined as having social jetlag and the others had a routine sleep schedule. All participants were healthy and lean, and slept for over seven hours a night throughout the week.
In an analysis of their gut microbiomes, three out of six microbiota species linked to ‘unfavourable’ health outcomes were more abundant in the social jet lag group. These microbes are associated with poor diet quality and are indicators of obesity and cardiometabolic health, and create markers in the blood related to higher levels of inflammation.
Senior author for the study Wendy Hall, said: ‘We know that major disruptions in sleep, such as shift work, can have a profound impact on your health. This is the first study to show that even small differences in sleep timings across the week seems to be linked to differences in gut bacterial species.
‘Some of these associations were linked to dietary differences, but our data also indicates that other, as yet unknown, factors may be involved. We need intervention trials to find out whether improving sleep time consistency can lead to beneficial changes in the gut microbiome and related health outcomes.‘
The gut microbiome refers to the community of bacterial species within the intestines and plays an important role in the overall health of the host. In fact, the microbiome can be easily disturbed, for instance after taking antibiotics, although taking a probiotic yogurt appears to restore the antibiotic-induced disturbance.
A robotic-assisted bronchoscopy system is being used in the UK for the first time in a move that could help to transform the early diagnosis of suspected lung cancer by improving precision and speed when taking tissue biopsies of lung nodules.
NHS clinicians at the Royal Brompton Hospital and St Bartholomew’s Hospital are participating in a clinical study to determine if the Ion Endoluminal System (Ion), which was developed by the robotic-assisted surgery company Intuitive, could benefit patients and the NHS.
Each hospital site will aim to recruit around 50 patients with small lung nodules located in areas that are challenging to reach via traditional bronchoscopy.
Ion uses unique shape-sensing technology and robotic assistance to allow clinicians access to deep and hard-to-reach areas in each of the 18 segments of the lung. This means tissue samples can be removed for biopsy with greater precision and accuracy.
During a procedure with the Ion system, a physician inserts the Ion, fully articulating the catheter into the patient’s lung via the mouth and throat through an endotracheal tube, which may have fewer complications than biopsy approaches that use a needle inserted from outside the body.
Kelvin Lau (pictured), consultant thoracic surgeon for St Bartholomew’s Hospital, said: ’The UK is leading the world in rolling out a national lung cancer screening programme. However, only some of the lung nodules identified during screening are cancerous and need treatment. Current biopsy techniques carry risk and are not always accurate, and many patients end up waiting for a repeat scan. The uncertainty of the wait causes anxiety and could allow a cancer to grow and spread.
’With this shape-sensing robotic technology, I have the precision and stability to lock onto a very small lung nodule and obtain an accurate biopsy quickly and safely. This could transform early diagnosis and treatment, reduce the need for repeat scans and treat lung cancer earlier.’
Also commenting on the ’transformative’ technology, Professor Pallav Shah, consultant respiratory physician based at Royal Brompton Hospital, added: ’We know that an earlier diagnosis of lung cancer leads to significantly improved outcomes for our patients. When we see patients with cancerous lung nodules of more than 30mm, their five year survival rate is around 68%, but if we are able to detect these nodules at a smaller size, when they are less than 10mm in size, we are looking at a 92% survival rate.’
There are already over 400 Ion systems installed in US hospitals, and Intuitive continues to explore its applications in other countries including in the UK, across Europe and beyond.
7th August 2023
With varenicline currently unavailable, it is possible that cytisine might serve as an alternative pharmacotherapy to help patients to stop smoking. Here, clinical writer Rod Tucker investigates.
Tobacco smoking is a major cause of premature death and it is estimated that current smokers will die an average of 10 years earlier than non-smokers. But, despite the widespread acknowledgement of the dangers associated with smoking, millions of people across the world continue to smoke. In its most recent assessment, the World Health Organization suggests that tobacco kills more than eight million people each year – a figure that includes 1.3 million non-smokers who are exposed to secondhand smoke.
