Tag: 13/12/23

Categories : CancerTags : Leave a comment

Resounding Success for New Personalised Treatment for Adult Leukaemia

On By ModernMedia
Photo by Tima Miroshnichenko on Pexels

Personalised treatment for the most common form of adult leukaemia helps patients survive for longer and stay in remission, a phase III trial has found. The trial, by the University of Leeds, has been identified as groundbreaking research by the New England Journal of Medicine and the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, where the results were presented.

The data shows that the duration of therapy can be individualised for each patient by using regular blood tests to monitor their response. In the trial, this approach resulted in significant improvements in both progression-free and overall survival in patients with previously untreated chronic lymphocytic leukaemia (CLL). The effect was stronger among patients with poorer outcomes to standard treatments, such as those with some genetic mutations.

Adult patients were given a combination of cancer growth blocking drugs over varied durations depending on how rapidly their disease responded.

The trial found that this approach significantly improved progression-free and overall survival compared to the standard treatment for CLL, with more than 19 in 20 patients in remission three years after starting treatment.

The study, named FLAIR, is a phase III randomised controlled trial for untreated CLL, taking place in more than 100 hospitals across the UK.

Lead author Peter Hillmen, Professor of Experimental Haematology in the University of Leeds’ School of Medicine, and Honorary Consultant Haematologist at Leeds Teaching Hospitals NHS Trust, said: “Our findings show that, for this group of patients, the treatment is very effective at tackling their disease and is well tolerated by them. This means that patients on our trial had better outcomes while also enjoying a better quality of life during their treatment. Most patients treated with the new combination have no detectable leukaemia in their blood or bone marrow by the end of treatment which is better than with previous treatments and is very encouraging.”

Dr Iain Foulkes, Executive Director of Research and Innovation at Cancer Research UK, said: “We are delighted to see these results from the FLAIR trial which show the importance and effectiveness of tailoring cancer treatment to the individual patient. Not only this, but the trial has found a way to do so without requiring frequent bone marrow tests which are more invasive and can be painful.

“The collaborative effort that went into this trial – involving researchers, healthcare professionals, funders and dedicated patients and their families – point to a new standard of care which could see real progress made against leukaemia.”

Chronic lymphocytic leukaemia is a type of cancer that affects the blood and bone marrow. It cannot usually be cured but can be managed with treatment. More than nine in 10 people are aged 55 and over when they are diagnosed.

Current treatments include chemotherapy, immunotherapy, or cancer growth blockers.

The FLAIR trial tested cancer growth blockers called Ibrutinib and Venetoclax (I+V), which are usually administered either continuously or for the same fixed duration rather than tailored to each patient’s response. This means that many patients may stop treatment too early, missing the full potential benefit from their therapy or continue therapy for longer than necessary. This could lead to a greater chance of relapse of their leukaemia and/or of treatment side effects.

FLAIR researchers aimed to discover whether it was possible to personalise I+V treatment duration for patients based on regular blood sampling and / or bone marrows, and whether this was as effective or better than standard treatment (FCR).

This regular blood and bone marrow monitoring gave researchers a more up-to-date picture of how patients were responding to I+V, and meant that the duration of I+V treatment could be tailored accordingly to each patient. In addition, it was found that basing the duration of treatment on less invasive, quicker blood samples was just as effective as using bone marrows, which can be painful and sometimes require sedation.

FLAIR was launched in 2014, recruiting 1509 patients with CLL. They were randomised to four treatment groups, each receiving a different treatment.

This part of the FLAIR trial compared two of the groups, placing 260 patients on I+V and 263 on the standard treatment, known as FCR. Almost three quarters were male, which was to be expected as CLL occurs more frequently in males. The average age was 62, and just over a third had advanced disease.

At the end of this stage of the trial, 87 patients had seen their disease progress, 75 of which were on FCR, and 12 on I+V.

To date, 34 of these patients have died during the trial. Of these, 25 were treated with FCR and only nine with I+V.

The patients on I+V underwent blood tests and bone marrows to monitor their response to treatment. The technique used is known as measurable residual disease (MRD) which allows clinicians to see the number of remaining cancer cells. The number of cells may be so small that the patient is asymptomatic. An MRD positive test result means that there are remaining cancer cells.

The research team now hope that this more personalised therapy approach, guided by blood test monitoring will be adopted as a new standard of care for patients needing first line CLL treatment.

