Winston Tan, MD
All 3 FDA-approved second-generation androgen receptor (AR) inhibitors—apalutamide (Erleada), enzalutamide (Xtandi), and darolutamide (Nubeqa)—have shown an improvement in metastasis-free survival (MFS) in patients with high-risk nonmetastatic castration-resistant prostate cancer (CRPC), said Winston Tan, MD.
"We no longer wait for patients to have metastatic disease before we start treating them," said Tan. "We now have 3 drugs, which have shown that we can prevent metastasis in patients with high-risk disease. When you prevent metastasis, you improve survival."
The approvals of apalutamide, enzalutamide, and darolutamide were based on data from the phase III SPARTAN,1
and ARAMIS trials,3
in which each of the AR inhibitors were added to androgen deprivation therapy (ADT) in this patient population. In SPARTAN, results showed a median MFS of 40.5 months with apalutamide (HR, 0.28; 95% CI, 0.23-0.35; P
<.0001), and the median MFS was 36.6 months with enzalutamide in PROSPER (HR, 0.29; 95% CI, 0.24-0.35; P
<.0001). In the ARAMIS trial of darolutamide, the median MFS was 40.4 months (HR, 0.41; 95% CI, 0.34-0.50; P
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