My take here is: patients receiving darolutamide and ADT had a 46% reduction in the risk of disease progression or death compared to those on ADT alone (hazard ratio [HR] 0.54). Secondary endpoints also favored the darolutamide group, including delays in the time to castration-resistant prostate cancer (HR 0.40) and time to PSA progression (HR 0.31). Impressively, 62.6% of patients in the darolutamide group achieved undetectable PSA levels, versus 18.5% in the placebo group.
Safety profiles between the two groups were comparable, with a slightly lower discontinuation rate due to adverse events in the darolutamide group (6.1% vs. 9.0%). Common side effects associated with androgen receptor inhibitors were similar or less frequent in the darolutamide group, with fatigue reported less often.
Some numbers:
- at 24 months, 70.2 % was the probability of patients using daro +adt to be still radiologically progression free, compared to 52% of placebo arm
- at 36 months the median of castrate resistant patients in daro + adt arm was still not reached (far from being reached) compared to 16.8 months of the placebo + adt arm
- PSA < 0.2 ng/mL at any time during treatment occurred in 62.6% of daro +adt patients compared to 18.5% for placebo +adt
Abiraterone Acetate Plus Prednisone in Newly Diagnosed High-Risk Metastatic Castration-Sensitive Prostate Cancer: Final OS Results