Professor Hillmen said: “The results of the FLAIR Trial, led by the Leeds Cancer Research UK Clinical Trials Unit at the University of Leeds, are exceptional and herald a change in the way chronic lymphocytic leukaemia will be treated. FLAIR has been a huge collaborative effort over the last decade by the UK’s leading CLL specialists and by the haematology teams in over 100 hospitals throughout the UK. The participation of patient groups, individual patients and their families were critical to delivering such progress particularly through the challenges of the pandemic.”

The trial was co-ordinated by the Leeds Cancer Research UK Clinical Trials Unit at the University of Leeds. Deputy Director Professor David Cairns said: “The vision of the Leeds Cancer Research UK CTU is to improve the length and quality of survival for cancer patients on a worldwide scale. Our strategy to do this is to ensure that we build evidence to identify the correct treatment, for the correct duration, for the correct patient. FLAIR is a trial well aligned to our strategy, and reflects team science including clinicians, laboratory scientists, methodologists and operational experts working together to deliver important trial results. None of this would be achieved without the selfless commitment of trial participants who contribute their time and data.”

The FLAIR trial was funded by Cancer Research UK, Janssen Research & Development, LLC, and AbbVie Pharmaceutical Research and Development.

Source: University of Leeds

Categories : Expert OpinionTags : Leave a comment

The NHI Will Enforce the Use of EHRs – Resulting in a Steep Learning Curve for 60% Of SA’s GPs

On By ModernMedia
Photo by National Cancer Institute on Unsplash

As the development of the National Digital Health Strategy for South Africa (2019 – 2024) progresses, and the implementation of the National Health Insurance (NHI) implementation looms closer, it is clear that digital health will be the significant driver behind transforming our health system.

To date, a Health Patient Registration System (HPRS) Project has been started as an initial requirement before developing a template for what a patient Electronic Health Record (EHR) would include. Although the diagnostic, treatment and billing modules necessary for EHR’s within the NHI still need to be developed, one thing is certain: a complete, shareable, electronic health record for each patient will be key.  

How will it work

CompuGroup Medical South Africa, (CGM SA), a leading MedTech company describes an EHR as a portable, interactive, digital set of health records for a patient that assists healthcare providers in managing their care. The wealth of information provided in each EHR – from a patient’s medical history, demographics, their laboratory test results over time, medicine prescribed, a history of medical procedures, X-rays to any medical allergies – offers endless opportunities for real time patient care.

EHRs have the potential to play a role in closing the healthcare gap in South Africa by improving affordable access to healthcare and reducing health disparities. This is particularly important for marginalised populations who may have limited access to healthcare services.

GPs must adapt

Although the adoption of EHRs in South Africa is very low, with an estimated 40%* of healthcare professionals currently using digital health records in their practice or hospital, the looming National Health Insurance (NHI) Bill will encourage the adoption of EHRs, potentially improving care coordination, enhancing population health management, increasing efficiency and cost savings.

Globally, EHRs are responsible for improving efficiency by reducing duplicates within patient records, reducing unnecessary interventions such as repeat prescriptions and duplicate referrals. Of those using any form of healthcare technologies daily, 69% have found an improvement in the quality of care and 59% have seen a positive impact on patient outcomes.

Looking at the usage of technology by patients in South Africa, the statistics show that we lag behind the world average, with less than a third of our population using digital health technologies to track their health. It appears this is partially due to a distrust for the security of their health data and an affordability consideration.  

“One of the major challenges from a general practitioner perspective is that there is currently a lack of government policy and guidelines for patient data security, which in turn, affects their willingness to adopt EHRs as a standard,” says Dillip Naran, Vice President for Product Architecture at CGM SA.  

“If these hurdles can be overcome, the adoption of EHRs by GPs is predicted to have a positive impact on healthcare outcomes, and improve efficiency in the long run. The successful implementation and utilisation of EHRs will require careful planning, investment, and collaboration across the proposed NHI healthcare system, “ he goes on to mention.

