Prostate cancer: with innovative drugs, treatment becomes personalised

Prostate cancer is the most frequent cancer among men in Italy, with over 40,000 new diagnoses each year. The 5-year survival rate is very high, reaching 91%. But, for patients presenting with the hormone-sensitive metastatic form, this percentage is much lower and does not exceed 30%. Hence the importance of having innovative therapies that guarantee efficacy and quality of life, including darolutamide, a new-generation oral androgen receptor inhibitor, for which the Italian Drug Agency has approved reimbursability, in combination with androgen deprivation therapy, for the treatment of patients with metastatic hormone-sensitive prostate cancer. Thanks to this approval, disease management is becoming increasingly personalised.

Aifa had already approved the reimbursability of darolutamide in March 2024 - it was recalled at a virtual press conference promoted by Bayer - plus androgen deprivation therapy in combination with docetaxel chemotherapy, precisely for the treatment of patients with metastatic hormone-sensitive prostate cancer.

"Aifa's new approval extends the use of darolutamide to a broader group of patients," explains Luigi Formisano, member of the Aiom (Italian Medical Oncology Association) National Board and professor of medical oncology at the University of Naples Federico II. In fact, thanks to the new indication, darolutamide is the only androgen receptor inhibitor approved by Aifa that makes it possible to customise treatment, with or without chemotherapy, to meet the needs of each patient and improve clinical outcomes. The combination of darolutamide with androgen deprivation therapy alone prolongs disease progression-free survival and preserves quality of life, which are very important aspects for patients with metastatic malignancy'.

"The majority of men with metastatic hormone-sensitive prostate cancer progress to the metastatic castration-resistant disease stage, a condition characterised by limited long-term survival," says Elisa Zanardi, secretary of Aiom guidelines on prostate cancer and medical oncologist at Irccs Ospedale Policlinico San Martino in Genoa. "Hence the importance of having more treatment options available, capable of slowing tumour progression. In the Aranote study published in the 'Journal of Clinical Oncology', darolutamide, combined with androgen deprivation therapy alone, significantly reduced the risk of radiological progression or death by 46%'.

'Its high tolerability derives from its peculiar chemical structure, which is able to inhibit the growth of tumour cells, limiting side effects that may impact daily life,' Zanardi continues. 'In the Aranote study, fewer patients treated with darolutamide had to discontinue treatment due to adverse events compared to placebo. It also showed a delay in pain progression and a clinically significant slowdown in the deterioration of important health-related quality of life outcomes. In order to highlight the need to integrate the views of people affected by the disease on treatment decisions, the Aiom Foundation recently promoted a project on quality of life in prostate cancer, which resulted in a document signed by a panel of experts'.