ASCO 2019: Adding Apalutamide to Androgen-Deprivation Therapy in Prostate Cancer
Posted: Friday, June 21, 2019
For patients with metastatic castration-sensitive prostate cancer, the addition of apalutamide to androgen-deprivation therapy (ADT) may significantly improve radiographic progression-free and overall survival, according to the first results of the TITAN clinical trial presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 5006). Patients with high- and low-volume disease prior docetaxel also reaped benefits from apalutamide, which had a tolerable safety profile, concluded Kim N. Chi, PhD, FRCPC, of BC Cancer, Vancouver, and colleagues.
“These results support the addition of [apalutamide] to ADT for [prior treatment] of [patients] with [metastatic castration-sensitive prostate cancer],” the authors observed.
For the randomized, double-blind phase III study (ClinicialTrials.gov identifier NCT02489318), patients with metastatic castration-sensitive prostate cancer received 240 mg/d of apalutamide (525 patients) or placebo (527 patients) in addition to ADT in 28-day cycles. Of the patients, 8% had prior treatment for localized disease, 11% had prior docetaxel for prostate cancer, and 63% and 37% displayed high- or low-volume disease, respectively.
After a median follow-up of 22.6 months, patients treated with apalutamide had significantly improved radiographic progression-free survival, with a 52% reduction in risk of death or radiographic disease progression. Apalutamide also improved overall survival, with a 33% reduction in risk of death; in addition, the time to initiation of cytotoxic chemotherapy was significantly improved with apalutamide as well (hazard ratio = 0.39).
Based on the results, the independent data monitoring committee recommended unblinding to allow crossover of patients treated with placebo to receive apalutamide. In both apalutamide and placebo cohorts, the rates of grade 3 or 4 adverse events were similar at 42% and 41%, respectively. The treatment discontinuation rate due to adverse events was low for both populations (8% vs. 5%, respectively).
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.