New drug can help stop certain breast cancer tumours early, trial shows
A trial called Serena-6 shows that camizestrant stops cancer cells from using hormones to grow, which helps patients stay well longer and delays the need for chemotherapy.
It is the first worldwide study to show that using blood tests to find early signs of cancer resistance to treatment helps patients, scientists say.
The study looked at patients who had hormone-positive, HER2-negative breast cancer, which is about 70% of cases.
Results showed patients given camizestrant reduced their chances of cancer progression by 56%, compared with just standard therapies.
Doctors used a simple blood test to spot changes in the cancer's DNA that show whether current treatments might soon stop working.
When they found these signs, some patients were given camizestrant, while others stayed on their usual treatment.
Those on camizestrant had their cancer stay the same and not get worse for much longer, 16 months on average, compared with about nine months for the others.
The drug was safe for most patients but 1% stopped taking it because of side effects.
More than 3,000 patients from 23 countries took part in the study, which was funded by AstraZeneca and co-led by researchers at The Institute of Cancer Research in London.
Co-principal investigator Professor Nick Turner, group leader in molecular oncology at The Institute of Cancer Research, London, said the drug is 'a pivotal moment in breast cancer care'.
Professor Kristian Helin, chief executive of The Institute of Cancer Research said: 'The results of the Serena-6 trial represent more than a clinical milestone, they represent a transformational shift in how we approach precision medicine.'
About 55,000 women are diagnosed with breast cancer in the UK every year and 11,500 will die from the disease, The Institute of Cancer Research said.
The Serena-6 trial results were to be presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago on Sunday.
Dr Catherine Elliott, director of research at Cancer Research UK, said: 'This study is a clear example of how blood tests are starting to transform cancer treatment.
'By tracking tiny traces of tumour DNA in the blood, researchers were able to spot early signs of treatment resistance and switch therapies before cancer had a chance to grow.
'It shows how circulating tumour DNA, or ctDNA, could help doctors make smarter, more timely treatment decisions.
'This approach could become an important part of how we personalise care for people with advanced breast cancer.'
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Scottish Sun
2 days ago
- Scottish Sun
Urgent warning over drug taken by millions – as AstraZeneca accused of ‘misreporting' safety data
Click to share on X/Twitter (Opens in new window) Click to share on Facebook (Opens in new window) MEDICS have raised concerns over a drug taken by millions to prevent heart attacks and strokes, claiming key safety data was "misreported" by its manufacturer AstraZeneca. Anti-clotting pill ticagrelor has been available on the NHS in 2011, after trials appeared to show it could prevent one in five deaths after a heart attack. Sign up for Scottish Sun newsletter Sign up 1 A BMJ investigation has raised concerns over clinical trials that spurred on the approval of ticagrelor, sold as Brilique But an investigation published in the BMJ cast doubt "over the integrity of the clinical trials that underpinned its approval". Ticagrelor is an antiplatelet medicine that prevents blood cells from sticking together and forming dangerous clots. The twice-daily pill is prescribed to patients with acute coronary syndrome who are at greater risk of blood clots due to a history of heart attack, angina or stroke - often in combination with a low dose of aspirin. In the UK, the drug is prescribed around 45,000 times per month on the NHS. Now, experts claim to have uncovered "evidence of serious misreporting" in two clinical trials that were pivotal to the drug's approval in the UK and US. These findings raise "doubts over the approval and decade long use of ticagrelor", sold as Brilique in the UK, the report authors wrote in the BMJ. In response, an AstraZeneca spokesperson told Sun Health: 'We are confident in the integrity of the trials and its evidence in support for Brilique.' Two AstraZeneca studies, known as ONSET/OFFSET and RESPOND, were published in the leading journal Circulation, reporting the drug's effects on platelet function. The ONSET/OFFSET trial involved 123 patients and found that ticagrelor was faster and better at preventing clots than a competitor drug. Similar results were published in RESPOND, which involved 98 patients. Early warning sign of heart attack you may notice in bed But the report authors claimed claimed 'primary endpoint' results in the two key trials - which were pivotal in determining the treatment's effectiveness - were inaccurately reported in Circulation. "We found evidence that the trials were inaccurately reported," they said. "In one instance, AstraZeneca's trial failed to show statistical significance, but was published in a leading cardiology journal as significant." It also said around a quarter of the readings from machines used in the trials were not included in the data sets, the US medicine's regulator, the Food and Drug Administration (FDA) used to approve the drug. In order for ticagrelor to get approved, clinical trials had to prove that it was a better drug than competitors in a phase 3 trial. After phase 3 and drug approval, the FDA and MHRA in the UK, continues monitoring it in phase 4 trials, to see if there are any additional problems with the drug. But the BMJ analysis of two phase 2 trial results found there were instances of patients whose blood "platelet aggregation dramatically increased". This is when blood cells stick together to form clumps, which can lead to