A breast cancer drug that can melt away tumours in weeks has been given the green light for NHS patients in Scotland – raising hopes that health chiefs across the rest of the UK will soon follow suit.
There was deep disappointment among experts and patient groups last October when England’s prescribing watchdog, the National Institute for Health and Care Excellence (NICE), failed to recommend the medication, tucatinib, even though it has shown huge promise for women with advanced HER2-positive breast cancer – a form of the disease that is difficult to treat.
It raised concerns over the method of studying the drug.
The Scottish Medicines Consortium said last week that they would finance the two-daily pills for cancer patients who failed to respond to all other treatments and have seen their cancer returns.
This decision was made just days after the release of new trial data showing that trastuzumab and chemotherapy combined with tucatinib held the disease back for longer periods and increased survival rates.
Importantly, the drug, also known by the brand name Tukysa, has been shown to be highly effective in targeting tumours that appear in the brain – and experts are now studying whether giving the tablets to women with early-stage HER2-positive breast cancer might prevent the disease from ever spreading there, as it does in half of cases.
Dr David Cameron, professor of oncology at Edinburgh University who was involved in the drug’s clinical trial, said: ‘This is potentially a game-changing treatment for the many patients who desperately need it.’
One woman who benefited from tucatinib said she agreed to take the drug as part of a trial ‘because I had nothing to lose’ after other treatments failed to work.
Lesley Stephen, a mother of four, was diagnosed in 2014 with HER2-positive breast carcinoma at 48. It had spread to her liver, bones and lungs.
One year later, she had brain tumours. Although they were cleared by chemotherapy and radiotherapy, the cancer returned in her lungs.
Mother-of-four Lesley Stephen benefited from tucatinib and said she agreed to take the drug as part of a trial ‘because I had nothing to lose’ after other treatments failed to work
Following a family holiday to New York that Lesley thought would be her last, as she said doctors had told her ‘to get my affairs in order’, 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.
‘At the start, scans of my lungs showed white splodges – tumours – everywhere. The scene looked almost like a Jackson Pollock picture.
‘After three weeks, they had disappeared. There was some scarring left, but it was like the tumours had melted away.’
Communications consultant Lesley, who lives in Edinburgh with husband Doug, 50, a human resources director, added: ‘I am still on that drug now, over six years on, and the tumours in my brain 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 university and my youngest go to secondary school. It’s been a miracle lifesaver for me.’
Breast cancer is diagnosed in approximately 55,000 Britons each year. Most of these are women over 50.
Most women are able to live for at least 10 years with positive treatment.
One in five patients has breast cancer, which is characterized by excess levels of the protein involved in cell proliferation called HER2.
These tumors are known as HER2-positive and have three times the chance of spreading to other areas of the body than other types of breast cancer.
Half of the HER2-positive women develop brain tumors.
To add to this, even if the cancer is initially eradicated, tumours can recur – either in the breast or elsewhere, where they are known as metastases.
Breast cancer is diagnosed in approximately 55,000 Britons each year. Most of these are women over 50. [File image]
Although there are some drugs that can help these patients, the results are usually short-lived and they often run out of options in a matter of months.
A major step forward in treatment for HER2-positive patients came in May last year, with the approval of trastuzumab deruxtecan, or Enhertu, a drug that boosted the time the cancer was held at bay from seven months to over two years – results that were called ‘mind-blowing’ by experts.
Peter Schmid from the Barts Cancer Centre, Professor of Cancer Medicine, stated that Tucatinib represents another breakthrough.
‘Trastuzumab deruxtecan was a major move forward for patients with incurable HER2-positive breast cancer, but eventually it does stop working,’ he said.
‘Tucatinib gives us an additional treatment to help us control the disease for a bit longer, and keep patients well so they can live their lives.’
He added: ‘The big hope now is that giving tucatinib to patients with early-stage HER2-positive breast cancer could prevent brain metastases from ever forming, and trials are under way to find out.’
Tucatinib, a drug that is part of the tyrosinekinase inhibitions or TKIs class, works by blocking certain chemicals which help cancer cells divide and grow.
Lesley said at the start of her treatment she saw coloured ‘splodges’ all over her lungs ‘like a Jackson Pollock painting’ until she started using tucatinib
Following a study called HER2CLIMB that found that tucatinib combined with trastuzumab (and chemotherapy drug capecitabine) reduced the risk for death by almost a third, and increased the likelihood of developing disease by 46%, respectively, compared to taking only trastuzumab or capecitabine.
This was true regardless of whether patients were suffering from brain tumours.
Lesley, who is mother to Finn, 21, Alex, 20, Archie, 17, and Evie, 13, describes the drug’s effect as ‘absolutely extraordinary’, adding: ‘Before taking it, I was so breathless because of the tumours in my lungs I could barely walk up stairs.
‘Now I’m living a pretty normal life. It’s vital that all women in the UK who need it can get it.’
NICE will make its final decision about tucatinib on March 1, and it is possible that this will change previous guidance.
Baroness Delyth Morgan, Breast Cancer Now’s chief executive, said the Scottish ruling was ‘a significant leap forward for women living with incurable HER2-positive secondary breast cancer’ that brought ‘hope to patients who urgently need new, effective options’.
She added: ‘The drug company that makes it, Seagen, and NICE must continue to urgently work together to ensure it can also be recommended for routine use on the NHS in England, so that more patients can benefit.’
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