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New blood test could predict if breast cancer will return years before relapse

Researchers could be able to identify patients who go on to relapse by detecting very low levels of cancer found in the blood

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A new type of blood test could predict the recurrence of breast cancer in high-risk patients, months or even years before they relapse, research has shown.

A team from The Institute of Cancer Research, London, used an ultra-sensitive liquid biopsy to detect the presence of tiny amounts of cancer DNA left in the body following treatment for early breast cancer.

The findings, presented at the American Society of Clinical Oncology (ASCO) annual meeting, involved analysing blood samples from the ChemoNEAR sample collection study for circulating tumour DNA (ctDNA) that is released into the bloodstream by cancer cells.

The researchers were able to identify all patients from the study who later went on to relapse by detecting very low levels of cancer found in the blood, known as molecular residual disease.

By helping to spot the patients most likely to relapse, the ICR scientists hope the results will pave the way for a new strategy for treating recurrent breast cancer where treatment can be started much earlier, without waiting for incurable, advanced disease to develop and show up on a scan.

Although previous studies have shown that ctDNA blood tests can identify relapse long before it can be seen on a scan, most tests use a technique called whole exome sequencing (WES) as it focuses on the exons – the protein-coding regions of genes – which are directly related to diseases.

However, the approach in this study involves sequencing the entire genome, known as whole genome sequencing (WGS). This enabled researchers to identify up to 1,800 mutations, which is much more sensitive and includes a larger number of cancer-related changes that could occur in a patient’s DNA.

Blood samples from 78 patients with different types of early breast cancer were screened for ctDNA.

The samples were collected from the women at diagnosis before their therapy, after the second cycle of chemotherapy, following their surgery and every three months during follow-up for the first year. After that, samples were collected every six months for the next five years.

The results showed that detection of ctDNA at any point after surgery or during the follow up period was associated with a high risk of future relapse and poorer overall survival.

Molecular residual disease was detected in all 11 patients who relapsed. The median lead time to clinical relapse in this group of patients was 15 months, an increase of over three months, compared with current tests in all types of breast cancer. The longest lead time to clinical relapse was 41 months.

None of the 60 women in whom ctDNA remained undetected, relapsed throughout the follow-up period.

Author, Dr Isaac Garcia-Murillas, staff scientist in the Molecular Oncology Group at The Institute of Cancer Research, London, said: “Breast cancer cells can remain in the body after surgery and other treatments but there can be so few of these cells that they are undetectable on follow-up scans.

“These cells can cause breast cancer patients to relapse many years after their initial treatment. Ultra-sensitive blood tests could offer a better approach for the long-term monitoring of patients whose cancer is at high risk of returning.

“Most personalised liquid biopsies currently use whole exome sequencing to identify mutations. But this approach goes one step further and uses whole genome sequencing to identify up to 1,800 mutations in a patient’s tumour DNA that could identify recurrence of the patient’s cancer from a blood sample.

“A more sensitive test is very important for this group of early breast cancer patients as they tend to have a very low amount of cancer DNA in their blood.

“This proof-of-principle retrospective study lays the groundwork for better post-treatment monitoring and potentially life-extending treatment in patients.”

Professor Nicholas Turner, professor of molecular oncology at the ICR, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, said: “Testing a patient’s blood for ctDNA will allow clinicians to diagnose the return of cancer at the very earliest stage. However, further research and testing are needed before we can demonstrate whether detecting molecular residual disease could guide therapy in the future.

“The ongoing TRAK-ER trial at The Royal Marsden, for example, is using a different molecular test to identify circulating tumour DNA and predict relapse in ER positive breast cancer patients. This trial is looking at whether relapse in patients with residual disease could be prevented by altering their treatment.”

Professor Kristian Helin, chief executive of the ICR, said: “Breast cancer is much easier to treat before it spreads to other parts of the body, so it is vital to be able to detect signs of recurrence of the disease as early as possible to give people the best chance of survival.

“It is very exciting to see advances in technology that can detect cancer cells and DNA with greater sensitivity to pick up residual disease or detect the early signs of breast cancer recurrence while a cure is still possible.

“These approaches are having a transformative effect on cancer diagnosis. They will help us exploit our knowledge of cancer risk to develop new strategies for targeted screening and detection.”

Dr Simon Vincent, director of research, support and influencing at Breast Cancer Now, which part-funded this study, added: “Early detection is one of our greatest weapons against breast cancer and these initial findings, which suggests new tests could be able to detect signs of breast cancer recurrence over a year before symptoms emerge, are incredibly exciting.

“While this research is still in its early stages, catching breast cancer recurrence earlier means treatment is much more likely to destroy the cancer and stop it spreading to other parts of the body, at which point it becomes incurable.

“With around 11,000 people dying every year in the UK from secondary breast cancer, breakthroughs like these are urgently needed so that we can stop people losing their lives to this devastating disease.”

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‘Groundbreaking’ endometriosis study identifies patient priorities

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A “groundbreaking” study into endometriosis has identified three areas for future research that can help improve the outcomes for women with the condition.

