the The vaccine developed in the country To treat The most dangerous type of skin cancer Given its aggressiveness, it began commercialization after more than a year of regulatory fluctuations. He asked for more Three decades of work From Argentine researchers in this unprecedented development and with a license from the first laboratory in Argentina to produce advanced treatments, such as this immunotherapy.
Its trade name is facsimail It is not a preventive vaccine like orthotopic vaccines, but is intended to treat cutaneous skin cancer In the early stages of the disease (IIB, IIC, and IIIA), with a moderate to high risk of relapse (recurrence of cancer cells). It is not sold in pharmacies, but rather through the department that follows oncology drugs or high-cost drugs by covering every patient. Its use depends on the indication of the oncologist or skin oncologist, once the stage of the tumor has been determined.
The full treatment lasts for two years and the first team to start offering it is Maria Curie Oncology HospitalFrom the city of Buenos Aires, according to what was reported to Nation from Laboratory of Pablo Casarawhich is responsible for producing this first-of-its-kind cell therapy approved for the treatment of intermediate-stage skin cancer.
It is used under medical supervision and in specialized centers, while the laboratory responded that its cost is “comparable” to the cost of the available monoclonal antibody that is “non-specific and has harmful effects.”
Melanoma contains antigens (proteins from a foreign agent that causes the disease and must be recognized by the immune system to eliminate it) that are different from those found in normal cells in the body. But cancer cells develop mechanisms to obstruct the immune system and no one notices them. The 13-dose regimen teaches the body to recognize different tumor antigens through different lymphocyte clones.
“The body begins to create many clones, which begin to recognize different skin cancer antigens: in more than 60% of patients, these clones are sufficient to prevent recurrence of the disease (relapse),” he himself explained to this medium last January. Joseph Mordoha Conicet researcher who, with his team from the Cancer Pathology Laboratory in Leloir Institute FoundationHe led the work that led to the development of this treatment in Sales Enterprise Software and Conicet for more than three decades.
At the time, forecasts estimated that There will be about 1,703 new cases of skin cancer annually (If all stages of the disease are taken into account when making the diagnosis). If all is revealed, 442 will be in the three phases for which the vaccine is approved (17% in IIB and IIC and 9% in IIIA). If so, in the first year, one hundred patients could be started. Early detection is essential for this, with timely consultation to check for skin spots or moles.
The doses were scheduled to be available to health centers in March of last year, which was postponed until July 2024, and was finally completed this month. The official announcement of the market launch was made two weeks ago, at the 74th edition of the Intensive Dermatology Improvement Graduate Course by Prof. Dr. Luis Perini, from Argentine Society of Dermatology (sad). This came during a presentation to Mario MariniProfessor Emeritus of Dermatology at the University of Buenos Aires.
When the dermatologist was asked about the importance of this new treatment option Ana de Pablomember of SAD and vice chair of the department of dermatology at Austral HospitalHe stressed primarily that this does not prevent skin cancer.
“It is not that people have the right to be vaccinated, but in order to treat those patients whose skin cancer (because it was initially a thick cancer or perhaps had some involvement in the lymph nodes) will be at greater risk of developing lesions outside the skin and lymph nodes. This is what we call distant metastasis,” the professional explained. “We know that perhaps, with adjuvant therapy, we can avoid these metastases in the future.”
He stated that there are now two ways to achieve this; One with traditional treatment and the other with the mechanism of action of this vaccine. “What it is trying to do is increase the patient’s immunity to attack cancer cells that could be hidden somewhere in the body,” said De Pablo, co-coordinator of the 32nd National Skin Cancer Prevention Campaign organized by SAD.
He believed that the advantage of this mechanism lies, on the one hand, in that it has “very few general negative effects,” and on the other hand, “even if it fails, there is the possibility of moving to the other line of treatment, which is the line currently used.”
In short, the dermatologist considered the new treatment to be “a new therapeutic weapon that can treat small foci of cells that can be hidden and have not yet been discovered, in patients who have a higher risk of developing malignancy.”
Ana Clara Acosta She is also a member of SAD and co-coordinator of the entity’s national campaign for the prevention and timely detection of skin cancer. She is also the head of the dermatology and oncology department at the hospital Ramos Mejia Hospital. About the vaccine that the National Food, Drug and Medical Technology Administration (Anmat) has just approved to “optimally control” melanoma in patients with a high risk of recurrence/metastasis.
“They are those in which, after analyzing the clinical characteristics, how the cells mutate and many other factors, the tumor is identified and its stages are determined. They may not have metastasis or spread (of cancer cells), but there is a high chance of developing them at some stage of their development,” he described before the consultation.
Acosta said that chemotherapy treatments that were used before “recently have not had a good response,” so, with advances in new therapeutic mechanisms, treatments that aim to allow the immune system to do its job against cancer cells have begun to be used.
“The limitations that the vaccine will impose are a bridge to the future of the study. See, for example, whether it can be linked to some treatment with an immunological approach. Another option would be to increase the pool of patients who would be suitable to receive the vaccine. The professional suggested that they would be patients with metastases in another part of the body.”
He explained that these treatments are what is required Extending life expectancy in those high-risk cases. Before, as mentioned, with usual chemotherapy it was less than two years.
“With immunotherapy, this has changed a lot: today we have patients with high-risk tumors that are under control, and they are doing well after five or ten years of follow-up,” Acosta said. The dermatologist insisted, “The vaccine is an adjuvant treatment, that is, the patient receives the first treatment, which is always surgical, and the vaccine is added for high-risk patients. Melanoma is not diagnosed and the vaccine is given as a monotherapy. The correct method to follow is to diagnose the melanoma, perform the operation, and if the patient meets the (clinical) requirements to be a high-risk patient, the vaccine can be indicated.”
In the campaign carried out by the SAD Association every year, monthly self-examination is promoted to determine whether spots appear on the skin or moles that change in size, shape or colour. Hence, dermatologists recommend applying the following ABCDE rule for consultation if there is any variation from month to month:
A: Analyze whether it is asymmetric
B: Check if its edges are irregular
A: Consider the color if it is diverse and if there are color changes
D: Pay attention to the diameter and consult a dermatologist if it measures 6 mm or more
That is, studying its development: Does it cause itching, bleeding, or does it have crusts?
They stated from SAD that the prognosis of skin cancer will depend on the cell affected, for example, with exposure to sunlight without adequate protection or at the time of UV intensity (between 10 a.m. and 4 p.m.) now that summer has arrived.
“he melanoma It accounts for about 5% of skin cancer cases, and can be very aggressive, spreading to lymph nodes or distant organs. On the other hand, if detected early, a person can survive without experiencing future problems.