Here are the seven main ways EHRs will contribute to the success of a National Health Insurance (NHI) programme in South Africa:

  • Improved patient safety: Reducing adverse effects related to medication prescription errors, dispensing errors, labelling errors and even, wrong site surgery.
  • Improved care coordination: Helping healthcare providers share patient information easily and more accurately, improving the coordination of care across different providers and settings, and eliminating the duplication of services.
  • Enhanced population health management: Providing data on health outcomes and trends to identify and address public health issues, such as disease outbreaks or health disparities, potentially informing policy decisions and resource allocation within the NHI.
  • Increased efficiency and cost savings: Reducing the administrative burden and streamlining processes, which can improve efficiency and reduce costs within the healthcare system.
  • Enhanced decision-making: Providing healthcare professionals with immediate access to relevant patient data, including medical history, allergies, medications, and test results. This information empowers clinicians to make well-informed decisions about patient care, leading to better diagnosis and treatment options.
  • Efficient claims processing: Streamlining the claims process, in the context of the NHI model, with the electronic submission of medical information leading to faster claims processing and reducing the chances of errors or fraud.
  • Early detection and management of chronic conditions: Flagging individuals who may be at a higher risk for chronic conditions, and monitoring the management of their care. 

It is important to realise that the implementation of EHRs can’t be expected to be solely responsible for closing the gap in healthcare. Other factors such as access to healthcare services, poverty and education need to be addressed, along with solving challenges such as data privacy, security concerns and improving digital literacy within certain previously disadvantaged population groups.

By Andrea Desfarges on behalf of CompuGroup Medical SA.

*. *Statistics taken from “Adapt as you adopt: Adjusting to digital health tech to drive access to care” by Jasper Westerlink, Dec 2019.  

Categories : Injury & Trauma NeurologyTags : Leave a comment

Key Protein Coordinates Healing in Brain Injuries

On By ModernMedia
Image of an astrocyte, a subtype of glial cells. Glial cells are the most common cell in the brain. Credit: Pasca Lab, Stanford University NIH support from: NINDS, NIMH, NIGMS, NCATS

A new study published in PNAS Nexus provides a better understanding of how the brain responds to injuries. Researchers at the George Washington University discovered that a protein called Snail plays a key role in coordinating the response of brain cells after an injury.

The study shows that after an injury to the central nervous system (CNS), a group of localised cells start to produce Snail, a transcription factor or protein that has been implicated in the repair process. The GW researchers show that changing how much Snail is produced can significantly affect whether the injury starts to heal efficiently or whether there is additional damage.

“Our findings reveal the intricate ways the brain responds to injuries,” said senior author Robert Miller, the Vivian Gill Distinguished Research Professor and Vice Dean of the GW School of Medicine and Health Sciences.

“Snail appears to be a key player in coordinating these responses, opening up promising possibilities for treatments that can minimise damage and enhance recovery from neurological injuries.”

This study identified for the first time a special group of microglial-like cells that produce Snail. Microglial cells are found in the central nervous system. The researchers found that lowering the amount of Snail produced after an injury results in inflammation and increased cell death. During this process, the injury worsens and there are fewer connections or synapses between brain cells. In contrast, when Snail levels are increased the outcome of brain injury improves-suggesting this protein can help limit the spread of injury-induced damage.

The research raises questions about whether an experimental drug that affects Snail production could be used to limit the damage incurred after someone suffers a stroke or has been injured in an accident, Miller said.

Additional studies must be done to show that increasing Snail production could curtail injury or even promote healing of the brain.

Miller and his team also plan to study the regulation of Snail in diseases like multiple sclerosis, a disease resulting in damage to the myelin nerve sheath. If drugs targeting Snail could be used to stop that damage, many of the future symptoms of this disease could be eased, he says.

But researchers have years of work to do before new drugs targeting Snail can be tested in clinical trials. The payoff ultimately might be drugs that can lead to accelerated healing for stroke damage, head wounds and even neurodegenerative diseases like dementia.

Source: George Washington University

Categories : Ethics and Law Injury & TraumaTags : Leave a comment

Male Murder Rate is a National Health Priority, say Researchers

On By ModernMedia
Photo by Maxim Hopman on Unsplash

By Daniel Steyn

A study by researchers at the South African Medical Research Council (MRC) recommends that the murder of men in South Africa deserves an urgent national response.

Richard Matzopoulos of the MRC’s Burden of Disease Unit and his team, which included scientists from the UCT School of Public Health, studied postmortem reports from 2017 to compare murders of women and men. Among the factors looked at were cause of death, age, geographic location and whether alcohol played a role.

The study, published in PLOS Global Public Health, found that 87% of people murdered in 2017 were men. The authors note similar percentages in 2009 (86%) and 2000 (84%). 

According to the researchers, this is the first study on male murders in South Africa. Previous studies have focused mainly on femicide (the killing of women). The study focused on 2017 to coincide with the third national femicide study (previous femicide studies were in 2000 and 2009).

