Background and importance Apalutamide, enzalutamide and darolutamide have recently been approved for treating castration resistant non-metastatic prostate cancer (nmCRPC). The three drugs demonstrated efficacy over placebo in clinical trials, but the lack of direct comparisons, particularly with regard to safety, makes the selection and positioning of these drugs in this new scenario difficult.
Aim and objectives The aim of this study was to compare the relative safety of darolutamide versus apalutamide and enzalutamide using clinical trial data to determine the positioning and objective differences in security profiles of new antiandrogenic drugs in the treatment of nmCRPC.
Material and methods We performed adjusted indirect comparisons using Bucher´s method. We used security data from the main clinical trials for each drug (ARAMIS, PROSPER and SPARTAN trials). The three studies had a similar design and included populations with similar characteristics. We calculated risk differences and number needed to harm (NNH) for each relevant outcome and selected those with statistically significant difference.
No statistically significant difference was found using Bucher´s method for any outcome so the NNH was not calculated.
Conclusion and relevance There were no differences in the safety profiles of the drugs evaluated, although the number of patients for some variables was small. According to preclinical studies, darolutamide does not cross the blood–brain barrier. This could explain the similar incidence of AE in the darolutamide and placebo groups in the ARAMIS trial. Data on larger patient samples are needed to determine differences.
Conflict of interest No conflict of interest
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