2023-11-13 06:00:00
He ESMO medical congress 2023held in the city of Madrid, has highlighted new data on the progress in the prostate cancer treatment thanks to the results obtained in a clinical trial. Specifically, the conclave of European oncologists witnessed the presentation of the conclusions of the Phase 3 of the EMBARK trialwhich highlight the usefulness of a medication in improving the quality of life of patients, because prevents the development of metastases. Miguel Ramirezone of the authors of the study and clinical head at the Valencian Institute of Oncology (IVO), has described this improvement in the survival of patients who receive the drug after undergoing surgery or radiotherapy as “a milestone”.
The ‘key’ to the results, published in the scientific journal The New England Journal of Medicineis in the early administration of the drug enzalutamide for those patients who, after surgery or radiotherapy, are in biochemical progression or whose prostate-specific antigen (PSA) level is rising. In those cases, as Ramírez explains to Medical Writingthe risk of the disease progressing to the stage of suffering metastasis decreases by approximately 60 percent. “It will mean that an intensified treatment in nine months will then allow the patient to be long period without medication. This is very important, as it will improve your quality of life and your toxicity level. And, why not say it, there will also be a savings for the Administration itself“, details the uro-oncologist.
On the other hand, Ramírez adds that Phase 3 of the EMBARK trial has confirmed that the drug reduces the risk of mortality by up to 40 percent in the patients included in the study: “The benefit is triple, since the risk of develop a biochemical progression in more than 93 percent, in 60 percent of suffering metastasisand between 35 and 40 percent the risk of mortality,” he pointed out.
All these achievements are achieved thanks to “early use” of the medication in patients whose SPA rises exponentially after the treatment. The rise in prostate-specific antigen is linked to a further metastatic progression, according to Ramírez. Furthermore, the specialist emphasizes that the EMBARK clinical trial interrupts the Natural history of disease. “To the 60 months, Among the subgroup of patients who received enzalutamide, disease progression occurred in very few cases. This represents peace of mind for both health professionals and the patient themselves, since the fact that the SPA remains at undetectable figures represents a benefit in oncological terms and quality of life,” explains the uro-oncologist.
Clinical trial with a thousand patients
The study presented in the ESMO 2023 medical congress It was carried out from January 2015 to August 2019, and its first analysis was carried out at the beginning of this year. They have participated in the trial thousand cancer patients who had undergone surgery or radiotherapy, but in whom the disease progressed. Until the results of the study, which have reflected the “success” of EMBARK, clinical professionals did not have a Standard of treatment for patients in buiochemical progressionaccording to Ramírez.
The co-author of the study points out that during the analysis of the results, “no toxicity that was not foreseen” was observed. However, he emphasizes that the administration of the drug can generate side effects linked to lack of testosterone such as, for example, fatigue. “But in general terms it is a grade one toxicity, that is, mild. “It can be controlled and treated diligently,” she assures.
The drug is available for patients with metastatic prostate cancer. In all Europe, Asia, North America and Latin America The indication of enzalutamide is approved in late stage of the illness. But its use in early stages, a scenario evaluated in the EMBARK trial, is being evaluated by the relevant regulatory agencies. “This new indication of the drug for patients who have not yet developed metastasis but who are undoubtedly at risk of suffering from it is being evaluated right now by the American and European medicine agencies. Once we have his approval, the Ministry of Health will have to evaluate it and negotiate the price and its inclusion in the Spanish health system network,” says Ramírez.
It is, as the uro-oncologist predicts, a process that will probably receive the approval of regulatory agencies. “The study has very solid results and the molecule has demonstrated its benefit in all clinical scenarios of prostate cancer. Although the data are immature to speak of the improvement of overall survivalthe early use of enzalutamide will significantly and relevantly reduce the risk of patients not only developing metastasis, but also dying,” he ditches.
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