Although smoking is linked to a range of adverse health effects, much attention has been directed at the links with lung cancer. In fact, estimates suggest that 90% of lung cancer deaths are due to smoking. Fortunately, there is a large body of robust evidence supporting the effectiveness of pharmacotherapies for smoking cessation. In fact, even if smoking cessation is started at the time of a lung cancer diagnosis, there is still an improvement in overall survival.
The benefits of smoking cessation treatment were highlighted in a 2021 systematic review, which suggested that there was strong evidence for a range of pharmacologic and behavioural interventions at increasing smoking cessation. One such treatment is varenicline, which, according to the systematic review, was associated with a more than two-fold increase in the smoking cessation success rate.
However, varenicline is currently unavailable in the UK and Europe. It was withdrawn by the manufacturer, Pfizer in 2021 due to the presence of high levels of N-nitroso-varenicline – a probable human carcinogen.
Attention then turns to the most suitable alternatives to varenicline. One potential treatment cytisine but, despite being available for over 50 years, the drug is still not licensed in many countries beyond Eastern Europe. So, how effective is cytisine as an aid to smoking cessation, and why is it not widely available?
Cytisine, or, more correctly, cytisinicline, is an alkaloid that is a partial nicotinic acetylcholine receptor agonist. Derived from the plant Cytisus laburnum, it was discovered in 1865, but it was not until 1912, that its pharmacological actions were described as almost indistinguishable from that of nicotine.
The drug was brought to market in 1964 under the brand name Tabex by the Bulgarian company Sopharma, which described it as a plant-based drug used for smoking secession. Today, cytisine is marketed in 18 countries, but is not authorised in the UK, European or US markets, nor any country where the regulatory approval processes of these countries are followed, such as New Zealand.
Much of the early research on cytisine was undertaken during the 1960s in Eastern Europe. However, due to a combination of language and Iron-Curtain barriers, many clinicians in westernised countries were largely unfamiliar with the drug.
Nevertheless, the early research had not gone completely unnoticed. The development of varenicline for instance, which has an identical mode of action to cytisine, was influenced by the recognition that partial nicotinic acetylcholine receptor agonists were implicated in regulating the mesolimbic dopaminergic pathway, which mediates many aspects of tobacco dependence.
The first systematic review of the clinical data on cytisine was undertaken in 2006. The review included data from 10 studies published between 1967 and 2005 in Bulgaria, Germany, Poland and Russia, three of which, were placebo-controlled trials. Although the authors of the review concluded that cytisine appeared to be effective, they also noted how most trials were of poor quality.
Since that first review, several more rigorous randomised trials have been conducted. One such trial in 2011, observed a significantly higher rate of sustained 12-month abstinence of 8.4% for cytisine compared to 2.4% with placebo (p = 0.001). The following year, a double-blind, randomised, placebo-controlled trial, also showed that cytisine was associated with a significantly greater abstinence rate compared to placebo (p = 0.01).
But, the true value of a drug‘s efficacy is really only established in trials using an active comparator. To date, several such trials have been undertaken with either varenicline or nicotine replacement therapy (NRT).
One such trial from 2014 compared cytisine for 25 days to eight weeks of NRT. In terms of continuous abstinence, cytisine was superior to NRT after one week, two months and six months.
When it comes to comparing varenicline, a trial in 2021 concluded that cytisine treatment for 25 days, compared with varenicline for 84 days, failed to demonstrate non-inferiority regarding smoking cessation. A second 2021 trial also concluded that cytisine and varenicline were not significantly different.
In contrast, however, a comparative study published in 2023, found that the standard 12-week varenicline treatment was more effective than the standard 4-week cytisine treatment. The study, which was undertaken in primary care practices in Croatia and Slovenia, showed that the smoking cessation rate after 24 weeks was 32.5% for varenicline but only 23.1% for cytisine. Despite this lower efficacy, the authors did conclude that adherence was higher, and the rate of adverse events lower, among participants assigned to cytisine.
The most recent trial, published in July 2023, compared a 3 mg dose of cytisine taken three times daily for 12 weeks, to the same dose for only six weeks followed by six weeks of placebo, or a placebo for 12 weeks. In both active regimens, cytisine significantly improved smoking cessation rates more than placebo.