The study, commissioned by Endometriosis New Zealand, attracted 1,262 participants, including 1,024 people with confirmed endometriosis, making it the largest ever study involving endometriosis patients and supporters in New Zealand.

Study participants identified the management and treatment of endometriosis, the need for a better understanding of its cause and improvements to diagnostic capability as the three main priorities for further research.

While these findings provide a clear pathway for future work, Endometriosis New Zealand chief executive, Tanya Cooke, said endometriosis research had historically been underfunded.

“With an estimated 120,000 New Zealanders living with endometriosis, much more needs to be invested into finding solutions,” Cooke explained.

“The reality is the outcomes for many endometriosis patients are pretty poor, with diagnosis often taking many years and treatment patchy across the country.”

Estimates based on Australian data suggest that endometriosis is likely to be costing New Zealand somewhere in the range of $1.3-1.5bn annually through increased healthcare costs and lost workforce productivity.

Cooke said: “The good news is that our findings align closely with those in Australia and provide three clear priorities for future research – improved treatment options, causation and better diagnostic capability.

“What New Zealand now requires is proper funding for a future research programme that can investigate these priorities more closely and improve the outcomes for individuals living with endometriosis.”

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Virtual care platform secures US$46m to address US maternal health crisis

Pomelo Care will use the funding to scale its care model and improve maternal and infant outcomes

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Marta Bralic Kerns, founder and CEO of Pomelo Care

The US virtual maternity care platform Pomelo Care has secured US$46m in funding to address the US maternal health crisis.

One in 10 babies born in the US today start their life in a neonatal intensive care unit.

Healthcare access continues to worsen, with one in eight births occurring in US counties with limited-to-no access to maternal care. Due to significant gaps in postpartum care, about half of pregnancy-related deaths in the US occur after hospital discharge.

The evidence exists for how to identify people at highest risk for complications and which interventions are most effective, but existing data gaps and provider capacity challenges make it difficult to apply these interventions at scale.

Pomelo has developed a care model that aims to address these challenges by analysing claims and health record data to identify individual risk factors and providing virtual pregnancy, postpartum, and infant care to patients to reduce those risks.

“We’ve long known what works to reduce maternal and infant complications,” said Marta Bralic Kerns, founder and CEO of Pomelo Care.

“The questions have always been: can you identify the patients who are at highest risk, can you deeply engage them in care to drive uptake of the prevention strategies we know work, and can you do it in the highest risk populations with the most limited access to care?”

“This data demonstrates that we absolutely can. And with this additional funding, we’ll have the opportunity to scale our care model to more pregnant people across the country.”

The funding, led by existing investors First Round Capital and Andreessen Horowitz (a16z) Bio + Health, is hoped to help Pomelo accelerate its partnerships with payors across the US and increase access to “evidence-based” care.

Josh Kopelman, partner at First Round Capital and Pomelo board member, said: “It’s rare to come across an opportunity where the incentives between patient, provider and payor are all aligned.

“Marta and the Pomelo team have found an incredible opportunity to dramatically improve outcomes for the highest risk populations, while helping payors reduce their avoidable costs.”

Vineeta Agarwala, general partner at a16z Bio + Health and Pomelo board member, added: “Pomelo is one among a small set of health tech companies that have earned true scale.

“This scale is evident in our partnerships with major Medicaid and commercial plans covering over three million lives, which create the opportunity to collaborate with OB providers, labour and delivery wards, and NICUs nationwide, while serving hundreds of thousands of expecting mothers and newborns with high quality, technology-enabled care.”

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One in three UK fertility patients seek treatment abroad due to high costs

Expensive fertility treatments prompt UK patients to seek help abroad

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One in three fertility patients in the UK seek treatment abroad due to high costs, a new survey has shown.

Fertility Family has gathered insights from 429 UK participants who have experienced difficulties with infertility.

The Infertility Awareness Report found that the high cost of fertility treatment in the UK has driven over one in four people to spend over £10,000 on both treatments and investigative procedures.

The research showed around 35 per cent of people struggling with infertility have considered seeking fertility treatment abroad due to the prospect of lower costs.

Of those seeking fertility treatment in a foreign country, however, only 14 per cent believed that clinics abroad have a higher success rate.

Of those actively trying to conceive almost one in five have used their life savings in the pursuit of having a child, whilst 25 per cent have paid for their fertility treatments using a credit card.

Dr Gill Lockwood, consultant at Fertility Family, said: “While we tend to cast our gaze on women when it comes to infertility, case studies have shown that infertility can impact both women and men in similar ways. However, women have been observed to seek help more than men.

“Although the psychological struggles of infertility can be overwhelming, many patients ultimately reach some type of resolution. Some of the alternatives include becoming parents to a relative’s children, adopting children, or deciding to adopt a child-free lifestyle.

“Needless to say, this resolution is usually psychologically demanding, and patients may feel forever impacted by the experience of infertility.”

A combination of fertility struggles and accessible healthcare have impacted people across the UK significantly, with one in two admitting to feeling “ashamed” due to their difficulties trying to conceive.

A further 31 per cent reported feeling that other people think “less” of them due to their fertility struggles, showcasing the need for better mental health support.

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