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In April 2020, the American Food and Drug Administration (FDA) approved the use of a new drug to treat breast cancer with metastases.
Breast cancer is the most common type of cancer among women. It kills over 500,000 people every year. The survival rate varies greatly by region: while it exceeds 80% in high-income countries, it is below 40% in third world countries. Tumours in later stages prone to metastasis are particularly dangerous.
The drug, which was created in the USA, stops the development of the disease in 33 women out of 100. Learn more about the new cure for breast cancer with metastases in this article.
In 2020, over 700 cancer drugs are in the late stages of research. This is a long and time-consuming process, as a result of which scientists are creating increasingly sophisticated cancer control methods.
FDA approval is a reliable confirmation that the product is safe and effective in use. In countries with advanced medicine, only treatments that have been approved by reputable organizations, such as the FDA or EMA, may be used.
Tukysa, also known as tucatinib, is a new FDA approved drug that will be used in combination with chemotherapy to treat HER-2 positive breast cancer with metastases. Stage 4 is considered a severe form of cancer which cannot be removed by surgery alone. In patients in the last stages of breast cancer, metastases often spread to the brain. Tucatinib gives patients the chance to extend and improve their quality of life.
The new drug is a type of targeted therapy. It is a group of drugs that target specific molecules on malignant cells. Targeted drugs weaken cancer symptoms and increase the effectiveness of chemotherapy, so they are taken simultaneously.
Before that, there were already targeted drugs that specialize in the treatment of HER-2 positive breast cancer. However, the creation of a new drug has another advantage – patients now have a wider choice of medicines. If the cancer is resistant to one drug, the doctor will be able to prescribe a replacement. Also, compared to other similar drugs, Tukysa causes fewer side effects and is more effective against metastases.
The drug is intended for patients who have already undergone one or more chemotherapy courses. In the future, doctors plan to test the effectiveness of Tukysa after the operation to prevent metastases.
In response to the coronavirus epidemic, the FDA has accelerated the drug approval process. Doctors understand that cancer patients are a vulnerable group. So the drug was released 4 months earlier than planned to help as many people as possible.
What is HER-2 positive breast cancer?
HER-2 positive breast cancer is a type of breast cancer that produces an increased amount of HER-2 protein in the body. It promotes the growth of cancerous cells. About 20% of breast cancers are this type of cancer.
HER-2 is a vital protein in the body that is responsible for cell growth and reproduction. In a normal cell of the body, there is one pair of the gene of this protein. However, in cancer-affected tissues, there is much more of this protein, which causes them to begin to divide uncontrollably. Tumours formed by the HER-2 protein are particularly aggressive. They are resistant to chemo- and hormonal therapy.
More than 25% of women with HER-2 positive breast cancer experience metastases in the brain.
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How did the research go?
In December of 2019, the results of the study were published, which confirmed the effectiveness of Tukysa in treating breast cancer.
The study involved 612 patients with HER-2 positive breast cancer in late stages. Half of them had brain metastases. All women were treated with the same chemotherapy regimen. 67% of the patients took Tukysa, and the rest took placebo pills. In this way, the doctors made sure that the effect came from the medicines, not from the patients’ expectations.
What tests do I need to complete before I can take Tukysa?
To prescribe the drug, the HER-2 status of the tumour must first be confirmed. In foreign clinics, two tests are most commonly used for this purpose:
IHS (Immunohistochemistry)
This test stains HER-2 proteins. The result shows a protein amount between 0 and +3. If the test gives a value of 0 or +1, the cancer is considered HER-2 negative. +3 is a positive result and +2 is considered borderline and requires additional testing.
FISH (Fluorescent Hybridization in Scintu)
The FISH test uses special markers that are light up upon joining HER2 proteins. This test is more expensive and time-consuming but gives a more accurate result.
If the HER-2 positive status is confirmed, the attending physician may consider prescribing tucatinib. A liver function test is also necessary before starting the course. It is usually based on a blood test and can be used to check many organ function indicators at once.
The effectiveness of Tukysa in treating breast cancer
During the first year of treatment, in 33.1% of the patients, cancer stopped progressing. For comparison, in the group that did not take Tukysa, this figure was half as low – 12.3%.
The two-year survival rate in patients with HER-2 positive cancer at advanced stages is 44.9%. Without it, it is 26.6%.
In 25% of the subjects, the brain metastases stopped spreading. This effect was absent in the placebo group.
Tukysa increases life expectancy by 21.9 months, which is 4.5 months more than with other treatments.
For the HER-2 positive breast cancer in late stages, these are very inspiring results. Potentially, this cure can give hope for healing to thousands of women.
Side effects of Tukysa
The most common side effect in patients taking Tukysa is diarrhoea. If it occurs, doctors prescribe anti-diarrhoea medicines. If the symptom cannot be controlled by the medication, the doctor may reduce the dosage or stop the course. Also, Tukysa may have toxic effects on the liver. Therefore, patients who take this medicine should have their organ checked every three weeks.
Tucatinibis shouldn’t be taken by pregnant and breastfeeding women.
At which clinics can I get Tukysa?
Since the drug was developed in the U.S., it will be the first to go to American hospitals. However, the price of treatment in this country is one of the highest in the world. For medical tourists, there is an alternative – hospitals in Europe and the Middle East, which work closely with the USA. In them, this medicine will be available earlier:
Resume
One in five women is diagnosed with HER-2 positive breast cancer. This type of oncology is particularly aggressive and hard to treat with chemotherapy or hormones.
25% of women with HER-2 positive breast cancer have metastases in their brains.
Tukysa/tucatinib is a new type of targeted therapy for HER-2 positive breast cancer.
Tukysa doubles the effectiveness of chemotherapy and stops the spread of metastases.
The two-year survival rate of patients who take Tukysa increases from 22.6% to 44.9%.
If you want to make an appointment with a breast cancer specialist at a foreign clinic – leave your application by clicking the “Get a free consultation” button on the MedicGlobus website. Our specialists will help you with the choice of clinic and organization of treatment.
