Long-Terms Results With Apalutamide Plus ADT in Metastatic Prostate Cancer
Posted: Monday, June 21, 2021
The final analysis of the double-blind, phase III TITAN study presented in the Journal of Clinical Oncology found that a combination treatment of the androgen signaling inhibitor apalutamide plus androgen-deprivation therapy (ADT) resulted in improved outcomes for patients with metastatic castration-sensitive prostate cancer. Neeraj Agarwal, MD, of the Huntsman Cancer Institute, Salt Lake City, and colleagues found these results to be consistent despite a nearly 40% crossover rate from placebo to apalutamide treatment following the study’s unblinding.
The TITAN study included 1,052 patients with metastatic castration-sensitive prostate cancer who were randomly assigned to receive ADT plus either 240 mg of daily apalutamide (n = 525) or placebo (n = 527). A first interim analysis revealed significantly superior overall survival and radiographic progression-free survival among patients receiving apalutamide, prompting the study to be unblinded, so patients receiving placebo could cross over. At a median follow-up of 44 months, 208 patients (39.5%) had moved from the placebo group to the apalutamide group. A total of 257 and 358 patients in the apalutamide and placebo groups, respectively, discontinued treatment, mostly due to disease progression.
The median treatment duration was 39.3 months with apalutamide, 20.2 months with placebo group, and 15.4 months in the crossover group. Risk of death was 35% lower for patients receiving apalutamide than for those receiving placebo (median overall survival not reached vs. 52.2 months; P < .0001) and 48% lower following an adjustment to account for crossover (P < .0001). Both second progression-free survival and castration resistance were delayed in the apalutamide group (P < .0001 for each). Patients receiving apalutamide as well as those receiving placebo reported maintaining their health-related quality of life throughout the study.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.