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Breast cancer patients face ‘postcode lottery’ for new drug

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Breast cancer patients in Scotland face a postcode lottery that could limit access to two newly approved NHS treatments.

The Scottish Medicines Consortium has approved Elacestrant and Capivasertib, which could be life-extending for some people with metastatic breast cancer.

Eligibility depends on genetic testing to confirm gene mutations before treatment can be prescribed, but the necessary testing is not yet available through the NHS in Scotland.

The testing is available to patients in England and to those able to pay for it privately.

Claire O’Donnell, who was diagnosed with metastatic breast cancer at 37, has raised concerns about the difference in access.

Ten years after her diagnosis, O’Donnell is receiving a treatment that works for her but does not know when it may stop being effective.

She said: “I know how lucky I am. It’s certainly not been easy but I’m incredibly lucky and incredibly privileged to be in that position.

“I’ve watched a lot of my friends die, and a lot of the circumstances has been about not being able to access a drug or getting the drug too late or being too poorly by the time the drug becomes available to them. It makes me angry, and it makes me sad.”

O’Donnell, who has been supported by secondary breast cancer charity Make 2nds Count, is frustrated by the gap in care for patients in Scotland.

She said: “These drug are a lifeline to people. It makes all the difference, and it only takes one drug to be your drug that you know can give you six months a year, two years, five years. It’s almost like they’ve given you a bit of good news, but they’ve also put a little bit of a criteria on it that you know they dangle the carrot in front of you.”

David Cameron, professor of oncology at Edinburgh University and chair of trustees for Make 2nds Count, said the system needed improving to better support patients.

He said: “It’s a frustration for many of us in the clinic because for a long time we’ve been saying as we move into an era of medicines, not just cancer medicines, but medicines that are increasingly driven by special tests, we need a system which absolutely locks the two things together.

“There has been progress in that direction, but they’re not locked together. this comes down to the way the NHS is in a sense fragmented internally.”

Health secretary Angela Constance said: “I welcome the acceptance of Elacestrant, known as Korserdu, for treatment of post-menopausal women, and men, with a certain type of advanced breast cancer.

“We work closely with the independent SMC and the NHS in Scotland to improve access to new medicines, helping to expand the range of treatment options available.

“We are aware that a genomic test is needed in order to access this therapy, and we are working in collaboration with the NHS and industry partners to secure access to this as soon as possible.”

Diagnosis

Trust to decide how far back to review unnecessary breast cancer surgeries

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A health trust will decide how far back to review breast cancer cases after more than 30 women were found to have undergone unnecessary surgery.

It has already been established that hundreds of patients came to harm during treatment at the breast unit at County Durham and Darlington Foundation Trust (CDDFT).

The trust has apologised and is using specialists from other hospitals to review cases to see if other women underwent unnecessary operations or received otherwise poor care.

An extraordinary trust board meeting in Durham will consider the scope of its Look Back Exercise.

Board papers recommend reviewing cases as far back as 2015, working backwards one year at a time.

Documents estimate that this could take five years and involve reviewing the care of approximately 4,500 patients.

Members of the Pink Justice Network, an online support group for women who have received breast cancer treatment from the trust, will attend the meeting.

Nadeen Lister, who runs the group of around 150 women with Amelia Green, said members were calling for a public inquiry into what went wrong.

Lister told the Press Association: “When we started the group, nobody was talking about compensation, they just wanted justice for what has been done.

“The Look Back Exercise has cost the trust more than £500,000 this year, with staff checking back over records, medical experts reviewing cases and psychological help offered to patients affected.”

Green said the trust could avoid the expense of the exercise “by backing our call for a public inquiry”.

Hayley Collinson, of Hudgell Solicitors, which represents many affected patients, said: “Given the scale of harm revealed so far, we can’t see how the Trust board can come to any other decision than to extend this lookback investigation given the findings of the first batch of cases to have been reviewed, and the high percentage of harm being identified.

“The reality is that any woman who had breast cancer treatment at this Trust from 2015 onwards is now going to be questioning whether their treatment was appropriate and if they were actually harmed.”

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New test could cut need for invasive womb cancer checks

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A urine and vaginal fluid test could help rule out womb cancer in women with postmenopausal bleeding, potentially reducing invasive checks.