While cost is always an important consideration for any treatment, cytisine has been shown in many analyses to be a cost-effective treatment option. For instance, one 2014 cost-effectiveness analysis concluded that cytisine is estimated to be both more clinically effective and cost-effective than varenicline. This was reaffirmed in a 2018 analysis, which concluded that the current provision of smoking cessation services in the Netherlands and England could benefit economically from the inclusion of cytisine.
With little doubt over its efficacy, other factors serve as a barrier to wider approval. Perhaps most pertinent is the concern that regulatory authorities in the UK, Europe and the US may require further placebo-controlled trials of cytisine in western European and/or North American populations. The current manufacturers, Sopharma in Bulgaria and Aflofarm in Poland, have little incentive to conduct such trials, especially as cytisine is now a generic product.
But, the current situation is more than likely to change in the near future. One US company, Achieve Life Sciences, has made great strides in evaluating cytisine through a series of randomised controlled trials. In fact, the company describes itself as ‘committed to advancing cytisinicline (cytisine) as a widely available treatment option to help people battling nicotine addiction.‘
Achieve Life Sciences established the Ongoing Research of Cytisinicline for Addiction (ORCA) program of clinical trials to advance the development and commercial availability of cytisine. Recently, the company reported findings from the ORCA-V1 Phase 2 trial in which a 3 mg dose of cytisine three times a day demonstrated a significantly significant better quit rate than placebo among adult users of nicotine e-cigarettes or vapes.
In the absence of a marketing authorisation, it is unlikely that cytisine will serve as an alternative to varenicline, at least in the short term. But, armed with a dossier of positive data, it is possible that cytisine will gain FDA approval in the next year or so. This is likely to lead to regulators in the UK and Europe also approving the drug, finally allowing many more millions of patients access to an effective smoking cessation aid.
3rd August 2023
A pilot study examining the benefits of nasal photodisinfection for the prevention of surgical site infections is being trialled at a UK hospital.
The six-month pilot at Pontefract Hospital has begun to make use of nasal decolonisation using Ondine Biomedical’s Steriwave nasal photodisinfection for 500 elective hip and knee surgery patients, prior to their surgery in an effort to reduce the incidence of surgical site infections.
Steriwave is a broad-spectrum antimicrobial providing targeted decolonisation safely, effectively and quickly. Nasal photodisinfection uses a proprietary light-activated agent to rapidly destroy pathogens that can lead to surgical site infections. It targets the bacterial biofilm as well as viruses, yeasts and fungi, but does not lead to resistance due to the speed of the treatment. Moreover, the technique does not harm human tissue.
Dr Stuart Bond, consultant antimicrobial pharmacist and director of innovation at Mid Yorkshire Teaching NHS Trust, commented: ‘We are very pleased to be the first NHS trust in the UK to pilot this exciting, non-antibiotic method of preventing infections after surgery. Although infections after hip and knee surgeries are rare, we know that they lengthen patients’ stay in hospital, complicate the recovery process and cause significant pain and suffering. We look forward to sharing the results of the Steriwave pilot in due course.‘
A patient with a surgical site infection will spend an average of seven to 11 days more in hospital, significantly increasing costs and lengthening patients’ recovery. Nasal mupirocin, an antibiotic, is usually used for nasal decolonisation, however, there are serious concerns about its antimicrobial resistance rates which have been reported as high as 81%.
The method is already in use at a number of hospitals across Canada and has demonstrated significant improvement in post-surgical outcomes including reduced patient length of stay, fewer readmissions, and lower rates of antibiotic prescribing as a result of nasal photodisinfection.
A study presented at the Prevention Society Conference 2022 examined the role of antimicrobial nasal decolonisation in combination with 2% chlorhexidine gluconate body wash cloths as standard pre-surgical practice. In this retrospective analysis, researchers compared the level of surgical site infections (SSIs), in those with and without nasal decolonisation.
