BREAST cancer patients in Scotland whose disease has spread to the brain will be able to routinely access a "game-changing" new drug on the NHS for the first time.
Patients with HER2-positive breast cancer - a particularly aggressive form of the disease - who have already received two rounds of targeted treatments can now be prescribed tucatinib, a life-extending medication which should reduce the need for radiotherapy or surgery.
Scottish patients are the first in the UK to have routine access to the drug on the NHS - the first of its kind for Her2-positive patients - following recommendations by the Scottish Medicines Consortium.
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Dr David Cameron, professor of oncology at Edinburgh University who was involved in the drug's clinical trial, said the move "changes the treatment landscape" for breast cancer care in Scotland.
He said: “Despite advances in breast cancer treatment, there remains a significant unmet need for additional effective, life-extending, tolerable therapies for Her2-positive locally advanced or metastatic breast cancer patients.
"Until today, no one in the UK has been able to routinely access the only cancer medicine approved specifically for these patients whose cancer has spread to the brain – a devastating condition that causes significant symptoms and shortens patients’ lives considerably...For the first time, we have a targeted, fully-funded treatment option for Her2-positive patients with advanced or metastatic disease that can significantly extend survival, in those with brain metastases where it can also reduce the risk of further tumours developing.
"This is potentially a game-changing treatment for the many patients who desperately need it,”
The approval follows a pivotal study known as HER2CLIMB which found that tucatinib - taken as two tablets twice daily in combination with the drugs trastuzumab and capecitabine - reduced the risk of death by just over a third (34 per cent), and of disease progression or death by 46%, compared with taking trastuzumab and capecitabine alone.
Overall survival was prolonged by 4.5 months compared to the control.
In patients with brain metastases, the tucatinib combination arm reduced disease progression and risk of death by more than half (52%) and extended overall survival by six months.
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Around half of metastatic Her2 patients will go on to develop cancer in the brain, causing symptoms such as pain, seizures, personality changes, headaches, slurred speech, blurred vision, balance problems and stroke-like symptoms.
By the time brain metastasis is diagnosed, the prognosis is usually little more than a year.
Approximately 40 patients in Scotland are expected to benefit annually from the drug, which can be taken at home.
Tucatinib works by blocking hormone signals, leading HER2-positive tumour cells to die.
Edinburgh mother-of-four Lesley Stephen is among the patients who gave evidence to the SMC following her own experience of Her2-positive breast cancer.
Ms Stephen, now 56, was diagnosed with disease in 2014 aged 48. It had already spread to her liver, lungs and bones.
"I used to joke that my cancer had moved faster than Usain Bolt on a good day, but really this was no laughing matter. I was told I had three-to-four years to live, which was a huge shock," said Ms Stephen, who later discovered that it had also spread to her brain.
She said: "I had 10 sessions of Whole Brain Radiotherapy (WRBT), where your entire brain is blasted by radiation. It isn't painful, but your brain can swell up leaving you nauseous and with terrible headaches."
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Following a family holiday to New York - which Ms Stephen thought would be her last - her oncologist offered her the last available place on a Glasgow clinical trial for tucatinib.
"I took the trial option because I had nothing to lose and had an immediate and very strong response to it," she said.
"I am still on that drug now, over six years on, but with compassionate use access and importantly my brain mets have never come back.
"I have been able to live a fairly normal life with my family for over six years, and been able to experience some of those milestones that I thought cancer had taken away from me - seeing my two eldest go to uni and my youngest go to secondary school. It's been a miracle lifesaver for me."
Jo Taylor, founder of advocacy group MET UP UK, said: “We know up to 50% of patients with metastatic Her2 positive breast cancer go on to develop brain metastases but until now there have been limited targeted drug treatments funded by the NHS for these patients.
"This means there is unmet need in this area for patients with metastatic breast cancer to be treated effectively, especially in difficult-to-treat patients with brain metastases.
"It is therefore great news that patients in Scotland now have access to treatment with tucatinib.”
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