In a study of 1,864 women with postmenopausal bleeding, the test identified 80 of 99 womb cancers and correctly gave a negative result for 93 per cent of women without the disease.

Researchers said the test was not accurate enough to rule out cancer on its own, but could help fast-track women at the highest risk for urgent investigation while reducing immediate invasive testing for those at lower risk.

Professor Emma Davidson, of the University of Manchester and Manchester University NHS Foundation Trust, said: “Bleeding after the menopause is understandably alarming for women because it can be a sign of cancer, but the vast majority of those investigated will not have the disease.

“At the moment, many women face invasive, uncomfortable tests that can be stressful as well as costly for health services before cancer can be ruled out.

“Our study shows that a simple test using urine and vaginal samples could help identify the women most likely to have cancer while safely reassuring many others much earlier in the diagnostic pathway.

“If further studies confirm these findings in routine practice, this approach has the potential to transform care for thousands of women every year.”

Developed at the University of Manchester and Manchester University NHS Foundation Trust, the test examines cells collected from urine and vaginal fluid samples.

Postmenopausal bleeding currently triggers an urgent cancer referral, although only about 5 to 10 per cent of women who report it have an underlying cancer.

Current investigations include an internal ultrasound scan, a biopsy of the womb lining and hysteroscopy, in which a camera is passed into the womb.

Women taking part in the study attended seven hospitals in north-west England and provided urine and vaginal fluid samples before undergoing their routine tests.

Five per cent of participants, 99 of 1,864 women, were diagnosed with womb cancer through biopsy or surgery.

Cytologists assessed the samples without knowing the women’s diagnoses.

Researchers said the test could be used to triage women suspected of having womb cancer, with lower-risk patients monitored through repeat sampling or given a full assessment if symptoms continued.

They cautioned that the samples were assessed by highly trained specialist cytologists, so it is not yet known whether the same accuracy could be achieved in other settings.

The test has also not been studied in women without symptoms.

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Diagnosis

Targeted nanotherapy shows endometriosis promise

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A targeted nanotherapy reduced endometriosis lesions and pain sensitivity after a single dose in mice, early research has found.

The experimental treatment uses a nanoparticle to deliver an existing drug to immune cells associated with endometriosis.

Researchers hope the approach could eventually lead to a treatment for people with the chronic condition, but it has not yet been tested in humans.

Kanako Hayashi, professor in Washington State University’s School of Molecular Biosciences in the College of Veterinary Medicine and a corresponding author of the research, said: “We found the disease-specific immune cell, and then we had a drug, but we couldn’t target the cell with the drug alone.

“So we used this nanocarrier that delivers the drug specifically to the disease site.”

The Washington State University team developed the therapy after previously identifying a distinct population of macrophages associated with endometriosis. Macrophages are white blood cells involved in immune defence.

They designed a nanocarrier, a specialised molecule used to transport drugs to the disease site, to target these cells without affecting surrounding cells and tissue.

The treatment uses niclosamide, a drug approved to treat intestinal tapeworms that is also being studied for other potential uses, including cancer treatment.

Previous research by the team found that niclosamide could reduce endometriosis lesions. However, the drug has low solubility, meaning large amounts are needed for it to work and limiting how long it can safely be taken.

The researchers engineered a nano-sized molecule called a dendrimer to bond with niclosamide and deliver it in a more soluble form.

In a mouse model, a single injection reduced the size and number of endometriosis lesions as well as sensitivity to pain.

Endometriosis affects roughly 190 million women worldwide and occurs when lesions similar to tissue inside the uterus grow outside it.

Symptoms can include chronic pain, severe cramps, pain during sex and infertility. Hormonal therapies can help manage symptoms but may affect fertility and bone density, while surgery can remove lesions but its effectiveness may be short-term.

Recent research has focused on immune system dysfunction in endometriosis, particularly problems involving macrophages.

The researchers are working with the WSU Office of Entrepreneurship and Innovation as they pursue patenting and commercialisation opportunities and seek support to test the technology in human trials.

Hayashi said: “Although we still need to clear multiple phases, this study is telling us the efficacy is strong, and this nanocarrier is stable, so far, for two weeks—and we think we can go longer.

“The idea is that if it’s stable for a month, you could go to the doctor once a month, get the shot, either IV or muscle injection, and then go home.”

 

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