Few side effects and increased survival. Positive toll for men with non-metastatic castration resistant prostate cancer (nmCRPC) at high risk of metastasis who received darolutamide for a long time, on average 25.8 months. The data demonstrating this will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held in virtual form from 4 to 8 June 2021.
“There are many approved therapies that lead to increased overall survival in patients with nmCRPC, typically asymptomatic. However, there are differences in adverse event profiles, which include, for example, fatigue, falls, fractures, rash, mental and cognitive impairment and hypertension. ; such adverse events can limit daily activities and patients’ willingness to continue therapy, negatively impacting the efficacy and outcomes of treatment, “says Karim Fizazi, MD, Ph.D., Professor of Medicine at Institut Gustave Roussy, Villejuif, France. “These data highlight the good tolerability of darolutamide over a prolonged period of treatment, with the majority of patients with nmCRPC able to receive the recommended dose, increasing the likelihood of extending overall survival and metastasis-free survival, compared to alone androgen deprivation therapy, and allowing them to maintain an active life. “
“Patients with prostate cancer are on average elderly and suffering from numerous comorbidities. A fragile population, where an adverse event can significantly compromise everyday life and where, therefore, quantity and quality of life must be combined whenever possible “, says Sergio Bracarda, Director of the Oncology Department and of the SC of Medical and Translational Oncology of the ‘Santa Maria di Terni Hospital.
Prostate cancer is the second most frequently diagnosed type of cancer in men and is the fifth leading cause of cancer-related death worldwide. Prostate cancer is defined as nmCRPC without evidence of metastasis on conventional imaging but no longer responds to androgen deprivation therapy. Patients with nmCRPC are normally active and have no symptoms, but may be at high risk of developing metastatic disease, with approximately one-third of patients with nmCRPC developing metastases within two years.
Men with nmCRPC who experience adverse events from treatment may need dose adjustments or discontinuation of therapy to better manage the impact of side effects on daily life. Additional data from the extended follow-up analysis shows that almost all patients receiving darolutamide, after a dose reduction, are able to resume the planned dose (89.6%), with a comparable frequency to those receiving placebo (89.7%). Discontinuation of darolutamide for AEs increased slightly: from 9% in the primary analysis of the ARAMIS study to 10.5% in the extended follow-up analysis. These data demonstrate that, in addition to the proven efficacy results, with extended follow-up, the safety and tolerability profile of darolutamide remains favorable at the full recommended dose, allowing patients with nmCRPC to continue their active lives.
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