blood clots - exactly what the drug aims to prevent. Key facts about ticagrelor Ticagrelor is an antiplatelet medicine that prevents platelets - a type of blood cell - from sticking together and forming a dangerous blood clot. Taking ticagrelor can help prevent blood clots if you have an increased risk of having them because you: Have had a heart attack Have unstable angina Have had a stroke or a transient ischaemic stroke (TIA, or mini-stroke) Ticagrelor is only available on prescription. You'll usually take ticagrelor twice a day and it's often prescribed together with low-dose aspirin at the start of treatment. The main side effects of ticagrelor are getting out of breath and bleeding more easily than normal. You may have nosebleeds, heavier periods, bleeding gums and bruising. According to medicines watchdog the National Institute for Health and Care Excellence (NICE), patients are advised to take the drug twice a day at 90mg for around a year after a heart attack. A lower dose of 60mg, may then be prescribed by doctors for up to a further three years. It may also be taken by those who have suffered a minor stroke or a transient ischaemic attack at 90mg alongside aspirin. Sources: NHS, NICE This is "an improbable effect for an anti-platelet drug" and "suggests an incorrect laboratory reading", the BMJ said. Assessing the readings from platelet machines used at the two trial sites, led by cardiologist Dr Paul Gurbel, investigators also found more than 60 of the 282 readings were not included in datasets submitted to the FDA. "The platelet activity levels not entered were significantly higher than those used in the Circulation papers and FDA datasets," they claimed. "It is unclear whose blood was sampled, and why those measurements did not contribute to data in either trial." The report authors conducted their investigation through interviews with trial investigators and platelet experts and access to the underlying trial data submitted to regulators. They also said that principal investigators involved in ticagrelor trials "were unreachable or declined to be interviewed". "The findings raise even deeper questions over the approval and decade long use of the drug," the authors claimed. Dr Victor Serebruany, an expert in cardiovascular pharmacology at Johns Hopkins University in Maryland, who has been critical of the drug for over a decade said: "It's been obvious for years that there is something wrong with the data. "That the FDA's leadership could look past all these problems- on top of the many problems their own reviewers identified and are now being discovered by The BMJ - is unconscionable. "We all need to know how and why that happened. "If doctors had known what happened in these trials, they would never have started using ticagrelor." But a spokesperson for the Sinai Center for Thrombosis Research and Drug Development, which Dr Gurbel leads, told MailOnline: "Any allegations of any research misconduct in the two studies are baseless and erroneous." Sun Health has also contacted Circulation for comment. The journal did not respond to the BMJ.
The Sun
2 days ago
- The Sun
Urgent warning over drug taken by millions – as AstraZeneca accused of ‘misreporting' safety data
MEDICS have raised concerns over a drug taken by millions to prevent heart attacks and strokes, claiming key safety data was "misreported" by its manufacturer AstraZeneca. Anti-clotting pill ticagrelor has been available on the NHS in 2011, after trials appeared to show it could prevent one in five deaths after a heart attack. But an investigation published in the BMJ cast doubt "over the integrity of the clinical trials that underpinned its approval". Ticagrelor is an antiplatelet medicine that prevents blood cells from sticking together and forming dangerous clots. The twice-daily pill is prescribed to patients with acute coronary syndrome who are at greater risk of blood clots due to a history of heart attack, angina or stroke - often in combination with a low dose of aspirin. In the UK, the drug is prescribed around 45,000 times per month on the NHS. Now, experts claim to have uncovered "evidence of serious misreporting" in two clinical trials that were pivotal to the drug's approval in the UK and US. These findings raise "doubts over the approval and decade long use of ticagrelor", sold as Brilique in the UK, the report authors wrote in the BMJ. In response, an AstraZeneca spokesperson told Sun Health: 'We are confident in the integrity of the trials and its evidence in support for Brilique.' Two AstraZeneca studies, known as ONSET/OFFSET and RESPOND, were published in the leading journal Circulation, reporting the drug's effects on platelet function. The ONSET/OFFSET trial involved 123 patients and found that ticagrelor was faster and better at preventing clots than a competitor drug. Similar results were published in RESPOND, which involved 98 patients. Early warning sign of heart attack you may notice in bed But the report authors claimed claimed 'primary endpoint' results in the two key trials - which were pivotal in determining the treatment's effectiveness - were inaccurately reported in Circulation. "We found evidence that the trials were inaccurately reported," they said. "In one instance, AstraZeneca's trial failed to show statistical significance, but was published in a leading cardiology journal as significant." It also said around a quarter of the readings from machines used in the trials were not included in the data sets, the US medicine's regulator, the Food and Drug Administration (FDA) used to approve the drug. In order for ticagrelor to get approved, clinical trials had to prove that it was a better drug than competitors in a phase 3 trial. After phase 3 and drug approval, the FDA and MHRA in the UK, continues monitoring it in phase 4 trials, to see if there are any additional problems with the drug. But