Triple-drug therapy TRIPLES survival rate of advanced breast cancer

Hopes have today been raised for thousands of patients battling terminal breast cancer following a drug breakthrough.

Giving incurable patients a cocktail of three drugs can extend their lives by almost five months, a study found. 

Results also showed 34 per cent of patients who took tucatinib alongside Herceptin and Xeloda did not see their disease get worse within a year.

In comparison, the rate was just 12 per cent for HER2 positive breast cancer patients given a placebo to take with the two drugs. 

And the three-drug combination was proven to keep the disease at bay in patients whose tumours had spread to their brain, when it is incurable.

Researchers said more effective treatments are needed at this stage of cancer, and said tucatinib is a promising avenue. 

Scientists found giving some breast cancer patients another medication to take alongside two existing drugs can extend their lives by almost five months

The findings were published in the prestigious New England Journal of Medicine.

HER2 positive breast cancer accounts for around one in five cases of the disease, which strikes 55,200 each year in the UK and 268,600 American women.

The tumours tend to be more aggressive than other types. An abnormality in the HER2 gene causes cells to grow and multiply at a rapid rate.

Survival rates are considered good – almost 100 per cent of patients diagnosed with breast cancer early are expected to live at least five years.

This drops to just 22 per cent in those at the metastatic stage, which isn’t considered curable. Treatment is used to extend life, but may stop working. 

The trial involved patients across the globe, whose disease was advanced and had already been treated with multiple medicines.

The triple-drug combination includes trastuzumab (Herceptin), capecitabine (Xeloda) and tucatinib, an experimental drug

The triple-drug combination includes trastuzumab (Herceptin), capecitabine (Xeloda) and tucatinib, an experimental drug

It was led by the Dana-Farber Cancer Institute in Boston, and involved clinics in the UK, such as The Royal Marsden NHS Foundation Trust.

In the first branch of the research, 480 patients were randomly assigned to receive either tucatinib, which has not been branded yet, or a placebo.

All of the patients were already taking both capecitabine (Xeloda) and trastuzumab (Herceptin).

The average length of time patients in the tucatinib group survived without their disease getting worse was 7.8 months.

WHAT IS THE DRUG COMBINATION? 

The triple-drug combination adds tucatinib to an already existing double-drug combination of capecitabine and trastuzumab.

These two drugs are marketed as Xeloda and Herceptin, respectively. 

  • Herceptin can help control the growth of cancer cells that contain high amounts of human epidermal growth factor receptor 2 (HER2). It blocks the effects of HER2 and encourages the immune system to attack and kill the cancer cells. It may be used to treat breast, oesophageal or stomach cancer that is HER2 positive.
  • Xeloda is a type of chemotherapy drug called an anti metabolite. The body changes the drug into a common chemotherapy drug called fluorouracil. It stops cells making and repairing DNA, which cancer cells need in order to grow and multiply. It is used for colon or rectal cancer, metastatic breast cancer and many others.
  • Tucatinib is a drug being researched. Its safety and efficacy have not yet been established. It inhibits HER2.

In comparison, the placebo group lived for around 5.6 months before their disease progressed.

In the second arm of the study, Dr Eric Winer and colleagues looked at 291 patients whose cancer had spread to their brain.

Results showed the risk of death or disease progression was 52 per cent lower in the tucatinib-combination group.

After one year, 24.9 per cent of patients in the tucatinib-combination group had not seen their disease progress, compared to none given the placebo.

Overall, 45 per cent of patients in the tucatinib-combination group survived for two years after treatment – at an average of 21.9 months.

In contrast, the rate was just 26.6 per cent in the patients who were given a placebo – at an average of 17.4 months.

Side effects, such as diarrhoea, nausea, fatigue, vomiting, decreased appetite and headaches, weren’t considered too severe for those taking tucatinib.

Co-author Dr Alicia Okines, oncologist at The Royal Marsden NHS Foundation Trust, said the findings were significant because they showed ‘genuine benefit’.

She said: ‘We found tucatinib was more likely to shrink the tumour, and saw evidence that it was able to stem the progression of the disease for longer than in the placebo group. Most importantly it showed women who received the tucatinib lived a number of months longer.

