the innovative treatment against the most aggressive breast cancer

Yolanda He is clear: “The treatment and all the professionals who have accompanied me in the process “They have saved my life”. In Catalan He was diagnosed in April. from 2023 triple negative breast cancerthe tumor subtype of worse prognosisbut thanks to an innovative therapy Today he is free of the disease.

October is Breast Cancer Awareness Month, with this date present Iolanda tells this newspaper that she put herself in the hands of the Dr. Laia Garrigós from the Barcelona-based International Breast Cancer Center (IBCC), the first hyper-specialized breast cancer center in Spain. He received several sessions of conventional chemotherapy, which was combined with pembrolizumaban immunotherapy little used until now in this type of cancer, but which has just been shown in a clinical trial to considerably increase the life expectancy of these patients.

The subtype of more aggressive breast tumor has come to have very low survival rates –data that has been improving in the last decade thanks to new approaches–, but the treatment that Iolanda has received has achieved that 86% of patients are alive at five yearsAccording to a recent study published in The New England Journal of Medicine. In the case of the Catalan, it summarizes the Dr. Javier Cortés Castán“the possibility of being cured has increased. What we have achieved is that when we operate, the patient has a complete pathological response, that is, the tumor has completely disappeared and there is no risk of disease remaining. “He has had an extraordinary prognosis.”

The international clinical trial KEYNOTE-522, led by Dr. Cortés together with Dr. Peter Schmidhas concluded that add pembrolizumab immunotherapy to chemotherapy increases the chances of healing of patients with localized triple negative breast cancer and, therefore, this should be a new standard of treatment that the majority of these patients should receive.

Photo: Europa Press/David Zorrakino.

Dr. Cortés, who is director of the IBCC and scientific director of the IOB Madrid at the Beata María Ana Hospital, explains that before this study they already knew that the addition of pembrolizumab to chemotherapy improved the prognosis of patients with triple breast cancer. localized negative, better controlling the disease and reducing relapse. but now They know that adding it to chemotherapy translates into more curesdescribes it as “truly novel and important.” In summary, what they say is that more patients are cured if they receive immunotherapy.

This immunotherapy is a monoclonal antibody directed against the PD-1 receptor, which is found on the surface of lymphocytes, and which acts by stimulating the immune system to destroy cancer cells. In 2021, Dr. Cortés led the previous study in patients with metastatic breast cancer, KEYNOTE-355, which was published in The Lancetand for whose positives results the FDA accelerated the combined use to treat the very aggressive subtype of cancer. Since then, he has continued with this line of research, of which the KEYNOTE-522 study is a new example. This clinical trial provides new positive results achieved with combined pembrolizumab versus chemotherapy alone, such as overall survival data, this time in cases of cancer of the localized triple negative breast (stages II and III), therefore, in earlier phases.

A study with more than 1,000 patients

The KEYNOTE-522 study is an international phase III, double-blind, randomized clinical trial. placebo controlled; Therefore, it has a very robust design. They have participated in it 181 centers (in addition to two satellite centers) from 21 countries in Europe, North America, Asia and Latin America. And they have had a total of 1,174 patients with triple negative breast cancer of stages II or III, not previously treated.

The thousand patients were randomized: 784 patients received pembrolizumab with neoadjuvant chemotherapy (that is, before surgery) and 390 patients, the control group, received placebo with neoadjuvant chemotherapy. After surgery to remove the tumor, patients received adjuvant pembrolizumab or placebo. After a follow-up of the patients for 75.1 months (more than 6 years), a significant improvement in overall survival was observed in the first group. At 5 years, in sum there is 5% more women alive, survival free of clinical events is 9% more and the time patients lived disease-free increased by more than a month. Regarding safety, the adverse effects observed were consistent with safety profiles that had been seen before for pembrolizumab and chemotherapy.

Photo: EFE/Sáshenka Gutiérrez.

For Dr. Cortés these figures are very important: “Increasing the patients’ chances of cure by 5% means that, for every 100 patients treated with immunotherapy, There are five more patients who are going to be cured when they didn’t before. This is data that is very difficult to obtain. To give an example: There are times that chemotherapy only achieves a benefit of 2-3% more. Therefore, 5% more patients surviving at 5 years is very significant data and, furthermore, rarely seen in terms of cures in the world of oncology. We are saying that today around 80% of these patients are cured.”

For all this, consider that “From now on they should give it to all patients who are in stages II and III of triple negative breast cancer” and that this study “reaffirms the importance of immunotherapy.” Likewise, the oncologist highlights that “it is essential not to operate on patients with triple negative breast cancer at the outset; they must be visited by medical oncologists.” In this sense, he emphasizes that “in addition to being seen by surgeons or gynecologists, they should also be seen by doctors before treatment. And we must also emphasize the importance of the second opinion.”

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As for the study he leads, it has not yet come to an end, KEYNOTE-522 continues to search for biomarkers, which patients benefit the most and which patients benefit the least, although the most important goal is overall survival has already been achieved. “However, research in triple negative breast cancer “continues and is currently moving in the direction of further optimizing these results, with the goal that no patient dies from this disease,” concludes Dr. Cortés.

Yolanda He is clear: “The treatment and all the professionals who have accompanied me in the process “They have saved my life”. In Catalan He was diagnosed in April. from 2023 triple negative breast cancerthe tumor subtype of worse prognosisbut thanks to an innovative therapy Today he is free of the disease.