The results showed that the proportion of patients who developed SSIs was approximately half among those who received the nasal decolonisation (0.8% vs 1.5%, p < 0.001). But nasal decolonisation also offered other advantages such as a significant reduction in mortality (p < 0.001) and the mean number of days in hospital (p < 0.001).
Lower rates of infection have also been demonstrated in patients undergoing high risk surgery. In one such study focusing on instrumented spine surgery, vascular, cardiothoracic and ortho-trauma, the SSI rate for spine cases decreased from 7.2% to 1.6%.
2nd August 2023
Using a reinforcement learning model that includes human preferences, improves the diagnostic accuracy of artificial intelligence (AI) decision support systems for skin cancer, according to the findings of a recent study.
Published in the journal Nature Medicine, researchers from the Department of Dermatology at MedUni Vienna in Austria integrated human decision-making criteria in the form of ‘reward tables‘ into the AI diagnostic system.
This reinforcement learning – a subset of machine learning – allows the system to learn through trial and error, based on both positive and negative feedback from its actions. In other words, it learns from its mistakes and is designed to mimic natural intelligence as closely as possible.
The dermatologist-generated reward tables incorporated the positive and negative consequences of clinical assessments into the decision-making process, from both the physician‘s and the patient‘s perspective. Consequently, an AI diagnosis was not only rated as right or wrong, but rewarded or penalised with a certain number of plus or minus points depending on the impact of the diagnosis or the resulting decisions.
The researchers found greater accuracy in AI diagnostic results was achieved by incorporating this human decision-making criteria, which was designed to balance the benefits and harms of various diagnostic errors, using melanoma and other skin cancers as an example.
When compared against supervised learning, the reinforcement learning model improved the sensitivity for melanoma diagnosis from 61.4% to 79.5% and for basal cell carcinoma from 79.4% to 87.1%. AI overconfidence was also reduced while simultaneously maintaining accuracy.
In addition, reinforcement learning increased the rate of correct diagnoses made by dermatologists by 12.0% and improved the rate of optimal management decisions from 57.4% to 65.3%.
Commenting on the importance of the results, study lead Harald Kittler, said: ‘In this way, the AI learned to take into account not only image-based features, but also consequences of misdiagnosis in the assessment of benign and malignant skin manifestations.‘
The improved performance of AI-based skin cancer diagnosis also occurs because reinforcement learning reduces the AI‘s overconfidence in its own predictions, making more nuanced and human-compatible suggestions.
‘This, in turn, helps physicians make more accurate decisions tailored to individual patients in complex medical scenarios,‘ Kittler added.
Two distinct genetic loci that contribute to the risk of an individual developing the chronic skin condition hidradenitis suppurativa (HS) have been identified by researchers at the University of North Carolina (UNC).
In an effort to better understand the genetic factors responsible for HS, researchers undertook a genome-wide association study, which looks for associations between loci and particular chronic diseases. The study, which was published in JAMA Dermatology, sought to identify genetic variants associated with HS and to shed light on the underlying genes involved.
A total of 720 patients with HS were included, and researchers integrated the information they obtained from these individuals with controls from the National Longitudinal Study of Adolescent to Adult Health study. The results were further combined with biological and genetic samples from three other databases.
The study revealed genomic variants pointing to two specific genes: SOX9 and KLF5. The SOX9 gene is thought to be involved in both hair follicle and epidermal development, whereas KLF5 promotes the generation of keratinocytes
The researchers identified mutations at these loci, which were more likely to be found in people with HS than in people without the disease. In addition, variants at these loci were located in enhancer regulatory elements detected in skin tissue. The researchers suggested that these or other nearby genes may be associated with genetic risk of HS and the development of its unique clinical features which include cysts, comedones, and inflammatory tunnels.
Karen Mohkle, from the Department of Genetics at UNC and one of the study authors, said: ‘While more studies are needed to understand how DNA variants near SOX9 and KLF5 contribute to the pathophysiology of HS, both genes are potentially highly relevant and have not previously been linked to the condition.‘
Previous research suggests as many as one person in every 100 has HS, which equates to around 3.5 million people in United States. It has also been shown that black women under the age of 40 have the highest risk of developing HS and are three times more likely to have the condition than white people.