the BMJ analysis of two phase 2 trial results found there were instances of patients whose blood "platelet aggregation dramatically increased". This is when blood cells stick together to form clumps, which can lead to blood clots - exactly what the drug aims to prevent. Key facts about ticagrelor Ticagrelor is an antiplatelet medicine that prevents platelets - a type of blood cell - from sticking together and forming a dangerous blood clot. Taking ticagrelor can help prevent blood clots if you have an increased risk of having them because you: Have had a heart attack Have unstable angina Have had a stroke or a transient ischaemic stroke (TIA, or mini-stroke) Ticagrelor is only available on prescription. You'll usually take ticagrelor twice a day and it's often prescribed together with low-dose aspirin at the start of treatment. The main side effects of ticagrelor are getting out of breath and bleeding more easily than normal. You may have nosebleeds, heavier periods, bleeding gums and bruising. According to medicines watchdog the National Institute for Health and Care Excellence (NICE), patients are advised to take the drug twice a day at 90mg for around a year after a heart attack. A lower dose of 60mg, may then be prescribed by doctors for up to a further three years. It may also be taken by those who have suffered a minor stroke or a transient ischaemic attack at 90mg alongside aspirin. Sources: NHS, NICE This is "an improbable effect for an anti-platelet drug" and "suggests an incorrect laboratory reading", the BMJ said. Assessing the readings from platelet machines used at the two trial sites, led by cardiologist Dr Paul Gurbel, investigators also found more than 60 of the 282 readings were not included in datasets submitted to the FDA. "The platelet activity levels not entered were significantly higher than those used in the Circulation papers and FDA datasets," they claimed. "It is unclear whose blood was sampled, and why those measurements did not contribute to data in either trial." The report authors conducted their investigation through interviews with trial investigators and platelet experts and access to the underlying trial data submitted to regulators. They also said that principal investigators involved in ticagrelor trials "were unreachable or declined to be interviewed". "The findings raise even deeper questions over the approval and decade long use of the drug," the authors claimed. Dr Victor Serebruany, an expert in cardiovascular pharmacology at Johns Hopkins University in Maryland, who has been critical of the drug for over a decade said: "It's been obvious for years that there is something wrong with the data. "That the FDA's leadership could look past all these problems- on top of the many problems their own reviewers identified and are now being discovered by The BMJ - is unconscionable. "We all need to know how and why that happened. "If doctors had known what happened in these trials, they would never have started using ticagrelor." But a spokesperson for the Sinai Center for Thrombosis Research and Drug Development, which Dr Gurbel leads, told MailOnline: "Any allegations of any research misconduct in the two studies are baseless and erroneous." Sun Health has also contacted Circulation for comment. The journal did not respond to the BMJ. How to reduce your risk of heart attacks and stroke You can reduce your risk of heart attack and stroke with many of the same methods. Heart attacks and strokes, although affecting different organs of the body, are both what we call cardiovascular events. Both arise from similar underlying conditions, such as atherosclerosis —a buildup of fatty deposits in the arteries. According to the American Heart Association, the risk factors for heart attacks and strokes are largely the same: high blood pressure, high cholesterol, smoking, obesity, physical inactivity and diabetes. Therefore, addressing these risk factors can simultaneously reduce the risk of both conditions. Here are ways you can prevent the two: Healthy diet More fruit and veg: The DASH, which emphasises fruit, vegetables, whole grains and lean proteins, has been shown to reduce blood pressure and improve heart health. Less fats: Too much saturated and trans fats can raise cholesterol levels and increase the risk of atherosclerosis. Go for healthier fats like those found in olive oil, nuts, and avocados. Limit salt: High salt intake is linked to high blood pressure, a major risk factor for both heart attack and stroke. The NHS recommends no more than 6g of salt per day for adults. Fibre: Foods high in soluble fibre, such as oats and beans, can help lower cholesterol levels. Exercise Walking, running, cycling, swimming - whatever you like, do it! Aerobic exercise can strengthen the heart and improve circulation. The NHS advises at least 150 minutes of moderate-intensity aerobic activity or 75 minutes of vigorous-intensity activity each week. Strength training exercises can help control weight, improve cholesterol levels, and reduce blood pressure. It is recommended twice a week by the NHS. Manage blood pressure Healthy diet and exercise can help keep your blood pressure in check. But it is worth monitoring it yourself after the age of 40, at least, when the NHS invites adults for a check-up every five years. High blood pressure often has no symptoms but significantly increases the risk of heart attack and stroke. Quit smoking One of the best ways to quit smoking is to use resources provided by NHS Smokefree. Support groups, medications, and other tools to help quit smoking such as vapes could be what you need to kick the habit for good - and it's free. Limit booze Excessive alcohol consumption can increase blood pressure and contribute to weight gain, which can snowball and become a heart health risk. The NHS recommends not regularly drinking more than 14 units of alcohol per week.