The researchers faced challenges getting the paper published in a peer-reviewed journal. Dr Morna Cornell, one of the study’s authors, told GroundUp that men’s health is generally understudied. Cornell believes “we are living in an outdated paradigm which regards all men as powerful and able to navigate health systems etc, and therefore less deserving of care”.

The most common causes of death among male murder victims were sharp stabbings and shootings. For people between the ages of 15 and 44, rates of male murders were more than eight times higher than female murders. The Western Cape has the biggest gap between male and female victims: for every female killed, 11.4 men were killed.

Male murders peaked over December and weekends, suggesting the role alcohol plays.

The study aims to challenge the idea that men are “invulnerable”.

“The fact that men are both perpetrators and victims of homicides masks the strong evidence that men are extremely vulnerable in many contexts,” the study reads.

Murder in South Africa is concentrated in poor neighbourhoods where the effects of poverty and inequality are most significant. According to the study, “violence has been normalised as a frequent feature of civil protest and political discourse”.

High levels of firearm ownership and imprisonment also contribute to violence in South Africa.

“Men are socialised into coping by externalising through anger, irritability, violence against intimate partners and others, and increased engagement in risk-taking behaviours. This, alongside the high levels of violence to which males are exposed across [life], [causes] a continuous, and often intergenerational cycle of violence,” the study says.

While the study acknowledges that “violence against women is endemic in South Africa, with rates almost six times the global figures”, it argues that “men’s disproportionate burden of homicide has not resulted in targeted, meaningful prevention”.

Interventions recommended by the researchers include stricter control of alcohol and firearms, programs to address societal norms that drive physical violence, and efforts to overcome the root causes of poverty and inequality.

Professor Richard Matzopolous, the main author of the study, told GroundUp that more research is needed to understand risks and interventions, especially in a South African context.

“Phase 2 of this study will explore victim/perpetrator and situational contexts,” said Matzopolous.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Categories : Cancer Medical Research & TechnologyTags : Leave a comment

Study Exposes Opportunities for Strengthening Cancer Drugs Trials in China

On By ModernMedia

Of more than four hundred phase 2 and 3 randomised trials of cancer drugs registered in China between 2016 and 2017, about sixty had suboptimal control arms

Photo by Rodion Kutsaiev on Unsplash

More than one-eighth of the randomised trials of cancer drugs seeking regulatory approval in China in recent years used inappropriate controls to test the effectiveness and safety of the drugs, according to a new study published December 12th in the open access journal PLOS Medicine by Professor Xiaodong Guan of Peking University, China, and colleagues.

In randomised trials, patients are assigned to either a control arm, in which they receive the current optimal treatment, or an experimental arm, in which they receive the new drug being tested. However, studies have previously found that control arms in cancer clinical trials (including in the United States) are not supported by relevant guidelines, instead using treatments other than the standard-of-care. Adopting a suboptimal control group may bias a study’s results in favour of the experimental arm, potentially exposing patients to substandard therapy and producing unreliable results of clinical efficacy.

In the new study, researchers analysed the control arms of 453 Phase II/III and Phase III randomised oncology trials authorised by Chinese institutional review boards between 2016 and 2021, supporting investigational new drug applications of these drugs in China.

Overall, 60 trials (13.2%) used suboptimal control arms. Of those suboptimal trials, 35 (58.3%) used comparators that were not recommended by a prior guideline. In total, 18 610 people enrolled in clinical trials (15.1% of the total number in all samples trials) were exposed to suboptimal treatments due to the control arms. Trials using suboptimal controls were more likely to report a positive result for the experimental arm. In addition, the researchers found an overall upward trend in the number of trials using inappropriate control arms.

“Trial sponsors, ethical review boards, and oncologists should make collaborative efforts to protect patients from unnecessary harm and drugs with uncertain clinical benefits over the existing standard of care,” the authors say. “Regulatory agencies should be cautious when reviewing investigational new drug applications whose supporting trial used a suboptimal control.”

The authors add, “This research highlights the necessity to refine the design of randomised trials to generate optimal clinical evidence for new cancer therapies. In November 2021, China issued the Guidance on Clinical Value-Oriented Oncology Drug Research and Development, aiming to promote a better generation of clinically relevant novel oncology drugs in China. We hope our research findings can provide empirical evidence to the stakeholders and draw regulators’ attention to this matter so that the guideline can be delivered in the manner that it set out to be.”

Provided by PLOS One