Earlier this year, bimekizumab was found to be an effective treatment for patients with hidradenitis suppurativa, according to the findings of a phase 3 trial.
28th July 2023
The recent development of a human kidney cell atlas will help researchers better understand the factors contributing to disease states and provide a critical foundation to help discover new treatments for acute kidney injury and chronic kidney disease.
In the study, published in the journal Nature, a team of US researchers developed a kidney tissue atlas consisting of 51 main cell types including rare and novel cell populations and 28 cellular states indicative of injury or disease.
The atlas also serves as a repository of raw gene data and interactive 3D models of cells and microenvironment relationships. It was created from 45 healthy donor organs and 48 kidney disease biopsies and allows for the comparison of healthy and injured cells.
Researchers applied multiple single-cell and single-nucleus assays and spatial imaging technologies to both healthy and diseased kidneys. This provided a high-resolution cellular atlas of 51 main cell types, which included rare and previously undescribed cell populations. The multiomic approach detailed transcriptomic profiles, regulatory factors and spatial localisations spanning the entire organ.
With the data, the researched were able to define 28 cellular states across nephron segments and interstitium that were altered in kidney injury, encompassing cycling, adaptive (successful or maladaptive repair), transitioning and degenerative states.
The identification of molecular signatures also allowed researchers to determine the location of these states within the injury neighbourhoods using spatial transcriptomics. Furthermore, large-scale 3D imaging analysis of around 1.2 million neighbourhoods provided corresponding linkages to active immune responses.
Taken together, the analyses enabled researchers to define the biological pathways that are relevant to injury time-course and niches, including the signatures underlying epithelial repair that predicted maladaptive states associated with a decline in kidney function.
The atlas is part of the Kidney Precision Medicine Project (KPMP) and, according to Dr Eric Brunskill, KPMP program director, ‘represents open, public science at its best‘.
He added: ‘With the atlas, we’ve created an interactive, hypothesis-generating resource for kidney disease investigators and clinicians around the world.‘
This follows the recent development of a comprehensive heart cell atlas, which offers new and unique insight into heart cells and function.
The use of plasma ctDNA testing in patients with suspected advanced lung cancer accelerates the time to treatment compared to standard tissue testing, according to the findings of a new study.
In a non-randomised clinical trial, researchers found that plasma ctDNA genotyping prior to a tissue diagnosis among patients with suspected advanced non-small cell lung cancer (NSCLC), enables faster access to treatment in comparison to patients who undergo standard tissue testing.
The findings, published in the journal JAMA Network Open, sought to understand the best way to integrate liquid biopsy (based on plasma ctDNA) into the diagnostic algorithm for patients newly diagnosed with advanced NSCLC.
The trial enrolled patients referred for investigation and diagnosis of lung cancer but only if they had radiologic evidence of advanced cancer prior to a tissue diagnosis. These individuals (referred to as the accelerate group) underwent plasma ctDNA testing with a next-generation sequencing assay before their lung cancer diagnosis.
The primary endpoint was the time to treatment, which the researchers defined as the time from diagnostic programme referral to systemic treatment initiation. This duration was then compared with a reference cohort of patients referred to the programme and who had standard tissue genotyping after tissue diagnosis.
Among the 150 patients enrolled patients, who had a median age at diagnosis of 68 years (53% men), 60% had advanced non-squamous NSCLC.
In patients assigned to the accelerate group, the median time to treatment was significantly shorter at 39 days compared to 62 days for the reference cohort (p < 0.001). In addition, the the median turnaround time from sample collection to genotyping results was only seven days for the accelerate group but 23 days for the reference group (p < 0.001).
The researchers suggested that complementing standard tissue testing with plasma ctDNA testing before diagnosis could increase access to precision medicine and may improve patient outcomes.
Nevertheless, they cautioned that the impact of this novel approach on clinically meaningful outcomes, such as quality of life, survival and cost-effectiveness, needs to be demonstrated.
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