Written on October 24, 2023.
The results of international research conducted on 1,068 patients were presented at the recent ESMO European congress in Madrid. In Italy it was coordinated by the Romagna Institute for the Study of Tumors ‘Dino Amadori’ of Meldola (FC). The Dr. Ugo De Giorgi: “More effective treatment that protects sexual functions and allows a good quality of life”
Patients affected by prostate cancer recurrence can increasingly benefit from the benefits of the anti-androgen drug enzalutamide. In fact, this new therapy proves to be more effective, does not deteriorate the patient’s quality of life and, above all, does not compromise sexual functions, avoiding the use of pharmacological castration which represents one of the standard treatments currently used. The results, demonstrated by the international EMBARK study, were published this month in the most prestigious clinical-scientific journal in the world, The New England Journal of Medicine, and presented at the Congress of the European Society for Medical Oncology (ESMO) which is taking place these days in Madrid.
“In almost 40% of cases, prostate cancer tends to recur even after 10 years – points out Ugo De GiorgiDirector of Clinical and Experimental Oncology in Innovative and High Dose Therapies of the IRCCS Romagna Institute for the Study of Tumors ‘Dino Amadori’ IRST of Meldola, the only Italian among the signatories of the work -. Hence the need for innovative drugs to be administered over a long period of time to patients who are often no longer very young. Enzalutamide is an androgen receptor inhibitor and works by blocking the activity of testosterone. It can limit the use of pharmacological castration which, although effective, causes side effects with important consequences especially in the sexual sphere”.
The EMBARK project involved a total of 1,068 men affected by prostate cancer at risk of recurrence, being treated at 244 different centers in 17 countries. In Italy it saw the IRST ‘Dino Amadori’ IRCCS at the forefront, involved in the study committee, in the enrollment of patients in our country and in the coordination of scientific activities.
The study fits and enriches the wide range of IRST therapeutic offers for patients suffering from prostate cancer, in all its stages: from radiotherapy to hormonal therapy to advanced treatments with radiometabolic drugs. The use of the enzalutamide approach would add to the benefit of patients who have a high risk of relapse.
Study participants were divided into three groups: 355 patients were treated with enzalutamide in addition to a therapy that inhibits testosterone production (androgen deprivation with leuprolide), 358 with placebo plus androgen deprivation therapy and 355 with enzalutamide alone. “The new data, presented at the Madrid congress, are based on patient-reported outcomes (PRO) and highlight that with the sole administration of the drug enzalutamide the majority of patients managed to maintain their sexual function and, therefore, libido and libido unchanged. ‘erection – adds De Giorgi -. Furthermore, the treatment does not compromise the overall quality of life and limits frequent symptoms such as tiredness, weakness or urinary disorders. The drug allows long-term benefits as it delays or reduces the appearance of metastases at five years by 80%, when used individually, and by 87% in combination with leuprolide. Finally, it slows down the time to progression of PSA (Prostate Specific Antigen) protein values as has never happened before in these patients”.
“The new study opens up extremely interesting perspectives in combating the most frequent tumor in the male population of Western countries – he adds Giovanni MartinelliScientific Director of the IRST ‘Dino Amadori’ IRCCS -. In Italy alone, more than 40,500 new cases are recorded every year for a total of 564 thousand men living with this oncological disease. The men involved in the international research had an early, non-metastatic neoplasm, sensitive to the presence of hormones and had already undergone surgical or radiotherapy treatments. Scientific research is focusing on this subgroup of patients, which must increasingly find new treatments that are increasingly less invasive for patients”.