Dr. Celestia Higano, MD of the University of Washington discusses the Titan Trial Apalutamide vs Placebo During Androgen-Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer.
At 22.6-month follow-up, 66% of patients in the apalutamide group and 46% of patients in the placebo group remained on treatment.
Apalutamide improved radiographic progression-free survival (hazard ratio [HR] = 0.48, 95% confidence interval [CI] = 0.390.60; P < .0001), with a 52% reduction in risk of death or radiographic progression; that benefit was observed across all subgroups analyzed. The median radiographic progression-free survival was not reached in the apalutamide group and was 22.1 months in the placebo group.
Apalutamide also improved overall survival (HR = 0.67, 95% CI = 0.510.89; P = .0053), with a 33% reduction in risk of death. Median overall survival was not reached in the apalutamide or placebo groups. In addition, time to initiation of cytotoxic chemotherapy was significantly improved with apalutamide (HR = 0.39, 95% CI = 0.270.56; P < .0001). Based on these results, the independent data monitoring committee recommended unblinding to allow crossover of patients receiving placebo to receive apalutamide.
Rates of grade 3/4 adverse events were similar42% in the apalutamide group and 41% in the placebo group. Treatment discontinuation due to adverse events was also low8% in the apalutamide group and 5% in the placebo group.
The investigators concluded, In the TITAN study in patients with metastatic castration-sensitive prostate cancer, including patients with high- and low-volume disease and prior docetaxel, addition of apalutamide to ADT significantly improved [radiographic progression-free survival] and [overall survival], and the safety profile was tolerable. These results support the addition of apalutamide to ADT for [the] treatment of patients with metastatic castration-sensitive prostate cancer.