Daily Mail
3 days ago
- Daily Mail
Top medics issue urgent warning over heart drug taken by millions - as makers AstraZeneca are accused of 'misreporting' safety data
Millions of patients at high risk of a fatal heart attack could be taking a drug that may not even be effective, top doctors have warned. Anti-clotting pill ticagrelor was approved for use on the NHS in 2011 after trials claimed it could prevent one in five deaths after a heart attack. The twice-daily pill, sold as Brilinta, is given to people with acute coronary syndrome —a sudden reduction of blood to the heart—reducing the risk of deadly clots and strokes. Since then, studies have questioned if the AstraZeneca drug is as good as its rivals, such as clopidogrel, with some even suggesting it may even increase the risk of bleeding. Now, experts have discovered 'evidence of serious misreporting' in two clinical trials, pivotal to getting the drug approved in the UK and US, 'raising doubts over its approval'. The BMJ investigation claimed the 'primary endpoint' results—the key measure to determine whether a treatment is effective—for both trials were inaccurately reported in leading cardiology journal Circulation. It also said around a quarter of the readings from machines used in the trials were not included in the data sets, the US medicine's regulator, the Food and Drug Administration (FDA) used to approve the drug. Dr Victor Serebruany, an expert in cardiovascular pharmacology at Johns Hopkins University in Maryland, who has been critical of the drug for over a decade said: 'It's been obvious for years that there is something wrong with the data. Since then, studies have questioned if the AstraZeneca drug is as good as its rivals, such as clopidogrel, with some even suggesting it may even increase the risk of bleeding 'That the FDA 's leadership could look past all these problems—on top of the many problems their own reviewers identified and are now being discovered by The BMJ—is unconscionable. 'We all need to know how and why that happened. 'If doctors had known what happened in these trials, they would never have started using ticagrelor.' In order for ticagrelor to get approved, clinical trials had to prove that it was a better drug than competitors in a phase 3 trial. After phase 3 and drug approval, the FDA and MHRA in the UK, continues monitoring it in phase 4 trials, to see if there are any additional problems with the drug. But the BMJ analysis of two phase 2 trial results found there were instances of patients who's blood 'platelet aggregation dramatically increased'. This is where platelets—a type of blood cell—stick together to form clumps which can lead to blood clots, exactly what the drug aims to prevent. It 'suggests incorrect laboratory readings', the BMJ said. Assessing the readings from platelet machines used at the two trial sites, led by cardiologist Dr Paul Gurbel, they also found more than 60 of the 282 readings were not included in the datasets submitted to the FDA. 'The platelet activity levels not entered were significantly higher than those used in the Circulation papers and FDA datasets,' they claimed. 'It is unclear whose blood was sampled, and why those measurements did not contribute to data in either trial.' A spokesperson for the Sinai Center for Thrombosis Research and Drug Development, which Dr Gurbel leads, said: 'Any allegations of any research misconduct in the two studies are baseless and erroneous.' In the UK, the drug is prescribed around 45,000 times per month on the NHS. According to medicines watchdog the National Institute for Health and Care Excellence (NICE), patients are advised to take the drug twice a day at 90mg for around a year after a heart attack. A lower dose of 60mg, may then be prescribed by doctors for up to a further three years. It may also be taken by those who have suffered a minor stroke or a transient ischaemic attack at 90mg alongside aspirin. The body naturally forms blood clots in order to patch wounds and stop bleeding. But over time, things like age, smoking and excessive weight gain can make blood clots more common. These kinds of clots also become more common after someone has a heart attack or blood vessel disorder, coronary artery disease. When someone overproduces these clots they can clog blood vessels, interrupting blood flow or weakening the walls of blood vessels, causing aneurysms and heart attacks. Circulation and AstraZeneca did not respond to a request for comment from the BMJ. MailOnline has also approached AstraZeneca for comment.