‘Sadly many women with HER2 positive advanced breast cancer will see it spread to the brain during the course of their illness.

‘Usually this is treated with radiotherapy, sometimes requiring repeat treatments. There is however a limit to the amount of radiotherapy that can be safely delivered to the brain, and so we need more treatments that can penetrate brain disease more effectively.

‘In our trial we found that the combination of drugs with tucatinib was significantly effective at controlling the disease in the brain.’

A 59-year-old woman involved in the study praised the drug for keeping her cancer ‘in check’.

Linda, who didn’t share her last name, was diagnosed with the HER2 positive form of the disease in 2004.

Despite being in remission for 10 years following successful treatment, her cancer returned.

Linda, from Essex, was then offered the opportunity to go onto the trial at The Royal Marsden. So far, her disease has not progressed further.

She said: ‘Thankfully it’s kept my cancer in check. I still come in for regular scans and treatment, but otherwise have been able to get on with my life.’      

WHAT IS BREAST CANCER, HOW MANY PEOPLE DOES IT STRIKE AND WHAT ARE THE SYMPTOMS?

Breast cancer is one of the most common cancers in the world. Each year in the UK there are more than 55,000 new cases, and the disease claims the lives of 11,500 women. In the US, it strikes 266,000 each year and kills 40,000. But what causes it and how can it be treated?

What is breast cancer?

Breast cancer develops from a cancerous cell which develops in the lining of a duct or lobule in one of the breasts.

When the breast cancer has spread into surrounding breast tissue it is called an ‘invasive’ breast cancer. Some people are diagnosed with ‘carcinoma in situ’, where no cancer cells have grown beyond the duct or lobule.

Most cases develop in women over the age of 50 but younger women are sometimes affected. Breast cancer can develop in men though this is rare.

The cancerous cells are graded from stage one, which means a slow growth, up to stage four, which is the most aggressive.

What causes breast cancer?

A cancerous tumour starts from one abnormal cell. The exact reason why a cell becomes cancerous is unclear. It is thought that something damages or alters certain genes in the cell. This makes the cell abnormal and multiply ‘out of control’.

Although breast cancer can develop for no apparent reason, there are some risk factors that can increase the chance of developing breast cancer, such as genetics.

What are the symptoms of breast cancer?

The usual first symptom is a painless lump in the breast, although most breast lumps are not cancerous and are fluid filled cysts, which are benign. 

The first place that breast cancer usually spreads to is the lymph nodes in the armpit. If this occurs you will develop a swelling or lump in an armpit.

How is breast cancer diagnosed?

  • Initial assessment: A doctor examines the breasts and armpits. They may do tests such as a mammography, a special x-ray of the breast tissue which can indicate the possibility of tumours.
  • Biopsy: A biopsy is when a small sample of tissue is removed from a part of the body. The sample is then examined under the microscope to look for abnormal cells. The sample can confirm or rule out cancer.

If you are confirmed to have breast cancer, further tests may be needed to assess if it has spread. For example, blood tests, an ultrasound scan of the liver or a chest x-ray.

How is breast cancer treated?

Treatment options which may be considered include surgery, chemotherapy, radiotherapy and hormone treatment. Often a combination of two or more of these treatments are used.

  • Surgery: Breast-conserving surgery or the removal of the affected breast depending on the size of the tumour.
  • Radiotherapy: A treatment which uses high energy beams of radiation focussed on cancerous tissue. This kills cancer cells, or stops cancer cells from multiplying. It is mainly used in addition to surgery.
  • Chemotherapy: A treatment of cancer by using anti-cancer drugs which kill cancer cells, or stop them from multiplying
  • Hormone treatments: Some types of breast cancer are affected by the ‘female’ hormone oestrogen, which can stimulate the cancer cells to divide and multiply. Treatments which reduce the level of these hormones, or prevent them from working, are commonly used in people with breast cancer.

How successful is treatment?

The outlook is best in those who are diagnosed when the cancer is still small, and has not spread. Surgical removal of a tumour in an early stage may then give a good chance of cure.

The routine mammography offered to women between the ages of 50 and 70 mean more breast cancers are being diagnosed and treated at an early stage.

For more information visit breastcancercare.org.uk or www.cancerhelp.org.uk

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