Posted: Thursday, May 18, 2023
Treatment with darolutamide may offer long-term clinical benefit for some patients with nonmetastatic castration-resistant prostate cancer, according to an update from the ARAMIS Rollover study, which were presented at the American Urological Association (AUA) Annual Meeting 2023 (Abstract MP11-14) and published in The Journal of Urology. In fact, about 30% of patients remained on the androgen receptor inhibitor for at least 4 years, with a favorable safety profile, according to Neal D. Shore, MD, FACS, of Atlantic Urology Clinics, Myrtle Beach, South Carolina, and colleagues.
The original ARAMIS double-blind study enrolled 954 patients with castration-resistant prostate carcinoma to receive oral darolutamide twice daily. Of these patients, 591 continued in the next phase, open-label trial. The current ARAMIS Rollover study enrolled 294 of these participants. All patients demonstrated evidence of clinical benefit from treatment and no evidence of metastases.
The most current study findings revealed a median duration of darolutamide treatment of 2.8 years. In addition, treatment-related adverse effects were cumulative throughout the duration of the trial, although most adverse events were found to have occurred in the first 2 years of treatment. A total of 91.5% of patients experienced treatment-related adverse effects of any grade, 35.5% experienced grade 3 or 4 adverse events, and 38.5% experienced serious adverse effects. Furthermore, 12.9% of patients required treatment discontinuation because of the severity of adverse effects. The most commonly reported treatment-emergent adverse events in the double-blind plus open-label and rollover study period were fatigue, hypertension, fracture, and cardiac arrhythmia. Increases in the incidences of treatment-emergent adverse events commonly associated with androgen receptor inhibition across the double-blind, double-blind plus open-label, and double-blind plus open-label and rollover study periods were mostly minimal, according to the study investigators.
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