A NEW ovarian cancer drug which can prolong survival by up to 21 months in women whose disease has relapsed has been licensed for use in the UK following a large-scale clinical trial which included patients in Scotland.

Niraparib is the first new targeted treatment for relapsed ovarian cancer in a decade which can be prescribed to women without the well-known BRCA mutation. In clinical trials it was shown to keep the disease at bay for twice as long as chemotherapy alone, with an average survival time of 9.3 months compared to 3.9 months.

Read more: Warning ovarian cancer symptoms being missed 

Although being a carrier of the BRCA gene mutation elevates a woman's lifetime risk of developing ovarian cancer - 39 per cent of BRCA1 carriers and between 11 and 17 per cent of BRCA2 carriers will develop the disease before they are 70 - the majority of women diagnosed with ovarian cancer do not have either of these mutations.

However, niraparib has also been shown to substantially prolong the lives of patients who do have the faulty BRCA gene - with progression-free survival of 21 months compared to 5.5 months for patients who received chemotherapy on its own.

HeraldScotland: Professor Charlie Gourlay

Professor Charlie Gourlay, chair of medical oncology at Edinburgh University who specialises in gynaecological cancers an oversaw the Edinburgh clinical trial, said: "At this point in time we don't have a drug of this class that we can give to patients without the mutation, and in fact the majority of patients don't have the mutation. So it offers up a new opportunity for some patients that previously wouldn't have had anything."

Read more: New ovarian cancer drug 'dramatically shrinks' tumours

Ovarian cancer is the sixth most common among women in Scotland, with 570 cases diagnosed in 2015 and 349 women losing their lives to the disease.

Survival five years on from diagnosis has substantially improved over the past 20 years and is now 64 per cent among women aged between 45 and 54. However, it still lags behind more common forms of the disease such as breast cancer and has the highest mortality rate of all gynaecological cancers.

It also high a very high recurrence rate, with 85 per cent of patients seeing the disease return. Currently, the only treatment at this stage is chemotherapy, but its diminishes with repeat courses.

Niraparib would be prescribed to women whose ovarian cancer has returned to prolong survival following chemotherapy.

Professor Jonathan Ledermann, director of Cancer Research UK, said: “The risk of recurrence in ovarian cancer is high, and once patients relapse, chemotherapy can no longer eradicate the disease. Giving women as much quality time as possible, free from further chemotherapy, is of key importance.”

For the time being, the drug - which can be taken as a tablet at home, without any need for hospital attendance - will only be available privately or on a limited case-by-case basis on the NHS if oncologists successfully argue that a health board should fund a particular treatment that is not routinely available on the grounds that it would benefit an individual patient.

Read more: Life-extending ovarian cancer drug approved by SMC

Its manufacturer, Tesaro, is expected to ask the Scottish Medicines Consortium next year to approve it for use on the NHS.

Katherine Taylor, chief executive of Ovarian Cancer Action, said: “Today’s news is an encouraging step in the right direction but we now need to ensure all UK women diagnosed with recurrent platinum-sensitive ovarian cancer can benefit. We call upon the National Institute for Health and Care Excellence and the Scottish Medicines Consortium to approve this drug to provide more treatment options for those diagnosed with ovarian cancer - for many women this could be life changing”


ANALYSIS: ‘It’s been shown to prolong the time before disease comes back’

THIS new drug does not offer a cure for ovarian cancer, but it does promise to delay the progression of the disease once it has relapsed for significantly longer than chemotherapy alone.

This is all the more important because, at present, there is no other medication of this kind available to women who are not carriers of the BRCA mutations – in effect, the majority of ovarian cancer patients.

Professor Charlie Gourlay, an oncologist who leads a clinical research team at the Edinburgh Cancer Centre, said: “Usually when patients are treated for relapsed ovarian cancer – which is what this is for – we give chemotherapy. And once we’ve given our six cycles of chemotherapy, then we stop.

But, ultimately, the cancer will come back again.

“What [niraparib] offers is something called a ‘maintenance treatment’. That is, a treatment that you add in order to try to prolong the amount of time until a patient’s cancer relapses.

“It’s been shown in the pivotal study that it will prolong the amount of time before the cancer comes back.

“For people with the BRCA1 and BRCA2 mutation, it will increase that three or four-fold.

“And even in patients without the BRCA mutation, on average it will more than double that.

“The reason why that is important is that, although there is another drug of this type licensed, it’s only for patients with the mutation.”

The incidence of the disease is higher in the UK than the European average.

Five-year survival, although improving, also lags behind Europe, at around 35 per cent overall compared to around 45 per cent in Portugal, Sweden and Finland.

It is not entirely clear why.

Experts at the Target Ovarian Cancer charity previously warned that women in Scotland were visiting their GPs three times on average with symptoms before being referred for the CA125 blood test and an ultrasound, which can detect ovarian cancer.

Part of the issue appears to be that the symptoms – bloating, a distended abdomen, abdominal pain, feeling full quickly or having difficulty eating, or going to the toilet more often – are too often conflated with more common conditions, such as irritable bowel syndrome.

However, other studies have also cited the higher prevalence of obesity and co-morbidities among UK patients for poorer long-term survival, and poorer availability and quality of radical surgery, such as hysterectomies, carried out by gynaecological oncologists on the NHS compared to other countries. There is also the issue of health spending.

The UK spends less of its gross domestic product (GDP) on health than most of its European neighbours – including France and Germany – making it harder to pay for new drugs.

Mr Gourlay added: “It’s true to say that our survival rates are still behind some of the other countries.

“It’s difficult to know whether that is because of our patients potentially presenting later, or whether there’s different biology underlying it. That’s not yet clear.”