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Breast cancer: SUS incorporates drug that reduces risk of metastasis

It was published earlier this week on Official Diary of the Union, an ordinance that incorporates the drug trastuzumab emtansine, or TDMI-1, into the SUS (Sistema Único de Saúde). The substance has been used for the treatment of breast cancer in Brazil since 2014, when it received approval from the National Health Surveillance Agency (Anvisa).

The drug does not cause some of the side effects associated with cancer treatment, such as hair loss, but it does require care. There is still no information on when the item will reach the public health network.

TDMI-1 is indicated for advanced cases of a type of cancer called HER2-positive, in which cancer cells have high levels of the HER2 protein and tend to spread more quickly.

According to the Ministry of Health, the medication was evaluated by the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec), which advises the portfolio regarding the incorporation, exclusion or alteration of health technologies by the SUS.

The cases in which there is amplification of the protein correspond to between 20% and 30% of invasive breast tumors, and the differential of the drug trastuzumab emtansine is its direct action on the HER2 protein. According to oncologist Laura Testa, who is a member of the Breast Tumors Committee of the Brazilian Society of Clinical Oncology (SBOC), it is a compound called drug-antibody conjugate.

“It is an anti-HER2 antibody, which will specifically bind to this protein and has a chemotherapeutic conjugate. This substance applied directly into the vein is very toxic, but together with the antibody it is delivered directly to the cell that is expressing HER2”, explains. Once in the cancer cell, it inhibits the production of a protein necessary for that cell to continue replicating.

When is the drug used?

There are two scenarios in which patients may benefit from using TDMI-1. The first occurs when other types of medication have not been able to stop the progression of the disease, which has spread in a process called metastasis. The other comprises cases in which, after chemotherapy and surgery, there is still residual disease and risks of possible metastasis.

According to the oncologist, the treatment usually has good tolerance levels. “Patients usually have good disease control and end up having fewer side effects than chemotherapy, for example. And for patients with post-neoadjuvant residual disease, it really reduces the risk of metastasis in the future”, she explains.

For Michelle Samora, oncologist at HCor, “it is very important that we have a drug in the SUS that, when it is proven that chemotherapy in the initial scenario was not able to eliminate the tumor, has a more potent drug so that the we increase the chance of improvement for this patient”.

Studies show that the chances of disease recurrence in people who have not been treated with TDMI-1 are up to 50% higher than in people who have been treated with other HER2 inhibitors.

Trastuzumab emtansine was the first with its mechanism of operation approved in Brazil. Since its registration, other drug-antibody conjugates on the market have demonstrated even greater response levels, but all remained restricted to supplementary health.

“The late incorporation into the SUS equates the treatment of SUS patients with what supplementary health patients have access to today. It was something that was lacking”, says Laura.

The technology does not cause some of the side effects associated with cancer treatment, such as hair loss, but requires careful monitoring by medical staff. Among the risks are a decrease in platelets, anemia and disorders in the functioning of the liver. “In some cases, it is also necessary to control the pressure, in addition to having the neuropathy (damage to the nerves) that we know is associated with the use of medication”, Michelle lists.

Currently, people with HER2-positive breast cancer who are treated by the SUS are treated with chemotherapeutic agents and trastuzumab, an anti-HER2 compound made up of part of the trastuzumab emtansine molecule and indicated for early stages of the disease.

Breast cancer in numbers

The World Health Organization (WHO) considers breast cancer a global public health problem and estimates that, in 2018, 627,000 women worldwide died as a result of the disease, whose incidence tends to increase with the aging of the population.

In Brazil, according to information from the Ministry of Health, the total number of new diagnoses per year reaches 60,000 – an incidence rate of 60 cases per 100,000 inhabitants. In 2018, the country was fourth in number of cases and fifth in mortality.

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